Remibrutinib new option beyond antihistamines for managing chronic spontaneous urticaria
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.
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
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