| Summary: | Ilaria Bertoldi,1 Roberto Caporali2 1Medical Department, Pfizer Italy, Rome, Italy; 2Department of Clinical Sciences and Community Health, University of Milan and ASST Pini-CTO Hospital, Milan, ItalyCorrespondence: Roberto CaporaliDepartment of Clinical Sciences and Community Health, University of Milan and ASST Pini-CTO Hospital, Milan, ItalyEmail roberto.caporali@unimi.itAbstract: Tofacitinib is an oral Janus kinase (JAK) inhibitor indicated for the treatment of rheumatoid arthritis (RA). The efficacy and safety/tolerability of tofacitinib have been extensively evaluated as monotherapy and combination therapy in multiple, randomised, multicentre studies in patients with RA. Tofacitinib as monotherapy (as first- and second-line treatment) or as combination with methotrexate (MTX) or other csDMARDs as second- and third-line treatment is effective and generally well tolerated in patients with RA. This article focuses on recent real-world evidence investigating the effectiveness, treatment persistence and safety/tolerability of tofacitinib in patients with RA. With this purpose, a literature review was conducted from April 2018 up to October 2020 for the effectiveness, persistence and safety of tofacitinib for the treatment of RA, primarily focusing on real-world studies. These retrospective and prospective and observational studies demonstrate the effectiveness of tofacitinib, thus supporting pivotal data from the clinical trial programme. Treatment persistence was generally comparable to that of biologic disease-modifying anti-rheumatic drugs. Safety findings in these observational studies were consistent with the known safety profile of the approved dose of 5 mg twice daily.Keywords: rheumatoid arthritis, real-world, effectiveness, persistence
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