TOPLINE:

Remibrutinib, an oral, highly selective Bruton tyrosine kinase inhibitor, showed sustained efficacy and a favorable safety profile over 52 weeks in patients with chronic spontaneous urticaria (CSU).

METHODOLOGY:

• Researchers conducted two phase 3 randomized trials to assess the efficacy, safety, and tolerability of oral remibrutinib administered twice daily in patients with CSU whose symptoms had not responded adequately to second-generation H1 antihistamines.
• More than 900 patients participated in the REMIX-1 and REMIX-2 trials. Prior research looked at outcomes such as itch severity and hive count at 12 weeks, and the medication was approved for the treatment of CSU in September on the basis of the results.
• To assess long-term efficacy and safety, the researchers looked at outcomes after 52 weeks.

TAKEAWAY:

• At week 52, the mean change in weekly Urticaria Activity Score (UAS7) from baseline was approximately -23. The response was similar in participants who switched from placebo to remibrutinib at 24 weeks.
• Well‑controlled disease (UAS7 ≤ 6) was achieved by 62.9% (95% CI, 56.5%-68.9%) and 62.2% (95% CI, 55.4%-68.5%) of patients who received remibrutinib in REMIX‑1 and REMIX‑2, respectively.
• The safety profile over 52 weeks was generally consistent with that seen at 24 weeks. Infections — most often respiratory tract infections — were the most common type of adverse event, and serious adverse events were infrequent and considered unrelated to treatment, the researchers reported.

IN PRACTICE:

“The efficacy, favorable safety, and tolerability of remibrutinib show its potential as a novel efficacious treatment that may provide fast (observed as early as week 1) and sustained symptom relief for patients with CSU who remain symptomatic despite H1 antihistamines,” the authors of the study wrote.

SOURCE:

Ana Maria Giménez-Arnau, MD, PhD, Universitat Pompeu Fabra, Barcelona, Spain, was the corresponding author of the study, which was published online on October 18, 2025, in The Journal of Allergy and Clinical Immunology.

LIMITATIONS:

Open questions about discontinuation of treatment, symptom recurrence, and the use of remibrutinib as monotherapy are being addressed in an ongoing extension study, the authors of the study wrote.

DISCLOSURES:

The study was sponsored by Novartis, which manufactures the drug, and several authors were employees of or had financial ties to the company.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.