Amsterdam University Medical Center Amsterdam, Utrecht, Netherlands
Introduction: Swallowed topical corticosteroids (STC) are a first-line treatment for eosinophilic esophagitis (EoE) but are not uniformly effective. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for IL-4/IL-13, key and central drivers of type 2 inflammation. In Parts A and B of the phase 3 LIBERTY-EoE-TREET (NCT03633617) study, weekly dupilumab 300mg improved clinical, symptomatic, histologic, and endoscopic aspects of EoE and was generally well tolerated in adult and adolescent patients with EoE. The objective of this analysis was to assess the efficacy of weekly dupilumab 300mg vs placebo at Week 24 in patients from Part B with and without prior STC use history for EoE.
Methods: Patients who received STCs for EoE ≤8 weeks prior to baseline were excluded from the study. Endpoints at Week 24 were: proportion achieving peak eosinophil count (PEC) ≤6/high-power field (hpf); absolute and % change in Dysphagia Symptom Questionnaire (DSQ) score; % change in PEC; absolute change in Histologic Scoring System (HSS) grade and stage scores and Endoscopic Reference Score (EREFS).
Results: 55/80 (69%) and 56/79 (71%) of dupilumab- and placebo-treated patients had STC use history; 38/80 (48%) and 39/79 (49%) of dupilumab- and placebo-treated patients had inadequate response/intolerance/contraindication to STCs. For patients treated with dupilumab qw vs placebo PEC≤6/hpf was achieved by 63.6% vs 5.4% of patients with, and 48.0% vs 8.7% without prior STC use. Difference vs placebo (95% CI) for patients with/without prior STC use: absolute change in DSQ −11.63 (−17.64,−5.62)/−6.79 (−15.78,2.20); % change in PEC −86.97 (−116.38,−57.57)/−91.23 (−124.23,−58.24); absolute change in EoE-HSS grade −0.73 (−0.86,−0.60)/−0.58 (−0.80,−0.35) and stage −0.74 (−0.87,−0.62)/−0.54 (−0.75,−0.33); absolute change in EREFS −4.2 (−5.31,−3.18)/−2.7 (−4.58,−0.86); % change in DSQ −49.3 (−72.3, −26.2)/−20.8 (−58.3,16.7). Dupilumab was generally well tolerated in the intent-to-treat population; the most common TEAEs for dupilumab/placebo were injection-site reactions (37.5/33.3%).
Discussion: In Part B of this phase 3 study, dupilumab improved clinical, symptomatic, histologic, and endoscopic aspects of EoE regardless of STC use history.
