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

Yuko Kaneko, Yutaka Kawahito, Masayo Kojima, Takeo Nakayama, Shintaro Hirata, Mitsumasa Kishimoto, Hirahito Endo, Yohei Seto, Hiromu Ito, Keiichiro Nishida, Isao Matsushita, Toshihisa Kojima, Naoyuki Kamatani, Kiichiro Tsutani, Ataru Igarashi, Mieko Hasegawa, Nobuyuki Miyasaka, Hisashi Yamanaka

Journal: Modern rheumatology 2021;31(1):61-69

PMID: 31960737

Full Text on Ovid Technologies, Inc. View on PubMed

Abstract

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 1-2 mg/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 1-2 mg/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.

Address: Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.; Inflammation and Immunology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.; Department of Public Health, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.; Department of Health Informatics, Kyoto University School of Public Health, Kyoto, Japan.; The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.; Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan.; Immuno-Rheumatology Center, St Luke's International Hospital, Tokyo Japan.; Division of Rheumatology, Department of Internal Medicine, School of Medicine, Toho University Tokyo, Tokyo, Japan.; Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.; Department of Orthopaedic Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.; Department of Orthopaedic Surgery, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.; Department of Orthopaedic Surgery Faculty of Medicine, University of Toyama, Toyama, Japan.; Department of Orthopedic Surgery, Nagoya University Hospital, Nagoya, Japan.; Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.; Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.; The Japan Rheumatism Friendship Association, Japan.; Tokyo Medical and Dental University, Tokyo, Japan.

DOI: 10.1080/14397595.2020.1719607