Remibrutinib safety profile continues with long term use for chronic spontaneous urticaria
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MILAN — Long term use of remibrutinib was safe and well tolerated for patients with chronic spontaneous urticaria, according to a poster presented at the European Academy of Dermatology and Venereology Congress.
“Chronic spontaneous urticaria (CSU) is characterized by the spontaneous occurrence of wheals (hives) and/or angioedema for [6 weeks or more] and has a major impact on patients’ well-being,” Ana Giménez-Arnau, MD, PhD, of the department of dermatology at Hospital Del Mar Medical Research Institute, and colleagues wrote. “Remibrutinib (LOU064), a novel, highly selective and potent covalent oral Bruton’s Tyrosine Kinase inhibitor (BTKi) is currently in phase 3 development for the treatment of CSU.”
Long term use of remibrutinib was safe and well tolerated for patients with chronic spontaneous urticaria.
Previous data analysis has found remibrutinib to be safe and well tolerated for CSU patients but did not focus on long-term results.
This analysis included data from the phase 2b trial and its long-term open-label extension study, during which patients received one of five doses of remibrutinib (once daily at 10 mg or 35 mg, or twice daily at 10 mg, 25 mg or 100 mg) or placebo for 12 weeks.
In the long-term study, eligible patients then received remibrutinib 100 mg twice daily for up to 52 weeks.
At least one adverse event was reported in 57.4% of patients in the long-term study, which was proportionate with the core study’s results of 58.1%.
Seven patients in the original study discontinued due to adverse events, while six did so in the extension study.
Serious adverse events were reported in five (1.9%) patients in the first 12 weeks and 4 (2.2%) of those in the extension study.
The most frequent adverse events were infections and infestations, skin and subcutaneous tissue disorders, nervous system disorders and gastrointestinal disease.
“Final analysis of the dose finding phase 2b trial and an interim analysis of its extension study, including long-term exposure with 100 mg [twice daily] dose for up to 52 weeks, shows favorable safety profile and good tolerability of remibrutinib in patients with CSU,” the authors wrote.