Quick Responses May Boost Adherence to Remibrutinib in CSU: Michael J. Palumbo, MD

Patients with chronic spontaneous urticaria (CSU) treated with remibrutinib (Rhapsido; Novartis) in the REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) trials experienced rapid responses and long-term symptom relief, according to a pooled analysis presented at the American College of Allergy, Asthma & Immunology 2025 Annual Meeting.

In an interview with The American Journal of Managed Care^® (AJMC^®), study investigator Michael Palumbo, MD, an allergy and immunology physician at Allergy and Clinical Immunology Associates in Pittsburgh, Pennsylvania, discussed the main findings of the pooled analysis and how the quick symptom control seen with remibrutinib could help lead patients to be consistent with their dosing.

This transcript has been lightly edited.

AJMC: What were the main efficacy findings of the analysis, and what do they add to prior analyses of remibrutinib in CSU?

We were very excited to present the information at the meeting showing the continued and sustained improvement in Itch Severity Score and Urticaria Activity Score. These data were now over 52 weeks. Previously, we had shown the data up to 24 weeks, and now we have the data out to 52 weeks for those patients who continued on the remibrutinib active arm, as well as those patients who were switched over from placebo to remibrutinib from 24 weeks out to 52 weeks.

AJMC: Can you speak to the clinical significance of achieving symptom control as early as week 1? How might this influence treatment decisions in practice?

I was one of the clinical trial sites for this study, and it's always exciting for us to see patients that have been suffering for so long have an improvement in their symptoms so quickly. Obviously, 1 week is never an end point for a clinical trial, but seeing patients already noticing symptom improvement within 3 days really leads to helping keep patients consistent on dosing. When patients are in clinical trials, they're being monitored closely, and we don't have to worry about dosing quite as much. But in the real world, we want to make sure the patients are going to be continuing to take the medicine as prescribed, and seeing improvements as early as 1 week is going to be really beneficial to helping keep patients consistent on their dosing.

AJMC: How do you interpret the safety profile of remibrutinib compared with other treatments for CSU?

There are mostly similar adverse reactions for remibrutinib vs the other agents that are currently being marketed—including nausea, headache, and respiratory infection. The only difference that we saw in this trial was the increased risk of bleeding, around 9%. That was very transient, fortunately, and most patients did not need to discontinue medication and were able to continue in the clinical trial. That's just something that needs to be monitored in patients. There are no labs that need to be obtained prior to starting treatment, and so no other changes need to be made before initiating treatment with [remibrutinib].

AJMC: How does remibrutinib fit into the current CSU treatment landscape?

It's very exciting to have an oral option for our patients that have failed high-dose oral antihistamines. That's where you're going to consider starting [remibrutinib]. Currently, the only medications that were approved and indicated for CSU were injectable medications, so it's very exciting to have an option for patients that is oral and not an injection, as a lot of patients are wary or afraid of getting an injection—especially an injection that would need to be repeated. It's great to have that option. It's going to be part of the shared decision-making plan with our patients when they fail these oral antihistamines at a high dose in terms of what would be the next step for treatment.

AJMC: How might real-world data complement or expand upon the findings from the REMIX trials?

The real world is definitely different than clinical trials. In clinical trials, everybody needs to be consistent and needs to be taking their doses twice a day as prescribed and continue to take that dose for 52 weeks. But in the real world, we know patients are not going to do that. Once their symptoms get under control, they're going to be able to start to consider backing off of these medications or not be as consistent in taking their doses as prescribed. It's going to be very interesting to see how patients are able to modify disease in the real world once the medication gets started and they get their symptoms under good control. Obviously we're always interested in seeing long-term safety data, as well. New things come up that were not seen in the clinical trials, so that's the other really important factor when it comes to real-world studies after clinical trials are completed.

Reference

Gogate S, Palumbo M, Giménez-Arnau A, et al. Early and sustained efficacy of remibrutinib in adult patients with CSU: pooled analysis of REMIX-1/-2. Poster presented at: American College of Allergy, Asthma & Immunology 2025 Annual Meeting; November 13-16, 2025; Orlando, FL. Poster R083.