教員業績データベース |
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論文種別 | 原著 |
言語種別 | 英語 |
査読の有無 | 査読なし |
表題 | Adalimumab for the Treatment of Japanese Patients With Intestinal Behçet's Disease. |
掲載誌名 | 正式名:Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 略 称:Clin Gastroenterol Hepatol ISSNコード:1542-7714(Electronic)1542-3565(Linking) |
巻・号・頁 | 13(5),pp.940-948.e3 |
著者・共著者 | Tanida Satoshi, Inoue Nagamu, Kobayashi Kiyonori, Naganuma Makoto, Hirai Fumihito, Iizuka Bunei, Watanabe Kenji, Mitsuyama Keiichi, Inoue Takuya, Ishigatsubo Yoshiaki, Suzuki Yasuo, Nagahori Masakazu, Motoya Satoshi, Nakamura Shiro, Arora Vipin, Robinson Anne M, Thakkar Roopal B, Hibi Toshifumi |
発行年月 | 2015/05 |
概要 | BACKGROUND & AIMS:Behçet's disease is a chronic, relapsing inflammatory disease that can involve the mouth, skin, eyes, genitals, and intestines. Active intestinal Behçet's disease can be complicated by gastrointestinal (GI) bleeding and perforation. We performed a multicenter, open-label, uncontrolled study to evaluate the efficacy and safety of adalimumab, a fully human monoclonal antibody against tumor necrosis factor α, in patients with intestinal Behçet's diseaseBACKGROUND & AIMS:who were refractory to corticosteroid and/or immunomodulator therapies.METHODS:The study was conducted at 12 sites in Japan, from November 2010 through October 2012. Twenty patients were given 160 mg adalimumab at the start of the study and 80 mg 2 weeks later, followed by 40 mg every other week for 52 weeks; for some patients, the dose was increased to 80 mg every other week. A composite efficacy index, combining GI symptom and endoscopic assessments, was used to evaluate efficacy. The primary efficacy end point was the percentage of patients with scores of 1 or lower for GI symptom and endoscopic assessments at week 24. Secondary end points included complete remission and resolution of non-GI Behçet's-related symptoms.RESULTS:Nine patients (45%) had GI symptom and endoscopic assessment scores of 1 or lower at week 24 of treatment, and 12 patients (60%) had these scores by week 52. Four patients (20%) achieved complete remission at weeks 24 and 52. Individual global GI symptom and endoscopic scores improved for most patients at weeks 24 and 52. Two thirds of patients with oral aphthous ulcers, skin symptoms, and genital ulcers, and 88% of patients with erythema nodosum had complete resolution of these conditions at week 52. |
DOI | 10.1016/j.cgh.2014.08.042 |
PMID | 25245624 |