Efficacy and safety of tacrolimus in patients with rheumatoid arthritis -- A systematic review and meta-analysis.

Objectives: To evaluate the efficacy and safety of tacrolimus in adult patients with rheumatoid arthritis (RA) by using the GRADE approach. Methods: We searched PubMed, Japana Centra Revuo Medicina Web (Ichu-shi web), and the Cochrane Database of Systematic Reviews. Articles fulfilling the predefined inclusion criteria were appraised and used for meta-analysis. The primary outcomes were American College of Rheumatology 20 (ACR20) and serum creatinine elevation. Other outcomes included ACR50, ACR70, changes in C-reactive protein, modified Health Assessment Questionnaire Disability Index, gastrointestinal disorders, metabolic and nutritional disorders, and infections and infestations. Results: We identified five randomized controlled studies, four of which compared tacrolimus to placebo and were included in the meta-analysis. The risk ratio of ACR20 achievement was 1.71 (95% confidence interval [CI] 1.20 -2.42) for 1 -2mg/day and 2.30 (95% CI 1.79 -2.96) for 3 mg/day. The risk ratio of creatinine elevation was 1.95 (95% CI 1.18 -3.23) for 1 -2mg/day and 3.81 (95% CI 2.43 -5.99) for 3 mg/day. Conclusion: Tacrolimus is effective with acceptable safety in the management of RA. [ABSTRACT FROM AUTHOR]