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PHOENIX -- Patients who received add-on dupilumab (Dupixent) treatment for chronic spontaneous urticaria (CSU) had reduced symptoms and experienced less itchiness, a phase III trial found.

In the 6-month study, participants (adults, adolescents, and children) treated with dupilumab on top of their usual H1-antihistamine (H1-AH) experienced a 4.2-point greater mean reduction in their Itch Severity Score over 7 days (ISS7) versus the placebo group (mean change from baseline -6.0 vs -10.2, P=0.0005). ISS& was measured on a scale of 0 to 21, with a lower score indicating less itchiness, reported Marcus Maurer, MD, of the Charité University Medicine in Berlin, in a pre-recorded presentation at the American Academy of Allergy, Asthma & Immunology annual meeting.

The dupilumab group also saw an improvement in their hives symptoms, with an 8.5-point greater decrease versus the placebo group in their Urticaria Activity Score over 7 days (UAS7) for a mean change from baseline of -12.0 vs -20.5 (P=0.0003), he said. The UAS7, which ranges from 0-42, is a sum of the daily Hives Severity score (HSS7, range 0-21) and ISS7.

"Current therapies for CSU, including H1-AH and omalizumab [Xolair], do not adequately control symptoms in all patients," Maurer said. The current trial included patients who were already being treated H1-AHs but remained symptomatic, he noted.

Treatment with dupilumab in addition to standard care with H1-AH is a "promising, novel treatment option," Maurer said, noting that it "demonstrated clinically and statistically significant efficacy" in patients compared to care with H1-AH alone.

Dupilumab is a fully human monoclonal antibody that works by blocking the receptor for interleukin-4 and -13, which regulate allergic inflammation. Currently, it is indicated for treating moderate-to-severe atopic dermatitis and as an add-on for moderate-to-severe asthma and chronic rhinosinusitis with nasal polyposis.

The included 138 patients (70 in the dupilumab arm; 68 in the placebo arm). Adults and adolescents, ages ≥12 years, who were at least 60 kg (about 132 lbs) were treated with a loading dose (LD) of 600 mg dupilumab, followed by 300 mg every 2 weeks. Adolescents and children ages ≥6 years who weighed ≥30 kg but <60 kg were injected with an LD of 400 mg followed by 200 mg dupilumab every 2 weeks. Children ages ≥6 and <12 years who weighed ≥15 kg and <30 kg were given an LD of 600 mg with 300 mg doses every 4 weeks. Patients were treated for 24 weeks with follow-up post-treatment for 12 weeks after.

Patients included in the study were at least age 6 years, had a diagnosis of CSU at least 6 months before the screening visit, had itchiness and hives for more than 6 straight weeks despite H1-AH treatment, and were omalizumab-naïve.

The average age of all patients was 41.3, with the average age of CSU onset at age 36.1. In the placebo group, 73.5% were female, and in the dupilumab group, 58.6% were female. Overall, 68.8% of participants were white, 3% were Black, and 25% were Asian. At baseline, the mean ISS7 score was 15.9, and the mean UAS7 score was 31.3.

Treatment-emergent adverse events (TEAEs) were comparable between the dupilumab and placebo groups (50% dupilumab vs 58.8% placebo), Maurer noted. Injection site reactions were rare with eight in the dupilumab group and nine in the placebo group. Five patients in the placebo group and one in the treatment group experienced an angioedema.