Real-world experience with tofacitinib for the treatment of rheumatoid arthritis

R. Caporali, D. Zavaglia

Research output: Contribution to journalArticlepeer-review


OBJECTIVES: Oral targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs), including the Janus kinase inhibitors tofacitinib and baricitinib, are the latest addition to the therapeutic options for rheumatoid arthritis (RA). Tofacitinib 5 mg, twice daily, is approved for treatment, with or without methotrexate, of moderate to severe active RA in adults not adequately responding to, or not tolerating one or more DMARDs. In this narrative review we aimed to provide an overview of the real-world evidence for tofacitinib in RA. METHODS: The literature was reviewed up to March 2018 for studies regarding the efficacy and safety of tofacitinib for the treatment of RA. The focus was mainly on real-world studies with implications for every day clinical practice. RESULTS: The efficacy and safety of tofacitinib have been comprehensively assessed in a wide programme of randomised controlled trials. Extensive observational research on tofacitinib in RA is also ongoing worldwide and a substantial body of post-marketing real-world data from clinical practice is becoming available. There was a degree of consistency across the real-world studies reviewed. Tofacitinib tends to be used as monotherapy more frequently than bDMARDS and appears to be effective without background methotrexate. The data show a manageable safety profile, with no new safety signals and a discontinuation rate from safety issues
Original languageEnglish
Pages (from-to)485-495
Number of pages11
JournalClinical and Experimental Rheumatology
Issue number3
Publication statusPublished - 2019


  • antirheumatic agent
  • piperidine derivative
  • pyrimidine derivative
  • pyrrole derivative
  • tofacitinib
  • adult
  • human
  • rheumatoid arthritis
  • treatment outcome
  • Adult
  • Antirheumatic Agents
  • Arthritis, Rheumatoid
  • Humans
  • Piperidines
  • Pyrimidines
  • Pyrroles
  • Treatment Outcome


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