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In part A of the trial, 60% of patients treated with dupilumab weekly met the primary endpoint of histologic remission, compared to 5% of the placebo group.
Dupilumab results in histologic improvements in patients with eosinophilic esophagitis (EoE).
A team, led by Evan S. Dellon, MD, MPH, FACG, Professor of Medicine and Adjunct Professor of Epidemiology, Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, analyzed the safety and efficacy of dupilumab in either weekly or biweekly doses compared to placebo in patients with EoE.
Dupilumab, currently the only treatment approved by the US Food and Drug Administration (FDA) for EoE, is a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13 signaling, both of which play key roles in the disease.
In the three-part, phase 3 trial, the investigators examined patients aged 12 years or older. Each participant was randomized to receive either subcutaneous dupilumab 300 mg weekly or placebo in part A of the study.
For part B, patients were treated with either dupilumab 300 mg weekly or biweekly or placebo weekly.
Patients who completed either part A or B were eligible to continue to part C.
Participants who completed part A were treated with dupilumab 300 mg up to week 52. Part C for those who completed part B is ongoing.
The investigators sought primary endpoints of histologic remission, defined as no more than 6 eosinophils per high-power field at week 24 and the change from baseline in the Dysphagia Symptom Questionnaire (DSQ) score.
The results show 60% (n = 25) of patients met the primary endpoint of histologic remission who were treated with dupilumab in part A, compared to 5% (n = 2) of the placebo group (difference, 55 percentage points; 95% CI, 40-71; P <0.001).
The results from part B show histologic remission occurred in 59% (n = 47) of the weekly dupilumab group, 60% (n = 49) of the biweekly dupilumab group, and 6% (n = 5) of the placebo group (difference between weekly dupilumab and placebo, 54 percentage points; 95% CI, 41-66; P <0.001; difference between dupilumab every 2 weeks and placebo, 56 percentage points; 95% CI, 43-69). At baseline, the mean DSQ scores were 33.6±12.41 in part A and 36.7±11.22 in part B.
However, these scores improved in the weekly dupilumab group compared to placebo, with differences of –12.32 (95% CI, –19.11 to –5.54) in part A and –9.92 (95% CI, –14.81 to –5.02) in part B (both P <0.001). The same was not true in the dupilumab every 2 weeks group (difference in part B, -0.51; 95% CI, -5.42 to 4.41).
For safety, serious adverse events were found in 9 patients during either part of the trial, 7 of which were treated with weekly dupilumab, 1 in the biweekly group, and 1 in the placebo group. There was also a serious adverse event found in the part A-C group during the part C treatment period. This patient was treated with placebo in part A and weekly dupilumab in part C.
“Among patients with eosinophilic esophagitis, subcutaneous dupilumab administered weekly improved histologic outcomes and alleviated symptoms of the disease,” the authors wrote.
The study, “Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis,” was published online in the New England Journal of Medicine.