Clinical response among golimumab-treated Japanese patients with rheumatoid arthritis by number of previous biologic therapies: Real-world evidence from post-hoc analysis of post-marketing surveillance data

Abstract

Objectives

To assess the real-world effectiveness of golimumab in Japanese patients with rheumatoid arthritis who had previously received one or more biologic therapies.

Methods

A post-hoc analysis of post-marketing surveillance was performed. The clinical response to golimumab was analyzed in 1216 patients who had previously received one or more biologic agents including non-TNF inhibitors with stratification by the number of previous biologic agents. Logistic regression analyses were conducted to identify factors associated with DAS28-CRP response to golimumab.

Results

While treatment persistence is comparable, the response to golimumab declined with an increasing number of previous biologic therapies. When stratified by golimumab dose, patients receiving golimumab at 100 mg had higher disease activity at baseline with an increasing number of previous bDMARDs, but they still achieved comparable disease activity at 24 weeks regardless of how many bDMARDs had been previously used. Univariate and multivariate analyses both identified concomitant oral corticosteroid therapy as a factor negatively associated with the likelihood of achieving a DAS28-CRP response.

Conclusion

Switching to golimumab was effective regardless of how many biologic agents had been previously used, but the response declined with an increasing number of prior biologic agents. A golimumab dose of 100 mg was also effective for those who previously received three or more bDMARDs.

Keywords:

• Disease-modifying antirheumatic drugs
• golimumab
• post-marketing surveillance
• rheumatoid arthritis
• switching

Author contributions

HS, HK and YI contributed to the 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.

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.

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.