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. 2023 Apr 1;118(4):744-747.
doi: 10.14309/ajg.0000000000002094. Epub 2022 Dec 20.

Dysphagia Days as an Assessment of Clinical Treatment Outcome in Eosinophilic Esophagitis

Ikuo Hirano  1 , Marc E Rothenberg  2   3 , Sandra Zhang  4 , Claudia de Oliveira  4 , Christina M Charriez  4 , Karin S Coyne  5 , Elizabeth Dansie Bacci  6 , Evan S Dellon  7
Affiliations

Dysphagia Days as an Assessment of Clinical Treatment Outcome in Eosinophilic Esophagitis

Ikuo Hirano et al. Am J Gastroenterol. .

Abstract

Introduction: The aim of this study was to evaluate Dysphagia Days as a measure of symptom improvement in patients with eosinophilic esophagitis from the HEROES study.

Methods: Dysphagia Days, defined as a yes answer to the following question: During any meal today, did food go down slowly or get stuck in your throat or chest? was assessed for cendakimab vs placebo.

Results: A statistically significant reduction in the mean number of Dysphagia Days experienced was observed with cendakimab 360 mg vs placebo at week 16 (-4.67 vs -1.83; P = 0.0115); an even greater improvement was observed in steroid-refractory patients vs placebo (-4.48 vs -0.04; P = 0.0079).

Discussion: Dysphagia Days represents a relevant clinical end point to capture dysphagia-related symptoms.

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Conflict of interest statement

Guarantor of the article: Ikuo Hirano, MD.

Specific author contributors: Conceptualization: E.S.D. Data curation: I.H. and S.Z. Investigation: I.H. and E.S.D. Methodology: E.B., E.S.D., S.Z., C.M.C., and K.S.C. Project administration: I.H. Supervision: I.H. Writing–original draft: I.H., S.Z., C.D.O., and C.M.C. Writing–review and editing: All authors.

Financial support: This study was supported by Bristol Myers Squibb. Writing and editorial assistance were provided by Claire Jarvis, PhD, and John Simmons, MD, of Peloton Advantage, an OPEN Health company, funded by Bristol Myers Squibb.

Potential competing interests: I.H. has served as a consultant for Ellodi/Adare, Allakos, Amgen, Arena, AstraZeneca, Celgene/Receptos/Bristol Myers Squibb, Esocap, Gossamer Bio, Nextsone, Parexel/Calyx, Regeneron/Sanofi, and Shire/Takeda and has received grant/research support from Ellodi/Adare, Allakos, Celgene/Receptos/Bristol Myers Squibb, Sanofi/Regeneron, and Shire/Takeda. M.E.R. has served as a consultant to Pulm One, Spoon Guru, ClostraBio, Serpin Pharm, Allakos, Celldex, Nextstone One, Bristol Myers Squibb, AstraZeneca, Ellodi Pharma, GlaxoSmithKline, Regeneron/Sanofi, Revolo Biotherapeutics, and Guidepoint; has an equity interest in Pulm One, Spoon Guru, ClostraBio, Serpin Pharm, Allakos, Celldex, and Nextstone One; and receives royalties from reslizumab (Teva Pharmaceuticals), PEESSv2 (Mapi Research Trust), and UpToDate. M.E.R. is an inventor of patents owned by Cincinnati Children's Hospital. S.Z, C.d.O., and C.M.C. are employees of Bristol Myers Squibb. K.S.C. and E.D.B. are employees of Evidera. E.S.D. has served as a consultant for Abbott, AbbVie, Adare/Ellodi, Aimmune, Allakos, Amgen, Arena, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/Bristol Myers Squibb, Celldex, Eli Lilly, EsoCap, GSK, Gossamer Bio, Landos, Morphic, Parexel/Calyx, Regeneron, Robarts/Alimentiv, Salix, Sanofi, and Shire/Takeda; has received grant/research support from Adare/Ellodi, Allakos, AstraZeneca, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/Bristol Myers Squibb, Regeneron, and Shire/Takeda; and has received educational grants from Allakos, Banner, and Holoclara.

Figures

Figure 1.
Figure 1.
Mean (SE) Dysphagia Days in the double-blinded treatment period (ITT). DB, double-blind; ITT, intent-to-treat.
Figure 2.
Figure 2.
Mean (SE) Dysphagia Days in the double-blinded treatment period (steroid-refractory subgroup). Of the randomized ITT patients, 46.5% were steroid-refractory. DB, double-blind; ITT, intent-to-treat.
See this image and copyright information in PMC

References

    1. Schoepfer AM, Straumann A, Panczak R, et al. Development and validation of a symptom-based activity index for adults with eosinophilic esophagitis. Gastroenterology 2014;147(6):1255–66.e21. - PMC - PubMed
    1. Dellon ES, Irani AM, Hill MR, et al. . Development and field testing of a novel patient-reported outcome measure of dysphagia in patients with eosinophilic esophagitis. Aliment Pharmacol Ther 2013;38(6):634–42. - PubMed
    1. Martin LJ, Franciosi JP, Collins MH, et al. Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS v2.0) identify histologic and molecular correlates of the key clinical features of disease. J Allergy Clin Immunol 2015;135(6):1519–28.e8. - PMC - PubMed
    1. Blanchard C, Mingler MK, Vicario M, et al. IL-13 involvement in eosinophilic esophagitis: Transcriptome analysis and reversibility with glucocorticoids. J Allergy Clin Immunol 2007;120(6):1292–300. - PubMed
    1. Tripp CS, Cuff C, Campbell AL, et al. RPC4046, A novel anti-interleukin-13 antibody, blocks IL-13 binding to il-13 α1 and α2 receptors: A randomized, double-blind, placebo-controlled, dose-escalation first-in-human study. Adv Ther 2017;34(6):1364–81. - PMC - PubMed

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