Sponsored by Novartis Medical Affairs | December 1, 2025 

LIMITATIONS: Post hoc or prespecified exploratory analyses were performed in the poster above and results are observational in nature. These analyses were not adjusted for multiplicity. Data after week 24 should be interpreted with caution due to the open-label design and absence of a control group. No statistical tests were done on data after week 24.

The efficacy of remibrutinib for chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment was evaluated in REMIX-1 and REMIX-2, two identical, 52-week, multi-center, randomized, double-blind, placebo-controlled clinical trials.

Across both REMIX trials, 912 patients were randomized in a 2:1 ratio to receive either remibrutinib 25 mg or placebo, respectively, orally twice daily for 24 weeks during the double-blind treatment period and subsequently continued in a 28-week open-label treatment period, during which all patients received remibrutinib 25 mg twice daily. While REMIX-1 and REMIX-2 clinical trials included an open-label period, efficacy is based on results from 912 patients treated during the controlled period of 24 weeks.

The co-primary end points were absolute change from baseline (CFB) in HSS7 and ISS7 at week 12 and the key secondary end point was absolute change from baseline in UAS7 at week 12. Least squares (LS) means CFB results from REMIX-2 are shown below. Multiple imputation techniques were implemented for missing data. Results were similar in REMIX-1.

HSS7 vs placebo at week 12: LS mean CFB -10.47 with remibrutinib vs -6.00 with placebo (P<.001).

ISS7 vs placebo at week 12: LS mean CFB -8.95 with remibrutinib vs -5.72 with placebo (P<.001).

UAS7 vs placebo at week 12: LS mean CFB in REMIX-2: -19.41 with remibrutinib vs -11.73 with placebo (P<.001)

Remibrutinib Indication and Important Safety Considerations

Indication: Remibrutinib is a kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: Not indicated for other forms of urticaria.

Important Safety Considerations

Risk of Bleeding: Mucocutaneous-related bleeding occurred in 9% of patients who received remibrutinib.  Interrupt treatment with remibrutinib if bleeding is observed and resume if the benefit is expected to outweigh the risk. Interrupt treatment with remibrutinib for 3 to 7 days pre- and post-surgery or invasive procedures. Use of antithrombotic agents concomitantly with remibrutinib may further increase the risk of bleeding. Consider the benefits and risks of antithrombotic agents when used with remibrutinib. Monitor for signs and symptoms of bleeding.

Live-Attenuated Vaccines: The use of live and live-attenuated vaccines should be avoided in patients receiving remibruitinib.

Adverse Reactions: The most common adverse reactions (incidence ≥ 3%) were nasopharyngitis, bleeding, headache, nausea, and abdominal pain.

Drug Interactions: Remibrutinib is a CYP3A4 substrate and a P-glycoprotein (P-gp) inhibitor. Avoid use of remibrutinib with strong or moderate CYP3A4 inhibitors. Concomitant use with a strong or moderate CYP3A4 inhibitor increases remibrutinib exposure, which may increase the risk of remibrutinib adverse reactions. Avoid use of remibrutinib with strong or moderate CYP3A4 inducers. Concomitant use with a strong or moderate CYP3A4 inducer decreases remibrutinib exposure, which may decrease the efficacy of remibrutinib. Monitor more frequently for adverse reactions when using remibrutinib with P-gp substrates where minimal concentration changes may lead to serious adverse reactions (eg, digoxin). Remibrutinib increases exposure of P-gp substrates, which may increase the risk of adverse reactions related to P-gp substrates. No data are available on concomitant use of remibrutinib with anticoagulants. The concomitant use of remibrutinib and anticoagulants was not allowed in clinical studies. Use of the antiplatelet agents, acetyl salicylic acid at doses up to 100 mg daily or clopidogrel up to 75 mg daily, was allowed in the remibrutinib clinical studies.

Use in Specific Populations: Avoid use of remibrutinib in patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, and C). Remibrutinib exposure is increased in these patients relative to patients with normal hepatic function.

This poster was previously presented at Maui Derm Hawaii 2025, Maui, HI, USA, January 20-24, 2025. 

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