Remibrutinib reduces need for rescue medication in chronic spontaneous urticaria

MILAN — Remibrutinib reduced the need for second-generation H1 antihistamines as a rescue medication in patients with chronic spontaneous urticaria across all doses in a 12-week study.

In a multicenter, randomized, double-blind, placebo-controlled, phase 2b study, remibrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, was evaluated for its efficacy in reducing rescue medication for patients with chronic spontaneous urticaria (CSU). The results of this study were presented during the European Academy of Dermatology and Venereology Congress.

“Chronic spontaneous urticaria, characterized by wheals and angioedema both for at least 6 weeks, has a major impact on patients’ quality of life and well-being,” Marcus Maurer, MD, PhD, professor of dermatology and allergy and the executive director of the Institute of Allergology at Charité-Universitätsmedizin Berlin said during the poster presentation. “The standard first line treatment of second-generation H1 antihistamines is not sufficient in most patients and remibrutinib, a BTK inhibitor, showed good results.”

In the study, 311 patients were equally randomly assigned to remibrutinib 10 mg once daily, 35 mg once daily, 100 mg once daily, 10 mg twice daily, 25 mg twice daily or 100 mg twice daily or placebo for up to 12 weeks. Patients were uncontrolled by second-generation H1 antihistamines and were allowed to take it as a rescue medication for the treatment of unbearable symptoms during the trial. The daily use of rescue medication was recorded by patients on an eDiary device to indicate the effectiveness of remibrutinib.

As early as week 1, patients with any dosage of remibrutinib recorded a decreased use of rescue medication compared with baseline, whereas placebo patients showed an increased use. By week 12, the mean weekly use of rescue medication tablets among remibrutinib arms across all doses was numerically lower than the baseline (10 mg once daily, 5.8 vs. 8.7; 35 mg once daily, 3.9 vs. 6.6; 100 mg once daily, 4 vs. 6.4; 10 mg twice daily, 5.1 vs. 7.6; 25 mg twice daily, 4.5 vs. 9; 100 mg twice daily, 7.1 vs. 9.4). In contrast, placebo patients increased their rescue medication tablet intake to 11.9 from a baseline of 9.

Additionally, despite the reduced use of second-generation H1 antihistamines, the study reported an improvement in CSU symptoms among patients treated with remibrutinib.

“This analysis from a first-in-patient phase 2b study on remibrutinib shows that the need for rescue medication is reduced and reduced early,” Maurer said, “and all of this with a favorable safety profile.”