OBJECTIVES : This study is aimed to describe the impact of access limitations on Patient Centered Outcomes (PCOs) in Latin-American patients with Rheumatoid arthritis (RA) treated with tofacitinib or biological DMARDs (bDMARDs) after failure to conventional DMARDs in real-life conditions.

METHODS:This was a non-interventional prospective study performed in Colombia and Peru between February-2017 to November-2019. Demographic, clinical and access characteristics (access limitations and time to supply [TtS]) were collected. The change between baseline and 6-month follow-up of following variables was measured: Disease activity (RAPID3 and DAS28), Functional Status (HAQ-DI), Health-related Quality of life (EQ-5D-3L). The impact of access limitation was determined describing the changes of PCOs expressed in Least Mean Difference (LMD) and TtS measured in mean number of days for delivery of treatment at baseline; variability measures were Standard Deviation (SD) and Standard Error (SE).

RESULTS:

One hundred and seventy patients with mean age 53.53 (SD 13.77) years, mean years since RA diagnosis 6.31 (SD 7.02), treated with tofacitinib (n=70) or bDMARDs (n=100) were recruited. The mean TtS (SD) was 24.08 (30.59) for bDMARDs and 21.66 (44.80) for tofacitinib group; patients without access limitations were 81.43% (n=57) and 62.00% (n=62), respectively. In the bDMARDs group, the mean TtS was 22% longer in patients with access limitations compared to those without access limitations; for tofacitinib group TtS was 304% greater, respectively.

The baseline differences of PCOs (SE) in patients without access limitations were higher than those with access limitation for RAPID3 (LMD -3.56 (0.21) vs -1.13 (0.36)), HAQ-DI (LMD -0.79 (0.05) vs -0.29 (0.10)), EQ-5D-3L (LMD 0.45 (0.30) vs 0.18 (0.06)), and DAS28 (LMD -2.85 (0.30) vs -1.24 (0.57)).

CONCLUSIONS:Access limitations had a negative impact in the PCOs during the 6-months follow-up and longer TtS in RA patients. Therefore, it is a relevant factor for the achievement of better clinic results.