Clinical efficacy, radiographic progression, and safety through 156 weeks of therapy with subcutaneous golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis despite prior methotrexate therapy : final results of the randomized GO-FORTH trial

Tanaka, Yoshiya; Harigai, Masayoshi; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Yamamoto, Kazuhiko; Miyasaka, Nobuyuki; Koike, Takao; Baker, Daniel; Ishii, Yutaka; Yoshinari, Toru; The GO-FORTH study group

Clinical efficacy, radiographic progression, and safety through 156 weeks of therapy with subcutaneous golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis despite prior methotrexate therapy : final results of the randomized GO-FORTH trial

Tanaka, Yoshiya; Harigai, Masayoshi; Takeuchi, Tsutomu et al.

Modern Rheumatology, 2016, 26(4), 481-490

Permalink : https://hdl.handle.net/2115/62847

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アクセス権	open access
URI	https://hdl.handle.net/2115/62847
タイトル	Clinical efficacy, radiographic progression, and safety through 156 weeks of therapy with subcutaneous golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis despite prior methotrexate therapy : final results of the randomized GO-FORTH trial
著者	Tanaka, Yoshiya ; Harigai, Masayoshi ; Takeuchi, Tsutomu ; Yamanaka, Hisashi ; Ishiguro, Naoki ; Yamamoto, Kazuhiko ; Miyasaka, Nobuyuki ; Koike, Takao ; Baker, Daniel ; Ishii, Yutaka ; Yoshinari, Toru ; The GO-FORTH study group
e-Rad_Researcher 30248562 著者名 Tanaka, Yoshiya
e-Rad_Researcher 20238207 著者名 Harigai, Masayoshi
e-Rad_Researcher 50179610 著者名 Takeuchi, Tsutomu
e-Rad_Researcher 10166754 著者名 Yamanaka, Hisashi
e-Rad_Researcher 20212871 著者名 Ishiguro, Naoki
e-Rad_Researcher 80191394 著者名 Yamamoto, Kazuhiko
e-Rad_Researcher 30157622 著者名 Miyasaka, Nobuyuki
e-Rad_Researcher 80146795 著者名 Koike, Takao
著者名 Baker, Daniel
著者名 Ishii, Yutaka
著者名 Yoshinari, Toru
著者名 The GO-FORTH study group
言語	英語
キーワード	Anti-tumor necrosis factor
	Asian
	Golimumab
	Rheumatoid arthritis
発行日	2016
出版者	Taylor & Francis
収録物名	Modern Rheumatology
巻(号)	26(4)
ページ	481-490
抄録	Objective: To evaluate the safety and efficacy of golimumab + methotrexate (MTX) in Japanese patients with active rheumatoid arthritis (RA). Methods: Japanese patients with active RA despite MTX were randomized to placebo + MTX (Group 1, n = 88), golimumab 50 mg + MTX (Group 2, n = 86), or golimumab 100 mg + MTX (Group 3, n = 87). Patients with <20% improvement in swollen/tender joint counts entered early escape at week 16. At week 24, all remaining placebo patients crossed over to golimumab 50 mg. Efficacy assessments included ACR20, DAS28-ESR, and HAQ-DI. Radiographic progression was assessed with the van der Heijde-modified Sharp (vdH-S) score. Results: ACR20 response rates in Group 1, Group 2, and Group 3 were 67.9, 86.1, and 82.4%, respectively, at week 52 and were maintained through week 104 (87.1, 94.0, and 88.7%) and week 156 (97.1, 94.1, and 89.5%). Proportions of patients with good/moderate DAS28-ESR response or clinically meaningful improvement in HAQ-DI were also maintained through week 156. The majority of patients did not experience radiographic progression through week 156. Among 257 golimumab-treated patients, 251 (97.7%) had≥1 AE; 54 (21.0%) had≥1 serious AE through week 156. Infections were the most common type of AE. Conclusions: Response to golimumab + MTX was maintained over 3 years in Japanese patients with active RA despite MTX. Safety results were consistent with the known safety profile of golimumab.
資源タイプ	学術雑誌論文
出版タイプ	Version of Record
権利情報	Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported
PISSN	1439-7595
NCID	AA1157187X
関連情報 (isIdenticalTo)	出版社版DOI https://doi.org/10.3109/14397595.2015.1109762