Dupixent: First Biologic to Significantly Improve Bullous Pemphigoid Remission and Symptoms

PARIS, France and TARRYTOWN, NY, USA I September 11, 2024 I A recent pivotal study of Dupixent (dupilumab) for the treatment of moderate-to-severe bullous pemphigoid (BP) has yielded promising results. Conducted under the ADEPT study, the trial achieved its primary and all key secondary endpoints, demonstrating significant potential for Dupixent in treating this challenging condition. In the study, patients treated with Dupixent were five times more likely to achieve sustained disease remission compared to those given a placebo.

BP is a chronic, relapsing condition marked by intense itching, blisters, and painful lesions. These symptoms can cover large areas of the body, leading to skin crusting and bleeding, and heightening the risk of infections which can severely impact daily life. Dr. Dietmar Berger, Chief Medical Officer and Global Head of Development at Sanofi, emphasized the debilitating nature of BP, especially in elderly patients. He noted the urgent need for new treatment options as current standards—oral and topical corticosteroids and immunosuppressants—pose significant safety concerns and often yield poor clinical outcomes.

The ADEPT study involved 106 adults with moderate-to-severe BP who were randomized to receive either Dupixent 300 mg biweekly or a placebo, along with standard-of-care oral corticosteroids (OCS). Patients underwent a protocol-defined OCS tapering regimen once disease control was achieved. The study's primary endpoint was sustained disease remission at 36 weeks, defined as complete clinical remission with the completion of OCS taper by week 16 without relapse and no need for rescue therapy.

Results showed that 20% of patients on Dupixent achieved sustained disease remission at 36 weeks compared to just 4% of patients on placebo. The trial also assessed various secondary endpoints, all of which further supported Dupixent's efficacy. Importantly, overall adverse event (AE) rates were equivalent between the two groups at 96%, although some specific AEs were more common in the Dupixent group, such as peripheral edema, blurred vision, and asthma. However, there were no deaths attributed to AEs in the Dupixent group, while the placebo group reported two.

Dr. George D. Yancopoulos, Board co-Chair, President, and Chief Scientific Officer at Regeneron, highlighted the groundbreaking nature of these findings, noting that Dupixent is the first medication to show such significant effectiveness in BP patients. He underscored the broader implications of these results for understanding type-2 inflammation, which plays a critical role in multiple skin diseases.

Additionally, a smaller phase 3 study (Study A) investigating Dupixent in adults with uncontrolled severe chronic pruritus of unknown origin (CPUO) did not meet its primary endpoint but showed improvements in other itch-related measures. Safety results were consistent with Dupixent’s known profile in other dermatological conditions.

The ADEPT study's design involved a 52-week treatment period where patients received either Dupixent or a placebo biweekly, along with OCS. The OCS taper began after two weeks of sustained disease control and was intended to be completed by week 16. After tapering, patients continued with Dupixent or placebo alone, unless rescue treatment was needed.

Dupixent, already approved in over 60 countries for various indications, is being developed by Sanofi and Regeneron. The drug has shown considerable benefits across multiple clinical studies, highlighting the central role of IL4 and IL13 in type-2 inflammation, which is linked to various chronic diseases. 

The safety and efficacy of Dupixent for BP and CPUO are currently under clinical investigation and have yet to be evaluated by regulatory authorities. The detailed results of these studies will be presented at an upcoming medical meeting.

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