James Del Rosso, DO, highlights the significance of the FDA approval of Dupixent for bullous pemphigoid, including clinical trial outcomes, safety profile, and implications for dermatology practice

Sanofi and Regeneron have announced the FDA approval of Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP), a rare, relapsing chronic skin disease driven in part by type 2 inflammation. This marks the first FDA-approved treatment for BP, offering a new therapeutic pathway for a condition previously managed with broad immunosuppressants.

Clinical trial insights

The approval is based on results from the pivotal Phase 2/3 ADEPT trial, which evaluated Dupixent in adults with moderate-to-severe BP. Patients received Dupixent or placebo alongside a standard-of-care oral corticosteroid (OCS) tapering regimen.

Key results at Week 36 include:

• Patients receiving Dupixent achieved sustained disease remission at a rate of 18.3%, compared to 6.1% in the placebo group, meeting the study’s primary endpoint
• Clinically meaningful itch reduction was observed in 38.3% of patients treated with Dupixent, compared to 10.5% of those receiving placebo
• Medians for cumulative OCS dose were lower in the Dupixent group (2.8 g) than placebo (4.1 g)

Sustained disease remission was defined as complete clinical remission with successful OCS taper by Week 16 and no relapse or need for rescue therapy through Week 36.

Safety profile 

The safety profile of Dupixent for BP was consistent with prior experience across other indications. Adverse events (≥2%) more commonly reported with Dupixent included arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. One case of acute generalized exanthematous pustulosis was observed in the Dupixent group.

Expanding therapeutic indications 
Dupixent is now approved by the FDA for the treatment of 8 distinct diseases that share an underlying mechanism of type 2 inflammation. These conditions span multiple organ systems, including the skin, lungs, and gastrointestinal tract. In addition to bullous pemphigoid, approved indications include atopic dermatitis, asthma, chronic spontaneous urticaria, and prurigo nodularis. The addition of bullous pemphigoid expands the utility of Dupixent into a new category of autoimmune blistering diseases, offering a targeted treatment approach where limited options have historically been available.