Dupilumab shows therapeutic potential in eosinophilic gastritis

In the treatment of patients with eosinophilic gastritis, the use of dupilumab helps improve histological outcomes, according to the proof-of-concept, phase II DEGAS study.

DEGAS consisted of a 12-week, double-blind, placebo-controlled treatment period, followed by a 24-week open-label extension period. The trial involved patients aged 12–70 years with histologically active eosinophilic gastritis (≥30 eosinophils per high-power field [HPF] in at least five HPFs in the gastric antrum and/or body) and moderate-to-severe symptoms occurring at least 2 days per week in the 2 weeks before screening. Those who were currently or had recently used biologics or were receiving systemic steroids at ≥10 g/day were excluded.

A total of 41 patients (mean age 30.5 years, 61 percent female, 90 percent White) were included in the study. These patients were randomly assigned to receive dupilumab (600 mg once followed by 300 mg every 2 weeks; n=21) or placebo (n=20), administered subcutaneously every 2 weeks, for a total of six injections over 12 weeks.

The primary endpoint was mean gastric eosinophil count from the five most eosinophil-dense HPFs in the gastric antrum and/or body at week 12. Secondary endpoints included Eosinophilic Gastritis Histologic Scoring System (EoS-HSS) total score, mean gastric eosinophil count from the five most eosinophil-dense HPFs, and Eosinophilic Gastritis Endoscopic Reference System (EoG-REFS) total score.

At week 12, dupilumab-treated patients had a greater reduction in the primary endpoint compared with those who received placebo (estimated mean change, –50 percent vs –4 percent; difference, –47 percentage points; p<0.0001).

Results for the secondary endpoints also favoured dupilumab vs placebo, with significant reductions observed in EoS-HSS total score (difference, –0.10; p=0.0055), gastric eosinophil count (difference, –38.8; p=0.0008), and EoG-REFS total score (difference, –3.42; p=0.016).

At week 12, the incidence of treatment-emergent adverse events (TEAEs) did not significantly differ between dupilumab and placebo (81 percent vs 85 percent, respectively). Blood eosinophilia was the most common TEAE, occurring in 29 percent of patients in the dupilumab group and 30 percent in the placebo group. No serious adverse events or treatment-related deaths were documented.