Add-on Remibrutinib Quickly Improves Urticaria Control in CSU

Martin Metz, MD

Credit: Charite-Universitatsmedizin Berlin, Germany

Add-on remibrutinib quickly improved urticaria control and demonstrated superiority over placebo in patients with chronic spontaneous urticaria (CSU), in new findings from the REMIX-1/-2 phase 3 trials.

These data will be presented at the 2025 American Academy of Allergy, Asthma, and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress, February 28-March 3, in San Diego, California, by Martin Metz, MD, Deputy Director, Head of Translational Research and Clinical Studies, Institute of Allergology, Charite-Universitatsmedizin Berlin, Germany.

“In REMIX-1/-2, add-on remibrutinib improved urticaria control as early as week 2, with improvements sustained through week 52, as measured by UCT7, a reliable, practical measurement of urticaria control,” Metz and colleagues wrote.¹

Remibrutinib is a novel, highly selective, oral Bruton tyrosine kinase (BTK) inhibitor evaluated for efficacy and safety in the identical REMIX-1/-2 multicenter, randomized, double-blind, placebo-controlled phase 3 trials. The trials enrolled participants with symptomatic CSU despite second-generation H1-antihistamines to be randomized 2:1 to add-on remibrutinib 25 mg twice daily (bid), or placebo. Starting at week 24, all patients received add-on open label remibrutinib 25 mg bid until week 52. Investigators assessed urticaria control using the weekly urticaria control test (UCT7) at baseline and weeks 2, 4, 12, 24, 52.¹

Data reported are from 912 patients in the full analysis set, 606 receiving remibrutinib and 306 receiving placebo. The remibrutinib groups demonstrated fast improvements in mean change from baseline in UCT7 versus placebo at week 2 (REMIX-1: 5.74 versus 1.95; REMIX-2: 5.57 versus 2.27) and week 24 (REMIX-1: 7.17 versus 4.60; REMIX-2: 6.93 versus 4.47), which was sustained through week 52. The remibrutinib groups also had a higher proportion of patients with well controlled urticaria (UCT7 ≥12) at week 24 compared with the placebo groups (REMIX-1: 63.1% versus 41.6%; REMIX-2: 64.8% versus 40.2%), with similar proportions observed at week 52. Furthermore, patients transitioning from placebo to remibrutinib at week 24 experienced similar improvements through week 52.¹

Metz is also presenting other research in the CSU field at AAAAI on barzolvolimab from a phase 2 study demonstrating that the treatment yielded marked and sustained improvements in urticaria control and quality of life in 208 patients whose CSU was refractory to antihistamines.

Participants in the 150mg Q4W groups had mean baseline UCT scores of 3.7 (standard deviation [SD], 2.5) and participants in the Q8W groups had mean baseline UCT scores of 3.0 (SD, 2.6), indicating poorly treated urticaria in both dosage groups. The investigators found that barzolvolimab improved UCT with a mean change from baseline at 52 weeks of 10.5 (SD, 3.9) in the Q4W groups and 9.4 (SD, 5.0) in the Q8W groups.²

Participants in the 150mg Q4W groups had mean baseline DLQI scores of 15.7 (SD, 7.6) and participants in the 300 mg Q8W groups had mean baseline DLQI scores of 17.4 (SD, 7.5), indicating a very large impact of disease on QoL. The investigators found that barzolvolimab improved DLQI with a mean change from baseline at 52 weeks of -14.2 (SD, 7.3) in the 150mg Q4W groups and -15.0 (SD, 8.5) participants in the 300 mg Q8W groups.²

REFERENCES

1. Metz M, Bin Y, Boren E, et al. The Impact of Remibrutinib on Urticaria Control in Patients with Chronic Spontaneous Urticaria: Long-term Results from the REMIX-1/-2 Phase 3 Trials. Presented at: 2025 AAAAI/WAO Joint Congress, February 28-March 3. Abstract 551

2. Maurer M, Metz M, Kobielusz-Gembala I, et al. Barzolvolimab Improves Urticaria Control and Quality of Life in Patients with Chronic Spontaneous Urticaria: 52-Week Data. Presented at: 2025 AAAAI/WAO Joint Congress, February 28-March 3. Abstract L11.