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CSU: Novel agent targeting Bruton’s tyrosine kinase leads to disease control

Presented by
Prof. Marcus Maurer, Charité University Hospital, Germany
EADV 2021
Phase 2
Remibrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, showed a fast onset of action with marked and maintained reduction of chronic spontaneous urticaria (CSU) disease activity. A considerable rate of participants in a phase 2b study achieved disease control without raising safety concerns.

“Despite treatment options such as antihistamines and omalizumab, an anti-IgE, there are still a lot of patients who need better treatment of CSU to achieve complete control,” explained Prof. Marcus Maurer (Charité University Hospital, Germany) [1]. Prof. Maurer presented results of a phase 2b study (NCT03926611) assessing remibrutinib as a novel, selective, oral BTK inhibitor. The study enrolled 311 adult patients with CSU. All participants suffered from CSU for at least 6 months, which was uncontrolled despite antihistamine treatment, and presented at baseline with an Urticaria Activity Score (UAS7) of ≥16 points. The dose-finding trial evaluated placebo versus 6 different dosages of remibrutinib, ranging from 10 mg once daily to 100 mg twice daily. The primary endpoint was defined as change from baseline UAS7 at week 4. Key secondary endpoints included UAS7 change at week 12, UAS7=0 response over time, as well as safety and tolerability. “The key features and demographics were by and large evenly distributed,” stated Prof. Maurer. The mean duration of CSU was almost 5 years.

At the 4-week assessment, a clear dose-response relationship was seen in all study arms. “More importantly, for all of these different doses used, we saw an effect with a marked reduction in disease activity measured by UAS7 as compared with placebo,” Prof. Maurer stressed. Looking at the changes over 12 weeks, there was an early onset of later maintained disease activity reduction in weeks 1 and 2 with least square mean changes in the different remibrutinib arms between -15.3 and -20.2 compared with -7.9 on placebo. “Half of the patients who were treated with remibrutinib oral treatment achieved a marked reduction in their disease activity at the end, reflecting mild disease or well-controlled disease, so a very encouraging result for this oral BTK inhibitor,” Prof. Maurer elaborated. In terms of safety, the drug was well-tolerated and showed no apparent dose-dependent adverse effects.

    1. Maurer M. The Bruton’s tyrosine kinase inhibitor remibrutinib (LOU064) in chronic spontaneous urticaria: Top-line results of a phase 2b dose-finding study. D1T01.3C, EADV Congress 2021, 29 Sept–2 Oct.


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