CSU: Rapid symptom relief with remibrutinib

A new analysis of phase 3 data revealed that 58% of remibrutinib-treated patients with chronic spontaneous urticaria (CSU) achieved well-controlled disease. After 5 weeks, 51% of patients on this Bruton’s kinase (BTK) inhibitor were symptom-free.

Prof. Martin Metz (Charité University Medicine Berlin, Germany) presented data from the identical phase 3 REMIX-1 and -2 studies (NCT05030311 and NCT05032157) on remibrutinib for CSU [1]. The novel analysis focused on the time to onset of well-controlled disease (weekly urticaria activity score (UAS7) ≤6) or complete absence of itch and hives (UAS7=0).

Remix -1 and -2 included 613 participants treated with oral remibrutinib 25 mg twice daily and 312 in the placebo arm. Overall, 70.3% on remibrutinib and 49.3% on placebo reached UAS7≤6 at week 24, and 57.1% and 27.5% achieved UAS7=0, respectively. By week 3, 58% of remibrutinib-treated participants versus 18% of placebo-treated participants had well-controlled disease. The median time to achieve UAS7=0 was longer: by week 5, 51% of the remibrutinib group were symptom-free, compared with 13% in the placebo group.

Prof. Metz also reviewed the published safety profile of remibrutinib, which was overall comparable between groups. The main difference was a higher incidence of mild-to-moderate petechiae, observed in 3.8% on remibrutinib and 0.3% on placebo.

“Remibrutinib shows a fast onset of action leading to both well-controlled and complete responses,” Prof. Metz summarised. He concluded that remibrutinib represents a fast and effective oral treatment option for patients inadequately controlled with antihistamines.

1. Metz M, et al. Remibrutinib-treated patients with CSU who achieve well-controlled disease activity reach this by week 3 in the majority of patients: Results from REMIX-1/-2 studies. EPS02.03., EADV Congress 2025, 17–20 September, Paris, France.

Medical writing support was provided by Dr Susanne Kammerer and Karin Drooff

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Posted on 23 September 2025