A CLINICAL trial has shown that dupilumab, a monoclonal antibody targeting IL-4 and IL-13, may offer benefits to patients in managing bullous pemphigoid, a rare autoimmune blistering disease. The Phase 2/3 ADEPT trial, tested the efficacy and safety of dupilumab in 106 adult patients with moderate to severe bullous pemphigoid.
The randomized, double-blind, placebo-controlled trial compared dupilumab administered every 2 weeks alongside oral corticosteroids (OCS) to a placebo group over a 52-week period. Results demonstrated that 20% of patients receiving dupilumab achieved sustained disease remission by week 36, compared to just 4% in the placebo group (P =0.0114). Additionally, 59% of patients treated with dupilumab did not experience disease relapse following OCS taper, a significant contrast to the 16% in the placebo group (P =0.0023).
Moreover, the trial revealed that 41% of dupilumab-treated patients achieved a 90% or greater reduction in disease severity, while only 10% of placebo-treated patients reached the same outcome (P =0.0003). The drug also reduced itching in 40% of patients compared to 11% in the placebo group (P =0.0006), offering considerable symptom relief.
Overall, 77% of patients on dupilumab experienced some reduction in disease severity, higher than the 50% in the placebo group (P =0.0021). These findings suggest that dupilumab could become a game-changer for managing bullous pemphigoid, particularly in reducing the reliance on long-term corticosteroids.
Dupilumab’s consistent safety profile, combined with these efficacy results, positions it as a potential first-in-class biologic for this challenging condition.
Reference: Dupixent® (dupilumab) Is the First and Only Biologic to Achieve Significant Improvements in Disease Remission and Symptoms in Bullous Pemphigoid (BP) Positive Pivotal Trial. Regeneron Pharmaceuticals Inc. 2024. Available at: https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-first-and-only-biologic-achieve-significant. Last accessed: October 2, 2024.
Anaya Malik | AMJ
