Sanofi Reports High Efficacy in Dupilumab for BP

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Dupilumab (Dupixent; Sanofi) has demonstrated “significant” efficacy in treating bullous pemphigoid (BP), according to results from the ADEPT study reported in a press release today. This phase 2/3 trial, involving 106 adults with moderate to severe BP, met its primary and all key secondary endpoints, showcasing dupilumab’s potential as a transformative treatment for BP.¹

“The itchy blisters caused by bullous pemphigoid can be so intense they are debilitating, especially for elderly patients. There is a significant unmet medical need for new medicines for people suffering with this hard-to-treat disease in which the standard of care is oral and topical corticosteroids and immunosuppressants – treatments that have poor clinical outcomes and safety concerns, respectively, and should be used sparingly in an elderly population,” Dietmar Berger, MD, PhD, chief medical officer and global head of development at Sanofi, said in the release. “These positive pivotal results for bullous pemphigoid add to an immense body of scientific evidence that underscores the important role IL-4 and IL-13 play in driving diseases characterized by itch. Combined with the consistent safety profile of the other dermatology indications, these results show the potential of Dupixent to transform the treatment paradigm for bullous pemphigoid.”

According to the release, the ADEPT study revealed that patients receiving dupilumab experienced sustained disease remission at a rate 5 times higher than those on placebo. Sustained disease remission was defined as complete clinical remission with the discontinuation of oral corticosteroids by week 16, without relapse or need for rescue therapy during the 36-week treatment period. Specifically, the company stated that 20% of dupilumab treated patients achieved sustained remission compared to just 4% in the placebo group.

More highlights of the study included:

In terms of safety, the release stated that the overall rate of adverse events was similar between dupilumab and placebo groups. However, some adverse effects, such as peripheral edema and arthralgia, were reported more frequently in the dupilumab group. Importantly, the company reported no deaths attributable to dupilumab, compared to 2 in the placebo group.

“Bullous pemphigoid is a debilitating skin disease with a high mortality rate due to infection. Dupixent is the first medication to show significant and robust impacts in this patient population,” George Yancopoulos, MD, PhD, board co-chair, president, and chief scientific officer at Regeneron, said in the release. “These latest pivotal results reaffirm the underlying role type-2 inflammation plays in driving multiple skin diseases. We look forward to further advancing this research and sharing the positive results from the bullous pemphigoid pivotal trial with regulatory authorities.”

The release stated the positive results from the ADEPT study build on dupilumab’s existing orphan drug designation from the US Food and Drug Administration for BP and will support global regulatory submissions, starting with the US later this year.

In addition to BP, dupilumab is also under investigation for other conditions, including chronic pruritus of unknown origin (CPUO).² A related phase 3 study did not meet its primary endpoint for itch reduction but showed promising results in secondary measures related to itch improvement.

Dupilumab has already been approved in over 60 countries for various indications, such as atopic dermatitis and asthma. With over one million patients treated worldwide, Sanofi stated that dupilumab's ongoing research aims to expand its benefits to additional conditions, potentially revolutionizing treatment paradigms for several serious skin diseases.

The detailed results from both the BP and CPUO studies are expected to be presented at an upcoming medical conference, according to the release.

References

1. Dupixent is the first and only biologic to achieve significant improvements in disease remission and symptoms in bullous pemphigoid positive pivotal study. News Release. Sanofi. September 11, 2024. Accessed September 11, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-11-05-00-00-2944237
2. Efficacy and safety of subcutaneous dupilumab for the treatment of adult participants with chronic pruritus of unknown origin (CPUO) (Liberty-CPUO-chic). Clinical Research Studies Listing. Accessed September 11, 2024. https://www.sanofistudies.com/us/en/listing/291216/efficacy-and-safety-of-4/.