FDA Approves Dupixent for Treatment of Bullous Pemphigoid

The U.S. Food and Drug Administration has granted approval for Dupixent (dupilumab) to be used in treating adult patients suffering from bullous pemphigoid, a chronic autoimmune skin condition characterized by large, tense blisters. The approval was based on compelling results from the ADEPT phase 2/3 clinical trial, which demonstrated significant benefits for patients.

In the study, individuals with moderate-to-severe bullous pemphigoid were randomly assigned to receive either Dupixent 300 mg or a placebo, both added to standard oral corticosteroid therapy. After 36 weeks, 18.3% of those treated with Dupixent achieved sustained disease remission, compared to only 6.1% in the placebo group. Moreover, 38.3% of patients on Dupixent experienced a meaningful reduction in itch severity, a common and distressing symptom, versus 10.5% on placebo. The treatment also allowed for a lower median cumulative dose of oral corticosteroids (2.8 grams with Dupixent vs. 4.1 grams with placebo), indicating a potential to reduce steroid-related side effects.

Patients receiving Dupixent commonly experienced adverse events such as joint pain, conjunctivitis, blurred vision, herpes viral infections, and keratitis. There was also a case of acute generalized exanthematous pustulosis reported. Despite these side effects, experts highlight the importance of this therapeutic advance, especially considering the challenges of managing bullous pemphigoid in elderly populations who often face additional health burdens.

Alyssa Johnsen, M.D., Ph.D., from Sanofi, noted that until now, treatment options for bullous pemphigoid have been limited and often problematic. She emphasized that Dupixent uniquely targets key mechanisms underlying the disease, addressing the type 2 inflammation central to its pathology, which may enable patients to achieve sustained remission and experience less itching.

The approval was a collaborative effort between Sanofi and Regeneron, marking a significant step forward in targeted therapy for autoimmune skin disorders.

For more details, see the original report at MedicalXpress.