Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Limited data from large real-world patient populations exist to describe treatment outcomes of patients who receive tofacitinib for the management of RA in Australia. The objective of this study was to evaluate effectiveness and treatment patterns of tofacitinib in a large real-world cohort of Australian adult patients with RA.

Methods: Routinely collected, de-identified clinical data were sourced from the Optimising Patient outcomes in Australian rheumatology – Quality Use of Medicines Initiative (OPAL-QUMI) dataset. Data from adult patients with a diagnosis of RA, who initiated treatment with tofacitinib or a biologic disease-modifying antirheumatic drug(bDMARD) and had at least 12 months of follow‑up between March 2015 and September 2018, were included.Descriptive analyses were performed on overall and propensity score matched populations. Treatment effectiveness was evaluated from baseline to month 18 by DAS28-ESR, simple disease activity index (SDAI) and clinical disease activity index (CDAI) measures. Treatment persistence, in part a surrogate for efficacy, was estimated by Kaplan-Meier methods. Treatment pattern evaluation included percentage of patients receiving monotherapy or combination therapy at treatment initiation.

Results: 1950 patients were included in the matched population (1300 bDMARD initiators; 650 tofacitinib initiators). Patients were predominantly aged 55 to 74 years (57.8%), and female (81.2%). At baseline, median disease duration was 107 and 120 months, with 16.1% and 17.3% of patients in DAS28-ESR defined disease remission for the bDMARD and tofacitinib groups respectively. After three months of treatment, 49.1% and 49.7% had achieved DAS remission and after 18 months of treatment, 52.4% and 57.8% of patients had achieved DAS remission in the bDMARD and tofacitinib groups respectively. At 18 months the percentage of patients achieving CDAI/SDAI remission was similar with 29.2%/29.0% bDMARD patients and 30.9%/30.5% tofacitinib patients reporting CDAI/SDAI remission respectively. The median persistence of treatment was similar for bDMARD and tofacitinib groups: 33.8 (95% confidence interval (CI) 28.8 to 40.4) and 34.2 (95% CI 32.2 to not reached) months, respectively.  In the overall population, more patients were prescribed tofacitinib as monotherapy (43.4%) compared to bDMARD monotherapy (33.4%).

Conclusion: In this analysis of a large real world dataset, tofacitinib demonstrated treatment effectiveness and persistence that was similar to bDMARDs. Overall, there was a trend for more use of tofacitinib as monotherapy than bDMARDs.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/evaluation-of-effectiveness-and-usage-patterns-of-tofacitinib-in-treatment-of-rheumatoid-arthritis-in-australia-an-analysis-from-the-opal-qumi-real-world-dataset/