Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU

• Confirming the results of CUPID-A, this second pivotal study in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compared to placebo
• More than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is inadequately controlled by antihistamines
• Data will support regulatory resubmission in the US by year-end; if approved, Dupixent would be the first targeted therapy for CSU in a decade
  
  

A Dupixent (dupilumab) confirmatory phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamines. CSU is a chronic skin condition that causes sudden and debilitating hives and persistent itch, which can impact quality of life. This positive study confirms resultsfrom Study A, the first phase 3 study of Dupixent in this setting. Earlier this year, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A.

Dietmar Berger, M.D., Ph.D.
Chief Medical Officer, Global Head of Development at Sanofi
“The positive pivotal data from this study reinforce the potential of Dupixent to offer a new treatment option for the many people suffering from chronic spontaneous urticaria who do not respond to standard-of-care antihistamines. With clinically meaningful reductions in itch and hives for patients receiving Dupixent, we look forward to sharing these data with the FDA to bring Dupixent to patients with CSU in the US as soon as possible. With Dupixent now treating 1 million patients across seven approved indications, these new results underscore there are still many more patients that Dupixent can potentially benefit.”

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. At 24 weeks, efficacy among patients receiving Dupixent compared to placebo was as follows:

• 8.64-point reduction in itch severity from baseline with Dupixent versus a 6.10-point reduction with placebo (p=0.02)
• 15.86-point reduction in urticaria activity (itch and hive) severity from baseline with Dupixent versus an 11.21-point reduction with placebo (p=0.02)

Notably, 30% of Dupixent-treated patients reported no urticaria (complete response), compared to 18% of those on placebo (p=0.02).

The safety results were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. Overall rates of treatment emergent adverse events (AE) were 53% for Dupixent and 53% for placebo. AEs more commonly observed with Dupixent (≥5%) compared to placebo included injection site reactions (12% vs. 4%), accidental overdose (7% vs. 3%), and COVID-19 infection (8% vs. 5%).

Detailed results from this study will be provided to the US Food and Drug Administration in response to the additional data requested for inclusion in the supplemental biologics application for Dupixent in CSU. These data are also planned for presentation at a forthcoming medical meeting.

George D. Yancopoulos, M.D., Ph.D.
Board Co-Chair, President, and Chief Scientific Officer at Regeneron
“Patients with uncontrolled chronic spontaneous urticaria experience debilitating itch and hives that appear without warning and disrupt their lives. With a nearly 50% reduction in itch and urticaria activity scores compared to placebo, these positive phase 3 results reaffirm the potential of Dupixent to bring relief and its well-established safety profile to those living with this chronic inflammatory skin disease.”

Outside of Japan, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority.