Dupixent® Shows Significant Improvement in Bullous Pemphigoid Remission and Symptoms

Regeneron Pharmaceuticals, Inc. and Sanofi have announced significant results from a pivotal trial (ADEPT) investigating the use of Dupixent® (dupilumab) for moderate-to-severe bullous pemphigoid (BP). This chronic, relapsing skin disease is marked by severe itching, blisters, and painful lesions, which can increase susceptibility to infections and greatly impair daily life. The findings revealed that Dupixent effectively achieved sustained disease remission in five times more patients compared to those receiving a placebo.

The primary endpoint of the trial defined sustained disease remission as complete clinical remission with successful tapering off oral corticosteroids (OCS) by week 16, without relapse or need for rescue therapy over the 36-week treatment period. Dupixent was also previously granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for BP, highlighting its potential in treating rare diseases that affect fewer than 200,000 people in the U.S. The positive results from this trial are expected to support regulatory submissions in the U.S. and globally later this year.

In the ADEPT trial, 106 adults with moderate-to-severe BP were randomized, with half receiving Dupixent 300 mg every two weeks and the other half receiving a placebo, alongside standard-of-care OCS. The trial results showed that 20% of patients treated with Dupixent achieved sustained disease remission at 36 weeks, compared to just 4% of the placebo group. Key components of the primary endpoint were also notably better in Dupixent patients, including the absence of disease relapse after completing OCS taper (59% vs. 16%), and the absence of need for rescue therapy during the treatment period (42% vs. 12%).

Additionally, selected secondary endpoints favored Dupixent significantly. About 41% of Dupixent patients achieved a 90% or greater reduction in disease severity, compared to 10% of placebo patients. Clinically meaningful itch reduction was seen in 40% of Dupixent patients versus 11% of the placebo group. Lower overall cumulative OCS use and prolonged time to rescue medication use were also observed in the Dupixent group.

In terms of safety, adverse events were similar between the two groups, with 96% of patients in both the Dupixent and placebo groups experiencing some adverse events. Commonly reported side effects with Dupixent included peripheral edema, arthralgia, back pain, blurred vision, and upper respiratory tract infections. Notably, there were no deaths in the Dupixent group, while two deaths occurred in the placebo group.

George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, noted the significance of these findings, emphasizing the role of type 2 inflammation in driving multiple skin diseases and the potential of Dupixent to transform the treatment landscape for BP. Similarly, Dietmar Berger, M.D., Ph.D., Chief Medical Officer at Sanofi, highlighted the unmet medical need in treating BP and the promising efficacy and safety profile of Dupixent.

In addition to the BP trial, a separate Phase 3 trial (Study A) for Dupixent in adults with chronic pruritus of unknown origin (CPUO) showed nominally significant improvements in several itch endpoints, despite not achieving statistical significance in the primary itch responder endpoint. These results further underscore the potential of Dupixent in addressing various dermatological conditions driven by type 2 inflammation.

Lastly, the trial results are slated for presentation at an upcoming medical meeting, and efforts are ongoing to advance the regulatory submissions for Dupixent in BP and CPUO.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!