Remibrutinib in CSU: Findings from Phase 3 BISCUIT study

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Created On: 16/05/2026

Remibrutinib, a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, is emerging as a next-generation therapy for the management of chronic spontaneous urticaria (CSU).

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Key take away

Remibrutinib (25 mg twice daily) rapidly improves itch and hives in chronic spontaneous urticaria and sustains symptom control over 52 weeks with a favorable safety profile.

Background

Remibrutinib, a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, is emerging as a next-generation therapy for the management of chronic spontaneous urticaria (CSU). Building on positive global phase 3 data, the 52-week study determined its long-term safety and efficacy in Japanese patients who remained symptomatic despite H1-antihistamine treatment.

Method

The phase 3 BISCUIT trial was an open-label, single-arm study assessing remibrutinib 25 mg twice daily as add-on therapy. The key endpoint focused on adverse events, while efficacy was measured using the urticaria activity score (UAS7) and weekly itch and hives severity scores.

Result

Overall, 71 patients (mean age 43.5 years) received remibrutinib for a median of 52.1 weeks. Overall, 87.3% reported at least one adverse event, all of which were found to be mild to moderate. The most common events included COVID-19 (19.7%) and headache (12.7%). Three serious adverse events occurred but were not treatment-related, and no deaths were reported. Remibrutinib illustrated a rapid onset of action, with symptom improvement evident as early as week 1, and sustained disease control through week 52 (Table 1).

Conclusion

Remibrutinib offered fast, clinically meaningful, and sustained relief of itch and hives, with a consistent safety profile over 52 weeks. These findings position it as a promising intervention for difficult-to-treat CSU, particularly in those inadequately controlled on antihistamines.