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Hokkaido University Collection of Scholarly and Academic Papers >
Graduate School of Medicine / Faculty of Medicine >
Peer-reviewed Journal Articles, etc >
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
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| Title: | 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 |
| Authors: | Tanaka, Yoshiya Browse this author →KAKEN DB | | Harigai, Masayoshi Browse this author →KAKEN DB | | Takeuchi, Tsutomu Browse this author →KAKEN DB | | Yamanaka, Hisashi Browse this author →KAKEN DB | | Ishiguro, Naoki Browse this author →KAKEN DB | | Yamamoto, Kazuhiko Browse this author →KAKEN DB | | Miyasaka, Nobuyuki Browse this author →KAKEN DB | | Koike, Takao Browse this author →KAKEN DB | | Baker, Daniel Browse this author | | Ishii, Yutaka Browse this author | | Yoshinari, Toru Browse this author | | The GO-FORTH study group Browse this author |
| Keywords: | Anti-tumor necrosis factor | | Asian | | Golimumab | | Rheumatoid arthritis |
| Issue Date: | 2016 |
| Publisher: | Taylor & Francis |
| Journal Title: | Modern Rheumatology |
| Volume: | 26 |
| Issue: | 4 |
| Start Page: | 481 |
| End Page: | 490 |
| Publisher DOI: | 10.3109/14397595.2015.1109762 |
| Abstract: | 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. |
| Rights: | https://creativecommons.org/licenses/by-nc-nd/3.0/ |
| Type: | article |
| URI: | http://hdl.handle.net/2115/62847 |
| Appears in Collections: | 医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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Submitter: 小池 隆夫
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