Effectiveness and Safety of Tofacitinib in Rheumatoid Arthritis: a Cohort Study
A retrospective cohort study of tofacitinib (TOF) revealed that patients previously treated with methotrexate who initiated TOF, presented no differences in hospitalised infections or effectiveness, compared with non-TNF biologics.
Currently, TOF is recommended in ACR and EULAR guidelines as an alternative to biologics after first-line cDMARD therapy. Previous indirect comparisons have shown that patients with RA who experience cDMARD failure show similar efficacy when given TNFis, abatacept, tocilizumab or TOF. This study evaluated the effectiveness and risk of serious infection of TOF, csDMARDs, TNFis and non-TNF biologics in a clinical setting.
The MarketScan® Commercial Claims and Encounters database and the MarketScan Medicare Supplemental and Coordination of Benefits database were used to collect patient data over a 5-year period. Six criteria were used to assess therapy effectiveness: high adherence, no biologic or TOF switch or addition, no DMARD switch or addition, no increase in dose/frequency of index drug, one or less glucocorticoid joint injection and no new or increased oral glucocorticoid dose. To be considered effective, each therapy had to meet all six-criteria post cohort entry. Safety was defined as the occurrence of serious infections requiring hospitalisation and was assessed during follow-up.
For each therapy group, less than 20% of patients met all effectiveness criteria. Patients using either TNFi or non-TNF biologics reached better effectiveness rates, followed by TOF. Hazard ratios for serious infections were similar with no significant differences found between groups. Significant increases in serious infection hazard ratios were associated with current methotrexate use, previous biologic use, oral glucocorticoid use in the year before cohort entry and current use of oral glucocorticoids.