ArticleDermatology and therapy2026
Remibrutinib Showed a Favorable Safety Profile and Sustained Efficacy in Japanese Patients with Chronic Spontaneous Urticaria Over 52 Weeks.
Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05048342 (A Multicenter, Open-label Phase 3 Study of Remibrutinib), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Open-label Phase 3 Study of Remibrutinib (LOU064) to Investigate the Safety, Tolerability and Efficacy for 52 Weeks in Adult Japanese Chronic Spontaneous Urticaria Patients Inadequately Controlled by H1-antihistamines
Who cites it
1 citing paper in PubMed.
- Targeted Therapy for Antihistamine-Refractory Chronic Spontaneous Urticaria: A Critical Narrative Review and an Evidence-Graded Approach to Agent Selection.Antibodies (Basel, Switzerland) · 2026Review
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionRemibrutinib, an oral, highly selective, Bruton's tyrosine kinase (BTK) inhibitor, has shown efficacy and favorable safety in pivotal global phase 3 studies in patients with chronic spontaneous urticaria (CSU). This 52-week safety study evaluated the effect of remibrutinib in Japanese patients with CSU.
methodsBISCUIT, a phase 3 (NCT05048342), open-label, single-arm study, investigated the safety and efficacy of remibrutinib 25 mg twice-daily as an add-on medication in Japanese patients with CSU who remain symptomatic despite treatment with H
resultsOverall, 71 Japanese patients (mean age 43.5 years) had a median remibrutinib exposure of 52.1 weeks; 87.3% of patients reported ≥ 1 AE, and all events were mild or moderate in severity. COVID-19 (19.7%) and headache (12.7%) were the most common AEs. Three serious AEs, unrelated to remibrutinib, were reported. No deaths occurred during the treatment period. At week 12, mean change from baseline in weekly Urticaria Activity Score (UAS7) and weekly Itch/Hives Severity Scores was - 18.1, - 8.0, and - 10.1, respectively; responses appeared to occur as early as week 1 and appeared to be sustained until week 52. Additionally, 53.6% of the patients had well-controlled disease (UAS7 ≤ 6) and 30.4% had complete absence of itch and hives (UAS7 = 0) at week 52.
conclusionRemibrutinib showed a favorable safety profile and a meaningful improvement in CSU symptoms (itch and hives) at week 12, with fast improvement as early as week 1 that was sustained up to week 52, supporting its potential as an effective oral BTK inhibitor for Japanese patients with CSU.
trial registrationTrial Registration: NCT05048342.
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