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Clinical Trial
. 2024 Feb 23;73(3):398-406.
doi: 10.1136/gutjnl-2023-330220.

Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: a subgroup analysis of the phase 3 LIBERTY EoE TREET study

Albert J Bredenoord  1 , Evan S Dellon  2 , Ikuo Hirano  3 , Alfredo J Lucendo  4 , Christoph Schlag  5 , Xian Sun  6 , Lila Glotfelty  7 , Leda Mannent  7 , Jennifer Maloney  6 , Elizabeth Laws  7 , Eric Mortensen  6 , Arsalan Shabbir  6
Affiliations
Clinical Trial

Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: a subgroup analysis of the phase 3 LIBERTY EoE TREET study

Albert J Bredenoord et al. Gut. .

Abstract

Objective: To assess the effect of long-term dupilumab on histological, symptomatic and endoscopic aspects of eosinophilic oesophagitis (EoE) in adolescent and adult patients with and without prior use of swallowed topical corticosteroids (STC) or prior inadequate response, intolerance or contraindication to STC.

Design: Pre-specified analysis of data from the phase 3 LIBERTY EoE TREET study on patients who received dupilumab 300 mg once a week or placebo for 24 weeks (W24) in parts A and B, and an additional 28 weeks (W52) in part C. Patients were categorised as with/without prior STC use and with/without inadequate/intolerance/contraindication to STC. The proportion of patients achieving ≤6 eosinophils per high-power field (eos/hpf), absolute change in Dysphagia Symptom Questionnaire (DSQ) score, mean change in Endoscopic Reference Score and Histologic Scoring System grade/stage scores were assessed for each subgroup.

Results: Regardless of prior STC use, dupilumab increased the proportion of patients achieving ≤6 eos/hpf and improved DSQ score versus placebo at W24, with improvements maintained or improved at W52. The DSQ score and the proportion of patients achieving ≤6 eos/hpf after switching from placebo to dupilumab at W24 were similar to those observed in the dupilumab group at W24, regardless of prior STC use or inadequate/intolerance/contraindication to STC. Improvements in other outcomes with dupilumab were similar in patients with/without prior STC use or inadequate/intolerance/contraindication to STC.

Conclusion: Dupilumab 300 mg once a week demonstrated efficacy and was well tolerated in patients with EoE regardless of prior STC use or inadequate response, intolerance and/or contraindication to STC.

Trial registration number: NCT03633617.

Keywords: clinical trials; gastrointestinal pathology; health economics; inflammatory diseases; quality of life.

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Conflict of interest statement

Competing interests: AJB: Dr Falk Pharma, Norgine, Nutricia, Sanofi, SST and Thelial—research funding; Alimentiv, Aqilion, AstraZeneca, Dr Falk Pharma, Laborie, Medtronic, Regeneron Pharmaceuticals and Sanofi—consulting fees. ED: Adare/Ellodi, Allakos, Arena/Pfizer, AstraZeneca, Celgene/Receptos/BMS, GSK, Meritage, Miraca, Nutricia, Regeneron Pharmaceuticals, Revolo and Shire/Takeda—research funding; 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, Gossamer Bio, GSK, Holoclara, Invea, Knightpoint, Landos, LucidDx, Morphic, Nexstone Immunology, Nutricia, Parexel/Calyx, Phathom, Regeneron Pharmaceuticals, Revolo, Robarts/Alimentiv, Salix, Sanofi, Shire/Takeda, Target RWE and Upstream Bio—consulting fees; Allakos, Holoclara and Invea—educational funding. IH: Allakos, AstraZeneca, Calyx/Parexel, Eli Lilly, Ellodi/Adare, EsoCap, Gossamer Bio, Nexstone, Pfizer/Arena, Phathom, Receptos/BMS, Sanofi/Regeneron Pharmaceuticals and Shire/Takeda—consulting fees; Allakos, AstraZeneca, Ellodi/Adare, Pfizer/Arena, Receptos/BMS, Regeneron Pharmaceuticals and Shire/Takeda—research funding; Sanofi/Regeneron Pharmaceuticals—speaker fees. AJL: Dr Falk Pharma and EsoCap—consulting fees; Dr Falk Pharma, Ellodi and Regeneron Pharmaceuticals—research funding. CS: Adare Pharmaceuticals, AstraZeneca, Calypso, EsoCap, Dr Falk Pharma, GmbH and Regeneron Pharmaceuticals—consulting fees. AS, EM, JM and XS: employees of Regeneron Pharmaceuticals and may hold stock and/or stock options in the company. EL, LG and LM: employees of Sanofi and may hold stock and/or stock options in the company.

Figures

Figure 1
Figure 1
Proportion of patients with peak oesophageal intraepithelial eosinophil count ≤6 eos/hpf with or without use of prior STC at (A) week 24 and (B) week 52, and with or without inadequate response, intolerance and/or contraindication to STC at (C) week 24 and (D) week 52. ****p<0.0001, **p<0.01, *p<0.05 versus placebo. eos/hpf, eosinophils per high-power field; qw, once a week; STC, swallowed topical corticosteroids.
Figure 2
Figure 2
Change from baseline part A or B in DSQ score for patients with or without use of prior STC at (A) week 24 and (B) week 52, and with or without inadequate response, intolerance and/or contraindication to STC at (C) week 24 and (D) week 52. DSQ, Dysphagia Symptom Questionnaire; LS, least squares; qw, once a week; STC, swallowed topical corticosteroids.
Figure 3
Figure 3
Per cent change from baseline part A or B in peak oesophageal intraepithelial eos count in patients with or without use of prior STC at (A) week 24 and (B) week 52, and with or without inadequate response, intolerance and/or contraindication to STC at (C) week 24 and (D) week 52. eos, eosinophils; LS, least squares; qw, once a week; STC, swallowed topical corticosteroids.
Figure 4
Figure 4
Absolute change in EREFS total score from baseline part A or B with or without use of prior STC at (A) week 24 and (B) week 52, and with or without inadequate response, intolerance and/or contraindication to STC to (C) week 24 and (D) week 52. EREFS, Endoscopic Reference Score; LS, least squares; qw, once a week; STC, swallowed topical corticosteroids.
Figure 5
Figure 5
Absolute change in HSS grade score from baseline part A or B with or without use of prior STC at (A) week 24 and (B) week 52, and with or without inadequate response, intolerance and/or contraindication to STC to (C) week 24 and (D) week 52. HSS, Histology Scoring System; LS, least squares; qw, once a week; STC, swallowed topical corticosteroids.
Figure 6
Figure 6
Absolute change in HSS stage score from baseline part A or B with or without use of prior STC at (A) week 24 and (B) week 52, and with or without inadequate response, intolerance and/or contraindication to STC to (C) week 24 and (D) week 52. HSS, Histology Scoring System; LS, least squares; qw, once a week; STC, swallowed topical corticosteroids.
Figure 7
Figure 7
Proportion of patients with peak oesophageal intraepithelial eosinophil count <15 eos/hpf with or without use of prior STC at (A) week 24 and (B) week 52, and with or without inadequate response, intolerance and/or contraindication to STC at (C) week 24 and (D) week 52. ****p<0.0001, ***p<0.001, *p<0.05 versus placebo. eos/hpf, eosinophils per high-power field; qw, once a week; STC, swallowed topical corticosteroids.
See this image and copyright information in PMC

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