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Dupilumab Improves Health-Related Quality of Life (HRQoL) and Reduces Symptom Burden in Patients with Eosinophilic Esophagitis (EoE): Results From Part A of a Randomized, Placebo-Controlled Three-Part Phase 3 Study

2021; Elsevier BV; Volume: 147; Issue: 2 Linguagem: Inglês

10.1016/j.jaci.2020.12.347

1097-6825

Evan S. Dellon, Marc E. Rothenberg, Ikuo Hirano, Mirna Chehade, Albert J. Bredenoord, Jonathan M. Spergel, Qiong Zhao, Bethany Beazley, Isabelle Guillemin, Leda Mannent, Elizabeth Laws, Nikhil Amin, Brad Shumel, Jennifer Maloney, Siddhesh Kamat,

Eosinophilic Esophagitis

Dupilumab, a fully human mAb, blocks the shared receptor component for interleukin-4/interleukin-13. Part A of a 3-part, phase 3 study (NCT03633617) evaluated the efficacy/safety of weekly dupilumab 300mg versus placebo in adolescent/adult EoE patients. Co-primary endpoints, proportion of patients achieving peak esophageal intraepithelial eosinophil count ≤6eos/hpf, and change from baseline in Dysphagia Symptom Questionnaire score at Week 24, were achieved and dupilumab was well tolerated. This analysis assesses dupilumab’s effect versus placebo on HRQoL and symptom burden at Week 24 (secondary/exploratory endpoints). 81 patients (dupilumab=42; placebo=39) were enrolled. HRQoL was assessed by 11-item EoE Impact Questionnaire (EoE-IQ), measuring emotional, social, productivity, and sleep-related impacts of EoE (score range: 1–5). Symptom burden was assessed by 5-item EoE Symptom Questionnaire (EoE-SQ-Frequency), measuring frequency of EoE symptoms other than dysphagia/swallowing pain, including chest pain, stomach pain, heartburn, regurgitation, and vomiting (score range: 5–25). Higher EoE-IQ/EoE-SQ-Frequency scores indicate greater impact on HRQoL/symptom burden. Proportion of patients reporting dysphagia improvement on the Patient Global Impression of Change (PGIC) was evaluated. At baseline, mean EoE-IQ was 2.0/2.4 and mean EoE-SQ-Frequency 10.1/11.5 in dupilumab/placebo groups, respectively. At Week 24, LS mean change from baseline difference for dupilumab versus placebo was −0.4(95% CI:−0.6,−0.1;nominal P=0.008) for EoE-IQ and −1.7(−2.9,−0.5;nominal P=0.005) for EoE-SQ-Frequency. At Week 24, 40.5% versus 7.7% (nominal P<0.001) of dupilumab versus placebo patients reported dysphagia as “very much better” compared with baseline on the PGIC; 26.2% versus 10.3%(nominal P=0.074) reported “moderately better”. Weekly dupilumab improved disease-specific HRQoL and reduced symptom burden in adolescent/adult EoE patients.