Poster Session II - A196 DUPILUMAB IMPROVES DYSPHAGIA, ODYNOPHAGIA, CHEST PAIN, AND HEARTBURN IN ADULT AND ADOLESCENT PATIENTS WITH EOSINOPHILIC ESOPHAGITIS UP TO 52 WEEKS: POST HOC ANALYSIS OF THE LIBERTY EOE TREET STUDY

TL;DR

Dupilumab significantly improves swallowing difficulties and chest pain in patients with eosinophilic esophagitis up to 52 weeks.

Contribution

This study shows sustained improvement in EoE symptoms with dupilumab over 52 weeks.

Findings

Dupilumab improved dysphagia and odynophagia compared to placebo at Week 24.

Improvements in chest pain and heartburn were maintained through Week 52.

Patients switching from placebo to dupilumab also showed symptom improvement by Week 52.

Abstract

Dysphagia, odynophagia, chest pain, and heartburn are symptoms that disrupt the daily lives of patients with eosinophilic esophagitis (EoE). Dupilumab, a fully human monoclonal antibody, is approved in the US and EU for EoE in patients aged ≥1 year weighing ≥15 kg. In the pivotal phase 3 LIBERTY EoE TREET study (NCT03633617), dupilumab 300 mg weekly (qw) significantly improved dysphagia vs placebo at Week (W)24.

We assessed the impact of continued dupilumab use on dysphagia, odynophagia, chest pain, and heartburn to Week 52.

Data were pooled from patients aged ≥12 years, treated with dupilumab qw or placebo for 24 weeks in Parts A and B of LIBERTY EoE TREET who continued to Part C and received dupilumab qw to W52. The number of days without dysphagia (Dysphagia Symptom Questionnaire [DSQ] question [Q] 2) and number of days without odynophagia (DSQ Q4; answered only if dysphagia is reported in Q2) over a 14-day period were analyzed at baseline and every 2 weeks to W52. Odynophagia outcomes were assessed in patients with ≥1 day of odynophagia in the 14 days prior to baseline. The proportion of patients without both chest pain and heartburn over the previous 7 days was measured by the EoE Symptom Questionnaire (EoE-SQ), which assesses 5 symptoms (chest pain, stomach pain, heartburn, regurgitation, throwing up) on a 5-point scale (1=never, 5=more than once a day) at W24 and W52.

At W24, the mean number of days without dysphagia and without odynophagia was greater in patients on dupilumab vs placebo at W24 (no dysphagia: 8.7 vs 5.5 days; no odynophagia: 10.1 vs 6.8 days respectively; both nominal P<0.0001) (Fig. 1). By W52, the mean number of days without dysphagia and without odynophagia increased in patients switching from placebo to dupilumab (no dysphagia: 8.6 days; no odynophagia: 8.9 days) and was maintained in patients continuing dupilumab (no dysphagia: 9.4 days; no odynophagia: 10.6 days) (Fig. 1). At W24, a greater proportion of patients on dupilumab had no chest pain or heartburn vs placebo (48.6% vs 28.4%, nominal P<0.01). By W52, the proportion of patients with no chest pain or heartburn increased in the group who switched from placebo to dupilumab at W24 (58.5%) and was maintained in patients continuing dupilumab (54.3%).

Dupilumab improved dysphagia, odynophagia, chest pain, and heartburn vs placebo, at W24 in patients with EoE. Improvements were further maintained to W52.

Sanofi and Regeneron Pharmaceuticals Inc.

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