HUSCAP logo Hokkaido Univ. logo

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

This item is licensed under: Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported

Files in This Item:
139_ModRheumatol26_481.pdf836.5 kBPDFView/Open
imor_a_1109762_sm9295.pdfSupplemental Table80.74 kBPDFView/Open
Please use this identifier to cite or link to this item:http://hdl.handle.net/2115/62847

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)

Submitter: 小池 隆夫

Export metadata:

OAI-PMH ( junii2 , jpcoar )

MathJax is now OFF:


 

 - Hokkaido University