REMIX-1
Trial question
What is the role of remibrutinib, a selective Bruton TKI, in patients with chronic spontaneous urticaria?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
68.0% female
32.0% male
N = 470
470 patients (321 female, 149 male).
Inclusion criteria: patients with chronic spontaneous urticaria.
Key exclusion criteria: clearly defined predominant or sole trigger of chronic urticaria; other diseases with symptoms of urticaria or angioedema; any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results; clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or hematological disorders; significant bleeding risk or coagulation disorder.
Interventions
N=313 remibrutinib (oral dose of 25 mg BID).
N=157 placebo (matching oral placebo BID).
Primary outcome
Least-squares mean reduction in Urticaria Activity Score during a 7-day period at week 12
20 points
13.8 points
20.0 points
15.0 points
10.0 points
5.0 points
0.0 points
Remibrutinib
Placebo
Significant
increase ▲
Significantly greater reduction in least-squares mean Urticaria Activity Score during a 7-day period at week 12 (20 points vs. 13.8 points; AD 6.2 points, 95% CI 4 to 8.5).
Secondary outcomes
Significantly greater reduction in Urticaria Activity Score during a 7-day period of ≤ 6 at week 12 (49.8% vs. 24.8%; OR 3.1, 95% CI 2 to 4.8).
Significantly greater reduction in Urticaria Activity Score during a 7-day period of 0 at week 12 (31.1% vs. 10.5%; OR 3.8, 95% CI 2.2 to 6.8).
Significant increase in well-controlled chronic spontaneous urticaria at week 2 (33.7% vs. 3.3%; OR 15.7, 95% CI 6.2 to 39.8).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In patients with chronic spontaneous urticaria, remibrutinib was superior to placebo with respect to a least-squares mean reduction in Urticaria Activity Score during a 7-day period at week 12.
Reference
Martin Metz, Ana Giménez-Arnau, Michihiro Hide et al. Remibrutinib in Chronic Spontaneous Urticaria. N Engl J Med. 2025 Mar 6;392(10):984-994.
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