Dupixent® (dupilumab) Late-Breaking Positive Pivotal Data in Bullous Pemphigoid Presented at AAD

Core Insights - Dupixent (dupilumab) shows significant efficacy in achieving sustained disease remission in adults with moderate-to-severe bullous pemphigoid (BP), with five times more patients achieving remission compared to placebo at 36 weeks [1][5] - The drug also significantly reduces disease severity and itch, as well as the use of oral corticosteroids and rescue medications compared to placebo [1][5] - Regulatory submissions for Dupixent to treat BP are currently under review in the U.S. and the European Union, with a decision from the FDA expected by June 20, 2025 [3][5] Group 1: Clinical Trial Results - The ADEPT Phase 2/3 trial enrolled 106 adults with moderate-to-severe BP, demonstrating that 20% of Dupixent-treated patients achieved sustained disease remission compared to 4% in the placebo group (p=0.0114) [2][5] - Additionally, 40% of Dupixent patients achieved a ≥90% reduction in disease severity compared to 10% in the placebo group (p=0.0003) [5] - The average cumulative oral corticosteroid exposure was reduced by 1678 mg (p=0.0220), and there was a 54% lower risk of rescue medication use (p=0.0016) in the Dupixent group [5] Group 2: Safety Profile - Adverse events (AEs) were reported at a rate of 96% for both Dupixent and placebo groups, with specific AEs more common in the Dupixent group including peripheral edema (n=8 vs. n=5) and arthralgia (n=5 vs. n=3) [3] - No AEs led to death in the Dupixent group, while two AEs led to death in the placebo group [3] Group 3: Regulatory and Market Context - Dupixent has received Orphan Drug Designation from the FDA for BP, which is applicable to treatments for rare diseases affecting fewer than 200,000 people in the U.S. [3] - The drug has been approved in over 60 countries for various indications, with more than 1,000,000 patients currently treated globally [10]