From Avoidance to Action: Emerging Therapies for Management of Chronic Inducible Urticaria - Episode 8
Remibrutinib Safety in CIndU: Bleeding, Surgery, and Immunoglobulins
Remibrutinib's safety profile in CIndU mirrors the CSU program, and the panel puts its bleeding warning, perioperative guidance, and immunoglobulin data in practical clinical context.
In "Remibrutinib Safety in CIndU: Bleeding, Surgery, and Immunoglobulins," our experts examine what clinicians and patients need to know before starting therapy.
Dr. Cotter asks about safety in REMIND. Dr. Trotter describes a favorable, consistent profile with no meaningful differences from the CSU trials. The most common adverse events were nasopharyngitis, headache, and upper respiratory infection. Dr. Cotter adds that overlapping safety across multiple disease programs offers reassurance about a molecule's true profile.
Dr. Finklea addresses the bleeding warning. None of her trial patients in either the CIndU or CSU studies experienced bleeding events, though she has seen minor events in practice. She reviews medication lists for antithrombotics, upcoming invasive procedures, and strong CYP3A4 inducers or inhibitors. As a highly selective third-generation BTK inhibitor, remibrutinib largely spares TEC kinase, preserving most platelet function. Short-term data were consistent with the REMIX CSU studies, and she would like to see 52-week data and beyond.
Dr. Cotter frames bleeding events at about 9% to 11%, or roughly one in nine patients. These are not life-threatening hemorrhages. They include bruising, petechiae, gum bleeding, and asymptomatic microscopic hematuria. Trial patients could take clopidogrel or low-dose aspirin, but not both. Dr. Finklea also reviews SSRIs and supplements.
On surgery, Dr. Cotter cites the prescribing information of stopping three to seven days before and after invasive surgery. Dr. Trotter follows similar guidance and notes that the main complaint is symptom return. Mohs surgery is not considered invasive, so therapy can continue.
Finally, Dr. Trotter addresses immunoglobulins. Because BTK inhibition could theoretically impair immunity, levels were monitored across studies, with no decreases observed. Dr. Cotter notes that patients with X-linked agammaglobulinemia lack functional BTK, which makes normal immunoglobulin levels on therapy particularly reassuring.
Our next episode, "Defining Treatment Success and Switching Treatment in CIndU," turns from trial endpoints to what control looks like for patients in clinic and when to consider switching treatment.
