Korean J Intern Med.  2014 Sep;29(5):656-663. 10.3904/kjim.2014.29.5.656.

Efficacy and safety of tofacitinib for active rheumatoid arthritis with an inadequate response to methotrexate or disease-modifying antirheumatic drugs: a meta-analysis of randomized controlled trials

  • 1Division of Rheumatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. lyhcgh@korea.ac.kr
  • 2Hospital for Rheumatic Diseases, Hanyang University College of Medicine, Seoul, Korea.


The aim of this study was to assess the efficacy and safety of tofacitinib (5 and 10 mg twice daily) in patients with active rheumatoid arthritis (RA).
A systematic review of randomized controlled trials (RCTs) that examined the efficacy and safety of tofacitinib in patients with active RA was performed using the Medline, Embase, and Cochrane Controlled Trials Register databases as well as manual searches.
Five RCTs, including three phase-II and two phase-III trials involving 1,590 patients, met the inclusion criteria. The three phase-II RCTs included 452 patients with RA (144 patients randomized to 5 mg of tofacitinib twice daily, 156 patients randomized to 10 mg of tofacitinib twice daily, and 152 patients randomized to placebo) who were included in this meta-analysis. The American College of Rheumatology 20% response rate was significantly higher in the tofacitinib 5- and 10-mg groups than in the control group (relative risk [RR], 2.445; 95% confidence interval [CI], 1.229 to 4.861; p = 0.011; and RR, 2.597; 95% CI, 1.514 to 4.455; p = 0.001, respectively). The safety outcomes did not differ between the tofacitinib 5- and 10-mg groups and placebo groups with the exception of infection in the tofacitinib 10-mg group (RR, 2.133; 95% CI, 1.268 to 3.590; p = 0.004). The results of two phase-III trials (1,123 patients) confirmed the findings in the phase-II studies.
Tofacitinib at dosages of 5 and 10 mg twice daily was found to be effective in patients with active RA that inadequately responded to methotrexate or disease-modifying antirheumatic drugs, and showed a manageable safety profile.


Tofacitinib; Efficacy; Safety; Arthritis, rheumatoid

MeSH Terms

Antirheumatic Agents/administration & dosage/adverse effects/*therapeutic use
Arthritis, Rheumatoid/*drug therapy
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Janus Kinases/antagonists & inhibitors
Methotrexate/therapeutic use
Piperidines/administration & dosage/adverse effects/*therapeutic use
Protein Kinase Inhibitors/administration & dosage/adverse effects/therapeutic use
Pyrimidines/administration & dosage/adverse effects/*therapeutic use
Pyrroles/administration & dosage/adverse effects/*therapeutic use
Randomized Controlled Trials as Topic
Treatment Outcome
Antirheumatic Agents
Janus Kinases
Protein Kinase Inhibitors
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