Background/Purpose: The objective of this study was to describe the efficacy, safety and patient reported outcomes in Latin-American patients with Rheumatoid Arthritis (RA) treated with tofacitinib 5mg (BID) or biological DMARDs (bDMARDs) after failure to respond to conventional DMARDs in real-life conditions. The primary objective of this study was to compare the disease activity measured by RAPID3 at 0- and 6-months follow-up.

Methods: This was a prospective and retrospective non-interventional study (NIS) comparing tofacitinib to bDMARDs treatments in patients with RA after failure of conventional DMARDs; the study was performed in 13 sites from Colombia and Peru between 2017 to 2019. Convenience sampling in the tofacitinib arm and randomized in the bDMARDs arm was performed. Demographic and clinical information was collected at baseline and follow up. The following questionnaires were applied at baseline and Month 6 (±1 month) of follow-up: RAPID3 (Routine Assessment of Patients Index Data) to measure Disease activity; HAQ-DI (Health Assessment Questionnaire) to measure Functional status; EQ-5D-3L (EuroQol Questionnaire) to measure Quality of life. Frequency of Adverse Events (AE) was taken from clinical records retrospectively and collected during visits when spontaneously reported. The clinical outcomes were adjusted through linear regression by demographic, clinical and access variables. Unadjusted and adjusted differences from baseline were reported in Standardized Mean Difference (SMD).

Results: Data from 100 RA patients treated with tofacitinib and 70 RA patients with bDMARDs (85% treated with etanercept, rituximab, tocilizumab and infliximab) was collected and patients were recruited between April 2017 and February 2019. At baseline, patients mean age was 53.53 years (SD 13.77), mean disease duration was 6.31 years (SD 7.01) and mean DAS28 was 5.48 (SD 2.97). There was a significant difference in the following baseline demographic and clinical characteristics of the patients: previous methotrexate therapy, complementary access mechanism and time to supply were higher in the tofacitinib group, while prednisolone treatment and concomitant use of leflunomide were higher in the biologics. At month 6, there was no statistical difference in the adjusted SMD [Standard Error] from baseline for tofacitinib versus bDMARDs for RAPID 3 (-0.20 [0.69] vs. -0.32 [0.71]), HAQ-DI (-0.56 [0.07] vs. -0.50 [0.08]), EQ-5D-3L (0.23 [0.06] vs. 0.29 [0.06]) and DAS28 (-3.86 [0.59] vs. -4.23 [0.61]). Patients with tofacitinib and biologics presented a similar proportion of non-serious AE (30.0% and 28.6%, respectively); there were two serious AE in the tofacitinib group (2.0%) that were not related to the treatment. These results have limitations (heterogeneity among groups, sample size) given the specific characteristics of NIS.

Conclusion: There were no differences between patients with RA treated with tofacitinib and biological DMARDs regarding the disease activity, quality of life and functional status. Tofacitinib had similar safety profile to biological DMARDs in Latin American RA patients.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/patient-reported-outcomes-in-rheumatoid-arthritis-patients-treated-with-tofacitinib-or-biological-dmards-in-real-life-conditions-in-two-latin-america-countries/