学術雑誌論文 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

26 ( 4 )  , pp.481 - 490 , 2016 , Taylor & Francis
ISSN:1439-7595
NII書誌ID(NCID):AA1157187X
内容記述
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.

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