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Review
. 2023 Jul 20;7(7):CD004065.
doi: 10.1002/14651858.CD004065.pub4.

Medical treatment of eosinophilic esophagitis

James P Franciosi #  1   2 , Morris Gordon #  3 , Vassiliki Sinopoulou  3 , Evan S Dellon  4 , Sandeep K Gupta  5 , Craig C Reed  4 , Carolina Gutiérrez-Junquera  6 , Rajitha D Venkatesh  7 , Elizabeth A Erwin  8 , Abdullah Egiz  3 , Assem Elleithy  3 , Edward B Mougey  9
Affiliations
Review

Medical treatment of eosinophilic esophagitis

James P Franciosi et al. Cochrane Database Syst Rev. .

Abstract

Background: Eosinophilic esophagitis (EoE) is a chronic antigen-mediated eosinophilic inflammatory disease isolated to the esophagus. As a clinicopathologic disorder, a diagnosis of EoE requires a constellation of clinical symptoms of esophageal dysfunction and histologic findings (at least 15 eosinophils/high-powered microscope field (eos/hpf)). Current guidelines no longer require the failure of response to proton pump inhibitor medications to establish a diagnosis of EoE, but continue to suggest the exclusion of other etiologies of esophageal eosinophilia. The treatment goals for EoE are improvement in clinical symptoms, resolution of esophageal eosinophilia and other histologic abnormalities, endoscopic improvement, improved quality of life, improved esophageal function, minimized adverse effects of treatment, and prevention of disease progression and subsequent complications. Currently, there is no cure for EoE, making long-term treatment necessary. Standard treatment modalities include dietary modifications, esophageal dilation, and pharmacologic therapy. Effective pharmacologic therapies include corticosteroids, rapidly emerging biological therapies, and proton pump inhibitor medications.

Objectives: To evaluate the efficacy and safety of medical interventions for people with eosinophilic esophagitis.

Search methods: We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and WHO ICTRP to 3 March 2023.

Selection criteria: Randomized controlled trials (RCTs) comparing any medical intervention or food elimination diet for the treatment of eosinophilic esophagitis, either alone or in combination, to any other intervention (including placebo).

Data collection and analysis: Pairs of review authors independently selected studies and conducted data extraction and risk of bias assessment. We expressed outcomes as a risk ratio (RR) and as the mean or standardized mean difference (MD/SMD) with 95% confidence interval (CI). We assessed the certainty of the evidence using GRADE. Our primary outcomes were: clinical, histological, and endoscopic improvement, and withdrawals due to adverse events. Secondary outcomes were: serious and total adverse events, and quality of life.

Main results: We included 41 RCTs with 3253 participants. Eleven studies included pediatric patients while the rest recruited both children and adults. Four studies were in patients with inactive disease while the rest were in patients with active disease. We identified 19 intervention comparisons. In this abstract we present the results of the primary outcomes for the two main comparisons: corticosteroids versus placebo and biologics versus placebo, based on the prespecified outcomes defined of the primary studies. Fourteen studies compared corticosteroids to placebo for induction of remission and the risk of bias for these studies was mostly low. Corticosteroids may lead to slightly better clinical improvement (20% higher), measured dichotomously (risk ratio (RR) 1.74, 95% CI 1.08 to 2.80; 6 studies, 583 participants; number needed to treat for an additional beneficial outcome (NNTB) = 4; low certainty), and may lead to slightly better clinical improvement, measured continuously (standard mean difference (SMD) 0.51, 95% CI 0.17 to 0.85; 5 studies, 475 participants; low certainty). Corticosteroids lead to a large histological improvement (63% higher), measured dichotomously (RR 11.94, 95% CI 6.56 to 21.75; 12 studies, 978 participants; NNTB = 3; high certainty), and may lead to histological improvement, measured continuously (SMD 1.42, 95% CI 1.02 to 1.82; 5 studies, 449 participants; low certainty). Corticosteroids may lead to little to no endoscopic improvement, measured dichotomously (RR 2.60, 95% CI 0.82 to 8.19; 5 studies, 596 participants; low certainty), and may lead to endoscopic improvement, measured continuously (SMD 1.33, 95% CI 0.59 to 2.08; 5 studies, 596 participants; low certainty). Corticosteroids may lead to slightly fewer withdrawals due to adverse events (RR 0.64, 95% CI 0.43 to 0.96; 14 studies, 1032 participants; low certainty). Nine studies compared biologics to placebo for induction of remission. Biologics may result in little to no difference in clinical improvement, measured dichotomously (RR 1.14, 95% CI 0.85 to 1.52; 5 studies, 410 participants; low certainty), and may result in better clinical improvement, measured continuously (SMD 0.50, 95% CI 0.22 to 0.78; 7 studies, 387 participants; moderate certainty). Biologics result in better histological improvement (55% higher), measured dichotomously (RR 6.73, 95% CI 2.58 to 17.52; 8 studies, 925 participants; NNTB = 2; moderate certainty). We could not draw conclusions for this outcome when measured continuously (SMD 1.01, 95% CI 0.36 to 1.66; 6 studies, 370 participants; very low certainty). Biologics may result in little to no difference in endoscopic improvement, measured dichotomously (effect not estimable, low certainty). We cannot draw conclusions for this outcome when measured continuously (SMD 2.79, 95% CI 0.36 to 5.22; 1 study, 11 participants; very low certainty). There may be no difference in withdrawals due to adverse events (RR 1.55, 95% CI 0.88 to 2.74; 8 studies, 792 participants; low certainty).

Authors' conclusions: Corticosteroids (as compared to placebo) may lead to clinical symptom improvement when reported both as dichotomous and continuous outcomes, from the primary study definitions. Corticosteroids lead to a large increase in histological improvement (dichotomous outcome) and may increase histological improvement (continuous outcome) when compared to placebo. Corticosteroids may or may not increase endoscopic improvement (depending on whether the outcome is measured dichotomously or continuously). Withdrawals due to adverse events (dichotomous outcome) may occur less frequently when corticosteroids are compared to placebo. Biologics (as compared to placebo) may not lead to clinical symptom improvement when reported as a dichotomous outcome and may lead to an increase in clinical symptom improvement (as a continuous outcome), from the primary study definitions. Biologics lead to a large increase in histological improvement when reported as a dichotomous outcome, but this is uncertain when reported as a continuous outcome, as compared to placebo. Biologics may not increase endoscopic improvement (dichotomous outcome), but this is uncertain when measured as a continuous outcome. Withdrawals due to adverse events as a dichotomous outcome may occur as frequently when biologics are compared to placebo.

PubMed Disclaimer

Conflict of interest statement

JPF: nothing to declare.

MG: Morris Gordon is a Cochrane editor. He was not involved in the editorial process for this review.

VS: nothing to declare.

ESD: Research funding: Adare/Ellodi, Allakos, Arena, AstraZeneca, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, Shire/Takeda. Consultant: Abbott, Abbvie, Adare/Ellodi, Aimmune, Akesobio, Alfasigma, ALK, Allakos, Amgen, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, Eupraxia, Ferring, GSK, Gossamer Bio, Holoclara, Invea, Landos, LucidDx, Morphic, Nexstone Immunology, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, Shire/Takeda, Target RWE, Upstream Bio. Educational grant: Allakos, Holoclara, Invea.

He is one of the authors of 13 of the included studies in this review (Dellon 2012; Dellon 2017; Dellon 2019; Dellon 2022; Dellon 2021b; Dellon 2022a; Dellon 2022b; Hirano 2020; Kliewer 2019; Hirano 2019; Kliewer 2021; Rothenberg 2022; Hirano 2021). These studies were screened, extracted for data, and assessed for risk of bias independently by EBM, VS, CGJ, CR, RDV, EAE, AbE, and AsE.

SKG: Consultant/DSMB member/Author – Adare, BMS, QOL, Takeda, MedScape, PVI, ViaSkin, UpToDate; Research support ‐ Allakos, Ellodi, AstraZeneca. He is one of the authors of seven of the included studies in this review (Assa'ad 2011; Dellon 2017; Gupta 2015; Hirano 2019; Kliewer 2021; Oliva 2018; Schaefer 2008). These studies were screened, extracted for data, and assessed for risk of bias independently by EBM, VS, CGJ, CR, RDV, EAE, AbE, and AsE.

CR: nothing to declare.

CGJ: Research funding: Dr. Falk Pharma GmbH.

RDV: nothing to declare.

EAE: nothing to declare.

AbE: nothing to declare.

AsE: nothing to declare.

