Abstract
Background. Tofacitinib, an oral Janus Kinase inhibitor, is indicated in the treatment of adult patients (pts) with active, moderate to severe rheumatoid arthritis (RA). At the present time we have no data concerning its efficacy in a French RA population in a real-life setting. Objectives. DeFacTo, is an on-going observational study the principal goal of which is to identify factors predictive of Tofacitinib drug survival in RA patients in real life. Methods. These are the results of interim descriptive analyses of effectiveness data after 1 year of follow up. Results Of the 313 pts enrolled in the study, 276 pts were included in the effectiveness analysis (POP1), 219 of whom were patients with a ≥1-year follow-up (POP2) including 122 patients who, as of 15 March 2021, were continuing to take Tofacitinib therapy. At inclusion, POP1 (n=276) was composed of 77.9% females of mean (± SD) age 59.7 ± 11.7 years, having a median disease duration of 9.1 years [Q1;Q3: 4.1; 19.2], TJC 7.5 ± 5.9 and SJC 5.3 ± 5.1; 115 patients presented with erosions, 206 had RF+ and 202 had ACPA+. The median CRP value was 7.4 [: 3.0; 20.0] mg/l, DAS28-4-CRP was 4.6 ±1.1, and the FACIT-Fatigue score was 28.3 ± 11.3. In all, 96.7% of the pts had received prior treatment with ≥1 csDMARDs, 65.2% with b/tsDMARDs (median = 2 [1; 4]). Tofacitinib was prescribed in combination with a csDMARD in 58.3% of cases. The baseline characteristics of the 122 patients still taking tofacitinib at 12 months were comparable to those of POP1. Results showed continued treatment with tofacitinib in 85.3% of pts with mean duration of treatment of 368 ± 197.1 days and reductions from baseline in the parameters of inflammatory markers, pain and the DAS28 activity scores; 20% of 122 pts were in DAS28-CRP remission (Table 1). Safety findings were similar to those reported previously in clinical studies 1 2 .