Bleeding Events Infrequent Around Procedures in Remibrutinib CSU Trial Analysis
Key Takeaways
- Among 868 remibrutinib-exposed patients, 61 (7.0%) underwent at least one surgical or invasive procedure.
- Four of the 61 patients (6.6%) experienced a bleeding adverse event within 14 days of a procedure.
- Most patients undergoing procedures (52 of 61; 85.2%) had no periprocedural remibrutinib interruption.
A post hoc analysis of the phase 3 REMIX-1 and REMIX-2 trials found that bleeding events were uncommon among patients receiving remibrutinib who underwent surgical or invasive procedures. The findings were presented at the 2026 Fall Clinical Dermatology Conference.1
Remibrutinib (Rhapsido; Novartis), an oral Bruton tyrosine kinase inhibitor, is approved in the United States for adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1-antihistamine treatment. Because Bruton tyrosine kinase is expressed in platelets, investigators examined bleeding outcomes around procedures.
Procedural Bleeding Outcomes Across REMIX-1 and REMIX-2
The randomized, double-blind, placebo-controlled trials evaluated remibrutinib 25 mg twice daily against placebo for 24 weeks, followed by 28 weeks of open-label remibrutinib. The pooled analysis included 868 remibrutinib-exposed patients and 306 placebo recipients. Investigators categorized procedures by bleeding risk and assessed bleeding adverse events within 14 days.
During the entire study period, 61 remibrutinib-exposed patients (7.0%) underwent at least one procedure: 23 had minimal-risk procedures, 22 had low-to-moderate-risk procedures, and 16 had high-risk procedures. Remibrutinib was not interrupted around the procedure in 52 patients (85.2%).
Bleeding events occurred in 3 of 52 patients (5.8%) without a protocol-defined interruption and 1 of 9 (11.1%) with an interruption. The four events included blood loss anemia, petechiae, hemorrhagic erosive gastritis, and hematuria. Only the anemia event was considered treatment-related by the investigators; the poster notes that the last recorded remibrutinib dose was 7 days before that procedure. All four events had resolved or were resolving by study completion.
The investigators concluded that periprocedural bleeding events were infrequent whether remibrutinib was continued or interrupted.
1. Palumbo M, Finklea L, Rodrigues J, Zharkov A, Incera E. Perioperative and periprocedural bleeding safety profile of remibrutinib in the phase 3 chronic spontaneous urticaria (CSU) REMIX-1/-2 studies. Poster presented at: 26th Annual Fall Clinical Dermatology Conference; October 8-11, 2026; Las Vegas, NV.