The following is a summary of “Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks,” published in the February 2024 issue of Allergy & Immunology by Jain, et al.

For a study, researchers sought to assess the long-term safety and efficacy of remibrutinib in patients with chronic spontaneous urticaria (CSU) inadequately controlled with H1 antihistamines.

In the phase 2b extension study, patients from the core study with a weekly Urticaria Activity Score (UAS7) ≥16 at the extension study’s initiation received remibrutinib 100 mg twice daily for 52 weeks. The primary objective was to evaluate long-term safety and tolerability, with key efficacy endpoints including changes in UAS7 from baseline, the proportion of patients achieving complete response (UAS7 = 0), and those achieving well-controlled disease (UAS7 ≤6) at weeks 4 and over 52 weeks.

A total of 84.3% (194/230) of patients transitioned to the treatment period and received ≥1 dose of remibrutinib. The safety profile remained consistent between the extension and core studies, with most treatment-emergent adverse events being mild to moderate and unrelated to remibrutinib. The most common treatment-emergent adverse events included infections (30.9%), skin and subcutaneous tissue issues (26.8%), and gastrointestinal disorders (16.5%). At weeks 4 and 52, the mean change from baseline in UAS7 was -17.6 ± 13.40 and -21.8 ± 10.70, with 28.2% and 55.8% achieving UAS7 = 0, and 52.7% and 68.0% achieving UAS7 ≤6, respectively.

Remibrutinib demonstrated consistent and favorable safety and efficacy profiles over 52 weeks in patients with CSU inadequately controlled with H1 antihistamines. The findings suggested that remibrutinib may be a promising long-term treatment option for CSU patients.

Reference: jacionline.org/article/S0091-6749(23)01346-5/fulltext