Early clinical effectiveness and safety of remibrutinib in chronic spontaneous Urticaria: A prospective multicenter real-world study

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Background Remibrutinib has recently become available for the clinical management of chronic spontaneous urticaria (CSU) in China, yet relevant clinical experience remains limited, highlighting an urgent demand for population-specific real-world evidence. We therefore evaluated the early effectiveness, safety and clinical utilization of remibrutinib in a heterogeneous Chinese outpatient cohort. Methods This interim analysis was conducted based on an ongoing prospective, multicenter observational cohort enrolling 32 adult patients with CSU receiving treatment in routine outpatient settings. Eligibility criteria did not restrict prior treatment regimens, nor did it limit physician-managed background or rescue therapies for CSU. The safety set consisted of 29 patients who received at least one dose of remibrutinib, and the Week 4 efficacy set comprised 25 patients with evaluable 7-day Urticaria Activity Score (UAS7) data. Assessed outcomes included UAS7, Urticaria Control Test (UCT), Dermatology Life Quality Index (DLQI), 7-day Angioedema Activity Score (AAS7), Angioedema Control Test (AECT), treatment patterns and adverse events. All analyses were descriptive. Baseline UAS7 > 6 was defined as failure to achieve well-controlled disease. Results At remibrutinib initiation, 22 of 27 patients (81.5%) with available baseline UAS7 had not achieved well-controlled disease. Baseline exposure to H1-antihistamines, omalizumab, and systemic corticosteroids was documented in 21 of 29 (72.4%), 19 of 29 (65.5%), and 12 of 29 patients (41.4%), respectively; 20 of 29 (69.0%) had exposure to at least two baseline CSU treatment classes. Two patients (6.9%) initiated remibrutinib after H1-antihistamines as their only documented baseline CSU drug class, and both had baseline UAS7 > 6. At Week 4, mean UAS7 decreased from 19.4 (95% confidence interval [CI], 14.20-24.68) to 5.3 (95% CI, 2.70-7.86). Nineteen of 25 patients (76%) had UAS7 ≤ 6, and 9 of 25 (36%) had UAS7 = 0. Mean UCT increased from 6.36 to 11.56 (P < 0.001), and mean DLQI decreased from 8.56 to 3.24 (P = 0.012). Among four patients with paired angioedema assessments, AAS7 decreased from 44.5 at baseline to 0 at Week 4, while median AECT increased from 3.0 to 16.0. These findings were exploratory because paired observations were limited. Ten of 29 patients (34.5%) reported at least one adverse event (AE); no serious or severe AEs occurred. Petechiae were recorded in 4 of 29 patients (13.8%). Conclusions Across patients with diverse baseline treatment exposures, remibrutinib was associated with rapid improvements in disease activity, disease control, and quality of life by Week 4. However, longer-term follow-up is necessary to assess the durability of these improvements and further characterize the safety profile of remibrutinib. (Chinese Clinical Trial Registry number: ChiCTR2600127540.)

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