TUESDAY, March 11, 2025 -- For patients with symptomatic chronic spontaneous urticaria after treatment with second-generation H1-antihistamines, administration of the oral, highly selective Bruton's tyrosine kinase inhibitor, remibrutinib, results in a significant improvement in a composite measure of itching and hives at week 12, according to a study published in the March 6 issue of the New England Journal of Medicine.

Martin Metz, M.D., from Charité–Universitätsmedizin Berlin, and colleagues examined the efficacy and safety of remibrutinib in patients with symptomatic chronic spontaneous urticaria after treatment with second-generation H1-antihistamines in the identical REMIX-1 and REMIX-2 trials. Patients were randomly assigned to receive remibrutinib at a dose of 25 mg twice daily or placebo (313 and 157 patients, respectively, in REMIX-1; 300 and 155 patients, respectively, in REMIX-2). The change from baseline to week 12 in the urticaria activity score during a seven-day period (UAS7), which is composed of severity scores for itch and hives during one week, was assessed as the primary end point.

The researchers found that compared with the placebo group, the remibrutinib group had a significantly greater decrease in the UAS7 at week 12, which was sustained at week 24. Significantly more patients in the remibrutinib group versus the placebo group had a UAS7 score of 6 or lower at week 12 (REMIX-1: 49.8 versus 24.8 percent; REMIX-2: 46.8 versus 19.6 percent) and a UAS7 score of 0 (REMIX-1: 31.1 versus 10.5 percent; REMIX-2: 27.9 versus 6.5 percent). Adverse event rates were similar in the remibrutinib group and the placebo group, although petechiae were reported in a higher percentage of patients in the remibrutinib group than in the placebo group.

"These results support the efficacy and safety of remibrutinib in patients with chronic spontaneous urticaria that remained symptomatic despite treatment with second-generation H1-antihistamines," the authors write.

The study was funded by Novartis, the manufacturer of remibrutinib.

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