Remibrutinib Shows Positive Effects on Sleep, Daily Activities for CSU Patients

Remibrutinib’s impact on sleep deprivation and daily activities for patients with chronic spontaneous urticaria (CSU) were highlighted in a presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

Robert Snyder, MD, FAAD, presented “Effect of Remibrutinib on Sleep and Daily Activities in Patients with Chronic Spontaneous Urticaria (CSU) up to Week 52 in the REMIX-1/-2 studies.”

“The data that I presented from the phase 3 trial had to do specifically with exploratory endpoints of reduction in sleep deprivation and daily activity,” Dr. Snyder told Practical Dermatology. “Sleep deprivation is a major burden of disease for patients in addition to the itch that they suffer. … The data showed very high levels of response, with zero impact of itch in daily activities in about six out of 10 patients at Week 24 and Week 52. So, the responses were seen early, they were progressive to Week 24, and they were maintained through Week 52. Overall, the primary points of the study measuring the urticaria activity scores were impressive. They occurred as early as Week 1, and again, like the patient-reported outcomes of sleep deprivation, they were progressive through Week 24 and maintained through Week 52. Also, the safety profile was very reassuring.”

Dr. Snyder said remibrutinib is one of the investigational therapeutics that is could “potentially change the treatment paradigm” for CSU.

“[In the study], I was hoping to see an effective drug that was safe and would bring the potential for oral therapy to patients who have failed to have their disease controlled by antihistamines or who were not responsive to the current systemic therapies,” he said. “The tendency for our specialty is to refer to allergists, who, for the most part, feel more comfortable using omalizumab. Also, the older understanding was that chronic urticaria was ‘an allergic condition,’ but we now know that, for the most part, it's not an allergic or immune disease—not different in any way from the other chronic inflammatory diseases that we treat in dermatology. This disease should be handled by dermatologists, and hopefully, with the newer therapeutics, that's going to bring the disease back into our specialty.”

The next steps will be US Food and Drug Administration approval and educating dermatologists about the mechanism of action, as remibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor.

“That is new to the specialty,” Dr. Snyder said. “It is a downstream inhibitor of mast cell activation.”

Once it is approved and dermatologists are educated about it, Dr. Snyder said he expects the impact to be significant.

“This has the potential to become a go-to therapy after patients fail second-generation antihistamines,” he said, “and it's oral, so it's easy administration for the patients.”