Rhapsido (Remibrutinib) for Chronic Spontaneous Urticaria: Phase 3 Efficacy Data

Is there finally a fast-acting oral treatment for chronic hives? In this episode of the Science of Skin Podcast, board-certified dermatologist Dr. Ted Lain is joined by Dr. Naiem Issa, a dermatologist in Northern Virginia and assistant professor of dermatology at the University of Miami and George Washington University, to break down the phase 3 clinical trial results for Rhapsido (remibrutinib), the first oral BTK inhibitor for chronic spontaneous urticaria (CSU).

Dr. Issa explains how Bruton's tyrosine kinase (BTK) inhibition works inside the mast cell to block the signals that lead to degranulation and histamine release, and why remibrutinib's covalent, highly selective binding helps explain its rapid onset and durable results. The doctors then walk through the pivotal trial data, including reductions in the Hives Severity Score (HSS7), Itch Severity Score (ISS7), and Urticaria Activity Score (UAS7). Patients saw about a 40% reduction in hives as early as week one, around 70% by week 12, and continued improvement through 52 weeks. Nearly 28% of patients reached UAS7 = 0, meaning complete absence of hives and itch, at week 12 compared with 6.5% on placebo, rising to almost 46% at one year.

They also discuss the challenging trial population, which included patients with severe disease uncontrolled on up to four times the standard dose of second-generation antihistamines, many with angioedema, and about a third with prior anti-IgE biologic therapy such as omalizumab. Dr. Lain and Dr. Issa cover angioedema-free weeks, what complete control means for quality of life, how this data may change CSU treatment for dermatologists and allergists, and what new data on even faster onset may be coming soon.

This episode is sponsored by Novartis with content independently created by the Science of Skin podcast.

⚠️ This content is for educational and informational purposes only and reflects the personal research findings and opinions of the speakers. It is not medical advice. The discussion involves animal studies and experimental research; consult a licensed healthcare provider for questions about your own health.

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