Safety of Remibrutinib in Chronic Spontaneous Urticaria: A Pooled Analysis of REMIX-1 and REMIX-2 Trials.

What was studied

This study looked at how safe remibrutinib is in chronic spontaneous urticaria. Remibrutinib is a drug taken by mouth. It blocks a target called Bruton's tyrosine kinase. The team pooled data from the phase 3 trials REMIX-1 and REMIX-2. For the first 24 weeks, people got the drug or a dummy pill. Who got which was set by chance. Neither people nor staff knew who got which. Then came 28 weeks of open treatment. Side effects and blood test results were checked up to week 52.

What they found

In all, 606 people got remibrutinib and 306 got the dummy pill. Side effects of any kind were about as common in both groups. Rates of infections did not differ much between the groups. Low blood cell counts and liver problems also did not differ much. Bleeding signs were more common with remibrutinib. This gap came from petechia and similar marks on the skin or inner linings. These events were mostly mild, and none were severe. No other side effect rose in a clear way with the drug. Results over the full 52 weeks were in line with the first 24.

What it means for patients

The authors say remibrutinib had a good safety record in these trials. The main extra issue was a slightly higher rate of petechia. Similar marks on the skin or inner linings were also part of this. These were mostly mild. Other safety results did not differ in a notable way from the dummy pill.

Why it is not certain yet

The drug was only compared with a dummy pill for 24 weeks. In the later 28 weeks, there was no dummy pill group. In that open part, people knew what they were taking. The data only go up to week 52. The abstract does not give details on who took part.

Source

Safety of Remibrutinib in Chronic Spontaneous Urticaria: A Pooled Analysis of REMIX-1 and REMIX-2 Trials.

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