Remibrutinib Yields Rapid, Sustained Relief in Urticaria

TOPLINE:

Remibrutinib, an oral Bruton’s tyrosine kinase inhibitor, reduced itch and hives in patients with chronic spontaneous urticaria and showed a favorable safety profile at week 12 in two trials.

METHODOLOGY:

• Two phase 3, multicenter, double-blind, randomized, placebo-controlled trials, REMIX-1 (n = 470; mean age, 45.0 years) and REMIX-2 (n = 455; mean age, 41.7 years) of patients with chronic spontaneous urticaria.
• Participants were randomly assigned in a 2:1 ratio to receive either oral remibrutinib, 25 mg twice daily, or placebo for 24 weeks.
• Primary endpoint: change in weekly urticaria activity score (UAS7) at 12 weeks; secondary endpoints: Well-controlled urticaria (UAS7 ≤ 6), complete symptom resolution (UAS7 = 0), and safety.

TAKEAWAY:

• UAS7 scores improved more in remibrutinib patients than in placebo recipients in both trials at week 12 (least-squares mean difference, –6.2 in REMIX-1 and –7.7 in REMIX-2; both P < .001).
• At week 12, a higher proportion of remibrutinib patients achieved well-controlled urticaria (odds ratio [OR], 3.1 in REMIX-1 and 3.8 in REMIX-2; both P < .001) and complete symptom resolution (OR, 3.8 in REMIX-1 and 5.8 in REMIX-2; both P < .001).
• The improvements in urticaria were evident as early as week 1 and maintained through week 24.
• Adverse events were comparable between the remibrutinib and placebo groups (64.9% vs 64.7%), and most were mild or moderate and transient.

IN PRACTICE:

“These results support the efficacy and safety of remibrutinib in patients with chronic spontaneous urticaria that remained symptomatic despite treatment with second-generation H1-antihistamines,” the authors wrote.

SOURCE:

The study was led by Martin Metz, MD, and Marcus Maurer, MD, Charité-Universitätsmedizin Berlin in Berlin, Germany. It was published online on March 5 in The New England Journal of Medicine.

LIMITATIONS:

The authors did not note any study limitations.

DISCLOSURES:

The study was funded by Novartis Pharmaceuticals. Metz and Maurer reported being consultants for various pharmaceutical companies, including Novartis. Two authors held stocks or were employed at Novartis. Some authors received consulting fees, speaker fees, and grants from various pharmaceutical companies, including Novartis. The sponsor collaborated with the trial steering committee in designing the trials, interpreting the data, and reviewing an earlier draft of the manuscript.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.