A recent study led by Dr. Martin Metz and Dr. Marcus Maurer from Charité-Universitätsmedizin Berlin has demonstrated the effectiveness of remibrutinib in treating chronic spontaneous urticaria. The research, funded by Novartis Pharmaceuticals, included two phase 3 trials, REMIX-1 and REMIX-2, which enrolled a total of 925 participants. These patients, who had a mean age of approximately 43 years, were randomly assigned to receive either 25 mg of oral remibrutinib twice daily or a placebo for 24 weeks.
The primary goal of the study was to assess changes in the weekly urticaria activity score (UAS7) at 12 weeks. Secondary endpoints included achieving well-controlled urticaria, complete symptom resolution, and evaluating safety.
“These results support the efficacy and safety of remibrutinib in patients with chronic spontaneous urticaria that remained symptomatic despite treatment with second-generation H1-antihistamines,” the authors highlighted in their findings.
Study Design and Methodology
The trials utilized a double-blind, randomized, placebo-controlled design to ensure robust and unbiased results. Participants were divided into two groups using a 2:1 ratio for receiving remibrutinib or placebo, respectively. The study's primary endpoint focused on the reduction in UAS7 scores after 12 weeks, while secondary endpoints examined the degree of urticaria control and symptom resolution.
The results indicated that remibrutinib significantly reduced itch and hives associated with chronic spontaneous urticaria. By week 12, patients receiving remibrutinib showed greater improvements in UAS7 scores compared to those on placebo. The least-squares mean differences were –6.2 in REMIX-1 and –7.7 in REMIX-2, both with statistical significance (P <.001).
Efficacy and Safety Outcomes
Remibrutinib's efficacy was evident early in the trials, with improvements noticeable as soon as week 1 and sustained through week 24. Notably, a higher proportion of patients on remibrutinib achieved well-controlled urticaria and complete symptom resolution compared to the placebo group. In REMIX-1, the odds ratio (OR) for well-controlled urticaria was 3.1, while it reached 3.8 in REMIX-2. Complete symptom resolution showed ORs of 3.8 and 5.8 in REMIX-1 and REMIX-2, respectively.
Safety evaluations revealed that adverse events were comparable between the remibrutinib and placebo groups, affecting approximately 64.9% and 64.7% of participants, respectively. Most adverse events were mild or moderate and transient in nature.
Funding and Publication
The study was published online on March 5 in The New England Journal of Medicine. It is important to note that some authors reported consulting fees, speaker fees, and grants from various pharmaceutical companies, including Novartis. Additionally, two authors held stocks or were employed at Novartis, and both lead researchers have served as consultants for several pharmaceutical companies.
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