Prevention of joint destruction in patients with high disease activity or high C-reactive protein levels: Post hoc analysis of the GO-FORTH study

Abstract

Objectives: To assess the influence of golimumab dosage and disease activity on joint destruction in patients with active rheumatoid arthritis (RA) in the GO-FORTH study.

Methods: Efficacy was compared among groups given basal methotrexate plus placebo, golimumab (50 mg), or golimumab (100 mg) with stratification by high (HDA) or moderate (MDA) baseline disease activity and by high or low baseline C-reactive protein (CRP).

Results: Among HDA or high CRP patients, the mean change of the total Sharp score was 3.48 and 3.41 in the placebo group, 1.94 and 2.71 in the 50 mg group, and 0.39 and 1.15 in the 100 mg group, respectively. The percentage of progression-free patients with HDA or high CRP was 40.4% and 40.0%, 43.1% and 38.2%, and 69.8% and 61.5%, respectively. Among MDA or low CRP patients, both golimumab doses showed similar prevention of joint destruction. Among HDA or high CRP patients, a shorter disease duration and higher TSS/disease duration ratio were associated with joint destruction.

Conclusion: Both doses of golimumab (50 or 100 mg) prevented joint destruction in MDA or low CRP patients, but 100 mg was better for HDA or high CRP patients with a shorter disease duration or higher TSS/disease duration ratio.

Keywords:

• Golimumab
• High disease activity
• Japanese
• Rheumatoid arthritis
• Total Sharp score

Acknowledgments

We thank the patients, investigators, and study personnel who made this investigation possible. We also thank Yoshifumi Ukyo (Janssen Pharmaceutical K.K.) for his assistance in preparing this manuscript.

Conflict of interest

This study was funded by Janssen Pharmaceuticals K. K. Yoshiya Tanaka has received research grants from Abbott, Astellas Pharmaceutical, Banyu Pharmaceutical, Chugai Pharmaceutical, Eisai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Pfizer, and Takeda Pharmaceutical. Masayoshi Harigai has received research grants from Abbott, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Takeda Pharmaceutical, and Pfizer, and has received consulting fees from Abbott, Bristol Myers Squibb, Chugai Pharmaceutical, Janssen Pharmaceutical, and Mitsubishi Tanabe Pharmaceutical. Tsutomu Takeuchi has received research grants from Abbott, Astra Zeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Novartis, Takeda Pharmaceutical, and Pfizer. Hisashi Yamanaka has received research grants from Abbott, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Otsuka Pharmaceutical, Roche, Takeda Pharmaceutical, and Pfizer. Kazuhiko Yamamoto has received research grants from Astellas Pharmaceutical, Chugai Pharmaceutical, Eisai Pharmaceutical, Immunofuture Inc., Mitsubishi Tanabe Pharmaceutical, Santen Pharmaceutical, and Pfizer. Yutaka Ishii and Hiroshi Nakajima are employees of Janssen Pharmaceutical K.K., a wholly owned subsidiary of Johnson & Johnson. Daniel Baker is an employee of Janssen Research & Development, LLC. and owns stock in Johnson & Johnson. NM has received research grants from Abbott, Astellas Pharmaceutical, Banyu Pharmaceutical, Chugai Pharmaceutical, Daiichi Sankyo Pharmaceutical, Eisai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharmaceutical. Takao Koike has received research grants from Abbott, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Otsuka Pharmaceutical, Pfizer, and Takeda Pharmaceutical.