One‐year safety and efficacy study of bilastine treatment in Japanese patients with chronic spontaneous urticaria or pruritus associated with skin diseases

Abstract

A number of second‐generation non‐sedating antihistamines are used in clinical practices over the world. However, long‐term safety and efficacy have not been proved high level evidence based medicine. We have performed an open‐label, multicenter, phase III study to evaluate the long‐term safety and efficacy of bilastine, a novel non‐sedating H1‐antihistamine for patients with chronic spontaneous urticaria (CSU) or pruritus associated with skin diseases (trial registration no. JapicCTI‐142528). Patients aged 18–74 years were treated with bilastine 20 mg once daily for up to 52 weeks. Safety and tolerability were assessed on the basis of adverse events (AE), bilastine‐related AE, laboratory tests and vital signs. Efficacy was assessed based on rash score, itch score, overall improvement and quality of life. One hundred and ninety‐eight patients enrolled, 122 of whom (61.6%) completed the 52‐week treatment period. AE were reported in 64.5% and bilastine‐related AE in 2.5% of patients throughout the 52‐week treatment period. All AE were mild to moderate in severity. AE associated with the nervous system occurred in 10 patients (5.1%) including seven patients (3.6%) with headache. Somnolence reported in two of these patients (1.0%) was related to bilastine. All efficacy variables improved during treatment with bilastine. In conclusion, long‐term treatment with bilastine 20 mg once daily for 52 weeks is safe and well tolerated in Japanese patients with CSU or pruritus associated with skin diseases. Bilastine improved disease symptoms of both conditions early in treatment, and the efficacy was maintained throughout the treatment.

OSMR gene effect on the pathogenesis of chronic autoimmune Urticaria via the JAK/STAT3 pathway

“…The number and total duration of pruritus in each mouse was recorded within 30 min of the 1 mL dextran injections through the tail vein. The CAU mouse model was considered to be successfully established if the number and total duration of pruritus were significantly higher than the normal mice (Yagami et al, 2017 ). A total of 60 mice were successfully established as CAU models which were classified into: the blank group (model mice without any treatment), the negative control group (NC) (model mice transfected with empty vector plasmid), the OSMR-siRNA group (model mice transfected with OSMR-siRNA plasmid), the anti-phospho-STAT3 (Tyr705) + OSMR-siRNA group (model mice transfected with OSMR-siRNA plasmid + the JAK/STAT3 signaling pathway agonist), and the Tyr705 group (model mice treated with the JAK/STAT3 signaling pathway agonist) groups.…”

Effect of bilastine on chronic spontaneous urticaria refractory to other antihistamines

“…Dear Editor, Bilastine, a nonsedating second-generation H 1 -antihistamine, has been widely utilized for urticaria in Japan based on the high-quality evidence provided by the excellent studies. 1,2 A previous randomized trial for perennial allergic rhinitis revealed bilastine is more effective than fexofenadine, 3 speculating its therapeutic potential for chronic spontaneous urticaria refractory to other antihistamines including fexofenadine.…”

Bilastine: a new H1‐antihistamine with an optimal profile for updosing in urticaria

“…In a further long‐term study, 122 Japanese patients with CSU were treated with 20‐mg bilastine daily for 52 weeks . Total symptom score was significantly ( P < 0.001) improved by 2 weeks and remained the same thereafter.…”