EBM: nothing to declare.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgments about each risk of bias item for each included study.
3
3
1.1
1.1. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 1: Clinical improvement at study endpoint (dichotomous)
1.2
1.2. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 2: Clinical improvement at study endpoint (dichotomous), sensitivity analysis, fixed‐effect
1.3
1.3. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 3: Clinical improvement at study endpoint (dichotomous), sensitivity analysis, validated instruments
1.4
1.4. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 4: Clinical improvement at study endpoint (dichotomous), subgrouped by age
1.5
1.5. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 5: Clinical improvement at study endpoint (dichotomous), subgrouped by type of steroid
1.6
1.6. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 6: Clinical improvement at study endpoint (dichotomous), subgrouped by delivery method
1.7
1.7. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 7: Clinical improvement at study endpoint (continuous)
1.8
1.8. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 8: Clinical improvement at study endpoint (continuous), sensitivity analysis, fixed‐effect
1.9
1.9. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 9: Clinical improvement at study endpoint (continuous), sensitivity analysis, validated instruments
1.10
1.10. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 10: Clinical improvement at study endpoint (continuous), subgrouped by age
1.11
1.11. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 11: Clinical improvement at study endpoint (continuous), subgrouped by type of steroid
1.12
1.12. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 12: Clinical improvement at study endpoint (continuous), subgrouped by delivery method
1.13
1.13. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 13: Histological improvement at study endpoint (dichotomous)
1.14
1.14. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 14: Histological improvement at study endpoint (dichotomous), sensitivity analysis, fixed‐effect
1.15
1.15. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 15: Histological improvement at study endpoint (dichotomous), sensitivity analysis, threshold < 15 eos/hpf
1.16
1.16. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 16: Histological improvement at study endpoint (dichotomous), sensitivity analysis, threshold ≤ 6 eos/hpf
1.17
1.17. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 17: Histological improvement at study endpoint (dichotomous), sensitivity analysis, threshold ≤ 1 eos/hpf
1.18
1.18. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 18: Histological improvement at study endpoint (dichotomous), subgrouped by age
1.19
1.19. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 19: Histological improvement at study endpoint (dichotomous), subgrouped by type of steroid
1.20
1.20. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 20: Histological improvement at study endpoint (dichotomous), subgrouped by delivery method
1.21
1.21. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 21: Histological improvement at study endpoint (continuous)
1.22
1.22. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 22: Histological improvement at study endpoint (continuous), sensitivity analysis, fixed‐effect
1.23
1.23. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 23: Histological improvement at study endpoint (continuous), subgrouped by age
1.24
1.24. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 24: Histological improvement at study endpoint (continuous), subgrouped by type of steroid
1.25
1.25. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 25: Histological improvement at study endpoint (continuous), subgrouped by delivery method
1.26
1.26. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 26: Endoscopic improvement at study endpoint (dichotomous)
1.27
1.27. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 27: Endoscopic improvement at study endpoint (dichotomous), sensitivity analysis, fixed‐effect
1.28
1.28. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 28: Endoscopic improvement at study endpoint (dichotomous), sensitivity analysis, validated instruments
1.29
1.29. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 29: Endoscopic improvement at study endpoint (dichotomous), subgrouped by age
1.30
1.30. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 30: Endoscopic improvement at study endpoint (dichotomous), subgrouped by delivery method
1.31
1.31. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 31: Endoscopic improvement at study endpoint (continuous)
1.32
1.32. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 32: Endoscopic improvement at study endpoint (continuous), sensitivity analysis, fixed‐effect
1.33
1.33. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 33: Endoscopic improvement at study endpoint (continuous), sensitivity analysis, validated instruments
1.34
1.34. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 34: Endoscopic improvement at study endpoint (continuous), subgrouped by age
1.35
1.35. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 35: Endoscopic improvement at study endpoint (continuous), subgrouped by type of steroid
1.36
1.36. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 36: Withdrawals due to adverse events
1.37
1.37. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 37: Withdrawals due to adverse events, sensitivity analysis, fixed‐effect
1.38
1.38. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 38: Withdrawals due to adverse events, subgrouped by age
1.39
1.39. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 39: Withdrawals due to adverse events, subgrouped by type of steroid
1.40
1.40. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 40: Withdrawals due to adverse events, subgrouped by delivery method
1.41
1.41. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 41: Serious adverse events
1.42
1.42. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 42: Total adverse events
1.43
1.43. Analysis
Comparison 1: Corticosteroids vs placebo for induction of remission, Outcome 43: Quality of life at study endpoint (continuous)
2.1
2.1. Analysis
Comparison 2: Corticosteroids vs placebo for maintenance of remission, Outcome 1: Clinical improvement at study endpoint (dichotomous)
2.2
2.2. Analysis
Comparison 2: Corticosteroids vs placebo for maintenance of remission, Outcome 2: Clinical improvement at study endpoint (continuous)
2.3
2.3. Analysis
Comparison 2: Corticosteroids vs placebo for maintenance of remission, Outcome 3: Histological improvement at study endpoint (dichotomous)
2.4
2.4. Analysis
Comparison 2: Corticosteroids vs placebo for maintenance of remission, Outcome 4: Histological improvement at study endpoint (continuous)
2.5
2.5. Analysis
Comparison 2: Corticosteroids vs placebo for maintenance of remission, Outcome 5: Endoscopic improvement at study endpoint (continuous)
2.6
2.6. Analysis
Comparison 2: Corticosteroids vs placebo for maintenance of remission, Outcome 6: Withdrawals due to adverse events
2.7
2.7. Analysis
Comparison 2: Corticosteroids vs placebo for maintenance of remission, Outcome 7: Serious adverse events
2.8
2.8. Analysis
Comparison 2: Corticosteroids vs placebo for maintenance of remission, Outcome 8: Total adverse events
2.9
2.9. Analysis
Comparison 2: Corticosteroids vs placebo for maintenance of remission, Outcome 9: Quality of life at study endpoint (continuous)
3.1
3.1. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 1: Clinical improvement at study endpoint (dichotomous)
3.2
3.2. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 2: Clinical improvement at study endpoint (dichotomous), sensitivity analysis, fixed‐effect
3.3
3.3. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 3: Clinical improvement at study endpoint (dichotomous), sensitivity analysis, validated instruments
3.4
3.4. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 4: Clinical improvement at study endpoint (dichotomous), subgrouped by age
3.5
3.5. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 5: Clinical improvement at study endpoint (dichotomous), subgrouped by mechanism
3.6
3.6. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 6: Clinical improvement at study endpoint (continuous)
3.7
3.7. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 7: Clinical improvement at study endpoint (continuous), sensitivity analysis, fixed‐effect
3.8
3.8. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 8: Clinical improvement at study endpoint (continuous), sensitivity analysis, peer‐reviewed manuscripts
3.9
3.9. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 9: Clinical improvement at study endpoint (continuous), sensitivity analysis, less than high risk of bias
3.10
3.10. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 10: Clinical improvement at study endpoint (continuous), sensitivity analysis, validated instruments
3.11
3.11. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 11: Clinical improvement at study endpoint (continuous), subgrouped by mechanism
3.12
3.12. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 12: Histological improvement at study endpoint (dichotomous)
3.13
3.13. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 13: Histological improvement at study endpoint (dichotomous), sensitivity analysis, fixed‐effect
3.14
3.14. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 14: Histological improvement at study endpoint (dichotomous), sensitivity analysis, peer‐reviewed manuscripts
3.15
3.15. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 15: Histological improvement at study endpoint (dichotomous), sensitivity analysis, less than high risk of bias
3.16
3.16. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 16: Histological improvement at study endpoint (dichotomous), sensitivity analysis, threshold < 15 eos/hpf
3.17
3.17. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 17: Histological improvement at study endpoint (dichotomous), sensitivity analysis, threshold ≤ 6 eos/hpf
3.18
3.18. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 18: Histological improvement at study endpoint (dichotomous), sensitivity analysis, threshold ≤ 1 eos/hpf
3.19
3.19. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 19: Histological improvement at study endpoint (dichotomous), subgrouped by age
3.20
3.20. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 20: Histological improvement at study endpoint (dichotomous), subgrouped by mechanism
3.21
3.21. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 21: Histological improvement at study endpoint (continuous)
3.22
3.22. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 22: Histological improvement at study endpoint (continuous), sensitivity analysis, fixed‐effect
3.23
3.23. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 23: Histological improvement at study endpoint (continuous), sensitivity analysis, less than high risk of bias
3.24
3.24. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 24: Histological improvement at study endpoint (continuous), subgrouped by age
3.25
3.25. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 25: Histological improvement at study endpoint (continuous), subgrouped by mechanism
3.26
3.26. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 26: Endoscopic improvement at study endpoint (dichotomous)
3.27
3.27. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 27: Endoscopic improvement at study endpoint (continuous)
3.28
3.28. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 28: Endoscopic improvement at study endpoint (continuous), sensitivity analysis, fixed‐effect
3.29
3.29. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 29: Endoscopic improvement at study endpoint (continuous), sensitivity analysis, less than high risk of bias
3.30
3.30. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 30: Withdrawals due to adverse events
3.31
3.31. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 31: Withdrawals due to adverse events, sensitivity analysis, fixed‐effect
3.32
3.32. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 32: Withdrawals due to adverse events, sensitivity analysis, less than high risk of bias
3.33
3.33. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 33: Withdrawals due to adverse events, sensitivity analysis, peer reviewed manuscripts
3.34
3.34. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 34: Withdrawals due to adverse events, subgrouped by age
3.35
3.35. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 35: Withdrawals due to adverse events, subgrouped by mechanism
3.36
3.36. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 36: Serious adverse events
3.37
3.37. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 37: Total adverse events
3.38
3.38. Analysis
Comparison 3: Biologics vs placebo for induction of remission, Outcome 38: Quality of life at study endpoint (continuous)
4.1
4.1. Analysis
Comparison 4: Cromolyn sodium vs placebo, Outcome 1: Clinical improvement at study endpoint (continuous)
4.2
4.2. Analysis
Comparison 4: Cromolyn sodium vs placebo, Outcome 2: Histological improvement at study endpoint (continuous)
4.3
4.3. Analysis
Comparison 4: Cromolyn sodium vs placebo, Outcome 3: Withdrawals due to adverse events
4.4
4.4. Analysis
Comparison 4: Cromolyn sodium vs placebo, Outcome 4: Serious adverse events
5.1
5.1. Analysis
Comparison 5: PGD2R antagonist OC000459 vs placebo, Outcome 1: Clinical improvement at study endpoint (continuous)
5.2
5.2. Analysis
