Chronic Spontaneous Urticaria and Bruton Tyrosine Kinase: A Multispecialty Expert Discussion - Episode 8
Overview of Remibrutinib Phase 3 Clinical Trials in CSU
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Panelists discuss how remibrutinib demonstrated rapid and sustained efficacy in the REMIX-1 and -2 trials through significant improvements in disease activity scores (UAS7, ISS7, HSS7) starting at week 1 and maintained through 52 weeks, with nearly half of patients achieving complete symptom resolution (UAS7 = 0) by week 52, while maintaining a favorable safety profile throughout the study period.
Video content above is prompted by the following:
- What is notable about the efficacy and safety data from the REMIX-1 and -2 studies for remibrutinib?
- Significant change from baseline in UAS7 scores as early as week 1 and sustained through week 24, with similar trends for ISS7 and HSS7
- Primary end point met of superiority in change from baseline in UAS7 and ISS7/HSS7 at week 12 compared to placebo
- A higher proportion of patients with remibrutinib achieve UAS7 ≤ 6 and UAS7 = 0
- Safety consistent with previous findings
- There was additional data presented this year from the REMIX trials: long-term 52-week data. What new insights do this data reveal about remibrutinib?
- At week 24, patients receiving placebo were transitioned to remibrutinib; responses with remibrutinib were observed as early as the first week after switching and were sustained until the end of the study (28 weeks of treatment)
- Almost half of patients were completely free of itch and hives (UAS7 = 0) as assessed at week 52
- Safety profile favorable and consistent
- What is the clinical utility of the measures used in these studies (UAS7, ISS7, HSS7), and what is considered clinically meaningful for patients?
