Background/Purpose: Tofacitinib is an oral Janus kinase (JAK) inhibitor approved in the USA in November 2012 for the treatment of rheumatoid arthritis (RA). As the first oral JAK inhibitor for RA, little is known about the real-world effects of tofacitinib. Our aim was to compare the effectiveness of traditional disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs and tofacitinib for RA patients with inadequate response to methotrexate.

Methods: We performed a retrospective cohort study using MarketScan Databases from 2011-2014. We studied RA individuals, 18 years or older, previously treated with methotrexate (oral or SQ, at any time) and newly prescribed one of the medications under study (DMARDs, biologics or tofacitinib), between January 2011 and December 2013. The date of first filled prescription or infusion drug was defined as the cohort entry and individuals must have had no prior use of biologics or tofacitinib at any point before cohort entry. We required subjects to be continuously enrolled in the medical and pharmacy plan for 12 months before and 12 months after the cohort entry. A patient’s therapy was defined as effective if none of the following occurred during the first year of follow-up: 1) non-adherence, defined as medication possession ratio (MPR) lower than 80% or the number of infusions lower than the minimum expected for each biologic. 2) Switching or adding a new biologic agent or tofacitinib. 3) Switching or adding a new DMARD. 4) Having at least one glucocorticoid joint injection between the months 4 and 12 of follow-up. We presented descriptive analysis of baseline characteristics and the proportion of patients achieving therapy effectiveness and the individual criteria by exposure groups.

Results: 16,962 RA patients were included; 3,033 began therapy with DMARD, 13,843 with biologics and 86 with tofacitinib. Among all patients, 77.4% were female and the mean age was 56.1 years (standard deviation 12.6). Table 1 shows the proportion of patients that failed the effectiveness criteria. Table 1. Proportion and 95% confidence interval (CI) of patients who achieved therapy effectiveness and the individual criteria.

Conclusion: Similar rates of therapy effectiveness were observed among groups, although the rates for the individual criteria differed. The number of RA patients starting therapy with tofacitinib was relatively low and most of them were non-adherent. Fewer patients using biologic agents were non-adherent compared to DMARD and tofacitinib therapy, while more patients using biologic agents switched to or added a new biologic agent or tofacitinib. The results suggest that tofacitinib are not usually prescribed as a therapy option after inadequate response to methotrexate. At least through the end of 2014, patients initiating tofacitinib before biologics appear quite dissimilar to initiators of first time biologics. Given this pattern of use, further analysis should focus on the comparative effectiveness and safety of tofacitinib and biologic drugs as second and third therapy options for RA patients.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparative-effectiveness-of-tofacitinib-biologic-drugs-and-traditional-disease-modifying-antirheumatic-drugs-in-rheumatoid-arthritis/