Overview of Remibrutinib Phase 3 Clinical Trials in CSU

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?