Oral Remibrutinib Shows Promise for Peanut Allergy Treatment, Offering Rapid Relief

PHILADELPHIA – A phase II trial has demonstrated that oral remibrutinib (Rhapsido) can increase peanut tolerance in adults with proven peanut allergy, with some patients experiencing benefits within as little as one week. The findings, presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, suggest a potential new approach to managing a condition affecting millions.

Rapidly Increasing Peanut Tolerance

The study involved 76 adults aged 18-55 with a documented history of peanut allergy. Participants were randomized to receive remibrutinib at doses of 10, 25, or 100 mg twice daily for four weeks, or placebo for three weeks followed by one week of remibrutinib 25 mg twice daily, or placebo alone. After four weeks, a significant proportion of patients treated with remibrutinib demonstrated an increased ability to tolerate peanut protein.

• 10 mg Twice Daily: 40.0% (6 of 15 patients) tolerated at least 600 mg of peanut protein (equivalent to 2.5 peanuts).
• 25 mg Twice Daily: 50.0% (8 of 16 patients) tolerated at least 600 mg of peanut protein.
• 100 mg Twice Daily: 86.7% (13 of 15 patients) tolerated at least 600 mg of peanut protein.
• Placebo: None of the patients were able to tolerate 600 mg of peanut protein.

Notably, all six patients who received just one week of remibrutinib at 25 mg twice daily after three weeks on placebo were able to tolerate the challenge without a reaction to at least 600 mg of peanut protein ¹.

How Remibrutinib Works and Compares to Existing Treatments

Remibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor. Currently, the only FDA-approved treatment for food allergies that isn’t allergen-specific is omalizumab (Xolair). Although effective, omalizumab doesn’t function for everyone ¹. Remibrutinib could offer a broader efficacy and the convenience of oral administration, avoiding regular injections.

Dr. Yamini Virkud, MD, MPH, of the University of North Carolina at Chapel Hill, suggested remibrutinib could be “a game changer” if it provides similar broad efficacy without the need for regular injections, which can be a deterrent even for older teenagers ¹. The rapid onset of action – potentially within a week – is another advantage, as patients often need protection quickly when facing uncertain food environments, such as travel or starting college.

Wayne G. Shreffler, MD, PhD, director of the Food Allergy Center at Massachusetts General Hospital and Harvard in Boston, noted that the efficacy of remibrutinib appears comparable to that of omalizumab, and potentially even better ¹. In the OUtMATCH trial, 67% of omalizumab-treated multi-food allergic children were able to tolerate 600 mg of peanut protein.

Future Directions and Considerations

Novartis, the manufacturer of remibrutinib (Rhapsido), plans to initiate a phase III study in adults and adolescents with IgE-mediated food allergy, potentially expanding beyond peanut allergy, later in 2026 ², ⁴.

A potential limitation is the impact of BTK inhibition on the immune response to vaccines, particularly in younger children. BTK plays a role in B cells and other immune cells involved in immunization ¹. Further research will be needed to determine the appropriate age range for remibrutinib treatment.

Safety Profile

The trial demonstrated a “exceptionally reassuring” safety profile, with no significant concerns regarding infections, or systemic effects ¹.

Disclaimer: This article provides information for general knowledge and informational purposes only, and does not constitute medical advice. It is essential to consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.