Comparison 5: PGD2R antagonist OC000459 vs placebo, Outcome 2: Histological improvement at study endpoint (continuous)
5.3
5.3. Analysis
Comparison 5: PGD2R antagonist OC000459 vs placebo, Outcome 3: Endoscopic improvement at study endpoint (continuous)
5.4
5.4. Analysis
Comparison 5: PGD2R antagonist OC000459 vs placebo, Outcome 4: Withdrawals due to adverse events
5.5
5.5. Analysis
Comparison 5: PGD2R antagonist OC000459 vs placebo, Outcome 5: Serious adverse events
6.1
6.1. Analysis
Comparison 6: Swallowed fluticasone vs oral prednisone, Outcome 1: Clinical improvement at study endpoint (dichotomous)
6.2
6.2. Analysis
Comparison 6: Swallowed fluticasone vs oral prednisone, Outcome 2: Histological improvement at study endpoint (dichotomous)
6.3
6.3. Analysis
Comparison 6: Swallowed fluticasone vs oral prednisone, Outcome 3: Histological improvement at study endpoint (continuous)
6.4
6.4. Analysis
Comparison 6: Swallowed fluticasone vs oral prednisone, Outcome 4: Endoscopic improvement at study endpoint (dichotomous)
6.5
6.5. Analysis
Comparison 6: Swallowed fluticasone vs oral prednisone, Outcome 5: Withdrawals due to adverse events
6.6
6.6. Analysis
Comparison 6: Swallowed fluticasone vs oral prednisone, Outcome 6: Serious adverse events
6.7
6.7. Analysis
Comparison 6: Swallowed fluticasone vs oral prednisone, Outcome 7: Total adverse events
7.1
7.1. Analysis
Comparison 7: Oral viscous budesonide vs swallowed fluticasone, Outcome 1: Clinical improvement at study endpoint (continuous)
7.2
7.2. Analysis
Comparison 7: Oral viscous budesonide vs swallowed fluticasone, Outcome 2: Histological improvement at study endpoint (dichotomous)
7.3
7.3. Analysis
Comparison 7: Oral viscous budesonide vs swallowed fluticasone, Outcome 3: Histological improvement at study endpoint (continuous)
7.4
7.4. Analysis
Comparison 7: Oral viscous budesonide vs swallowed fluticasone, Outcome 4: Endoscopic improvement at study endpoint (continuous)
7.5
7.5. Analysis
Comparison 7: Oral viscous budesonide vs swallowed fluticasone, Outcome 5: Withdrawals due to adverse events
7.6
7.6. Analysis
Comparison 7: Oral viscous budesonide vs swallowed fluticasone, Outcome 6: Serious adverse events
7.7
7.7. Analysis
Comparison 7: Oral viscous budesonide vs swallowed fluticasone, Outcome 7: Total adverse events
8.1
8.1. Analysis
Comparison 8: Esomeprazole vs fluticasone, Outcome 1: Clinical improvement at study endpoint (continuous)
8.2
8.2. Analysis
Comparison 8: Esomeprazole vs fluticasone, Outcome 2: Histological improvement at study endpoint (dichotomous)
8.3
8.3. Analysis
Comparison 8: Esomeprazole vs fluticasone, Outcome 3: Histological improvement at study endpoint (continuous)
8.4
8.4. Analysis
Comparison 8: Esomeprazole vs fluticasone, Outcome 4: Withdrawals due to adverse events
8.5
8.5. Analysis
Comparison 8: Esomeprazole vs fluticasone, Outcome 5: Serious adverse events
8.6
8.6. Analysis
Comparison 8: Esomeprazole vs fluticasone, Outcome 6: Total adverse events
9.1
9.1. Analysis
Comparison 9: One‐food elimination diet vs four‐food elimination diet, Outcome 1: Clinical improvement at study endpoint (continuous)
9.2
9.2. Analysis
Comparison 9: One‐food elimination diet vs four‐food elimination diet, Outcome 2: Histological improvement at study endpoint (dichotomous)
9.3
9.3. Analysis
Comparison 9: One‐food elimination diet vs four‐food elimination diet, Outcome 3: Endoscopic improvement at study endpoint (continuous)
9.4
9.4. Analysis
Comparison 9: One‐food elimination diet vs four‐food elimination diet, Outcome 4: Withdrawals due to adverse events
9.5
9.5. Analysis
Comparison 9: One‐food elimination diet vs four‐food elimination diet, Outcome 5: Serious adverse events
9.6
9.6. Analysis
Comparison 9: One‐food elimination diet vs four‐food elimination diet, Outcome 6: Total adverse events
9.7
9.7. Analysis
Comparison 9: One‐food elimination diet vs four‐food elimination diet, Outcome 7: Quality of life at study endpoint (continuous)
10.1
10.1. Analysis
Comparison 10: One‐food elimination diet vs six‐food elimination diet, Outcome 1: Clinical improvement at study endpoint (continuous)
10.2
10.2. Analysis
Comparison 10: One‐food elimination diet vs six‐food elimination diet, Outcome 2: Histological improvement at study endpoint (dichotomous)
10.3
10.3. Analysis
Comparison 10: One‐food elimination diet vs six‐food elimination diet, Outcome 3: Histological improvement at study endpoint (continuous)
10.4
10.4. Analysis
Comparison 10: One‐food elimination diet vs six‐food elimination diet, Outcome 4: Endoscopic improvement at study endpoint (continuous)
10.5
10.5. Analysis
Comparison 10: One‐food elimination diet vs six‐food elimination diet, Outcome 5: Withdrawals due to adverse events
10.6
10.6. Analysis
Comparison 10: One‐food elimination diet vs six‐food elimination diet, Outcome 6: Serious adverse events
10.7
10.7. Analysis
Comparison 10: One‐food elimination diet vs six‐food elimination diet, Outcome 7: Total adverse events
10.8
10.8. Analysis
Comparison 10: One‐food elimination diet vs six‐food elimination diet, Outcome 8: Quality of life at study endpoint (continuous)
11.1
11.1. Analysis
Comparison 11: Four‐food elimination diet with omeprazole vs omeprazole, Outcome 1: Histological improvement at study endpoint (dichotomous)
11.2
11.2. Analysis
Comparison 11: Four‐food elimination diet with omeprazole vs omeprazole, Outcome 2: Histological improvement at study endpoint (continuous)
11.3
11.3. Analysis
Comparison 11: Four‐food elimination diet with omeprazole vs omeprazole, Outcome 3: Withdrawals due to adverse events
12.1
12.1. Analysis
Comparison 12: Four‐food elimination diet with amino acid formula vs four‐food elimination diet, Outcome 1: Clinical improvement at study endpoint (continuous)
12.2
12.2. Analysis
Comparison 12: Four‐food elimination diet with amino acid formula vs four‐food elimination diet, Outcome 2: Histological improvement at study endpoint (dichotomous)
12.3
12.3. Analysis
Comparison 12: Four‐food elimination diet with amino acid formula vs four‐food elimination diet, Outcome 3: Histological improvement at study endpoint (continuous)
12.4
12.4. Analysis
Comparison 12: Four‐food elimination diet with amino acid formula vs four‐food elimination diet, Outcome 4: Endoscopic improvement at study endpoint (continuous)
12.5
12.5. Analysis
Comparison 12: Four‐food elimination diet with amino acid formula vs four‐food elimination diet, Outcome 5: Withdrawals due to adverse events
12.6
12.6. Analysis
Comparison 12: Four‐food elimination diet with amino acid formula vs four‐food elimination diet, Outcome 6: Serious adverse events
12.7
12.7. Analysis
Comparison 12: Four‐food elimination diet with amino acid formula vs four‐food elimination diet, Outcome 7: Total adverse events
13.1
13.1. Analysis
Comparison 13: Nebulized budesonide vs viscous budesonide, Outcome 1: Clinical improvement at study endpoint (continuous)
13.2
13.2. Analysis
Comparison 13: Nebulized budesonide vs viscous budesonide, Outcome 2: Histological improvement at study endpoint (continuous)
13.3
13.3. Analysis
Comparison 13: Nebulized budesonide vs viscous budesonide, Outcome 3: Serious adverse events
13.4
13.4. Analysis
Comparison 13: Nebulized budesonide vs viscous budesonide, Outcome 4: Total adverse events
14.1
14.1. Analysis
Comparison 14: Viaskin milk patch vs placebo, Outcome 1: Clinical improvement at study endpoint (continuous)
14.2
14.2. Analysis
Comparison 14: Viaskin milk patch vs placebo, Outcome 2: Histological improvement at study endpoint (continuous)
14.3
14.3. Analysis
Comparison 14: Viaskin milk patch vs placebo, Outcome 3: Endoscopic improvement at study endpoint (continuous)
14.4
14.4. Analysis
Comparison 14: Viaskin milk patch vs placebo, Outcome 4: Withdrawals due to adverse events
14.5
14.5. Analysis
Comparison 14: Viaskin milk patch vs placebo, Outcome 5: Serious adverse events
14.6
14.6. Analysis
Comparison 14: Viaskin milk patch vs placebo, Outcome 6: Total adverse events
14.7
14.7. Analysis
Comparison 14: Viaskin milk patch vs placebo, Outcome 7: Quality of life at study endpoint (continuous)
15.1
15.1. Analysis
Comparison 15: Leukotriene receptor antagonist vs placebo for maintenance of remission, Outcome 1: Clinical improvement at study endpoint (dichotomous)
15.2
15.2. Analysis
Comparison 15: Leukotriene receptor antagonist vs placebo for maintenance of remission, Outcome 2: Withdrawals due to adverse events
15.3
15.3. Analysis
Comparison 15: Leukotriene receptor antagonist vs placebo for maintenance of remission, Outcome 3: Serious adverse events
15.4
15.4. Analysis
Comparison 15: Leukotriene receptor antagonist vs placebo for maintenance of remission, Outcome 4: Total adverse events
16.1
16.1. Analysis
Comparison 16: Mepolizumab 10 mg/kg vs mepolizumab 0.55 mg/kg, Outcome 1: Histological improvement at study endpoint (dichotomous)
16.2
16.2. Analysis
Comparison 16: Mepolizumab 10 mg/kg vs mepolizumab 0.55 mg/kg, Outcome 2: Withdrawals due to adverse events
17.1
17.1. Analysis
Comparison 17: Mepolizumab 2.5 mg/kg vs mepolizumab 0.55 mg/kg, Outcome 1: Histological improvement at study endpoint (dichotomous)
17.2
17.2. Analysis
Comparison 17: Mepolizumab 2.5 mg/kg vs mepolizumab 0.55 mg/kg, Outcome 2: Withdrawals due to adverse events
18.1
18.1. Analysis
Comparison 18: Mepolizumab 10 mg/kg vs mepolizumab 2.5 mg/kg, Outcome 1: Histological improvement at study endpoint (dichotomous)
18.2
18.2. Analysis
Comparison 18: Mepolizumab 10 mg/kg vs mepolizumab 2.5 mg/kg, Outcome 2: Withdrawals due to adverse events
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Alexander 2012 {published data only}
    1. Alexander J, Jung KW, Arora A, Enders F, Francis D, Kita H, et al. A randomized placebo-controlled trial of swallowed fluticasone as treatment of eosinophilic esophagitis 2010 ACG auxiliary award. American Journal of Gastroenterology 2010;105 Suppl 1:S21-2. [DOI: 10.1038/ajg.2010.320-1] - DOI
    1. Alexander J, Jung KW, Arora A, Enders F, Katzka D, Kephardt G, et al. Swallowed fluticasone improves histologic but not symptomatic response of adults with eosinophilic esophagitis. Clinical Gastroenterology and Hepatology 2012;10(7):742-9. [DOI: 10.1016/j.cgh.2012.03.018] [PMID: ] - DOI - PubMed
    1. NCT00275561. Topical steroid treatment for eosinophilic esophagitis [A randomized placebo-controlled trial of swallowed fluticasone in treatment of eosinophilic esophagitis]. https://clinicaltrials.gov/ct2/show/NCT00275561 (first received 12 January 2006).
Alexander 2017 {published data only}
    1. Alexander J, Karthik R, Enders F, Geno D, Kryzer L, Mara K, et al. A randomized placebo-controlled trial of montelukast in maintenance treatment of eosinophilic esophagitis. Gastroenterology 2016;150(4 Suppl 1):S19.
    1. Alexander J, Ravi K, Enders F, Geno D, Kryzer L, Mara K, et al. Montelukast does not maintain symptom remission after topical steroid therapy for eosinophilic esophagitis. Clinical Gastroenterology and Hepatology 2017;15(2):214-21. [DOI: 10.1016/j.cgh.2016.09.013] [PMID: ] - DOI - PubMed
    1. NCT00511316. Trial of montelukast in eosinophilic esophagitis [A randomized placebo-controlled trial of montelukast in maintenance therapy of asymptomatic eosinophilic esophagitis]. https://clinicaltrials.gov/ct2/show/NCT00511316 (first received 3 August 2007).
Assa'ad 2011 {published data only}
    1. Aceves S, Gupta S, Justinich C, Assa'ad A, Heath A, Perschy T, et al. Clinical characteristics of pediatric eosinophilic esophagitis subjects with inadequate response to or intolerance of prior therapies receiving mepolizumab in a multicenter clinical trial. Journal of Allergy and Clinical Immunology 2010;125(2 Suppl 1):AB159. [DOI: 10.1016/j.jaci.2009.12.625] - DOI
    1. Aceves S, Newbury R, Chen D, Broide D, Bastian JF, Dohil R. Resolution of esophageal remodeling following oral viscous budesonide (OVB) therapy for eosinophilic esophagitis (EoE). Gastroenterology 2010;138(5 Suppl 1):S123.
    1. Assa'ad A, Collins M, Aceves S, Gupta S, Drouin E, Jurgensen C, et al. The pharmacodynamic effects of mepolizumab, a humanized monoclonal antibody against IL-5, in pediatric patients with eosinophilic esophagitis: A randomized, double-blind, controlled clinical trial. Journal of Allergy and Clinical Immunology 2010;125(2 Suppl 1):AB129. [DOI: 10.1016/j.jaci.2009.12.509] - DOI
    1. Assa'ad AH, Collins MH, Gupta SK, Thomson M, Heath AT, Smith DA, et al. An antibody against IL-5 reduces numbers of esophageal intraepithelial eosinophils in children with eosinophilic esophagitis. Gastroenterology 2011;141(5):1593-604. [DOI: 10.1053/j.gastro.2011.07.044] [PMID: ] - DOI - PubMed
    1. Collins M, Heath A, Jurgensen C. Effect of a monoclonal antibody (mepolizumab) against lnterleukin-5 (IL-5) in reducing eosinophilic inflammation in children with eosinophilic esophagitis (EoE). Laboratory Investigation 2010;90(2):291. [DOI: 10.1038/labinvest.2009.151] - DOI
Bhardwaj 2017 {published data only}
    1. Bhardwaj N, Ishmael F, Lehman E, Bethards D, Ruggiero F, Ghaffari G. Effect of topical beclomethasone on inflammatory markers in adults with eosinophilic esophagitis: a pilot study. Allergy Rhinol (Providence) 2017;8(2):85-94. [DOI: 10.2500/ar.2017.8.0202] [PMID: PMID: 28583232] - DOI - PMC - PubMed
    1. Ghaffari G. A randomized double blind placebo controlled crossover study of the effect of swallowed beclomethasone dipropionate on inflammatory markers in adult patients with eosinophilic esophagitis: a pilot study. Annals of Allergy, Asthma and Immunology 2012;109(5 Suppl):A19-20. [DOI: 10.1016/j.anai.2012.09.018] - DOI
    1. Ghaffari G. A randomized double blind placebo controlled crossover study of the effect of swallowed beclomethasone dipropionate on inflammatory markers in adult patients with eosinophilic esophagitis:a pilot study. Annals of Allergy, Asthma and Immunology 2011;107(5 Suppl 1):A99. [DOI: 10.1016/j.anai.2011.09.019] - DOI
