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Chronic spontaneous urticaria (CSU) is defined as recurrent hives and/or angioedema during at least 6 weeks for which no trigger is apparent. CSU is caused by inappropriate release of mast cell mediators by autoantibodies to IgE receptors. Remibrutinib is a Bruton tyrosine kinase (BTK) inhibitor that blocks BTK-mediated degranulation of mast cells and autoantibody production by B cells.
In two identical, industry-sponsored, international phase 3 trials, researchers examined remibrutinib's effectiveness in 925 adults with CSU that was not responsive to antihistamines. Patients were randomized to twice-daily oral remibrutinib or placebo for 1 year. After 12 weeks, mean itch and hive scores were significantly lower with remibrutinib; significan…