Real-World Data of Tofacitinib Versus Tumor Necrosis Factor Inhibitors in Taiwanese Patients With Rheumatoid Arthritis From a Drug-Based Cohort Study.

AIM: To assess the long-term effectiveness and safety of, and persistence/adherence to, tofacitinib (an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis [RA]) and tumor necrosis factor inhibitors (TNFi) in Taiwanese patients with RA in real-world settings.

METHODS

This was a 5 year, prospective cohort study in Taiwanese patients with RA newly initiating tofacitinib or TNFi. Patients received standard care per treating rheumatologists and fulfillment of National Health Insurance reimbursement criteria. Effectiveness outcomes (baseline and every 24 weeks) included: Disease Activity Score in 28 joints, erythrocyte sedimentation rate; Clinical Disease Activity Index; Health Assessment Questionnaire-Disability Index; and Work Productivity and Activity Impairment-RA. Differences between groups were compared using mixed logistic regression models. Safety and persistence/adherence were assessed throughout.

RESULTS

In total, 267 patients were included (tofacitinib, n = 145; TNFi, n = 122). No significant differences in effectiveness outcomes for tofacitinib versus TNFi were reported before or after propensity score adjustment. In patients receiving tofacitinib and TNFi, rates of adverse events (AEs; 56.6% vs. 55.7%), serious AEs (20.0% vs. 21.3%), major adverse cardiovascular events (0% vs. 0.8%), malignancy (2.1% vs. 0.8%), and deaths (1.4% vs. 3.3%) were similar. Serious infections/herpes zoster occurred in 13.1%/12.4% and 8.2%/3.3% of patients receiving tofacitinib and TNFi, respectively. No venous thromboembolism events were reported. Persistence/adherence was comparable between tofacitinib and TNFi.

CONCLUSION

Tofacitinib effectiveness and persistence/adherence were generally similar to TNFi in this real-world analysis in Taiwanese patients with RA. Safety outcomes were consistent with the known safety profiles of tofacitinib and TNFi.

TRAIL REGISTRATION: EUPAS13431.