A Dupixent (dupilumab) pivotal study (ADEPT) in bullous pemphigoid (BP) has met the primary and all key secondary endpoints evaluating its investigational use in adults with moderate-to-severe disease.

In the study, five times more Dupixent patients achieved sustained disease remission compared to those on placebo.

Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids (OCS) taper by week 16 without relapse and no rescue therapy use during the 36-week treatment period.

Dupixent was previously granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for BP.

BP is a chronic and relapsing disease that is characterised by intense itch and blisters, reddening of the skin, and painful chronic lesions.

Dietmar Berger, Chief Medical Officer, Global Head of Development at Sanofi, said: “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.

“These positive pivotal results for bullous pemphigoid add to an immense body of scientific evidence that underscores the important role IL4 and IL13 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.”

Results of the ADEPT study

In the ADEPT study, 106 adults with moderate-to-severe BP were randomised to receive Dupixent 300mg every two weeks after an initial loading dose or placebo, along with standard-of-care OCS.

For the primary endpoint, 20% of Dupixent patients experienced sustained disease remission at 36 weeks compared to 4% for placebo. For the components comprising the primary endpoint – with patients having to achieve all components – efficacy among patients receiving Dupixent compared to placebo was as follows:

George Yancopoulos, Board Co-Chair, President, and Chief Scientific Officer at Regeneron, added: “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. 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.”

Diana Spencer, Senior Digital Content Editor, DDW