Efficacy and safety of bilastine in Japanese patients with chronic spontaneous urticaria: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II/III study

摘要

Background Bilastine, a novel non-sedating second-generation H 1 -antihistamine, has been widely used in the treatment of allergic rhinoconjunctivitis and urticaria with a recommended dose of 20?mg once daily in most European countries since 2010. We evaluated its efficacy and safety in Japanese patients with chronic spontaneous urticaria (CSU). Methods We conducted a multicenter, randomized, double-blind, placebo-controlled phase II/III study (trial registration No. JapicCTI-142574). Patients (age, 18–74 years) were randomly assigned to receive bilastine 20?mg, 10?mg or placebo once daily for 2 weeks. The primary efficacy endpoint was the change from baseline (Day ?3 to 0) in total symptom score (TSS) at 2 weeks (Day 8–14), consisting of the itch and rash scores. Results A total of 304 patients were randomly allocated to bilastine 20?mg (101 patients), bilastine 10?mg (100 patients), and placebo (103 patients). The changes in TSS at 2 weeks were significantly decreased by bilastine 20?mg than did placebo ( p ??0.001), demonstrating the superiority of bilastine 20?mg. Bilastine 10?mg also showed a significant difference from placebo ( p ??0.001). The TSS changes for the bilastine showed significant improvement from Day 1, and were maintained during the treatment period. The Dermatology Life Quality Index scores were also improved in bilastine than in placebo. The bilastine treatments were safe and well tolerated. Conclusions Two-week treatment with bilastine (20 or 10?mg) once daily was effective and tolerable in Japanese patients with CSU, demonstrating an early onset of action.