    1. NCT01016223. A randomized double blind placebo controlled study of the effect of swallowed beclomethasone dipropionate on inflammatory markers in adult patients with eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT01016223 (first received 19 November 2009).
Butz 2014 {published data only}
    1. Butz B, Wen T, Gleich G, Furuta G, Spergel J, King E, et al. Efficacy, dose reduction, and resistance to high-dose fluticasone in patients with eosinophilic esophagitis. Gastroenterology 2014;147(2):324-33.e5. [DOI: 10.1053/j.gastro.2014.04.019] [PMID: ] - DOI - PMC - PubMed
    1. NCT00426283. A study of Flovent in patients with eosinophilic esophagitis [A double blinded, randomized trial of swallowed 1760mcg fluticasone propionate versus placebo in the treatment of eosinophilic esophagitis]. https://clinicaltrials.gov/ct2/show/NCT00426283 (first received 24 January 2007).
Clayton 2014 {published data only}
    1. Clayton F, Chen X, Emerson L, Fang J, Vinson L, Cox K, et al. Eosinophilic esophagitis in adults is associated with IgG4 and not mediated by IgE. Gastroenterology 2014;147(3):602-9. [DOI: 10.1053/j.gastro.2014.05.036] [PMID: ] - DOI - PubMed
    1. Fang J, Hilden K, Gleich G, Emerson L, Ogorman M, Lowichik A, et al. A pilot study of the treatment of eosinophilic esophagitis with omalizumab. Gastroenterology 2011;140(5 Suppl 1):S235. [DOI: 10.1016/S0016-5085%2811%2960951-7] - DOI
    1. NCT00123630. A pilot study of the treatment of eosinophilic esophagitis with omalizumab. https://clinicaltrials.gov/ct2/show/NCT00123630 (first received 25 July 2005).
Dellon 2012 {published data only}
    1. Dellon E, Sheikh A, Speck O, Woodward K, Whitlow A, Hores J, et al. Nebulized/swallowed vs viscous/swallowed budesonide for treatment of eosinophilic esophagitis: results from a randomized, open-label, clinical trial. Gastroenterology 2012;142(5 Suppl 1):S180.
    1. Dellon E, Sheikh A, Speck O, Woodward K, Whitlow A, Hores J, et al. Viscous topical is more effective than nebulized steroid therapy for patients with eosinophilic esophagitis. Gastroenterology 2012;143(2):321-4. [DOI: 10.1053/j.gastro.2012.04.049] [PMID: ] - DOI - PMC - PubMed
    1. Dellon E, Sheikh A, Whitlow A, Ivanovic M, Chau A, Woodward K, et al. Mucosal contact time determines histologic effectiveness of oral budesonide preparations in eosinophilic esophagitis: a randomized trial using scintigraphy. Gastroenterology 2012;142(5 Suppl 1):S180.
    1. NCT00961233. Topical budesonide treatment for eosinophilic esophagitis (EoE) [Topical budesonide treatment for eosinophilic esophagitis (eoe): esophageal medication distribution, treatment response, and effect on the adrenal axis]. https://clinicaltrials.gov/ct2/show/NCT00961233 (first received 18 August 2009).
Dellon 2017 {published data only}
    1. Collins M, Dellon E, Hirano I, Katzka D, Mukkada V, Williams J, et al. Baseline characterization of adolescent and adult patients with eosinophilic esophagitis (EOE) using the eoe histology scoring system: analyses from a randomized, placebo-controlled trial. Journal of Pediatric Gastroenterology and Nutrition 2019;69 Suppl 2:S26. [DOI: 10.1097/MPG.0000000000002518] - DOI
    1. Collins M, Dellon E, Hirano I, Katzka D, Williams J, Lan L, et al. Baseline characterization of patients with eosinophilic esophagitis (EOE) using the eoe histology scoring system and correlations with endoscopic and symptom outcomes: Analyses from a randomized, placebo-controlled trial. American Journal of Gastroenterology 2019;114 Suppl:S229-30. [DOI: 10.14309/01.ajg.0000591100.32919.d0] - DOI
    1. Collins M, Dellon E, Katzka D, Hirano I, Williams J, Lan L. Budesonide oral suspension significantly improves eosinophilic esophagitis histology scoring system results: analyses from a 12-week, phase 2, randomized, placebo-controlled trial. American Journal of Surgical Pathology 2019;43(11):1501-9. [DOI: 10.1097/PAS.0000000000001361] [PMID: ] - DOI - PubMed
    1. Dellon E, Katzka D, Collins M, Gupta S, Lan L, Williams J, et al. Safety and efficacy of budesonide oral suspension maintenance therapy in patients with eosinophilic esophagitis. Clinical Gastroenterology and Hepatology 2019;17(4):666-73. [DOI: 10.1016/j.cgh.2018.05.051] [PMID: ] - DOI - PubMed
    1. Dellon E, Katzka D, Collins M, Hamdani M, Gupta S, Hirano I. Safety and efficacy of oral budesonide suspension for maintenance therapy in eosinophilic esophagitis: Results from a prospective open-label study of adolescents and adults. Gastroenterology 2016;150(4 Suppl 1):S188.
Dellon 2019 {published data only}
    1. Cotton C, Woosley J, Moist S, McGee S, Shaheen N, Dellon E. Determination of an endoscopic response threshold for the eosinophilic esophagitis endoscopic reference score: analysis of a randomized comparative clinical trial of topical steroids. Gastroenterology 2020;158(6 Suppl 1):S819-20. [DOI: 10.1016/S0016-5085(20)32728-1] - DOI
    1. Cotton C, Woosley J, Moist S, McGee S, Shaheen N, Dellon E. Dysphagia in eosinophilic esophagitis improves with topical steroid treatment independent of improvement in endoscopic and histologic measures of mucosal inflammation: analysis of a randomized comparative effectiveness clinical trial. Gastroenterology 2020;158(6 Suppl 1):S-820. [DOI: 10.1016/S0016-5085%2820%2932729-3] - DOI
    1. Dellon E, McGee S, Moist S, Shaheen N, Woosley J. Utility of major basic protein, eotaxin-3, and mast cell tryptase staining for prediction of response to topical steroid treatment in eosinophilic esophagitis: analysis of a randomized, double-blind, double dummy clinical trial. Diseases of the Esophagus 2020;33(6):1-8. [DOI: 10.1093/dote/doaa003] [PMID: ] - DOI - PMC - PubMed
    1. Dellon E, Woosley J, Arrington A, McGee S, Covington J, Moist S, et al. Efficacy of budesonide vs fluticasone for initial treatment of eosinophilic esophagitis in a randomized controlled trial. Gastroenterology 2019;157(1):65-73. [DOI: 10.1053/j.gastro.2019.03.014] [PMID: ] - DOI - PMC - PubMed
    1. Dellon E, Woosley J, Arrington A, McGee S, Covington J, Moist S, et al. Rapid recurrence of symptoms, endoscopic findings, and esophageal eosinophilia without maintenance thearpy after successful initial treatment: results from the observation phase of a randomized, double-blind, double dummy clinical trial. Gastroenterology 2019;156(6 Suppl 1):713-4. [DOI: 10.1016/S0016-5085(19)38720-7] - DOI
Dellon 2021b {published data only}
    1. Dellon ES, Collins MH, Katzka DA, Mukkada VA, Falk GW, Morey R, et al. Long- term treatment of eosinophilic esophagitis with budesonide oral suspension. Clinical Gastroenterology and Hepatology 2021;20(7):P1488-98.E11. [DOI: 10.1016/j.cgh.2021.06.020] - DOI - PubMed
    1. Dellon ES, Collins MH, Katzka DA, Mukkada VA, Falk GW, Morey R, et al. Loss of histologic, symptom and endoscopic efficacy following treatment withdrawal in patients with eosinophilic esophagitis: a phase 3, randomized withdrawal study of budesonide oral suspension. Gastroenterology 2021;160(6):S‐247‐8.
    1. NCT02736409. An extension study to evaluate maintenance of efficacy and long-term treatment effect of oral budesonide suspension (OBS) in adults and adolescents with eosinophilic esophagitis (EoE). https://clinicaltrials.gov/ct2/show/NCT02736409 (first received 13 April 2016).
Dellon 2022 {published data only}
    1. Dellon E, Rothenberg M, Bredenoord A, Lucendo A, Hirano I, Sun X et al. Dupilumab improves clinical, symptomatic, histologic, and endoscopic aspects of EoE up to 24 weeks: pooled results from parts A and B of phase 3 LIBERTY-EoE-TREET. American Journal of Gastroenterology 2022;117(Supplement):s387.
    1. Dellon E, Rothenberg M, Hirano I, Chehade M, Bredenoord A, Spergel J, et al. Dupilumab improves health-related quality of life (HRQoL) and reduces symptom burden in patients with eosinophilic esophagitis (EoE): results from part A of a randomized, placebo-controlled three-part phase 3 study. Journal of Allergy and Clinical Immunology 2021;147(2 Suppl):AB91. [DOI: 10.1016/j.jaci.2020.12.347] - DOI
    1. Dellon ES, Rothenberg ME, Bredenoord A, Collins MH, Hirano I, Chehade M, et al. Clinical and histological improvements with weekly dupilumab treatment in adult and adolescent patients with eosinophilic esophagitis at week 24: weekly and every 2 weeks; results from part b of the 3-part LIBERTY EoT TREET study. Gastroenterology 2022;162(7 Suppl):S-1391-2.
    1. Dellon ES, Rothenberg ME, Bredenoord A, Collins MH, Hirano I, Chehade M, et al. Dupilumab improves histologic and clinical aspects of disease in adult and adolescent patients with eosinophilic esophagitis at week 24: results from part b of the 3-part LIBERTY EoT TREET Study. Gastroenterology 2022;162(7 Suppl):S-237-8.
    1. Dellon ES, Rothenberg ME, Collins MH, Hirano I, Chehade M, Bredenoord A. A phase 3, randomized, 3-part study to investigate the efficacy and safety of dupilumab in adult and adolescent patients with eosinophilic esophagitis: results from part A. American Journal of Gastroenterology 2020;115:LB3.
Dellon 2022a {published data only}
    1. Dellon E, Falk G, Hirano I, Lucendo A, Schlag C, Schoepfer A, et al. An episode-based, patient-reported outcome measure of dysphagia accurately captures response to treatment with apt-1011 in a phase 2b, randomized, double-blind, placebo-controlled, clinical trial in adults with eosinophilic esophagitis. Gastroenterology 2020;158(6 Suppl 1):S817. [DOI: 10.1016/S0016-5085(20)32722-0] - DOI
    1. Dellon E, Lucendo A, Schlag C, Schoepher A, Falk G, Richardson P, et al. Safety and efficacy of long-term treatment of EoE with fluticasone propionate orally disintegrating tablet (APT-1011): results from 40 weeks treatment in a phase 2b randomized double-blind placebo-controlled trial. American Journal of Gastroenterology 2020;115 Suppl:S169-70. [DOI: 10.14309/01.ajg.0000703428.23468.41] - DOI
    1. Dellon E, Lucendo Villarin A, Schlag C, Schoepfer A, Knoop K, Richardson P, et al. Safety and efficacy of 4 dosage regimens of APT-1011: results from a phase 2B randomized double-blind placebo-controlled trial to select the best dosage regimen for further development. United European Gastroenterology Journal 2019;7(10):1420. [DOI: 10.1177/2050640619888859] - DOI
    1. Dellon ES, Lucendo AJ, Schlag C, Schoepfer AM, Falk GW, Eagle G, et al. Fluticasone Propionate Orally Disintegrating Tablet (APT-1011) for Eosinophilic Esophagitis: randomized Controlled Trial. Clinical gastroenterology and hepatology 2022;20(11):2485‐2494.e15. - PubMed
    1. Dellon ES, Lucendo AJ, Schlag C, Schoepfer AM, Falk GW, Eagle G, et al. Fluticasone propionate orally disintegrating tablet (APT-1011) for eosinophilic esophagitis: randomized controlled trial. Clinical Gastroenterology and Hepatology 2022 Feb 15 [epub ahead of print]:S1542. [DOI: 10.1016/j.cgh.2022.02.013] [PMID: ] - DOI - PubMed
Dellon 2022b {published and unpublished data}
    1. Allakos. Allakos corporate update. https://investor.allakos.com/static-files/74ad659a-8f45-4448-b1fb-97b647... 2022.
    1. Dellon E, Chedhade M, Genta M, Leiman D, Peterson K, Spergel J. Results from KRYPTOS, a phase 2/3 study of lirentelimab (AK002) in adults and adolescents with EoE. American journal of Gastroenterology 2022;117(Suppl):S316.
De Rooij 2022 {published data only}
    1. De Rooij W, Bredenoord A, Vlieg-Boerstra B, Warners M, Van Ampting M, Eussen S, et al. Effect of elemental nutrition added to four-food elimination in adult eosinophilic esophagitis patients: a randomized controlled trial. United European Gastroenterology Journal 2020;8(8S):56-7. [DOI: 10.1177/2050640620927344] - DOI
    1. De Rooij W, Vlieg-Boerstra B, Warners MJ, Van Ampting MTJ, Van Esch BCAM, Eussen SRBM, et al. Effect of amino acid-based formula added to four-food elimination in adult eosinophilic esophagitis patients: a randomized clinical trial. Neurogastroenterology & Motility 2022;34(7):e14291. [DOI: 10.1111/nmo.14291] [PMID: ] - DOI - PMC - PubMed
    1. NTR6778. Effect of addition of elemental nutrition to an elimination diet on esophageal inflammation in adult eosinophilic esophagitis (EoE) patients: a randomized controlled trial. http://www.who.int/trialsearch/Trial2.aspx?TrialID=NTR6778 (first received 20 October 2017) .
    1. Rooij WE, Vlieg-Boerstra B, Warners MJ, Van Ampting MTJ, Esch BCAM, Eussen SRBM, et al. Effect of amino acid-based formula added to four-food elimination in adult eosinophilic esophagitis patients: a randomized clinical trial. Neurogastroenterology and Motility 2022;34(7):e14291. - PMC - PubMed
Dohil 2010 {published data only}
    1. Dohil R, Newbury R, Fox L, Bastian J, Aceves S. A randomized, double-blind, placebo-controlled study of oral viscous budesonide (OVB) in children with eosinophilic esophagitis (EoE). Gastroenterology 2010;138(5 Suppl 1):S62-3. - PubMed
    1. Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. American Journal of Gastroenterology 2010;139(2):418-29. [DOI: 10.1053/j.gastro.2010.05.001] [PMID: ] - DOI - PubMed
    1. NCT00638456. Use of topical budesonide in the treatment of eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT00638456 (first received 19 March 2008).
Gupta 2015 {published data only}
    1. Collins M, Irani A, Ngo PD, Vitanza JM. Reduction of esophageal epithelial pathology and endoscopic abnormalities following treatment with oral budesonide suspension (OBS) in pediatric subjects with eosinophilic esophagitis (EoE). Gastroenterology 2011;140(5 Suppl 1):S237. [DOI: 10.1016/S0016-5085%2811%2960956-6] - DOI
