Press Release: Dupixent late-breaking positive pivotal data in bullous pemphigoid presented at AAD

Core Insights - Dupixent (dupilumab) has shown positive results in a pivotal phase 2/3 study for treating moderate-to-severe bullous pemphigoid (BP), a chronic skin disease characterized by intense itch and blisters [2][3][6] - The study demonstrated that Dupixent significantly improved disease remission rates and reduced disease severity compared to placebo [6][7] Study Details - The ADEPT study enrolled 106 adults with moderate-to-severe BP, randomized to receive Dupixent 300 mg every two weeks or placebo, alongside standard-of-care oral corticosteroids [3][9] - Sustained disease remission was defined as complete clinical remission with no relapse and no rescue therapy use during the 36-week treatment period [10] Efficacy Results - 20% of Dupixent-treated patients achieved sustained disease remission at 36 weeks compared to 4% in the placebo group (p=0.0114) [7] - 40% of patients on Dupixent experienced a ≥90% reduction in disease severity compared to 10% for placebo (p=0.0003) [7] - Dupixent also led to a significant reduction in oral corticosteroid use, with an average reduction of 1678 mg in cumulative exposure (p=0.0220) [7] Safety Profile - Adverse event rates were similar between Dupixent (96%) and placebo (96%) groups, with no deaths reported in the Dupixent group [4] - Common adverse events associated with Dupixent included peripheral edema, arthralgia, and blurred vision [4] Regulatory Status - The FDA has accepted a supplemental biologics license application for Dupixent to treat BP, with a decision expected by June 20, 2025 [4][6] - Dupixent has received orphan drug designation for BP, indicating its potential as a treatment for a rare disease affecting fewer than 200,000 people in the US [4] Background on Bullous Pemphigoid - BP is a chronic, debilitating skin disease primarily affecting the elderly, characterized by intense itch and painful lesions [8] - Approximately 27,000 adults in the US suffer from uncontrolled BP despite systemic corticosteroid treatment [8] About Dupixent - Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling pathways, targeting type 2 inflammation [11] - It has received regulatory approvals in over 60 countries for various indications, with more than one million patients treated globally [12]