Effectiveness of tacrolimus in comparison with methotrexate or biologics in propensity score-matched patients with rheumatoid arthritis

Abstract

Objective: To analyze the effectiveness of tacrolimus (TAC) in comparison with methotrexate (MTX) or biologics in propensity score (PS)-matched rheumatoid arthritis (RA) patients.

Methods: RA patients with moderate or high disease activity as defined by the 28-joint disease activity score (DAS28) and who had completed at least two successive biannual RA cohort surveys were analyzed. Patients were assigned in a stepwise fashion to one of four groups (Biologics, MTX, TAC, or Control) according to medication changes during a 6-month period. A PS was generated for each of three conditions (Biologics, MTX or Control group versus the TAC group, respectively), followed by the assignment of PS-matched patients. At 1 year, the DAS28 in each treatment versus TAC group was analyzed using a mixed effect model with repeated measures.

Results: Compared with the respective PS-matched TAC group, the difference in DAS28 at 1 year was −0.398 [95% confidence interval (CI) − 0.660 to −0.136, p < 0.005] in the Biologics group (N = 120), −0.045 (95% CI −0.222 to 0.133, p = 0.622) in the MTX group (N = 465), and 0.182 (95% CI 0.010 to 0.353, p < 0.05) in the Control group (N = 462).

Conclusion: TAC may provide a potential therapeutic option for RA patients with moderate to high disease activity.

Keywords:

• Biologics
• Comorbidity
• Methotrexate
• Rheumatoid arthritis
• Tacrolimus

Conflict of interest

The IORRA study was organized and supported by the Tokyo Women’s Medical University. This study was supported by a research grant from Astellas Pharma Inc. The corresponding author is fully responsible for the study design and the interpretation and submission of the data for publication. The sponsor did not participate in the study design, data collection, data analysis or interpretation, or in the preparation of the manuscript. Nakajima A, Astellas Pharma Inc., Bristol-Myers, Chugai Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation; Inoue E, Merckserono Co. Ltd.; Taniguchi A, Abbvie Inc., Eisai Co. Ltd., Teijin Pharma limited, Mitsubishi Tanabe Pharma Corporation, Torii Pharmaceutical Co. Ltd., Momohara S, Abbvie Inc., Asahikasei Pharma Corporation, Astellas Pharma inc., Bristol-Myers, Chugai Pharmaceutical Co. ltd., Daiichi Sankyo Co. Ltd., Eisai Co. Ltd., Janssen Pharmaceutical K. K., Nippon Kayaku, Pfizer Japan Inc., Taishotoyama Pharmaceutical Co. ltd., Takeda Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Teijin Pharma Limited, UCB Japan Co. Ltd.; Yamanaka H, Abbott Japan Co. Ltd., AbbVie Inc., Asahikasei Pharma Corporation, Astellas Pharma Inc., AstraZeneca K. K., Bristol-Myers K.K., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., GlaxoSmithKline K. K., Janssen Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K. K., Nippon Kayaku, Pfizer Japan Inc., Santen Pharmaceutical Co. Ltd., Taishotoyama Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd. and Teijin Pharma Limited.