{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T04:55:58Z","timestamp":1782968158883,"version":"3.54.5"},"reference-count":25,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2016,11,14]],"date-time":"2016-11-14T00:00:00Z","timestamp":1479081600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009954","name":"Taiho Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009954","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2017,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>A number of second\u2010generation non\u2010sedating antihistamines are used in clinical practices over the world. However, long\u2010term safety and efficacy have not been proved high level evidence based medicine. We have performed an open\u2010label, multicenter, phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> study to evaluate the long\u2010term safety and efficacy of bilastine, a novel non\u2010sedating H<jats:sub>1<\/jats:sub>\u2010antihistamine for patients with chronic spontaneous urticaria (<jats:styled-content style=\"fixed-case\">CSU<\/jats:styled-content>) or pruritus associated with skin diseases (trial registration no. Japic<jats:styled-content style=\"fixed-case\">CTI<\/jats:styled-content>\u2010142528). Patients aged 18\u201374 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 (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>), bilastine\u2010related <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>, laboratory tests and vital signs. Efficacy was assessed based on rash score, itch score, overall improvement and quality of life. One hundred and ninety\u2010eight patients enrolled, 122 of whom (61.6%) completed the 52\u2010week treatment period. <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content> were reported in 64.5% and bilastine\u2010related <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content> in 2.5% of patients throughout the 52\u2010week treatment period. All <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content> were mild to moderate in severity. <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content> 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\u2010term treatment with bilastine 20 mg once daily for 52 weeks is safe and well tolerated in Japanese patients with <jats:styled-content style=\"fixed-case\">CSU<\/jats:styled-content> or pruritus associated with skin diseases. Bilastine improved disease symptoms of both conditions early in treatment, and the efficacy was maintained throughout the treatment.<\/jats:p>","DOI":"10.1111\/1346-8138.13644","type":"journal-article","created":{"date-parts":[[2016,11,16]],"date-time":"2016-11-16T16:35:07Z","timestamp":1479314107000},"page":"375-385","source":"Crossref","is-referenced-by-count":33,"title":["One\u2010year safety and efficacy study of bilastine treatment in Japanese patients with chronic spontaneous urticaria or pruritus associated with skin diseases"],"prefix":"10.1111","volume":"44","author":[{"given":"Akiko","family":"Yagami","sequence":"first","affiliation":[{"name":"Department of Dermatology School of Medicine Fujita Health University Aichi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masutaka","family":"Furue","sequence":"additional","affiliation":[{"name":"Department of Dermatology Graduate School of Medical Sciences Kyushu University Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michinori","family":"Togawa","sequence":"additional","affiliation":[{"name":"Clinical Development Division TAIHO Pharmaceutical Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiro","family":"Saito","sequence":"additional","affiliation":[{"name":"Clinical Development Division TAIHO Pharmaceutical Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michihiro","family":"Hide","sequence":"additional","affiliation":[{"name":"Department of Dermatology Institute of Biomedical and Health Sciences Hiroshima University Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,11,14]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.5021\/ad.2012.24.4.406"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2013.7696"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.2332\/allergolint.10-OA-0182"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-0305"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2010.03850.x"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.2332\/allergolint.12-RAI-0497"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12313"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2014.02.036"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-1400"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.13392"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12421"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011407191"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-013-0110-0"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2016.08.004"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2016.05.014"},{"key":"e_1_2_7_17_1","unstructured":"International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.The extent of population exposure to assess clinical safety for drugs intended for long\u2010term treatment of non\u2010life\u2010threatening conditions 1995."},{"key":"e_1_2_7_18_1","first-page":"881","article-title":"The efficacy and safety of SCH 29851 (loratadine), a long acting and selective histamine H1 receptor antagonist, for chronic urticaria in a phase III, randomized, double\u2010blind, multi\u2010center comparative study: investigation of superiority of SCH 29851 10 mg once daily to SCH 29851 1 mg once daily and of non\u2010inferiority of SCH 29851 10 mg once daily to ketotifen fumarate 1 mg twice daily","volume":"18","author":"Kawashima M","year":"2002","journal-title":"J Clin Therap Med"},{"key":"e_1_2_7_19_1","unstructured":"DLQI Instructions for use and scoring. 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