Dupilumab Improves Health-Related Quality of Life and a Range of Symptoms in Patients With Eosinophilic Esophagitis

Author:

Spergel Jonathan M.1ORCID,Chehade Mirna2,Dellon Evan S.3,Bredenoord Albert J.4ORCID,Sun Xian5,Glotfelty Lila6,Shabbir Arsalan5,Tilton Sarette T.6,McCann Eilish5

Affiliation:

1. Division of Allergy and Immunology, Children's Hospital of Philadelphia, and Department of Pediatrics, Perelman School of Medicine at University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA;

2. Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York, New York, USA;

3. Center for Esophageal Disease and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA;

4. Amsterdam University Medical Center, Amsterdam, the Netherlands;

5. Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA;

6. Sanofi, Cambridge, Massachusetts, USA.

Abstract

INTRODUCTION: Improvements in symptomatic experience and health-related quality of life (HRQoL) are among the most important treatment benefits in patients with eosinophilic esophagitis (EoE). We assessed the impact of dupilumab treatment on HRQoL, patients' impression of dysphagia, and symptoms beyond dysphagia in adults/adolescents (≥12 years) with EoE in parts A and B of the LIBERTY EoE TREET (NCT03633617) study. METHODS: The EoE Symptom Questionnaire (EoE-SQ; frequency and severity of nondysphagia symptoms), EoE Impact Questionnaire (impact of EoE on HRQoL), and Patient Global Impression of Severity and Patient Global Impression of Change of dysphagia were used to assess the efficacy of weekly dupilumab 300 mg vs placebo. RESULTS: At week 24, dupilumab reduced EoE-SQ Frequency (least squares mean difference vs placebo [95% confidence interval] part A −1.7 [–2.9, −0.5], part B −1.4 [–2.3, −0.5]; both P < 0.01) and EoE-SQ Severity (part A −2.0 [–3.9, 0.0], P < 0.05, part B −1.5 [–3.0, 0.1], P = 0.07) overall scores, and improved scores across all individual items. Improvement in the dupilumab group was clinically meaningful to patients. Dupilumab also meaningfully improved EoE Impact Questionnaire average scores and improved individual item scores at week 24, particularly emotional and sleep disturbance. More dupilumab-treated patients reported improvement in the Patient Global Impression of Change of dysphagia vs placebo or reported having no symptoms per the Patient Global Impression of Severity of dysphagia at week 24. DISCUSSION: Dupilumab reduced the impact of EoE on multiple aspects of HRQoL, patients' impression of dysphagia, and frequency and severity of symptoms beyond dysphagia in adults/adolescents with EoE.

Funder

Sanofi and Regeneron Pharmaceuticals Inc

Publisher

Ovid Technologies (Wolters Kluwer Health)

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