Novartis has reported 52-week results from its Phase 3 RemIND program evaluating Rhapsido (remibrutinib) in chronic inducible urticaria. Treatment with 25 mg twice daily showed sustained efficacy across three subtypes: symptomatic dermographism, cold urticaria and cholinergic urticaria.
Patients initially randomized to Rhapsido maintained symptom improvements through week 52. Those initially assigned placebo switched to Rhapsido at week 24 and achieved week 52 response rates similar to those receiving the drug from the outset.
At week 1, complete or partial response rates on subtype-specific provocation tests were 41.8% with Rhapsido versus 19.2% with placebo in symptomatic dermographism, and 67.4% versus 28.9% in cold urticaria. In cholinergic urticaria, response rates at week 2 were 65.2% versus 45.6%, respectively.
At week 52, response rates among patients initially randomized to Rhapsido were 46.8% for symptomatic dermographism, 83.3% for cold urticaria and 58.2% for cholinergic urticaria. Corresponding rates among patients who switched from placebo were 47.7%, 88.9% and 69.8%.
Novartis said Rhapsido was well tolerated through week 52, with a safety profile consistent with previous studies and established experience in chronic spontaneous urticaria. The company plans additional regulatory submissions for chronic inducible urticaria based on these data.
The findings will be presented as a late-breaking abstract at the American College of Allergy, Asthma & Immunology's 2026 annual meeting. Unlike chronic spontaneous urticaria, which has no specific triggers, inducible urticaria can cause hives or swelling following skin friction, cold exposure or increased body temperature, including during exercise or hot-water bathing, and can substantially interfere with patients' daily activities.
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