Remibrutinib Impacts on Sleep, Daily Activities in CSU up to Week 52, with Robert Snyder, MD

In data presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, remibrutinib’s positive impact on sleep and daily activities among patients with chronic spontaneous urticaria (CSU) was highlighted.1

Remibrutinib—an oral, highly selective Bruton’s tyrosine kinase (BTK) inhibitor that is in development for individuals suffering from CSU—was studied in the phase 3 REMIX 1 and 2 multicenter, double-blind, randomized trials. To discuss the biggest takeaways, Robert Snyder, MD, an investigator who works with Riverchase Dermatology, spoke with HCPLive.

“So this was two phase 3 trials, REMIX 1 and 2,” Snyder said. “Identical trials in which patients were randomized to receive 2 to 1 remibrutinib or placebo at the dose of 25 milligrams BID, with primary endpoints measured at 16 weeks and there was continued observation of responses at 24 weeks and up to 52 weeks. At 24 weeks, the placebo arm was transitioned to remibrutinib to examine the response, and the primary endpoint was here Urticaria Activity Score. Secondary endpoints and exploratory endpoints were examined.”

At the 1, 12, 24, and 52-week mark, Snyder and his team of investigators looked into the mean change from baseline (CFB) ± standard deviation in participants’ weekly Sleep/Activity Interference Scores (SIS7/AIS7) as well as proportions of those showing a complete lack of disease interference on their Sleep/Activity (SIS7=0/AIS7=0).

“My abstract that was presented at the meeting today had to do with the improvement in sleep deprivation and daily activity that are important components of the disease burden for patients with CSU,” Snyder explained. “So I'll start by saying there was a rapid response in terms of differentiating the improvement in sleep deprivation between placebo seen as early as 1 week.”

Snyder highlighted that there was progressive improvement through Week 24 as well as maintenance of improvement through Week 24. He noted that the high level of response of no impact on sleep and daily activity, which was the aim with treatment, was observed in 6 out of 10 patients at Week 24. This was maintained to the 52-week mark.

“I think the the key takeaway is this is a novel oral medication that has the potential to become a go-to therapy for patients who are second generation anti-histamine resistant,” Snyder said. “The current paradigm of treatment suggests treating patients with anti-histamines at maximized doses before moving on to systemic therapies.”

For additional information on Snyder’s research, view the full video interview posted above. To learn more about data presented at AAD 2025, view our latest conference coverage.

The quotes used in this video summary were edited for the purposes of clarity. Snyder is a speaker and/or advisor for and/or has received research funding from Janssen Biotech, Amgen, Novartis, BMS, Galderma, AbbVie, Leo Pharma, Sun Pharma, Regeneron, Sanofi, Pfizer, and UCB.

References

1. Snyder R, Bin Y, Metz M, et al. 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. Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.