OBJECTIVES:To describe the efficacy, safety and patient-reported outcomes (PROs) in patients with naïve rheumatoid arthritis (RA) treated with tofacitinib or biological DMARDs (bDMARDs) in real-life conditions.

METHODS:Non-interventional study performed between Mar’2017 and Sep’2019 in 13 sites from Colombia and Peru. Convenience and randomized sampling were performed for tofacitinib and bDMARDs, respectively. Demographic and clinical information was collected. Outcomes measured at baseline and 6-month follow-up were: Disease activity (RAPID3 [Routine Assessment of Patients Index Data]); Functional status (HAQ-DI [Health Assessment Questionnaire]); Quality of life (EQ-5D-3L [EuroQol Questionnaire]). Disease Activity Score-28 (DAS28) and frequency of Adverse Events (AE) were also reported. Unadjusted and adjusted differences from baseline were estimated and expressed in Least Square Mean Difference (LMD).

RESULTS:Data from 100 patients treated with tofacitinib and 70 patients with bDMARDs was collected. 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). Significant difference was found in following baseline characteristics: previous methotrexate, complementary access mechanism, time-to-supply (higher in the tofacitinib group), prednisolone treatment and concomitant use of leflunomide (greater in the bDMARDs group). Change from baseline at month-6 was not statistical different in the adjusted LMD [SE] for tofacitinib vs. 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 from both groups presented a similar proportion of non-serious AE; two serious AE (2.00%) were reported in the tofacitinib group. Serious AE were not related to the treatment. These results have the non-interventional studies specific limitations.

CONCLUSIONS: Change from baseline was not statistically different between tofacitinib and bDMARDs for RAPID3 and the secondary outcomes (HAQ-DI, EQ-5D-3L and DAS28). Patients from both groups presented a similar proportion of non-serious AE.