06 Dec ACAAI: Remibrutinib As Oral option for Patients with Chronic Spontaneous Urticaria who have failed high dose antihistamines

Dr. Gogate

MedicalResearch.com Interview with:
Dr. Shaila Gogate, MD
Colorado Allergy & Asthma Centers
Allergist
REMIX-1/-2 Investigator

MedicalResearch.com: What is the background for this study? What are the main findings?

A: The Phase III REMIX-1/-2 studies were randomized, double-blind, placebo-controlled studies assessing the efficacy and safety of oral  remibrutinib 25 mg twice daily or placebo over a 24-week double-blind period, followed by a 28-week open-label remibrutinib treatment period.

The purpose of this pooled analysis was to examine the early and long-term efficacy data of remibrutinib vs. placebo over time, looking at the mean percentage change from baseline (CFB) in weekly scores of disease activity (UAS7), itch severity (ISS7) and hives severity (HSS7) over 52 weeks. This analysis demonstrated that remibrutinib showed reductions in urticaria symptoms vs. placebo as early as week 1:

• • 38.4% vs. 10.3% in UAS7
  • 37.0% vs. 9.8% in ISS7
  • 39.8% vs. 10.1% HSS7
    Greater reductions vs. placebo were seen over 24 weeks and results were observed in the open-label period through week 52 in all remibrutinib-treated patients (including those transitioned from placebo).

MedicalResearch.com:  How does remibrutinib differ from other medications for urticaria?

A: Remibrutinib is an oral, targeted Bruton’s tyrosine kinase inhibitor (BTKi) treatment approved by the FDA for CSU in adults whose symptoms persist despite taking H1 AHs. It is a pill taken twice daily and does not require injections or laboratory monitoring.

Remibrutinib helps to inhibit the release of histamine and proinflammatory mediators by targeting BTK, offering a unique approach to CSU treatment by blocking IgE- and IgG-mediated degranulation of mast cells – potentially benefiting a broad pool of patients.

There have been no head-to-head studies conducted between remibrutinib and other CSU medications.

MedicalResearch.com:  What is the clinical significance of these early-term and sustained results, and what are key takeaways that medical practitioners should keep in mind as a result?

A: What clinicians should take away from this analysis is that remibrutinib showed symptom improvement as early as week 1, which improved further and was sustained through week 52.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

A: I’m excited about ongoing and future research on remibrutinib for CSU to continue to optimize treatment outcomes and personalized medicine approaches.

Head-to-head comparisons with other treatments like biologics, as well as real-world studies on patient preferences, adherence, and quality of life, are necessary to evaluate the effectiveness of remibrutinib comprehensively.

• • • At ACAAI, Novartis presented two study design abstracts relevant to this, with a Phase IIIb head-to-head study comparing Rhapsido to Dupixent in CSU patients and a Phase III study investigating Rhapsido in adolescent CSU patients.
    • Novartis is currently conducting a Phase IIIb trial (NCT06042478) assessing the efficacy, safety and tolerability of Rhapsido in comparison to placebo, with omalizumab as active control.
    • These studies underscore our continued commitment to investigating the safety and efficacy of Rhapsido as a potential oral treatment option for people living with CSU.

      Remibrutinib is a good oral option for patients with chronic spontaneous urticaria who have failed high dose antihistamines.

MedicalResearch.com: Is there anything else you would like to add?

A: Approximately 1.7 million people in the United States live with CSU, and more than half remain symptomatic despite taking increased doses of H1 antihistamines (AH). Although injectable treatments are available, today less than 20% of people with CSU who are still experiencing symptoms on AHs receive them, highlighting the urgent need for an effective, oral treatment.

The REMIX-1/-2 studies are significant because they showed that patients were able to experience fast and sustained relief with oral remibrutinib– a recently approved treatment option.

For many patients, now having an oral option is exciting.

Disclosures: I am an allergist and study author in Denver, CO. I also have served as a consultant for Novartis in the past, but nothing currently.

Citation:

ACAAI abstract  2025
Early And Sustained Efficacy of Remibrutinib in   Adult Patients with CSU: Pooled Analysis of REMIX1/-2
Annals of Allergy, Asthma & Immunology, Volume 135, Issue 5, S30
S. Gogate, M. Palumbo, A. Giménez-Arnau, S. Tao, M. Hide, K. Lheritier, and others

—-

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Some links may be sponsored. Products are not warranted or endorsed.

Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

Last Updated on December 8, 2025 by Marie Benz MD FAAD