Weekly dupilumab shots work well in eosinophilic esophagitis

Weekly treatment with subcutaneous dupilumab yields improvements in histologic outcomes and symptoms in patients with eosinophilic esophagitis, according to the results of a phase III study.

The study was conducted in three parts and included patients aged ≥12 years. These patients were randomized to receive subcutaneous dupilumab at a weekly dose of 300 mg or placebo (part A) or to receive 300 mg of dupilumab either weekly or every 2 weeks or weekly placebo (part B). Treatment lasted up to 24 weeks.

Eligible patients who completed part A or part B then continued in part C, wherein those who completed part A received dupilumab at 300 mg up to week 52 (the part A–C group); the part C that included the eligible patients from part B is ongoing.

Researchers assessed two primary endpoints at week 24: histologic remission (≤6 eosinophils per high-power field) and the change from baseline in the Dysphagia Symptom Questionnaire (DSQ) score (range, 0 to 84, with higher values indicating more frequent or more severe dysphagia).

In part A, 25 of 42 patients (60 percent) who received weekly dupilumab and two of 39 patients (5 percent) who received placebo achieved histologic remission (difference, 55 percentage points, 95 percent confidence interval [CI], 40–71; p<0.001).

In part B, the outcome occurred more frequently among patients who received dupilumab either weekly (47 of 80 patients; 59 percent) or every two weeks (49 of 81 patients; 60 percent) than among those who received placebo (5 of 79 patients; 6 percent). Only the difference between weekly dupilumab and placebo achieved statistical significance (54 percentage points, 95 percent CI, 41–66; p<0.001).

Furthermore, DSQ scores decreased by 12.32 points (95 percent CI, –19.11 to –5.54) in part A and by 9.92 (95 percent CI, –14.81 to –5.02) in part B (both p<0.001) with weekly dupilumab. This improvement was not seen with dupilumab every 2 weeks in part B (–0.51, 95 percent CI, –5.42 to 4.41).

In terms of safety, serious adverse events were documented in nine patients during the part A or B treatment period (in seven who received weekly dupilumab, one who received dupilumab every 2 weeks, and one who received placebo) and in one patient in the part A–C group during the part C treatment period.