    1. Gupta S, Collins M, Lewis J, Farber R. Efficacy and safety of oral budesonide suspension (OBS) in pediatric subjects with eosinophilic esophagitis (EoE): results from the double-blind, placebo-controlled PEER study. Gastroenterology 2011;140(5 Suppl 1):S179. [DOI: 10.1016/S0016-5085%2811%2960725-7] - DOI
    1. Gupta S, Vitanza J, Collins M. Efficacy and safety of oral budesonide suspension in pediatric patients with eosinophilic esophagitis. Clinical Gastroenterology and Hepatology 2015;13(1):66-76. [DOI: 10.1016/j.cgh.2014.05.021] [PMID: ] - DOI - PubMed
    1. NCT00762073. Dose-ranging study of oral viscous budesonide in pediatrics with eosinophilic esophagitis [Oral viscous budesonide suspension (MB-7) in subjects with eosinophilic esophagitis: a randomized, placebo-controlled, dose-ranging study in children and adolescents]. https://clinicaltrials.gov/ct2/show/NCT00762073 (first received 30 September 2008).
Heine 2019 {published data only}
    1. ACTRN12613001210763. Effects of diet and omeprazole in patients with eosinophilic oesophagitis: a multi-centre, randomised controlled trial and investigation of novel disease mechanisms. http://www.who.int/trialsearch/Trial2.aspx?TrialID=ACTRN12613001210763 (first received 4 November 2013).
    1. Heine R, Peters R, Cameron D, O-Loughlin E, Axelrad C, Allen K, et al. Effect of a 4-food elimination diet and omeprazole in children with eosinophilic esophagitis - a randomized controlled trial. Journal of Allergy and Clinical Immunology 2019;143(2 Suppl):AB309. [DOI: 10.1016/j.jaci.2018.12.940] - DOI
Hirano 2019 {published data only}
    1. Dellon E S, Collins M H, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer A, et al. Long-term efficacy and safety of RPC4046, an anti-interleukin-13 monoclonal antibody, in patients with eosinophilic esophagitis: Results from the openlabel extension of the heroes study. United European Gastroenterology Journal 2018;6(8 Suppl):A124-5. [DOI: 10.1177/2050640618792817] - DOI
    1. Dellon E S, Collins M H, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer A, et al. Long-term efficacy and safety of RPC4046, an anti-interleukin-13 monoclonal antibody, in patients with eosinophilic esophagitis: results from the open-label extension of the heroes study. Allergy: European Journal of Allergy and Clinical Immunology 2019;74(Suppl 106):308-9. [DOI: 10.1111/all.13961] - DOI
    1. Dellon E S, Collins M H, Rothenberg M, Assouline-Dayan Y, Evans L, Gupta S, et al. Efficacy of RPC4046, an anti-interleukin-13 monoclonal antibody, in patients with active eosinophilic esophagitis: Analysis of the steroid-refractory subgroup from the heroes study. Allergy: European Journal of Allergy and Clinical Immunology 2019;74(Suppl 106):98. [DOI: 10.1111/all.13957] - DOI
    1. Dellon E, Collins M, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer A, et al. Long-term efficacy and safety of RPC4046, an anti-interleukin-13 monoclonal antibody, in patients with eosinophilic esophagitis: results from the open-label extension of the HEROES study. Journal of Allergy and Clinical Immunology 2019;143(2 Suppl):AB208. [DOI: 10.1016/j.jaci.2018.12.635] - DOI
    1. Dellon E, Collins M, Rothenberg M, Assouline-Dayan Y, Evans L, Gupta S, et al. Efficacy of RPC4046, an anti-interleukin-13 monoclonal antibody, in patients with active eosinophilic esophagitis: Analysis of the steroidrefractory subgroup from the heroes study. United European Gastroenterology Journal 2018;6(8 Suppl):A51-2. [DOI: 10.1177/2050640618792817] - DOI
Hirano 2020 {published data only}
    1. Collins M, Hirano I, Dellon E, Peterson K, Chehade M, Schoepfer A, et al. Baseline characteristics and correlation between dysphagia and disease activity in patients with eosinophilic esophagitis in a randomized, placebo-controlled, phase 2 dupilumab trial. Gastroenterology 2018;154(6 Suppl):S259. [DOI: 10.1016/S0016-5085(18)31232-0] - DOI
    1. Collins M, Rothenberg M, Hamilton J, Lim W, Hamon S, Wipperman M, et al. The gene expression signature modulated by dupilumab is highly correlated with eosinophilic esophagitis histological severity. United European Gastroenterology Journal 2020;8(8 Suppl):57-8. [DOI: 10.1177/2050640620927344] - DOI
    1. Corren J, Canonica GW, Graham NMH, Harel S, Chen Z, Amin N, et al. Dupilumab suppresses serum total IgE levels across multiple atopic, allergic diseases. Allergy: European Journal of Allergy and Clinical Immunology 2020;75(Suppl 109):64. [DOI: 10.1111/all.14504] - DOI
    1. Hirano I, Collins M, Dellon E, Rothenberg M, Schoepfer A, Chehade M, et al. Endoscopic features are significantly associated with histologic measures of disease activity in patients with active eosinophilic esophagitis: a post HOC analysis of a randomized, placebo-controlled, phase 2 dupilumab trial. Gastroenterology 2018;154(6 Suppl 1):S244. [DOI: 10.1016/S0016-5085%2818%2931193-4] - DOI
    1. Hirano I, Dellon E S, Hamilton J D, Qing Z, Graham N M, Akinlade B, et al. Dupilumab efficacy and safety in adult patients with active eosinophilic oesophagitis: a randomised double-blind placebo-controlled phase 2 trial. United European Gastroenterology Journal 2017;5(8):1146-7. [DOI: 10.1177/2397847317743186] - DOI
Hirano 2020f {published data only}
    1. Hirano I, Safroneeva E, Roumet MC, Comer GM, Eagle G, Schoepfer A, et al. Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis. Alimentary Pharmacology and Therapeutics 2020;51(8):750-9. [DOI: 10.1111/apt.15670] [PMID: ] - DOI - PubMed
    1. Hirano I, Schoepfer A, Comer G, Safroneeva E, Meltzer B, Falk G. A randomized, double-blind, placebo-controlled trial of a fluticasone propionate orally disintegrating tablet in adult and adolescent patients with eosinophilic esophagitis: a phase 1/2A safety and tolerability study. Gastroenterology 2017;152(5 Suppl 1):S195.
    1. NCT01386112. Safety and tolerability study of oral EUR-1100 to treat eosinophilic esophagitis [A multicenter, randomized, double-blind, placebo-controlled, safety and tolerability phase 1/2a study of two dosing regimens of EUR-1100 for oral use, in subjects with eosinophilic esophagitis (EoE)]. https://clinicaltrials.gov/ct2/show/NCT01386112 (first received 30 June 2011).
Hirano 2021 {published data only}
    1. Collins M, Hirano I, Katzka D, Cianferoni A, Williams J, Desai N, et al. Budesonide oral suspension improves histologic features in patients with eosinophilic esophagitis: results from a phase 3, randomized, double-blind, placebo-controlled trial. Journal of Allergy and Clinical Immunology 2020;145(2 Suppl):AB166. [DOI: 10.1016/j.jaci.2019.12.341] - DOI
    1. Collins M, Mukkada V, Hirano I, Katzka D, Falk G, Williams J, et al. Improved histopathologic features in patients with eosinophilic esophagitis: results and analyses from a phase 3, randomized, placebo-controlled trial of budesonide oral suspension. American Journal of Gastroenterology 2020;115 Suppl:S200-1. [DOI: 10.14309/01.ajg.0000703664.24718.78] - DOI
    1. Dellon E, Hirano I, Mukkada V, Katzka D, Gold B, Desai N, et al. Study design and baseline patient characteristics of a phase 3, randomized, placebo-controlled trial of budesonide oral suspension in patients with eosinophilic esophagitis. Journal of Pediatric Gastroenterology and Nutrition 2019;69(Suppl 2):283. [DOI: 10.1097/MPG.0000000000002518] - DOI
    1. Goodwin B, Williams J, Desai N, Lan L. PGI1 estimation of the minimal important differences in eosinophilic esophagitis quality of life (EoE-QoL): analysis from a phase 3, randomized, placebo-controlled trial of budesonide oral suspension. Value in Health 2020;23(Suppl 1):S143. [DOI: 10.1016/j.jval.2020.04.361] - DOI
    1. Goodwin B, Williams J, Desai N, Lan L. PGI36 Estimation of the minimal important differences in euroqol-5 dimensions (EQ-5D) for patients with eosinophilic esophagitis: analysis from a phase 3, randomized, placebo-controlled trial of budesonide oral suspension. Value in Health 2020;23 Suppl 1:S149. [DOI: 10.1016/j.jval.2020.04.390] - DOI
Kliewer 2019 {published data only}
    1. Kliewer K, Aceves SS, Atkins D, Bonis PA, Chehade M, Collins MH, et al. Efficacy of 1-food and 4-food elimination diets for pediatric eosinophilic esophagitis in a randomized multisite study. Gastroenterology 2019;156(6 Suppl 1):S-172-3.
    1. Kliewer K, Gonsalves N, Dellon ES, Katzka DA, Aceves SS, Arva N, et al. Efficacy of one-food versus six-food elimination diet for treatment of eosinophilic esophagitis in adults: results from the multicenter randomized controlled sofeed trial. Gastroenterology 2021;160((6 Suppl)):S-109-10.
    1. NCT02610816. Eosinophilic esophagitis intervention trial-1 food vs. 4 food elimination diet followed by swallowed glucocorticoids. https://clinicaltrials.gov/ct2/show/NCT02610816 (first received 20 November 2015).
Kliewer 2021 {published data only}
    1. Kliewer K, Gonsalves N, Dellon E, Katzka DA, Seema S, Aceves NA, et al. 535 Efficacy of one-food versus six-food elimination diet for treatment of eosinophilic esophagitis in adults: results from the multicenter randomized controlled sofeed trial. Gastroenterology 2021;160(6 Suppl 1):S109. [DOI: 10.1016/S0016-5085(19)37223-3] - DOI
    1. NCT02778867. SOFEED: Six food vs. one food eosinophilic esophagitis diet study [Six food vs one food eosinophilic esophagitis elimination diet (SOFEED) followed by swallowed glucocorticoid trial]. https://clinicaltrials.gov/ct2/show/NCT02778867 (first received 20 May 2016).
Konikoff 2006 {published data only}
    1. Konikoff MR, Noel RJ, Blanchard C, et al. A randomized, double-blind, placebo-controlled trial of fluticasone propionate for pediatric eosinophilic esophagitis. Gastroenterology 2006;131(5):1381-91. [DOI: 10.1053/j.gastro.2006.08.033] [PMID: ] - DOI - PubMed
    1. NCT00266578. A study comparing swallowed Flovent and placebo in patients with eosinophilic disorders [Effect of swallowed fluticasone propionate on eosinophilic esophagitis; a prospective, randomized, placebo-controlled trial]. https://www.clinicaltrials.gov/ct2/show/NCT00266578 (first received 19 December 2005).
Lieberman 2018 {published data only}
    1. Lieberman J, Whitworth J, Cavender C, Zhang J. A randomized, double-blinded, placebo-controlled study of the use of viscous oral cromolyn sodium for the treatment of eosinophilic esophagitis. Annals of Allergy, Asthma and Immunology 2018;120(5):527-31. [DOI: 10.1016/j.anai.2018.03.006] [PMID: ] - DOI - PubMed
    1. Lieberman J, Zhang J, Cavender C. Viscous oral cromolyn for the treatment of eosinophilic esophagitis: a double-blind, placebo-controlled trial. Annals of Allergy, Asthma and Immunology 2017;119(5 Suppl 1):S9. - PubMed
    1. NCT02371941. Oral cromolyn sodium for the treatment of eosinophilic esophagitis [A randomized, double-blind, placebo-controlled study of the use of oral cromolyn sodium for the treatment of eosinophilic esophagitis]. https://clinicaltrials.gov/ct2/show/NCT02371941 (first received 26 February 2015).
Lucendo 2019 {published data only}
    1. Lucendo A, Miehlke S, Vieth M, Schlag C, Von A, Molina-Infante J, et al. Budesonide orodispersible tablets are highly effective for treatment of active eosinophilic esophagitis: results from a randomized, double-blind, placebo-controlled, pivotal multicenter trial (EOS-1). Gastroenterology 2017;152(5 Suppl 1):S207.
    1. Lucendo A, Miehlke, Schlag C, Vieth M, Arnim U, Molina-Infante J, et al. Efficacy of budesonide orodispersible tablets as induction therapy for eosinophilic esophagitis in a randomized placebo-controlled trial. Gastroenterology 2019;157(1):74-86. [DOI: 10.1053/j.gastro.2019.03.025] [PMID: ] - DOI - PubMed
    1. Schlag C, Miehlke S, Lucendo A, Biedermann L, Santander C, Hartmann D, et al. Efficacy of budesonide orodispersible tablets for induction of remission in patients with active eosinophilic esophagitis: results from the 6-weeks open-label treatment phase of EOS-2 trial. Gastroenterology 2019;156(6 Suppl 1):S715. [DOI: 10.1016/S0016-5085%2819%2938723-2] - DOI
Miehlke 2016 {published data only}
    1. EUCTR2009-016692-29-BE. A study to investigate the efficacy and tolerance of budesonide tablets and suspension in patients suffering from esophagitis over a 14 day period. https://www.clinicaltrialsregister.eu/ctr-search/search?query=EUCTR2009-... (first received 24 November 2011).
    1. Hruz P, Miehlke S, Von Arnim U, Madisch A, Vieth M, Bussmann C, et al. A randomized, double-blind, double-dummy, placebo-controlled, European multicentre trial of two new budesonide formulations for treatment of active eosinophilic esophagitis. United European Gastroenterology Journal 2014;2(1 Suppl 1):A128. [DOI: 10.1177/2050640614548974] - DOI
    1. Miehlke S, Hruz P, Vieth M, Bussmann C, Von Arnim U, Bajbouj M, et al. A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis. Gut 2016;65(3):390-9. [DOI: 10.1136/gutjnl-2014-308815] [PMID: ] - DOI - PMC - PubMed
    1. Miehlke S, Hruz P, Von Ulrike A, Madisch A, Vieth M, Bussmann C, et al. Two new budesonide formulations are highly efficient for treatment of active eosinophilic esophagitis: Results from a randomized, double-blind, double-dummy, placebo-controlled multicenter trial. Gastroenterology 2014;146(5 Suppl 1):S16. [DOI: 10.1016/S0016-5085%2814%2960055-X] - DOI
    1. NCT02280616. Budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in eosinophilic esophagitis [Double-blind, double-dummy, randomized, placebo-controlled, phase iia study on the efficacy and tolerability of a 14-day treatment with budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in patients with eosinophilic esophagitis]. https://clinicaltrials.gov/ct2/show/NCT02280616 (first received 31 October 2014).
Moawad 2013 {published data only}
