Dupilumab relieves chronic spontaneous urticaria symptoms
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PHOENIX — Patients with H1 antihistamine-resistant chronic spontaneous urticaria experienced improvements with dupilumab, according to a study presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.
The itchy hives and angioedema that patients with chronic spontaneous urticaria (CSU) experience significantly impact their quality of life, often despite treatment with recommended and escalated doses of H1 antihistamines, the researchers said.
“Clearly, there is a need for new and better treatment for patients with chronic spontaneous urticaria,” Marcus Maurer, MD, professor of dermatology and allergy at Charité – Universitätsmedizin Berlin Institute of Allergology, said during the presentation.
The randomized, placebo-controlled 24-week LIBERTY-CSU CUPID Study A phase 3 trial evaluated the efficacy and safety of dupilumab (Dupixent, Regeneron/Sanofi) among patients aged 6 years and older with moderate or worse CSU for at least 6 months who remained symptomatic despite treatment with H1 antihistamines.
“Dupilumab is a licensed treatment for atopic dermatitis,” Maurer said. “It’s a human monoclonal antibody that blocks interleukin-4 receptor alpha, and that is the shared receptor for IL-4 and IL-13.”
Patients who were taking standard, fourfold or fewer doses of antihistamines subcutaneously received add-on doses of dupilumab (n = 70) — including 300 mg for adults and adolescents weighing 60 kg or more, and 200 mg for adolescents weighing less than 60 kg and children weighing 30 kg or more — or a matching placebo (n = 68) every 2 weeks.
“[Patient characteristics] were pretty even between the two groups, and that includes their age, sex, race, BMI, age at disease onset and the time that they were first diagnosed,” Maurer said.
Patients were evaluated based on their Itch Severity Score over 7 days (ISS7) and Urticaria Activity Score over 7 days (UAS7). In each score, symptoms are rated on a scale of 0 for no symptoms to 3 for ISS7 and 6 for UAS7 for the worst symptoms each day and totaled per week (ISS7 0-21 and UAS7 0-42).
At baseline, the dupilumab and placebo groups had comparable mean ISS7 scores (16.1 vs. 15.7) and UAS7 scores (31.9 vs. 30.8).
After 24 weeks, the least squares (LS) mean change in ISS7 from baseline was –10.2 for dupilumab and –6 for placebo (range, 0-21; LS mean difference, –4.2; P = .0005). For UAS7, the LS mean change was –20.5 for dupilumab and –12 for placebo (range, 0-42; difference, –8.5, P = .0003).
“We see after 24 weeks of treatment clinically meaningful and statistically significant marked improvement vs. placebo,” Maurer said.
There were 35 (50%) treatment-emergent adverse events (TEAS) with dupilumab and 40 (58.8%) with placebo. Also, there were eight (11.4%) injection site reactions, no cases of conjunctivitis and two serious TEAS (2.9%) with dupilumab, compared with nine (13.2%) injection site reactions, one (1.5%) case of conjunctivitis and five serious TEAEs (7.4%) with placebo.
“If you’ve used dupilumab in clinical practice, you will appreciate that this is a very well-tolerated treatment in most patients, and also a safe treatment, and this was also what comes out of this study,” Maurer said.
Calling the results “very exciting,” Maurer said these patients with antihistamine-resistant CSU who had never received omalizumab (Xolair; Genentech, Novartis) experienced clinically and statistically significant benefits with dupilumab treatment.
“This is good,” he said. “Dupilumab promises novel treatment options.”