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Dupilumab in Bullous Pemphigoid Represents Leap Forward for Dermatology, with Jonathan Silverberg, MD, PhD, MPH
Silverberg discusses the significance of the dupilumab approval in BP and why he thinks it's the most important news in dermatology in 2025 so far.
On June 20, 2025, the US Food and Drug Administration (FDA) approved dupilumab (Dupixent) for the treatment of adult patients with bullous pemphigoid, marking the first targeted therapy approved for this chronic, autoimmune skin disease. The approval, announced by Sanofi and Regeneron, is based on results from the pivotal ADEPT trial and represents the eighth approved indication for dupilumab in diseases driven by type 2 inflammation.
“By addressing two central drivers of the underlying type 2 inflammation that contributes to bullous pemphigoid, Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remission and reduce itch," Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi, said in a statement.1 "This approval in the U.S. is important for the thousands of patients living with bullous pemphigoid, and we look forward to working with regulators around the world to bring this innovative medicine to more patients in need.”
In the 36-week ADEPT trial, 106 adults with moderate-to-severe disease were randomized to receive dupilumab or placebo. Sustained remission was achieved by 18.3% of dupilumab-treated patients versus 6.1% with placebo (difference: 12.2%; 95% CI, –0.8% to 26.1%). Additionally, 38.3% of dupilumab recipients experienced clinically meaningful itch reduction, compared to 10.5% on placebo. Patients on dupilumab also used fewer oral corticosteroids, with a median cumulative dose of 2.8 grams compared to 4.1 grams in the placebo group.
The most common adverse events reported in the trial included joint pain, back pain, edema, upper respiratory infections, and conjunctivitis, with investigators noting the safety profile was consistent with that established in prior trials of dupilumab.
In a recent interview, Jonathan Silverberg, MD, PhD, MPH, professor of dermatology and director of clinical research at the George Washington University School of Medicine and Health Science, noted the approval as the most impactful news in dermatology for the first half of 2025. For more on the importance of the approval for dupilumab in bulls pemphigoid, check out our interview with Silverberg below:
Relevant disclosures of interest for Silverberg include AbbVie, lamar, Aldena, Amgen, AObiome, Arcutis, Arena, Asana, Aslan, BioMX, Biosion, Bodewell, Boehringer-Ingelheim, Bristol-Myers Squibb, and others.
