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Remibrutinib Shows Rapid Symptom Relief in CSU, With Mark Lebwohl, MD
At AAAAI 2026, Lebwohl discussed REMIX trial data showing oral remibrutinib reduced CSU symptoms within 12 hours and improved disease control.
Pooled data from the phase 3 REMIX clinical trials suggest the oral Bruton’s tyrosine kinase inhibitor remibrutinib may reduce daily disease activity within 12 hours of treatment initiation in patients with chronic spontaneous urticaria (CSU). Investigators presented the results at the 2026 American Academy of Allergy, Asthma, & Immunology (AAAAI) annual meeting in Philadelphia.
Following the conference, HCPLive spoke with investigator Mark G. Lebwohl, MD, the dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai, who discussed the clinical implications of these findings and remibrutinib’s impact.
“I vividly recall a woman who was coming to me planning a wedding,” Lebwohl said.
The woman had come covered in urticaria, which had been on her skin for months. With remibrutinib, she could quickly improve her symptoms.
“The ability to give that rapid improvement is such an instant relief, which is greatly appreciated by patients,” he continued. “Often when we start treatments that take a while to work, the patients are not aware [of this fact] ... and they become skeptical that the treatments [are] not working. One of the worst things that happens with some of the other drugs is [that] you're starting a patient on a treatment for chronic urticaria, and they think they can then stop their antihistamines. It turns out, for many of the other treatments, that's a huge problem because the treatments don't kick in sometimes for days or even weeks. With remibrutinib, the treatment kicks in right away.”
The analysis pooled results from the phase 3 REMIX-1 and REMIX-2 trials evaluating remibrutinib 25 mg twice daily in patients with CSU inadequately controlled with H1-antihistamines. Across both studies, 606 and 306 participants received remibrutinib and placebo, respectively. Investigators examined daily disease activity using the daily Urticaria Activity Score (UAS), which ranges from 0 to 6 and incorporates both hive severity and itch intensity.
At baseline, mean daily UAS scores were 4.44 among patients receiving remibrutinib and 4.30 among those receiving placebo. Within 12 hours of the first dose, mean UAS scores declined to 3.96 with remibrutinib compared with 3.99 with placebo. Improvements continued over the first week of treatment; mean scores reached 3.09 vs 3.92 on day 2 and 2.25 vs 3.49 by day 7.
The analysis also examined shifts in symptom severity bands over the first week of treatment. At baseline, only 1.3% of patients receiving remibrutinib and 0.7% of those receiving placebo were classified in the lowest UAS severity band (0–1), representing no or mild symptoms. Within 12 hours, those proportions increased to 6.5% and 2.4%, respectively. By day 7, 37.0% of patients receiving remibrutinib had reached the lowest symptom band compared with 9.7% of patients receiving placebo.
Lebwohl noted that evaluating daily symptom scores rather than relying solely on the traditional weekly UAS7 metric allows clinicians to better understand how quickly therapies begin working. With UAS7, it adds scores over the 7 days; the worst score a patient can get is 21.
“That doesn't really tell us what happens on day 1,” Lebwohl said. “We now have data that in the first 12 hours, patients on remibrutinib have improved.”
Another takeaway from the findings is that remibrutinib appears effective in patients who have previously failed standard therapies. According to Lebwohl, many individuals receiving advanced therapies for CSU have already failed high-dose antihistamines, a prerequisite recommended by current treatment guidelines.
Lebwohl also highlighted the potential impact of remibrutinib’s oral formulation on treatment decisions. While several biologic therapies are available for CSU, they are administered by injection. In contrast, remibrutinib is taken orally, which may influence patient preference.
The study showed adverse events were generally mild. The therapy does not require routine blood monitoring, and the main safety signal noted in clinical trials has been minor bleeding-related events such as petechiae, though Lebwohl has observed this less in practice than as reported in the trials.
Current CSU guidelines recommend omalizumab after failing non-sedating antihistamines. However, after the publication, the FDA had approved dupilumab and remibrutinib for CSU.
“I think all 3 of them, when algorithms or guidelines are developed…will be in the same space where a decision will be made,” Lebwohl said. “All 3 are…good options. Remibrutinib does have the advantage of being fast and being a pill.”
Disclosures for Lebwohl include Boehringer Ingelheim Pharmaceuticals, Incyte Corporation, Genentech USA, Inc., Verrica Pharmaceuticals Inc., PFIZER INC., E.R. Squibb & Sons, L.L.C., Hexal AG, Takeda Pharmaceuticals U.S.A., Inc., MAYNE PHARMA COMMERCIAL LLC, Novartis Pharmaceuticals Corporation, ABBVIE INC., Janssen Biotech, Inc., Amgen Inc., Celltrion, Inc., Almirall LLC, and Incyte Corporation.
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