Urticaria Symptoms, Sleep Improve With Remibrutinib: Mark Lebwohl, MD

Patients with chronic spontaneous urticaria (CSU) experienced improved quality of life and sleep when symptoms were mitigated with remibrutinib (Rhapsido; Novartis) in the REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) trials, according to a pooled analysis presented at the American College of Allergy, Asthma & Immunology 2025 Annual Meeting.¹

In an interview with The American Journal of Managed Care^® (AJMC^®), study investigator Mark Lebwohl, MD, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai and professor and chairman emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at Icahn School of Medicine, discussed the study's findings and the importance of persistent symptom control for patients with CSU.

This transcript has been lightly edited.

AJMC: What were the main outcomes of the analysis, and what are their clinical implications?

One of the things that comes across in every chronic urticaria study is that chronic urticaria has a profound impact on patients' quality of life. In many ways, it improves their day-to-day functions, their interactions with others, and, very specifically, their ability to sleep. It's characterized by severe itching, and anything that gets rid of it, and especially something that gets rid of it quickly, is a welcomed development. When the study was done, the drug wasn't approved. It is now, and even though it's been on the market just a short time, the benefits that we've had from it have been exactly what we saw in the clinical trials: very rapidly effective. We see it working quickly, and that is a real benefit; apart from it being very rapidly effective, all the things that you would expect to happen when you take an awful condition and make it better happen. Patients are able to sleep when they couldn't before, and they're able to interact—both in intimate ways and in just day-to-day social interactions—much more easily than when they don't have it, and they're able to conduct their day-to-day business on a regular basis in a much more effective and pleasant way than they did before. The questions that we ask about quality of life hit literally every aspect of your day-to-day life activities, including intimacy, including social interactions, including just the ability to do things, and all of that improves substantially when you have a drug that works as rapidly as this one does.

AJMC: What was the rationale for pooling data from REMIX-1 and REMIX-2, and how did this enhance your ability to assess relationships between disease activity and quality-of-life measures?

REMIX-1 and REMIX-2 are the pivotal trials that led to the approval of the drug. The primary end points are what go into the publications of why it should be approved and the major publications that come out. But there's a tremendous amount of other data that's collected at the same time, including impact on sleep, including these questionnaires that were asked to all the patients about their quality of life. The primary end points occurred at a certain fixed time, but measurements were taken throughout the study, so the speed of the improvement actually was quite apparent, and it was apparent in every measurement that they took at each of the frequent visits, so we know that this is one of the fastest treatments—if not the fastest—that we have.

AJMC: From a managed care perspective, what do these data suggest about the potential value of remibrutinib for patients who remain symptomatic despite guideline-directed antihistamines?
It turns out roughly half the patients who go through chronic urticaria don't respond adequately to high doses of antihistamines, and the guidelines are 4 times the recommended daily dose of the non-sedating antihistamines, and it's roughly half of patients who don't respond adequately to that. Now we have an oral medicine, so we don't have to go to injections, which is what we had before. We have an oral medicine that works faster than some of the injectable medicines, and you don't need to take an injection.

AJMC: Can you speak to therapy adherence with injectable therapies vs oral therapies?

In the trial, the adherence seemed to be good—and when you have a very bad condition and you take something as simple as a pill that makes it go away, your body will remind you if you don't adhere to the regimen because the condition will come back. Adherence is quite good with remibrutinib, and for the same reasons it is also quite good with the injectable medicines. When patients have a bad condition, they are perfectly happy to inject themselves to make sure it stays away.

Reference

Lebwohl M, Jain V, Hide M, et al. Remibrutinib improves urticaria symptoms, quality of life, and sleep: an analysis from the REMIX-1/-2 studies. Poster presented at: American College of Allergy, Asthma & Immunology 2025 Annual Meeting; November 13-16, 2025; Orlando, FL. Poster R093.