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

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)61-69
Number of pages9
JournalModern rheumatology
Issue number1
Publication statusPublished - 2021


  • Conventional synthetic disease-modifying antirheumatic drug
  • rheumatoid arthritis
  • systematic review
  • tacrolimus

ASJC Scopus subject areas

  • Medicine(all)


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