Data from two separate trial programs show that dupilimab (Dupixent, Sanofi-Aventis) met primary and secondary endpoints in the treatment of spontaneous urticaria (CSU) and bullous pemphigoid (BP). Regulatory filings for approval of Dupixent for CSU are expected, with possible submission to the FDA later this year.
The phase 3 LIBERTY-CUPID Study C enrolled 151 children and adults randomized to receive Dupixent (n=74) or placebo (n=77) added to standard-of-care histamine-1 (H1) antihistamines. Active treatment met the primary and key secondary endpoints, confirming results from Study A, the first phase 3 study of Dupixent in this setting.
In the latest study, 30% of Dupixent-treated patients reported no urticaria (complete response), compared to 18% of those on placebo at week 24. Dupixent-treated patients had an 8.64-point reduction in itch severity and 15.86-point reduction in urticaria activity (itch and hive) severity from baseline compared to 6.10-point and 11.21-point reductions, respectively, with placebo.
Dupixent is approved currently in Japan for treatment of adult and adolescent CSU patients based on results from Study A.
In the ADEPT study in BP, dupilumab met the primary and all key secondary endpoints adults with moderate-to-severe disease. In the study, five times more Dupixent patients achieved sustained disease remission– 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–compared to those on placebo.
FDA previously granted Dupixent Orphan Drug Designation for BP.
ADEPT included 106 adults with moderate-to-severe BP randomized to receive Dupixent 300mg (n=53) every two weeks after an initial loading dose or placebo (n=53), along with standard-of-care oral corticosteroids (OCS). During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained.
While 59% of dupilumab-treated patients had no relapse after OCS taper, only 16% of controls were relapse-free. Additionally, 42% of dupilumab-treated patients did not need rescue therapy and 38% achieved complete remission off OCS, compared to 12% and 27% (not statistically significant), respectively, of controls.
Safety results for dupilumab in both programs were generally consistent with the known safety profile of Dupixent in its approved dermatological indications.
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