TOPLINE

Remibrutinib showed early improvements in disease symptoms, sleep, and daily functioning in patients with chronic spontaneous urticaria (CSU) who continued to have symptoms despite receiving second-generation H₁-antihistamines (sgH1-AHs).

METHODOLOGY

• Researchers conducted a pooled analysis of two phase 3 trials to evaluate the efficacy of remibrutinib — an oral, highly selective Bruton tyrosine kinase inhibitor — in adults with CSU who remained symptomatic despite treatment with sgH1-AHs.
• A total of 912 patients were randomly assigned to receive either oral remibrutinib 25 mg twice daily (n = 606; mean age, 43.3 years; 66.5% women) or placebo (n = 306; mean age, 43.7 years; 66.7% women) for 24 weeks, followed by an open-label treatment period of 28 weeks during which all patients received remibrutinib and a treatment-free follow-up period of 4 weeks.
• Outcome measures included improvements in disease control, sleep interference, and quality of life, assessed using validated scales.
• Patients completed a Urticaria Patient Daily Diary throughout the study, and additional patient-reported outcome measures including the 7-day Urticaria Control Test (UCT7) score; 7-day Urticaria Activity (UAS7) score; 7-day Sleep Interference Score (SIS7)/Activity Interference Score; Dermatology Life Quality Index (DLQI); EuroQol Five-Dimension Five-Level questionnaire; and Work, Productivity, and Activity Impairment (WPAI) were assessed at respective on-site visits.

TAKEAWAY

• Within 1 week of initiating treatment, greater improvements were observed with remibrutinib than placebo in terms of urticaria activity (mean change from baseline in the UAS7, -11.8 vs -3.6) and sleep interference (mean change in the SIS7, -4.9 vs -1.9), with improvements sustained through week 52.
• By week 1, 50.7% of patients receiving remibrutinib compared with 14.5% of those receiving placebo achieved noticeable improvement in disease symptoms (meaningful within-patient change in UAS7, -10.5 points), with a median time to the first meaningful change being significantly shorter with remibrutinib than placebo (1 vs 5 weeks; P < .001).
• Greater improvements in disease control were observed with remibrutinib than with placebo at week 2 (mean change in UCT7, -5.7 vs -2.1) and week 24 (mean change in UCT7, -7.1 vs -4.5); a higher proportion of patients receiving remibrutinib vs placebo had well-controlled disease at week 24 (63.9% vs 40.9%).
• By week 4, 68.0% of patients receiving remibrutinib compared with 45.5% of those receiving placebo achieved meaningful within-patient change in the DLQI score (-4.0 points); improvements across WPAI domains were greater with remibrutinib than with placebo at weeks 12 and 24.

IN PRACTICE

“[The study] highlights how the day-to-day lives of patients with CSU are also improved with remibrutinib aside from clinical symptoms. Thus, these data enhance our understanding of remibrutinib's clinical profile and support its use as a valuable therapeutic option in CSU with benefits extending beyond symptom control,” the authors wrote.

SOURCE

Giselle Mosnaim, MD, with Endeavor Health, Evanston, Illinois, was the corresponding author of the study, which was published online on June 16 in Annals of Allergy, Asthma & Immunology.

LIMITATIONS

Most of the patient-reported outcome measures were exploratory, so only limited statistical comparisons were reported as they were not part of the predefined testing strategy.

DISCLOSURES

This study was funded by Novartis Pharma AG, Basel, Switzerland. Some authors, including the lead author, reported receiving research grants or consulting fees and serving on advisory boards of various pharmaceutical companies, including the funding agency. Few authors declared being employees of Novartis Pharmaceuticals Corporation. Detailed disclosures are noted in the original article.

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