Clinical characteristics and treatment outcomes of stepwise bilastine up-dosing in chronic spontaneous urticaria at Thanh Hoa dermatology hospital

Abstract

Objective: To describe the clinical characteristics and evaluate the treatment outcomes and safety of stepwise bilastine up-dosing in patients with chronic spontaneous urticaria (CSU). Methods: This prospective, single-arm interventional study included 93 patients with CSU aged ≥12 years who were treated at Thanh Hoa Dermatology Hospital in 2026. Bilastine was initiated at 20 mg/day; in patients with uncontrolled disease (UAS7 >6), the dose was increased to 40 mg/day at week 2 and to a maximum of 80 mg/day at week 4. Results: The mean age was 37.6 ± 18.7 years, and 61.3% of patients were female. Wheals were present in 100.0%, pruritus in 97.8%, and angioedema in 26.9%. At baseline, 78.5% had moderate-to-severe disease activity according to UAS7 and 94.6% had UCT <12. Median UAS7 decreased from 22 (17–31) at baseline to 0 (0–3) at week 6, whereas mean UCT increased from 5.31 ± 2.61 to 15.19 ± 0.95 (p<0.001). Cumulative disease-control rates were 45.2% after the 20-mg step, 93.5% after the 40-mg step, and 97.8% after the 80-mg step; 62.4% achieved UAS7=0 at week 6. Overall, 54.8% required ≥40 mg/day and 6.5% required 80 mg/day. Higher baseline UAS7 was independently associated with the need for dose escalation (aOR=1.15; 95% CI: 1.06–1.25; p=0.001). The most frequently reported adverse events were headache (5.4%) and somnolence (4.3%); no patient discontinued treatment because of adverse events. Conclusion: In this cohort, stepwise bilastine up-dosing was accompanied by reduced disease activity and improved disease control over 6 weeks. Higher baseline UAS7 was associated with the need for dose escalation to ≥40 mg/day.