ハリガイ マサヨシ
HARIGAI MASAYOSHI
針谷 正祥 所属 医学部 医学科(東京女子医科大学病院) 職種 教授・基幹分野長 |
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論文種別 | 原著 |
言語種別 | 英語 |
査読の有無 | 査読あり |
表題 | Clinical efficacy, radiographic, and safety results of golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior therapy with disease-modifying antirheumatic drugs: Final results of the GO-MONO trial through week 120. |
掲載誌名 | 正式名:Modern rheumatology 略 称:Mod Rheumatol ISSNコード:1439760914397595 |
掲載区分 | 国外 |
巻・号・頁 | 28(5),pp.770-779 |
著者・共著者 | Takeuchi Tsutomu, Harigai Masayoshi, Tanaka Yoshiya, Yamanaka Hisashi, Ishiguro Naoki, Yamamoto Kazuhiko, Miyasaka Nobuyuki, Koike Takao, Ukyo Yoshifumi, Ishii Yutaka, Yoshinari Toru, Baker Daniel, |
発行年月 | 2018/09 |
概要 | OBJECTIVE:Evaluate the safety and efficacy of golimumab through week 120 in Japanese patients with active rheumatoid arthritis (RA) previously treated with DMARDs.METHODS:Japanese patients with active RA despite prior DMARDs were randomized to placebo (Group 1, n = 105), golimumab 50 mg (Group 2, n = 101), or golimumab 100 mg (Group 3, n = 102). At week 16, Group 1 patients crossed over to golimumab 50mg; after week 52, a one-time golimumab dose reduction from 100 to 50 mg was permitted. Assessments included ACR20/50/70 responses and good/moderate DAS28-ESR responses. Radiographic progression was assessed with the van der Heijde-modified Sharp (vdH-S) score. Safety and efficacy were assessed through week 120.RESULTS:ACR20 response rates at week 52 in Group 1, Group 2, and Group 3 were 70.6%, 71.4%, and 81.9%, respectively, and maintained through week 104 (87.2%, 85.1%, 88.9%, respectively) and week 120 (86.1%, 87.0%, 89.5%, respectively). Similar trends were observed for ACR50, ACR 70, and DAS28-ESR. Median change in total vdH-S at weeks 52, 104, and 120 ranged from 0.0 to 1.5 across treatment groups. Through week 120, 93.8%/97.1% had an AE with golimumab 50 mg/100 mg, respectively, and 19.7%/11.8% had an SAE. Infections were the most common AE.CONCLUSION:Clinical response to golimumab 50 mg and 100 mg was maintained over 2 years in Japanese patients with active RA despite prior DMARDs. |
DOI | 10.1080/14397595.2017.1404731 |
PMID | 29219638 |