AAAAI: Remibrutinib Emerges as First Oral Advanced Therapy for Chronic Spontaneous Urticaria

In an interview with Pharmacy Times®, Giselle Mosnaim, MD, MS, FAAAAI, allergist and immunologist at Endeavor Health, discussed the clinical implications of her session, “A New Path Forward with Rhapsido,” presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, Pennsylvania.

Mosnaim highlighted the role of remibrutinib (Rhapsido; Novartis), an oral Bruton tyrosine kinase inhibitor, for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite high-dose second-generation antihistamines.

CSU management has historically followed a stepwise approach beginning with nonsedating antihistamines and escalating to injectable biologic therapies for refractory disease. Mosnaim explained that remibrutinib represents a significant advancement because it is the first oral agent categorized as an advanced therapeutic for CSU, offering an alternative to injectable treatments for appropriate patients.

Clinical efficacy was demonstrated in 2 large multinational phase 3 trials, REMIX-1 (NCT05030311)¹ and REMIX-2 (NCT05032157)₂. In both studies, remibrutinib met primary end points, showing statistically significant improvements vs placebo in itch severity score, hive severity score, and urticaria activity score over 7 days. These outcomes reinforce its potential role in patients who do not achieve adequate control with antihistamines alone.

“With all new therapies, it's important for the prescribing clinician, the pharmacist, and everyone to know about this new medication.”—Giselle Mosnaim, MD, MS, FAAAAI

Mosnaim noted that treatment decisions should incorporate patient preference, as some individuals may favor oral administration over injections. However, as with other advanced CSU therapies, prior authorization is required, making pharmacist involvement essential to facilitate access.

For pharmacists, the introduction of remibrutinib underscores the importance of formulary awareness, patient counseling, monitoring for adherence, and navigating payer requirements. As CSU treatment evolves, pharmacist collaboration will be central to optimizing timely access and individualized care.

REFERENCES

1. A phase 3 study of efficacy and safety of remibrutinib in the treatment of CSU in adults inadequately controlled by H1 antihistamines (REMIX-1). ClinicalTrials.gov. Updated April 8, 2025. Accessed March 1, 2026. https://clinicaltrials.gov/study/NCT05030311

2. A phase 3 study of efficacy and safety of remibrutinib in the treatment of CSU in adults inadequately controlled by H1-antihistamines (REMIX-2). ClinicalTrials.gov. Updated April 8, 2025. Accessed March 1, 2026. https://clinicaltrials.gov/study/NCT05032157