Effectiveness of golimumab in rheumatoid arthritis patients with inadequate response to first-line biologic therapy: Results from a Japanese post-marketing surveillance study

Abstract

Objectives

To assess the real-world effectiveness of golimumab in Japanese patients with rheumatoid arthritis who had previously received first-line biologic therapy.

Methods

A post-hoc analysis of post-marketing surveillance was performed. The effectiveness of golimumab was assessed in 731 patients with an inadequate response to first-line biologic therapy stratified by their prior biologic agents. Outcome variables included DAS28-CRP, DAS28-ESR, SDAI and CDAI, and medication persistence. Logistic regression analyses were conducted to identify factors associated with the likelihood of achieving a DAS28-CRP response (good/moderate) after 24 weeks of golimumab treatment.

Results

Patients demonstrated significant improvement in the clinical signs and symptoms of rheumatoid arthritis at 24 weeks, as indicated by the reduction of DAS28-CRP (Δ0.87), DAS28-ESR (Δ0.85), SDAI (Δ7.32), and CDAI (Δ6.98) scores. This result was consistent across the subgroups stratified by previous biologic therapy. Multivariate analysis failed to identify any factors associated with response to golimumab.

Conclusion

In the real-world clinical setting, switching to golimumab was effective for Japanese patients with an inadequate response to first-line biologic therapy regardless of the biologic agent, including both TNF and non-TNF inhibitors.

Keywords:

• Biological disease-modifying antirheumatic drugs
• golimumab
• real-wolrd evidence
• rheumatoid arthritis
• switching

Acknowledgements

The authors would like to thank all of the patients and physicians who participated in this PMS for their cooperation. The authors are also grateful to Toshiro Yano (Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation) for study conception and design. Support with statistical analysis was provided by Hiroki Nakane (EPS Corporation) and professional medical writing and editorial assistance was provided by Yamada Translation Bureau, Inc., both of which were jointly funded by Janssen Pharmaceutical K.K. (Tokyo, Japan) and Mitsubishi Tanabe Pharma Corporation (Osaka, Japan). Sponsorship for this study and article processing charges were jointly provided by Janssen Pharmaceutical K.K. and Mitsubishi Tanabe Pharma Corporation.

Author contributions

HS, HK and YI contributed to conception and design of the study; HS wrote the manuscript; HK, MK and YI critically reviewed and edited the manuscript; all authors approved the final version of this manuscript for submission.

Conflict of interest

Hirohito Shimizu, Hisanori Kobayashi, Masayoshi Kanbori, and Yutaka Ishii are employees of Janssen Pharmaceutical K.K., a wholly owned subsidiary of Johnson & Johnson.