Bullous pemphigoid remission shown with Dupixent treatment

Key takeaways:

• Sustained disease remission occurred in 20% of the study cohort vs. 4% of the placebo group at week 36.
• 41% of the Dupixent group and 10% of the placebo group had at least a 90% disease severity reduction.

Patients with bullous pemphigoid treated with Dupixent maintained disease control and symptom relief, according to phase 2/3 trial results released by Regeneron and Sanofi.

The randomized, double-blind, placebo-controlled ADEPT trial included 106 adult patients with moderate to severe bullous pemphigoid who were randomly assigned to receive Dupixent (dupilumab) or placebo every 2 weeks with oral corticosteroids (OCS) for a total of 52 weeks.

Sustained disease remission, defined as complete clinical remission with completion of OCS without relapse or rescue therapy use, was achieved by 20% of patients in the Dupixent group compared with 4% of those in the placebo group at week 36 (P = .0114).

After OCS taper, there was an absence of disease relapse in 59% of Dupixent-treated patients compared with 16% of placebo-treated patients (nominal P = .0023), whereas 42% of the Dupixent group and 12% of the placebo group did not need rescue therapy during the treatment period (nominal P = .0004).

By week 16, 38% of those in the study cohort achieved complete remission and were off OCS compared with 27% of the placebo cohort, although this finding was not significant.

A 90% or greater reduction in disease severity was achieved by 41% and 10% of patients in the respective study and placebo groups (P = .0003), and a clinically meaningful reduction in itch was achieved in 40% and 11% (P = .0006).

Any reduction in disease severity occurred in 77% of the Dupixent group and 50% of the placebo group (P = .0021).

“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,” Dietmar Berger, MD, PhD, chief medical officer and global head of development at Sanofi, said in the press release. “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.”