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Randomized Controlled Trial
. 2016 Jul;26(4):481-90.
doi: 10.3109/14397595.2015.1109762. Epub 2015 Dec 23.

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

Yoshiya Tanaka  1 , Masayoshi Harigai  2 , Tsutomu Takeuchi  3 , Hisashi Yamanaka  4 , Naoki Ishiguro  5 , Kazuhiko Yamamoto  6 , Nobuyuki Miyasaka  7 , Takao Koike  8 , Daniel Baker  9 , Yutaka Ishii  10 , Toru Yoshinari  11 ; GO-FORTH study group
Affiliations
Randomized Controlled Trial

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

Yoshiya Tanaka et al. Mod Rheumatol. 2016 Jul.

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.

Keywords: Anti-tumor necrosis factor; Asian; Golimumab; Rheumatoid arthritis.

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Figures

Figure 1.
Figure 1.
Patient disposition through 156 weeks. AE, adverse event.
Figure 2.
Figure 2.
The proportions of patients* with an ACR20 (A), ACR50 (B), and ACR70 (C) response through week 156. *Observed data without imputation. ACR20/50/70, ≥ 20%/50%/70% improvement in American College of Rheumatology criteria; MTX, methotrexate.
Figure 3.
Figure 3.
The proportions of patients* with remission as defined by the CDAI (A), SDAI (B), and Boolean (C) criteria through week 156. *Observed data without imputation. CDAI, clinical disease activity index; MTX, methotrexate; SDAI, simplified disease activity index.
See this image and copyright information in PMC

References

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