Q&A: Late-Breaking REMIX-1 and REMIX-2 Data Demonstrated Efficacy of Remibrutinib in Chronic Spontaneous Urticaria

At the American Academy of Allergy, Asthma, and Immunology Annual Meeting (February 23-26) in Washington, DC, researchers presented late-breaking data from the phase 3 REMIX-1 and REMIX-2 studies of the investigational oral Bruton’s tyrosine kinase inhibitor remibrutinib in chronic spontaneous urticaria.

The abstract, titled, "Efficacy of Remibrutinib on Patients with Chronic Spontaneous Urticaria With or Without Prior Exposure to Biologics in the Phase 3 REMIX-1 and REMIX-2 Studies," was published in The Journal of Allergy and Clinical Immunology in February.

The REMIX-1 and REMIX-2 studies examined remibrutinib's effectiveness in treating chronic spontaneous urticaria in patients over 18 years old. Patients were divided into two groups based on whether they had prior exposure to anti-IgE biologics or not. They were then given either remibrutinib or a placebo for 24 weeks.

The study measured outcomes such as change from baseline in Urticaria Activity Score over 7 days (UAS7) and rates of disease control at week 12. Results showed that remibrutinib was more effective than placebo in reducing UAS7 scores and achieving disease control, regardless of prior exposure to anti-IgE biologics.

Giselle Mosnaim, MD, is an allergist immunologist at Endeavor Health in Chicago, Illinois, and an associate clinical professor at the University of Chicago School of Medicine. Mosnaim regularly sees patients with chronic spontaneous urticaria and recently spoke with Dermatology Times to discuss the data.

Q&A

Q: What is the significance of investigational oral remibrutinib in the treatment landscape of chronic spontaneous urticaria?

A: Chronic spontaneous urticaria is a very debilitating disease, and it affects over 40 million people around the world and over 1.7 million people in the United States. To date, we don't have enough effective therapies in this disease condition, and it's very exciting that remibrutinib it is an oral medication that helps patients that do not respond satisfactorily to oral antihistamines.

Q: How did the phase 3 REMIX-1 and REMIX-2 studies contribute to our understanding not only of its efficacy and safety profile in patients with CSU?

A: So the REMIX-1 and REMIX-2 studies, we'll have the full readout later. But it was very exciting at the recent American Academy of Allergy, Asthma, and Immunology Annual Scientific Meeting in Washington, DC. We presented a poster, and it showed that in patients that have been treated with anti IgE biologic therapy or not in the past for chronic spontaneous urticaria, whether they had been treated with this medication or not been treated with this medication, they responded well to remibrutinib and also had a favorable safety profile.

Q: Were there any unexpected findings or challenges encountered during the REMIX studies that you found particularly noteworthy?

A: The REMIX studies had an excellent safety profile, which was excellent, and the remibrutinib showed that it was effective as early as a week 2, and these improvements in symptoms for patients with CSU were sustained at week 12.

Q: Could you speak to the potential implications that these findings might have for clinical practice?

A: Chronic spontaneous urticaria is very debilitating. You wake up one day with red raised patches on your body. They're very itchy. They interfere with sleep. They come up randomly. They can affect your face, they can affect your arms, your legs, all over your body. It's a very, very difficult condition, and being able to offer new treatments for patients with CSU is tremendous, and especially new oral treatments that work as quickly as 2 weeks. So far, we've show that they continue to maintain that efficacy even at week 12.

Q: Considering the favorable efficacy and safety profile that remibrutinib demonstrated in the REMIX studies, what might be some of the next steps in further evaluating its role in the management of CSU?

A: We are awaiting the full readout of the entire data from the REMIX-1 and REMIX-2 trials. Hopefully that will be forthcoming later in 2024, so please stay tuned. This will be very exciting, very, very exciting, for our patients with CSU. As as a clinician that takes care of many patients with CSU, I am so excited to be able to offer them a new therapy that is oral, and that works quickly, and that has sustained effectiveness.

Q: What else about the REMIX studies and remibrutinib should dermatology clinicians consider?

A: I would reiterate is a major breakthrough to be able to have an oral treatment for patients that do not respond to antihistamines for chronic spontaneous urticaria. This is super, super exciting for the CSU community.

Reference

Mosnaim G, Gimenez-Arnau A, Hide M, et al. Efficacy of remibrutinib in patients with chronic spontaneous urticaria with or without prior exposure to biologics in the phase 3 REMIX-1 and REMIX-2 studies. J Allergy Clin Immunol. February 2024. Accessed March 12, 2024. DOI: https://doi.org/10.1016/j.jaci.2023.11.883