Regeneron and Sanofi announced positive Phase 2/3 trial results for Dupixent (dupilumab) in treating moderate-to-severe bullous pemphigoid (BP), a chronic skin disease. The ADEPT trial showed Dupixent significantly improved sustained disease remission, reduced disease severity and itch, and lessened the need for oral corticosteroids and rescue medication compared to placebo. This is particularly relevant as BP predominantly affects an elderly population for whom current immunosuppressant treatments can be difficult to tolerate.
This news is potentially transformative for BP patients who experience debilitating itch, blisters, and painful lesions. The results suggest Dupixent could offer a targeted treatment option without the broad immune suppression of current therapies, improving quality of life for this vulnerable patient group. The potential for sustained remission is especially important, as it could reduce the long-term burden of BP and minimize the need for ongoing treatment.
The ADEPT trial enrolled 106 adults with moderate-to-severe BP. At 36 weeks, 20% of Dupixent-treated patients achieved sustained disease remission versus 4% in the placebo group. Furthermore, Dupixent demonstrated a 40% achievement rate for both a ≥90% reduction in disease severity and clinically meaningful itch reduction, compared to 10% and 11% in the placebo group, respectively. A decrease in cumulative oral corticosteroid exposure and a lower risk of rescue medication use were also observed. The overall adverse event profile was similar between Dupixent and placebo.
The positive trial data supports regulatory submissions currently under review in the U.S. and EU, with a decision from the FDA expected by June 20, 2025. If approved, Dupixent would be the first targeted therapy for BP, potentially revolutionizing the treatment landscape and offering new hope for patients seeking relief from this challenging condition. This could also signify an expansion of Dupixent’s market reach, further solidifying its position as a key player in treating type 2 inflammatory diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