    1. Moawad F, Dias J, Veerappan G, Baker T, Maydonovitch C, Wong R. Comparison of aerosolized swallowed fluticasone to esomeprazole for the treatment of eosinophilic esophagitis. American Journal of Gastroenterology 2011;106:S12. - PubMed
    1. Moawad FJ, Veerappan GR, Dias JA, Baker TP, Maydonovitch CL, Wong RK. Randomized controlled trial comparing aerosolized swallowed fluticasone to esomeprazole for esophageal eosinophilia. American Journal of Gastroenterology 2013;108(3):366-72. [DOI: 10.1038/ajg.2012.443] [PMID: ] - DOI - PubMed
    1. NCT00895817. Fluticasone versus esomeprazole to treat eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT00895817 (first received 8 May 2009).
Oliva 2018 {published data only}
    1. Oliva S, Ruggiero C, Rossetti D, Tinti V, Salimbene L, Sarli M, et al. A randomized controlled trial comparing six-food elimination diet vs topical steroids in inducing and maintaining remission of paediatric eosinophilic esophagitis. Journal of Pediatric Gastroenterology and Nutrition 2018;66 Suppl 2:89.
    1. Oliva S, Ruggiero C, Rossetti D, Tinti V, Salimbene L, Sarli M, et al. A randomized controlled trial comparing six-food elimination diet vs topical steroids in inducing and maintaining remission of pediatric eosinophilic esophagitis. Gastroenterology 2018;154(6 Suppl 1):S163-4. [DOI: 10.1016/S0016-5085(18)30957-0] - DOI
Peterson 2010 {published data only}
    1. NCT00123656. Comparison of esomeprazole to aerosolized, swallowed fluticasone for eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT00123656 (first received 25 July 2005). - PubMed
    1. Peterson K, Thomas K, Hilden K, Emerson L, Wills J, Fang J. Comparison of esomeprazole to aerosolized, swallowed fluticasone for eosinophilic esophagitis. Digestive Diseases and Sciences 2010;55(5):1313-9. [DOI: 10.1007/s10620-009-0859-4] [PMID: ] - DOI - PubMed
Rothenberg 2015 {published data only}
    1. NCT01022970. Efficacy and safety of QAX576 in patients with eosinophilic esophagitis [A double blinded randomized placebo-controlled trial of intravenous qax576 in the treatment of eosinophilic esophagitis (EoE)]. https://clinicaltrials.gov/ct2/show/NCT01022970 (first received 1 December 2009).
    1. Rothenberg M, Wen T, Greenberg A, Alpan O, Enav B, Hirano I, et al. Intravenous anti-IL-13 mAb QAX576 for the treatment of eosinophilic esophagitis. Journal of Allergy and Clinical Immunology 2015;135(2):500-7. [DOI: 10.1016/j.jaci.2014.07.049] [PMID: ] - DOI - PubMed
Rothenberg 2022 {published data only}
    1. Dellon ES, Rothenberg ME, Collins MH, Hirano I, Chehade M, Bredenoord AJ, et al. Dupilumab in adults and adolescents with eosinophilic esophagitis. New England Journal of Medicine 2022;387(25):2317-30. - PubMed
    1. Rothenberg M, Dellon E, Bredenoord A, Collins M, Hirano I, Chehade M, et al. Dupilumab improves clinical and histologic aspects of disease in adult and adolescent patients with eosinophilic esophagitis at week 24: results from Part B of the 3-PartLIBERTY EoE TREET Study. Journal of Allergy and Clinical Immunology 2022;149(2 (Suppl)):AB312.
Schaefer 2008 {published data only}
    1. Gupta SK, Fitzgerald JF, Davis MM, Croffie JM, Pfefferkorn, MD, Molleston JP, et al. Treatment of allergic eosinophilic esophagitis (AEE) with oral prednisone (P) and swallowed fluticasone (F): a randomized, prospective study in children. Gastroenterology 2003;124(4 Suppl 1):A19.
    1. Schaefer ET, Fitzgerald JF, Molleston JP, Croffie JM, Pfefferkorn MD, Corkins MR, et al. Comparison of oral prednisone and topical fluticasone in the treatment of eosinophilic esophagitis: a randomized trial in children. Clinical Gastroenterology and Hepatology 2008;6(2):165-73. [DOI: 10.1016/j.cgh.2007.11.008] [PMID: ] - DOI - PubMed
Spergel 2012 {published data only}
    1. Markowitz J, Eke R, Frost C. Long-term safety and efficacy of reslizumab in children and adolescents with eosinophilic esophagitis: A review of 501 doses in 12 children over 8 years. Journal of Pediatric Gastroenterology and Nutrition 2016;63(Suppl 2):S143. [DOI: 10.1097/01.mpg.0000503536.79797.66] - DOI - PubMed
    1. Markowitz J, Jobe L, Miller M, Frost C, Eke R. Long-term safety and efficacy of reslizumab in children and adolescents with eosinophilic esophagitis: a review of 477 doses in 12 children over 7 years. Journal of Pediatric Gastroenterology and Nutrition 2016;137(2 Suppl 1):AB234. - PubMed
    1. Markowitz J, Jobe L, Miller M, Laney Z, Frost C, Eke R. Safety and efficacy of reslizumab for children and adolescents with eosinophilic esophagitis treated for 9 years. Journal of Pediatric Gastroenterology and Nutrition 2018;66(6):893-7. [DOI: 10.1097/MPG.0000000000001840] [PMID: ] - DOI - PubMed
    1. NCT00538434. Efficacy and safety study of reslizumab to treat eosinophilic esophagitis in subjects aged 5 to 18 years [An efficacy and safety study of reslizumab (CTx55700) in the treatment of eosinophilic esophagitis in subjects aged 5 to 18 years]. https://clinicaltrials.gov/ct2/show/NCT00538434 (first received 2 October 2007).
    1. Spergel J, Rothenberg M, Collins M, Furuta G, Markowitz J, Fuchs G, et al. Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled study. Gastroenterology 2011;140(5 Suppl 1):S136. - PubMed
Spergel 2020 {published data only}
    1. Burke D, Lewis M, Spergel J, Brown-Whitehorn T, Cianferoni A, Muir A, et al. Sustained milk consumption after 2 years post-milk epicutaneous immunotherapy for eosinophilic esophagitis. Allergy: European Journal of Allergy and Clinical Immunology 2021;76(5):1573-6. [DOI: 10.1111/all.14659] [PMID: ] - DOI - PubMed
    1. NCT02579876. Milk patch for eosinophilic esophagitis [A double, blind placebo-controlled, randomized trial to study efficacy and safety of the Viaskin milk for treating milk induced eosinophilic esophagitis in children]. https://clinicaltrials.gov/ct2/show/NCT02579876 2015.
    1. Spergel J, Elci O, Muir A, Liacouras C, Wilkins B, Burke D, et al. Efficacy of epicutaneous immunotherapy in children with milk-induced eosinophilic esophagitis. Clinical Gastroenterology and Hepatology 2020;18(2):328-36. [DOI: 10.1016/j.cgh.2019.05.014] [PMID: ] - DOI - PubMed
Straumann 2010a {published data only}
    1. Conus S, Straumann A, Bettler E, Simon H U. Mepolizumab does not alter levels of eosinophils, T cells, and mast cells in the duodenal mucosa in eosinophilic esophagitis. Journal of Allergy and Clinical Immunology 2010;126(1):175-7. [DOI: 10.1016/j.jaci.2010.04.029] [DOI: 10.1016/j.jaci.2011.01.014] [PMID: ] - DOI - DOI - PubMed
    1. EUCTR2005-006074-10-GB. A randomized, double-blind, parallel group clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab (SB240563) (0.55mg/kg, 2.5mg/kg or 10mg/kg) in pediatric subjects with eosinophilic esophagitis, ag. https://www.clinicaltrialsregister.eu/ctr-search/search?query=EUCTR2005-... (first received 7 February 2006).
    1. NCT00274703. An evaluation of mepolizumab in therapy of eosinophilic oesophagitis in adult patients [A randomised, double-blind, placebo-controlled, single-centre study to provide a preliminary evaluation of pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous anti-human interleukin-5 (mepolizumab, 750mg and 1500mg) in the treatment of eosinophilic oesophagitis in adults]. https://clinicaltrials.gov/ct2/show/NCT00274703 (first received January 2006).
    1. Straumann A, Conus H, Kita G, Kephart C, Bussmann C, Beglinger J et al. Mepolizumab, a humanized monoclonal antibody to IL-5, for severe eosinophilic esophagitis in adults: a randomized, placebo-controlled double-blind trial. Journal of Allergy and Clinical Immunology 2008;121(2 Suppl 1):S44.
    1. Straumann A, Conus S, Grzonka P, Simon H U, Kita H, Kephart G, et al. Anti-interleukin-5 antibody treatment (mepolizumab) in active eosinophilic oesophagitis: a randomised, placebo-controlled, double-blind trial. Gut 2010;59(1):21-30. [DOI: 10.1136/gut.2009.178558] [PMID: ] - DOI - PubMed
Straumann 2010b {published data only}
    1. Degen L, Bussmann C, Conus S, Thalmann C, Simon H, Straumann A. Budesonide as induction treatment for active eosinophilic esophagitis in adolescents and adults: a randomised, double-blind, placebo-controlled study (BEE-I trial). In: Allergy: European Journal of Allergy and Clinical Immunology. Vol. 65 Suppl 92. 2010:343-4. [DOI: 10.1111/j.1398-9995.2010.02393.x] - DOI
    1. Straumann A, Conus S, Degen L, Felder S, Kummer M, Engel H, et al. Budesonide is effective in adolescent and adult patients with active eosinophilic esophagitis. Gastroenterology 2010;139(5):1526-37. [DOI: 10.1053/j.gastro.2010.07.048] [PMID: ] - DOI - PubMed
    1. Straumann A, Degen L, Felder S, Conus S, Bussmann C, Thalmann C, et al. Budesonide as induction treatment for active eosinophilic esophagitis in adolescents and adults: a randomized, double-blind, placebo-controlled Study. Journal of Allergy and Clinical Immunology 2009;123(2 Suppl 1):S267-8.
Straumann 2011 {published data only}
    1. NCT00271349. Budesonide for eosinophilic esophagitis [Budesonide for eosinophilic esophagitis: a randomized, placebo-controlled, double-blind treatment study]. https://clinicaltrials.gov/ct2/show/NCT00271349 (first received 30 December 2005).
    1. Straumann A, Conus S, Bussmann C, Degen L, Beglinger C, Simon H. Maintenance-treatment of eosinophilic esophagitis with budesonide (BEE-M trial). Allergy: European Journal of Allergy and Clinical Immunology 2010;65 Suppl 92:342-3. [DOI: 10.1111/j.1398-9995.2010.02393.x] - DOI
    1. Straumann A, Conus S, Degen L, Frei C, Bussmann C, Beglinger C, et al. Long-term budesonide maintenance treatment is partially effective for patients with eosinophilic esophagitis. Clinical Gastroenterology and Hepatology 2011;9(5):400-9. [DOI: 10.1016/j.cgh.2011.01.017] [PMID: ] - DOI - PubMed
    1. Straumann A, Degen L, Bussmann C, Beglinger C, Schoepfer A, Thalmann C, et al. Long-term treatment of eosinophilic esophagitis with budesonide. Gastroenterology 2010;138(5 Suppl 1):S123.
Straumann 2013 {published data only}
    1. NCT01056783. Proof of concept study of OC000459 in eosinophilic esophagitis [A randomized, placebo-controlled, double-blind, single-centre proof-of-concept study of OC000459 in adult patients with active eosinophilic esophagitis]. https://clinicaltrials.gov/ct2/show/NCT01056783 (first received 26 January 2010).
    1. Straumann A, Bussmann C, Collins L P, Pettipher R, Hunter M, Steiner J, et al. Treatment of eosinophilic esophagitis with the CRTH2-antagonist oc000459: a novel therapeutic principle. United European Gastroenterology Journal 2013;1(1 Suppl 1):A123. [DOI: 10.1177/2050640613502899] - DOI
    1. Straumann A, Bussmann C, Perkins M, Pearce C, Pettipher R, Hunter M, et al. Treatment of eosinophilic esophagitis with the CRTH2-antagonist OC000459: a novel therapeutic principle. Swiss Medical Weekly 2012;142:8S.
    1. Straumann A, Bussmann C, Perkins MC, Collins LP, Pettipher R, Hunter M, et al. Treatment of eosinophilic esophagitis with the crth2-antagonist oc000459: a novel therapeutic principle. Gastroenterology May 2021;142(5 Suppl 1):S147. [DOI: 10.1016/S0016-5085(12)60552-6] - DOI
    1. Straumann A, Hoesli S, Stuck M, Simon HU, Bussmann Ch, Perkins M, et al. Anti-eosinophil activity and clinical efficacy of the CRTH2 antagonist OC000459 in eosinophilic esophagitis. Allergy: European Journal of Allergy and Clinical Immunology 2013;68(3):375-85. [DOI: 10.1111/all.12096] [PMID: ] - DOI - PubMed
Straumann 2020 {published data only}
    1. Biedermann L, Lucendo A, Miehlke S, Schlag C, Santander Vaquero C, Ciriza De Los Rios C, et al. A novel budesonide orodispersible tablet formulation is highly effective to maintain endoscopic inflammatory remission and even complete endoscopic remission in adult patients with eosinophilic esophagitis: Results from the 48-weeks, double-blind, placeb. United European Gastroenterology Journal 2019;7:55.
    1. EUCTR2014-001484-12-DE. Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active. https://eudract.ema.europa.eu/ (first received 9 April 2015).
    1. EUCTR2014-001485-99-DE. Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-. https://eudract.ema.europa.eu/ (first received 8 December 2015).
    1. Lucendo A, Miehlke S, Vieth M, Schlag C, Biedermann L, Santander C, et al. Budesonide orodispersible tablets are highly effective to maintain clinico-histological remission in adult patients with eosinophilic esophagitis: results from the 48-weeks, double-blind, placebo-controlled, pivotal eos-2 trial. Gastroenterology 2019;156:S-1509.
    1. Lucendo A, Miehlke S, Vieth M, Schlag C, Arnim U, Molina-Infante J, et al. Prolongation of eosinophilic esophagitis treatment with budesonide orodispersible tablets for incomplete responder is effective and safe: results from a 6-weeks open-label treatment phase of the pivotal trial EOS-1. Gastroenterology 2018;154:S-75.
Tytor 2021 {published data only}
    1. EUCTR2012-005842-39-SE. Treatment of patients with eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase II study. https://www.clinicaltrialsregister.eu/ctr-search/search?query=EUCTR2012-... (first received 5 November 2013).
    1. NCT02113267. Mometasone-furoate for treatment of eosinophilic esophagitis - a randomized placebo controlled study [Treatment of eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase ii study for evaluation of treatment effect on group level including symtom questionnaires]. https://clinicaltrials.gov/ct2/show/NCT02113267 (first received 14 April 2014).
    1. Tytor J, Larsson H, Bove M, Johansson L, Bergquist H. Topically applied mometasone furoate improves dysphagia in adult eosinophilic esophagitis-results from a double-blind, randomized, placebo-controlled trial. Scandinavian Journal of Gastroenterology 2021;56(6):629-34. [PMID: 10.1080/00365521.2021.1906314] [PMID: ] - DOI - PubMed

