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Effectiveness and safety of tofacitinib in rheumatoid arthritis: a cohort study

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Machado MAÁ1, Moura CS1, Guerra SF1, Curtis JR2, Abrahamowicz M1,3, Bernatsky S4,5. Arthritis Res Ther. 2018 Mar 23;20(1):60. doi: 10.1186/s13075-018-1539-6.

Abstract

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1 Division of Clinical Epidemiology, Research Institute of McGill University Health Centre, 5252 de Maisonneuve West, Montreal, QC, Canada.

2 Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, SRC 076, USA.

3 Department of Epidemiology, Biostatistics and Occupational Health, Research Institute of McGill University Health Centre, 5252 de Maisonneuve West, Montreal, QC, Canada.

4 Division of Clinical Epidemiology, Research Institute of McGill University Health Centre, 5252 de Maisonneuve West, Montreal, QC, Canada. sasha.bernatsky@mcgill.ca.

5 Department of Epidemiology, Biostatistics and Occupational Health, Research Institute of McGill University Health Centre, 5252 de Maisonneuve West, Montreal, QC, Canada. sasha.bernatsky@mcgill.ca.

Abstract

BACKGROUND: Tofacitinib is the first oral Janus kinase inhibitor approved for the treatment of rheumatoid arthritis (RA). We compared the effectiveness and safety of tofacitinib, disease-modifying antirheumatic drugs (DMARDs), tumor necrosis factor inhibitors (TNFi), and non-TNF biologics in patients with RA previously treated with methotrexate.

METHODS: We used MarketScan® databases (2011-2014) to study methotrexate-exposed patients with RA who were newly prescribed tofacitinib, DMARDs other than methotrexate, and biologics. The date of first prescription was defined as the cohort entry. The therapy was considered effective if all of the following criteria from a claims-based algorithm were achieved at the first year of follow-up: high adherence, no biologic or tofacitinib switch or addition, no DMARD switch or addition, no increase in dose or frequency of index drug, no more than one glucocorticoid joint injection, and no new/increased oral glucocorticoid dose. The safety outcome was serious infections requiring hospitalization. Non-TNF biologics comprised the reference group.

RESULTS: We included 21,832 patients with RA, including 0.8% treated with tofacitinib, 24.7% treated with other DMARDs, 61.2% who had started therapy with TNFi, and 13.3% treated with non-TNF biologics. The rates of therapy effectiveness were 15.4% for tofacitinib, 11.1% for DMARDs, 18.6% for TNFi, and 19.8% for non-TNF biologics. In adjusted analyses, tofacitinib and non-TNF biologics appeared to have similar effectiveness rates, whereas DMARD initiators were less effective than non-TNF biologics. We could not clearly establish if tofacitinib was associated with a higher rate of serious infections.

CONCLUSIONS: In patients with RA previously treated with methotrexate, our comparisons of tofacitinib with non-TNF biologics, though not definitive, did not demonstrate differences with respect to hospitalized infections or effectiveness.