Remibrutinib (LOU064) is a highly selective Bruton's tyrosine kinase inhibitor (BTKi). It has demonstrated the ability to effectively manage symptoms of chronic spontaneous urticaria (CSU) in patients who do not respond to second-generation H1-antihistamines. It is currently in the third phase of clinical trial development for CSU.

PAUSE
In a study published in the Journal of Allergy and Clinical Immunology, Remibrutinib demonstrated a consistently favourable safety profile with fast and sustained efficacy for up to 52 weeks in patients with CSU.

A team of researchers evaluated the long-term safety and efficacy of remibrutinib in CSU patients inadequately controlled with H1-antihistamines.
In this phase 2b extension study, participants who had completed the core study and had a weekly Urticaria Activity Score (UAS7)≥16 at the beginning of the extension study were given remibrutinib 100 mg twice daily for 52 weeks. The main goal was to evaluate the long-term safety and tolerability of the treatment. Key efficacy endpoints included baseline change in UAS7 and proportion of patients with complete response to treatment (UAS7=0) and well-controlled disease (UAS7≤6) at week four and over 52 weeks.
Key points of this study include:
One hundred ninety-four patients entered the treatment period and received ≥ 1 dose of remibrutinib.
The overall safety profile was comparable between the extension and core studies.
Mild to moderate treatment-emergent adverse events (TEAEs) were reported mostly. According to investigators, these were unrelated to remibrutinib.
Infections of skin and subcutaneous tissue and gastrointestinal disorders were the three most common TEAEs, constituting 30.9 %, 26.8 % and 16.5 %, respectively.
At weeks 4 and 52, mean±standard deviation change from baseline in UAS7 was −17.6±13.40 and −21.8±10.70; UAS7=0 was achieved in 28.2% and 55.8%, and UAS7≤6 in 52.7% and 68.0% of patients, respectively.
Long-term exposure of remibrutinib demonstrated consistent favorable safety, with fast and sustained efficacy for up to 52 weeks in CSU patients.
They said Remibrutinib has the potential to become a new oral therapeutic option for managing patients with CSU inadequately controlled with H1-antihistamines.
As acknowledged, the study was funded by Novartis Pharma AG, Basel, Switzerland.
Reference:
Jain, V. et al. Remibrutinib demonstrates a favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. The Journal of Allergy and Clinical Immunology. https://doi.org/10.1016/j.jaci.2023.10.007