REMIX-2
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
65.0% female
35.0% male
N = 455
455 patients (297 female, 158 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=300 remibrutinib (oral dose of 25 mg BID).
N=155 placebo (matching oral placebo BID).
Primary outcome
Least-squares mean reduction in urticaria activity score during a 7-day period at week 12
19.4 points
11.7 points
19.4 points
14.5 points
9.7 points
4.8 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 (19.4 points vs. 11.7 points; AD 7.7 points, 95% CI 5.5 to 9.9).
Secondary outcomes
Significantly greater reduction in least-squares mean urticaria activity score during a 7-day period of ≤ 6 at week 12 (46.8% vs. 19.6%; OR 3.8, 95% CI 2.4 to 6.2).
Significantly greater reduction in least-squares mean urticaria activity score during a 7-day period of 0 at week 12 (27.9% vs. 6.5%; OR 5.8, 95% CI 2.8 to 11.8).
Significant increase in well-controlled chronic spontaneous urticaria at week 2 (30% vs. 5.9%; OR 7.9, 95% CI 3.7 to 16.9).
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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