PARIS (dpa-AFX) - Regeneron Pharmaceuticals Inc. (REGN) and Sanofi presented positive results from the pivotal ADEPT Phase 2/3 trial evaluating the investigational use of Dupixent (dupilumab) in adults with moderate-to-severe bullous pemphigoid. The data were shared in a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting.
Adults on Dupixent experienced sustained disease remission five times more often at 36 weeks compared to those on a placebo. They also saw significant reductions in disease severity and itch. Additionally, Dupixent significantly reduced the use of oral corticosteroids and rescue medications compared to a placebo.
Bullous pemphigoid is a chronic, debilitating and relapsing skin disease with underlying type 2 inflammation and characterized by intense itch and blisters, reddening of the skin and painful lesions.
The companies noted that the ADEPT trial met all primary and key secondary endpoints, enrolling 106 adults with moderate-to-severe Bullous pemphigoid who were randomized to receive Dupixent 300 mg (n=53) every two weeks after an initial loading dose or placebo (n=53) added to standard-of-care oral corticosteroids (OCS).
During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained. Sustained disease remission was defined as complete clinical remission with completion of OCS taper by week 16 without relapse and no rescue therapy use during the 36-week treatment period.
As presented at AAD, results for patients treated with Dupixent at 36 weeks showed that 20% experienced sustained disease remission, the primary endpoint, compared to 4% of those treated with a placebo. Additionally, 40% achieved a 90% reduction in disease severity compared to 10% with placebo, and 40% experienced clinically meaningful itch reduction versus 11% for placebo. Furthermore, there was an average reduction of 1678 mg in cumulative OCS exposure and a 54% lower risk of rescue medication use in patients treated with Dupixent compared to those on placebo.
In this elderly population, overall rates of adverse events were 96% for Dupixent and 96% for placebo.
In February, the U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for Dupixent to treat Bullous pemphigoid. The FDA decision is expected by June 20, 2025. Dupixent was previously granted Orphan Drug Designation by the FDA for Bullous pemphigoid, which applies to investigational medicines intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Additional applications are also under review around the world, including in the European Union.
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