Remibrutinib new option beyond antihistamines for managing chronic spontaneous urticaria
Remibrutinib (LOU064) is a highly selective Bruton's tyrosine kinase inhibitor (BTKi). It has demonstrated the ability to effectively manage symptoms of chronic spontaneous urticaria (CSU) in patients who do not respond to second-generation H1-antihistamines. It is currently in the third phase of clinical trial development for CSU.
In a study published in the Journal of Allergy and Clinical Immunology, Remibrutinib demonstrated a consistently favourable safety profile with fast and sustained efficacy for up to 52 weeks in patients with CSU.
A team of researchers evaluated the long-term safety and efficacy of remibrutinib in CSU patients inadequately controlled with H1-antihistamines.
In this phase 2b extension study, participants who had completed the core study and had a weekly Urticaria Activity Score (UAS7)≥16 at the beginning of the extension study were given remibrutinib 100 mg twice daily for 52 weeks. The main goal was to evaluate the long-term safety and tolerability of the treatment. Key efficacy endpoints included baseline change in UAS7 and proportion of patients with complete response to treatment (UAS7=0) and well-controlled disease (UAS7≤6) at week four and over 52 weeks.
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