Remibrutinib results in significant improvement in composite measure of itching and hives at week 12 after second-generation H1-antihistamine treatment<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b>
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TUESDAY, March 11, 2025 (HealthDay News) — For patients with symptomatic chronic spontaneous urticaria after treatment with second-generation H1<\/sub>-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<\/em>.<\/p>\n Martin Metz, M.D., from Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin, and colleagues examined the efficacy and safety of remibrutinib in patients with symptomatic chronic spontaneous urticaria after treatment with second-generation H1<\/sub>-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.<\/p>\n 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.<\/p>\n “These results support the efficacy and safety of remibrutinib in patients with chronic spontaneous urticaria that remained symptomatic despite treatment with second-generation H1<\/sub>-antihistamines,” the authors write.<\/p>\n The study was funded by Novartis, the manufacturer of remibrutinib.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n