Chronic spontaneous urticaria symptoms improve with dupilumab through 24 weeks

Key takeaways:

• Approximately half of patients do not respond to H1 antihistamine treatment.
• 30% of patients had complete remission with dupilumab at 24 weeks.
• The safety profile was consistent with other dupilumab data.

BOSTON — Patients with chronic spontaneous urticaria experienced significant improvements through 24 weeks with dupilumab, according to an abstract presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting.

“Individuals with urticaria have low quality of life,” Thomas B. Casale, MD, chief of clinical and translational research, division of allergy and immunology, University of South Florida, said during his presentation.

“About half of them are unresponsive to either licensed or up to four times licensed doses of antihistamines,” Casale continued.

In the previous LIBERTY-CSU CUPID Study A, itch and hive severity fell for patients who used dupilumab (Dupixent; Regeneron, Sanofi) but who had not used omalizumab (Xolair; Genentech, Novartis).

The randomized, placebo-controlled, phase 3 LIBERTY-CSU CUPID Study C was designed to assess dupilumab’s efficacy and safety in treating hives and itch also among patients with chronic spontaneous urticaria (CSU) who had not used omalizumab previously.

The cohort included 74 patients (mean age, 45.6 years; 63.5% female) aged 6 years and older who used dupilumab and 77 (mean age, 44 years; 76.6% female) who used placebo, both for 24 weeks, with a 12-week follow-up.

“The demographics were very similar to almost every urticaria study,” Casale said. “The predominant population tends to be female and oftentimes throughout your 40s.”

Baseline Urticaria Activity Score-7 (UAS7) means included 28.1 for the placebo group and 28.6 for the dupilumab group. Also, baseline Itch Severity Score-7 (ISS7) means included 15 for the placebo group and 15.3 for the dupilumab group.

Additionally, 55.8% of the placebo group and 45.9% of the dupilumab group were using between two and four times the standard dose of H1 antihistamines at baseline.

“There’s really no difference between active and placebo,” Casale said.

Adults used 300 mg of dupilumab every 2 weeks. Adolescents used 300 mg if they weighed 60 kg or more or 200 mg if they weighed less than 60 kg, with both doses administered every 2 weeks. Children aged 6 to younger than 12 years used 200 mg every 2 weeks if they weighed at least 30 kg.

At week 24, least square (LS) mean changes from baseline in ISS7 included –6.1 for the placebo group and –8.6 for the dupilumab group (P = .02). LS mean changes from baseline in UAS7 included –11.2 for the placebo group and –15.9 for the dupilumab group (P = .02).

“Maybe even more important, if you look at the data at week 24, almost twice as many patients achieved a UAS7 score of less than or equal to 6, which means well controlled urticaria,” Casale said.

Specifically, 23.4% of the placebo group and 40.5% of the dupilumab group achieved a UAS7 of less than or equal to 6 (P = .005).

“If you look even further at patients that had a UAS7 score of 0 — that is, complete remission — at 24 weeks, you’re looking at about 30% vs. 18%,” Casale added. “So, very reassuring data.”

The safety profile included 53.2% of the placebo group and 52.7% of the dupilumab group who experienced a treatment-emergent adverse event, with one patient in the placebo group and three in the dupilumab group experiencing a severe treatment-emergent adverse event.

Also, one patient in the placebo group and five in the dupilumab group experienced a treatment-emergent serious adverse event. One patient in the placebo group dropped out of the study after experiencing a treatment-emergent adverse event.

Four patients in the placebo group and six in the dupilumab group developed COVID-19, five in the placebo group and four in the dupilumab group developed nasopharyngitis, and four in the dupilumab group experienced injection site erythema.

“Nothing really popped out in comparison to what we typically see with dupilumab, and the differences between active and placebo were very similar, so no surprises there,” Casale said. “It is safe.”

These findings demonstrate dupilumab’s clinically meaningful and statistically significant efficacy at week 24 among patients with CSU who have not used omalizumab and who remain symptomatic despite H1 antihistamine use, the researchers said.

“This is very reassuring,” Casale said. “It confirms the results of CUPID-CSU Study A.”