References to studies excluded from this review

Braathen 2006 {published data only}
    1. Braathen L, Straumann A, Wenk A, Spichtin H, Simon H U, Simon D. Eosinophilic esophagitis in adults - no clinical relevance of wheat and rye sensitizations. Allergy: European Journal of Allergy and Clinical Immunology 2006;61:1480-3. - PubMed
Ceves 2005 {published data only}
    1. Aceves SS, Dohil R, Newbury RO, Bastian JF. Topical viscous budesonide suspension for treatment of eosinophilic esophagitis. Journal of Allergy and Clinical Immunology 2005;116(3):705-6. - PubMed
Comer 2017 {published data only}
    1. Comer GM, Meltzer BA. A phase 1 study to assess the pharmacokinetics, safety, and tolerability of single dose APT-1011 administered under fed or fasted conditions or at bedtime in a randomised three-way, crossover design. United European Gastroenterology Journal 2017;5(5 Suppl 1):A351. [DOI: 10.1177/2050640617725676] - DOI
Della 2017 {published data only}
    1. Della Coletta M, Bartolo O, Savarino E, Tolone S, De Bortoli N, Bodini G, et al. Different proton pump inhibitors are equally effective in inducing endoscopic and histologic remission in patients with proton pump inhibitor-response esophageal eosinophilia. Neurogastroenterology and Motility 2017;29:23-4.
    1. Della Coletta M, Bartolo O, Savarino E, Tolone S, De Bortoli N, Bodini G, et al. Esomeprazole, rabeprazole and pantoprazole are equally effective in inducing endoscopic and histologic remission in patients with proton pump inhibitor-response esophageal eosinophilia. Digestive and Liver Disease 2018;50:e180-1.
    1. Della Coletta M, Savarino E, Tolone S, De Bortoli N, Bartolo O, Bodini G, et al. Esomeprazole, rabeprazole and pantoprazole are equally effective in inducing endoscopic and histologic remission in patients with proton pump inhibitor-response esophageal eosinophilia. UEG Journal 2017;5(5 Suppl 1):A352.
    1. Della Coletta M, Tolone S, De Bortoli N, Bartolo O, Bodini G, Marabotto E, et al. Different proton pump inhibitors are equally effective in inducing endoscopic and histologic remission in patients with proton pump inhibitor-response esophageal eosinophilia. Gastroenterology 2017;152(5 Suppl 1):S860-1.
Dellon 2020c {published data only}
    1. Dellon ES, Peterson KA, Murray JA, Falk GW, Gonsalves N, Chehade M, et al. Histologic and symptomatic improvement across multiple forms of eosinophilic gastrointestinal diseases in enigma, a randomized, double-blind, placebo-controlled trial of antolimab (AK002). Gastroenterology 2020;158(6 Suppl 1):S186.
    1. NCT04322708. A study of antolimab (AK002) in patients with active eosinophilic esophagitis. ClinicalTrials.gov 2020.
Eluri 2017 {published data only}
    1. Eluri S, Selitsky S, Parker J, Hollyfield J, Perjar I, Rusin S, et al. Clinical and molecular predictors of histologic response to topical steroid treatment in eosinophilic esophagitis: Results from a prospective study. Gastroenterology 2017;152:S858. - PMC - PubMed
Eluri 2017a {published data only}
    1. Eluri S, Shaheen NJ, Dellon ES, Perjar I, Hollyfield J, Rusin S, et al. A multivariable model predicts complete histologic response to topical corticosteroid treatment in eosinophilic esophagitis. Gastrointestinal Endoscopy 2017;85(5 Suppl 1):AB121.
EUCTR2014‐002465‐30‐IT 2014 {published data only}
    1. EUCTR2014-002465-30-IT. Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis. https://eudract.ema.europa.eu (first received 24 June 2014).
Francis 2012 {published data only}
    1. Francis D, Arora A, Jensen K, Nord S, Alexander J, Romero Y, et al. Results of ambulatory pH monitoring do not reliably predict response to therapy in patients with eosinophilic oesophagitis. Alimentary Pharmacology and Therapeutics 2012;35:300-7. - PubMed
Hefner 2016 {published data only}
    1. Hefner JN, Howard RS, Massey R, Valencia M, Stocker DJ, Philla KQ et al. A randomized controlled comparison of esophageal clearance times of oral budesonide preparations. Digestive Diseases and Sciences 2016;61:1582-90. - PubMed
Helou 2008 {published data only}
    1. Helou EF, Simonson J, Arora AS. 3-yr-follow-up of topical corticosteroid treatment for eosinophilic esophagitis in adults. American Journal of Gastroenterology 2008;9:2194-9. - PubMed
Hudgens 2017 {published data only}
    1. Hudgens S, Evans C, Phillips E, Hill M. Psychometric validation of the dysphagia symptom questionnaire in patients with eosinophilic esophagitis treated with budesonide oral suspension. Journal of Patient-reported Outcomes 2017;1:3. - PMC - PubMed
JPRN‐UMIN000021041 2016 {published data only}
    1. JPRN-UMIN000021041. A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis. https://trialsearch.who.int/?TrialID=JPRN-UMIN000021041 (first received 15 February 2016).
JPRN‐UMIN000026704 2017 {published data only}
    1. JPRN-UMIN000026704. A study investigating the effect of CYP2C19 polymorphism on the therapeutic efficacy in patients with eosinophilic esophagitis. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R0000... (first received 27 March 2017).
Kagalwalla 2006 {published data only}
    1. Kagalwalla AF, Sentongo TA, Ritz S, Hess T, Nelson SP et al. Effect of six-food elimination diet on clinical and histologic outcomes in eosinophilic esophagitis. Clinical Gastroenterology and Hepatology 2006;4:1097-102. - PubMed
Kavitt 2016 {published data only}
    1. Kavitt RT, Ates F, Slaughter JC, Higginbotham T, Shepherd BD, Sumner EL, et al. Randomized controlled trial comparing esophageal dilation to no dilation among adults with esophageal eosinophilia and dysphagia. Diseases of the Esophagus 2016;29:983-991. - PubMed
Kruszewski 2016 {published data only}
    1. Kruszewski P, Russo J, Franciosi J, Varni J, Platts-Mills T, Erwin E. Prospective, comparative effectiveness trial of cow's milk elimination and swallowed fluticasone for pediatric eosinophilic esophagitis. Diseases of the Esophagus 2016;29:377-84. - PubMed
Kuzumoto 2021 {published data only}
    1. Kuzumoto T, Tanaka F, Sawada A, Nadatani Y, Otani K, Hosomi S, et al. Vonoprazan shows efficacy similar to that of proton pump inhibitors with respect to symptomatic, endoscopic, and histological responses in patients with eosinophilic esophagitis. Esophagus 2021;18:372-9. - PubMed
Molina‐Infante 2017 {published data only}
    1. Molina-Infante J, Gonzalez-Cordero P, Casabona-Frances S, Arias A, Alcedo J, Garcia-Romero R, et al. Step-up empiric elimination diet for pediatric and adult eosinophilic esophagitis: The 2-4-6 study. Gastroenterology 2017;152:S207. - PubMed
NCT01458418 2011 {published data only}
    1. NCT01458418. A trial of montelukast for maintenance therapy of eosinophilic esophagitis in children. https://ClinicalTrials.gov (first received 18 October 2011).
NCT01498497 2011 {published data only}
    1. NCT01498497. A six month, safety follow-up study in eosinophilic esophagitis subjects who completed study PR-021. https://ClinicalTrials.gov (first received 16 December 2011).
NCT01702701 2012 {published data only}
    1. NCT01702701. Eosinophilic esophagitis treatment: montelukast vs fluticasone. https://ClinicalTrials.gov (first received 4 October 2012).
NCT01821898 2013 {published data only}
    1. NCT01821898. Eosinophilic esophagitis clinical therapy comparison trial. https://ClinicalTrials.gov (first received 27 March 2013).
NTR4892 2014 {published data only}
    1. NTR4892. Effect of amino acid formula on esophageal inflammation and intestinal permeability in adult eosinophilic esophagitis patients. https://trialsearch.who.int/Trial2.aspx?TrialID=NTR4892 (first received 5 November 2014).
Safroneeva 2015 {published data only}
    1. Safroneeva E, Coslovsky M, Kuehni CE, Zwahlen M, Haas N, Panczak R, et al. Eosinophilic oesophagitis: relationship of quality of life with clinical, endoscopic and histological activity. Alimentary Pharmacology and Therapeutics 2015;42:1000-10. - PubMed
Safroneeva 2018 {published data only}
    1. Safroneeva E, Balsiger L, Hafner D, Zwahlen M, Kuehni C, Roumet M, et al. Short- and long-term therapeutic goals of adult patients with eosinophilic esophagitis. Gastroenterology 2018;154:S256.
Safroneeva 2018a {published data only}
    1. Safroneeva E, Roumet MC, Coslovsky M, Kuehni C, Zwahlen M, Hirano I, et al. Both fibrotic and inflammatory endoscopic alterations contribute to symptom severity in adults with eosinophilic esophagitis. Gastroenterology 2018;154:S77.
Savarino 2015 {published data only}
    1. Savarino E, De Cassan C, Ottavia B, Caccaro R, Galeazzi F, Nicoletti L, et al. Clinical and high resolution manometry data support the hypothesis that proton pump inhibitor-responsive esophageal eosinophilia represent a GERD-related phenomenon. Gastroenterology 2015;148:S415. - PubMed
Song 2020 {published data only}
    1. Song I, Finkelman R, Lan L. A pharmacokinetic bridging study to compare systemic exposure to budesonide between budesonide oral suspension and entocort ec in healthy individuals. Drugs in R and D 2020;20:359-67. - PMC - PubMed
Spergel 2002 {published data only}
    1. Spergel JM, Beausoleil JL, Mascarenhas M, Liacouras CA. The use of skin prick tests and patch tests to identify causative foods in eosinophilic esophagitis. Journal of Allergy and Clinical Immunology 2002;109:363-8. - PubMed
Spergel 2005 {published data only}
    1. Spergel JM, Andrews T, Brown-Whitehorn TF, Beausoleil JL, Liacouras CA. Treatment of eosinophilic esophagitis with specific food elimination diet directed by a combination of skin prick and patch tests. Annals of Allergy, Asthma & Immunology 2005;95:336-43. - PubMed
Syverson 2020 {published data only}
    1. Syverson E, Hait E, McDonald D, Rubinstein E, Goldsmith J, Ngo P, et al. Oral viscous mometasone is an effective treatment for eosinophilic esophagitis. Journal of Allergy and Clinical Immunology 2020;8:1107-9. - PubMed
Tripp 2017 {published data only}
    1. Tripp C, Cuff C, Campbell AL, Hendrickson BA, Voss J, Melim T, et al. RPC4046, a novel anti-interleukin-13 antibody, blocks IL-13 binding to IL-13 alpha 1 and alpha 2 receptors: a randomized, double-blind, placebo-controlled, dose-escalation first-in-human study. Advances in Therapy 2017;34(6):1364-81. [DOI: 10.1007/s12325-017-0525-8] [PMID: ] - DOI - PMC - PubMed
    1. Tripp C, Cuff C, Miller R, Wu C, Campbell A, Hendrickson B, et al. The characterization of RPC4046, a novel anti-IL13 monoclonal antibody that blocks binding to IL-13 receptor alpha1 and alpha 2 in development for eosinophilic esophagitis: Results of a first-inhuman study. Annals of Allergy, Asthma and Immunology 2014;113(5 Suppl 1):A104-5.
Vazquez‐Elizondo 2013 {published data only}
    1. Vazquez-Elizondo G, Ngamruengphong S, Devault K R, Talley N, Achem S, Khrisna M. The outcome of patients with oesophageal eosinophilic infiltration after an eight-week trial of a proton pump inhibitor. Alimentary Pharmacology and Therapeutics 2013;38:1312-9. - PubMed
Wang 2017 {published data only}
    1. Wang R, Hirano I, Doerfler B, Zalewski A, Gonsalves N, Taft T. Assessing adherence and barriers to long term dietary elimination therapy in patients with eosinophilic esophagitis (EoE). Digestive Diseases and Sciences 2017;152:S864. - PMC - PubMed
    1. Wang R, Hirano I, Doerfler B, Zalewski A, Gonsalves N, Taft T. Assessing adherence and barriers to long-term elimination diet therapy in adults with eosinophilic esophagitis. Digestive Diseases and Sciences 2018;63:1756-62. - PMC - PubMed
Warners 2016 {published data only}
    1. Warners M, Vlieg-Boerstra B, Verheij J, Van Ampting M, Harthoorn L, De Jonge W, et al. Amino acid-based diet restores the esophageal mucosal integrity in eosinophilic esophagitis whereas duodenal mucosal integrity remains unaffected. Gastroenterology 2016;150:S18-9.
Wechsler 2017 {published data only}
    1. Wechsler J, Amsden K, Schwartz S, Manuel-Rubio M, Sulkowski M, Johnson K, et al. Efficacy of a 4-food elimination diet for children with eosinophilic esophagitis. Clin Gastroenterol Hepatol 2017;15:1698. - PMC - PubMed
Wright 2020 {published data only}
    1. Wright B, Rank M, Kita H, Katzka D, Shim K, Doyle A, et al. Peanut oral immunotherapy induces gastrointestinal eosinophilia in a longitudinal randomized controlled trial. Journal of Allergy and Clinical Immunology 2020;145:AB84.
Wright 2021 {published data only}
    1. Wright BL, Fernandez-Becker NQ, Kambham N, Purington N, Cao S, Tupa D, et al. Gastrointestinal eosinophil responses in a longitudinal, randomized trial of peanut oral immunotherapy. Clinical Gastroenterology and Hepatology 2021;19:1151-9. - PMC - PubMed

References to studies awaiting assessment

Amini 2022 {published data only}
    1. Amini N, Khademian M, Momen T, Saneian H, Nasri P, Famouri F, et al. The effectiveness of synbiotic on the improvement of clinical symptoms in children with eosinophilic esophagitis. International Journal of Pediatrics 2022;2022:4211626. - PMC - PubMed
NCT01846962 2012 {published data only}
    1. NCT01846962. Dietetic versus topical steroids for pediatric eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT01846962 2012;(first received 6 May 2013).

References to ongoing studies

ACTRN12619000141145 2019 {published data only}
    1. ACTRN12619000141145. Two food group elimination diet versus swallowed fluticasone for the management of adult eosinophilic esophagitis, a single-centred randomised prospective study. https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12619000141145 (first received 30 January 2019).
ACTRN12621001406897 {published data only}
    1. ACTRN12621001406897. Efficacy of Fucoidan for eosinophilic oesophagitis: a phase 2 pilot study. https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12621001406897 (first received 19 October 2021).
EUCTR2017‐003516‐39‐ES 2021 {published data only}
    1. EUCTR2017-003516-39-DE. A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003516-39/DE (first received 21 December 2020).
    1. EUCTR2017-003516-39-ES. A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003516-39/ES (first received 21 December 2020).
EUCTR2017‐003737‐29‐ES 2019 {published data only}
    1. EUCTR2017-003737-29-DE. Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receiv. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003737-29/DE (first received 17 December 2018).
    1. EUCTR2017-003737-29-ES. Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receiv. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003737-29/ES 2019.
EUCTR2019‐002871‐32‐ES 2019 {published data only}
    1. EUCTR2019-002871-32-ES. A study of benralizumab in patients with eosinophilic esophagitis. https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-002871-32/ES (first received 5 February 2019).
    1. EUCTR2019-002871-32-NL. A study of benralizumab in patients with eosinophilic esophagitis. https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-002871-32/NL (first reviewed 2 March 2020).
EUCTR2019‐004391‐19‐NL 2020 {published data only}
    1. EUCTR2019-004391-19-NL. Study to evaluate the efficacy and safety of AK002 in patients with active eosinophilic esophagitis. https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004391-19/NL (first received 2 March 2020).
EUCTR2020‐000082‐16‐DE 2020 {published data only}
    1. EUCTR2020-000082-16-DE. A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagus. https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000082-16/DE (first received 29 July 2020).
    1. NCT04849390. A study to investigate the efficacy and tolerability of ESO-101 in patients With eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT04849390 (first received 19 April 2021).
EUCTR2020‐001314‐37‐DE 2020 {published data only}
    1. EUCTR2020-001314-37-DE. clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagus. https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001314-37/DE (first received 27 November 2020).
EUCTR2020‐003226‐23‐BE 2020 {published data only}
    1. EUCTR2020-003226-23-BE. A study evaluating the efficacy and safety of etrasimod in the treatment of patients with eosinophilic esophagitis. https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003226-23/BE (first received 23 November 2020).
    1. NCT04682639. A study to assess the safety and efficacy of oral etrasimod in adult participants with eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT04682639 (first received 19 December 2020).
EUCTR2020‐004336‐16‐DE 2021 {published data only}
    1. EUCTR2020-004336-16-DE. A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis. https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004336-16/DE (first received 29 September 2021).
    1. NCT04753697. A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent participants With eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT04753697 (first received 29 September 2021).
Henry 2019 {published data only}
    1. Henry S, Al'Atrash H, James F, Molle-Rios Z, Lee D, Suskind D, et al. A novel food additive removal diet for eosinophilic esophagitis (free study): conceptual design and clinical trial methods. Journal of Pediatric Gastroenterology and Nutrition 2019;69(Suppl 2):195. [DOI: ]
IRCT20171230038142N14 2020 {published data only}
    1. IRCT20171230038142N14. evaluation of efficacy of synbiotics in children with eosinophilic esophagitis. https://en.irct.ir/search/result?query=IRCT20171230038142N14 (first received 11 March 2020).
IRCT20191211045703N1 2020 {published data only}
    1. IRCT20191211045703N1. Comparison of the efficay and side effects of nebulized oral pulmicort and inhaler budesonide in patients with eosinophilic esophagitis. https://en.irct.ir/search/result?query=IRCT20191211045703N1 (first received 24 June 2020).
JPRN‐jRCT2051200140 {published data only}
    1. JPRN-jRCT2051200140. A phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC-93538 in adult and adolescent subjects with eosinophilic esophagitis. https://trialsearch.who.int/Trial2.aspx?TrialID=JPRN-jRCT2051200140 (first received 19 February 2021).
NCT02873468 {published data only}
    1. NCT02873468. Efficacy and safety of three doses of florence oral suspension in adults with eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT02873468 (first received 16 August 2016).
NCT03656380 2019 {published data only}
    1. NCT03656380. Mepo for EoE study. https://clinicaltrials.gov/ct2/show/NCT03656380 (first received 18 August 2018).
NCT03657771 2018 {published data only}
    1. NCT03657771. A food additive removal diet for pediatric eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT03657771 (first received 31 August 2018).
NCT03781596 {published data only}
    1. NCT03781596. EoE RCT fluticasone and omeprazole vs fluticasone alone. https://clinicaltrials.gov/ct2/show/NCT03781596 (first received 20 December 2018).
NCT04248712 2020 {published data only}
    1. NCT04248712. Antihistamines in eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT04248712 (first received 28 January 2020).
NCT04281108 2020 {published data only}
    1. EUCTR2019-001521-27-DE. Study with eosinophilic esophagitis subjects. https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-001521-27/DE (first received 3 August 2020).
    1. NCT04281108. Efficacy and safety APT-1011 in adult subjects with eosinophilic esophagitis (EoE) (FLUTE-2). https://clinicaltrials.gov/ct2/show/NCT04281108 (first received 20 February 2020).
    1. NCT05083312. Efficacy and safety APT-1011 in adolescent subjects with eosinophilic esophagitis (EoE) - a sub-study of the FLUTE-2 Trial. https://clinicaltrials.gov/ct2/show/NCT05083312 (first received 6 October 2021).
NCT04394351 2020 {published data only}
    1. NCT04394351. Study to investigate the efficacy and safety of dupilumab in pediatric patients with active eosinophilic esophagitis (EoE). https://clinicaltrials.gov/ct2/show/NCT04394351 (first received 1 September 2020).
NCT04543409 {published data only}
    1. NCT04543409. A study of benralizumab in patients with eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT04543409 2020.
NCT04593251 2020 {published data only}
    1. NCT04593251. Dose escalation study to evaluate an experimental new treatment (CALY-002) in healthy subjects and subjects with celiac disease and eosinophilic esophagitis. https://ClinicalTrials.gov (first received 13 October 2020).
NCT04835168 2022 {published data only}
    1. NCT04835168. Safety and pharmacokinetics of orodispersible BT-11 in active eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT04835168 (first received 8 April 2021).
NCT05084963 2021 {published data only}
    1. NCT05084963. A study to assess the efficacy, safety and tolerability of IRL201104 in adults with active eosinophilic esophagitis. https://clinicaltrials.gov/ct2/show/NCT05084963 (first received 20 October 2021).
NCT05214599 {published data only}
    1. NCT05214599. Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE). https://ClinicalTrials.gov/show/NCT05214599 (first received 28 January 2022).
NCT05543512 {published data only}
    1. NCT05543512. The Immune Directed Individualized Elimination Therapy (iDIET) Study. https://ClinicalTrials.gov/show/NCT05543512 (first received 16 September 2022).
NCT05583227 {published data only}
    1. EUCTR2022-001294-31. Efficacy and safety of tezepelumab in patients with eosinophilic esophagitis. https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2022-001294-31-DK 2022 (first received 4 October 2022).
    1. NCT05583227. Efficacy and safety of tezepelumab in patients with eosinophilic esophagitis. https://ClinicalTrials.gov/show/NCT05583227 (first received 17 October 2022).
NCT05634746 {published data only}
    1. NCT05634746. 24- week induction study of APT-1011 in adult subjects with eosinophilic esophagitis (EoE) (FLUTE 3). https://ClinicalTrials.gov/show/NCT05634746 (first received 2 December 2022).
NCT05695456 {published data only}
    1. NCT05695456. Targeted elimination diet in EoE patients following identification of trigger nutrients using confocal laser endomicroscopy. https://ClinicalTrials.gov/show/NCT05695456 (first received 25 January 2023).

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References to other published versions of this review

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