title: 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.
authors.affiliation: Department of Dermatology, School of Medicine, Fujita Health University, Aichi, Japan.
authors.forename: Akiko
authors.initials: A
authors.lastname: Yagami
authors.affiliation: Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Masutaka
authors.initials: M
authors.lastname: Furue
authors.affiliation: Clinical Development Division, TAIHO Pharmaceutical, Tokyo, Japan.
authors.forename: Michinori
authors.initials: M
authors.lastname: Togawa
authors.affiliation: Clinical Development Division, TAIHO Pharmaceutical, Tokyo, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Saito
authors.affiliation: Department of Dermatology, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
authors.forename: Michihiro
authors.initials: M
authors.lastname: Hide
mesh_terms: D000328:Adult; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004485:Eczema / Q000150:complications; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D000069451:Long Term Adverse Effects / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011536:Prurigo / Q000150:complications; D011537:Pruritus / Q000188:drug therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014581:Urticaria / Q000188:drug therapy*
chemical_list: D001562:Benzimidazoles; D039563:Histamine H1 Antagonists, Non-Sedating; D010880:Piperidines; C445659:bilastine
keywords: H1-antihistamine; bilastine; chronic spontaneous urticaria; eczema/dermatitis; pruritus