Résumé
Background: Tofacitinib, an oral Janus Kinase inhibitor, is indicated for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA).Objectives: To describe the safety profile of Tofacitinib in a French prospective observational study DeFacTo.Methods: The safety profile of tofacitinib was assessed using interim data from a descriptive analysis of patients who took at least one dose of tofacitinib in the DeFacTo study.Results: Among 314 patients enrolled in the study, 306 received tofacitinib and were included in the safety analysis, including 274 patients with a follow-up ≥ 18 months (POP2) on 03/15/22 date of analysis) with a median exposure duration of 538 [Q1; Q3: 381; 554] days. 113 patients (41.2%) were still on tofacitinib (39 discontinued, 122 missing data regarding prescription). At inclusion, 78.3% of the 306 pts were women with a mean (± standard deviation) age of 59.5 ± 11.5 years, median disease duration of 8.9 years [Q1; Q3: 4.1; 18.9]. There was a history of cardiovascular (CV) disease in 11.9% of cases (including 4.6% myocardial infarction (MI), 5.0% stroke/transient ischemic attack (TIA), 1.7% heart failure, and 1.7% peripheral arterial disease); 5.6% history of cancer, 16.8% history of infection, and 46.6% smoker/former smoker. Tofacitinib was prescribed in combination with a csDMARD in 61.1% of patients and corticosteroids in 56.2% of cases. The results showed that adverse events (AEs) were reported in 54.2% of the 306 patients, 14.4% were considered as serious. Infections were found in 22.2% of patients, no deaths were reported (Table 1).Conclusion: These intermediate, descriptive results show a safety profile of tofacitinib in real-life RA similar to the one previously reported in clinical and observational studies. [1-2]REFERENCES:[1] Wollenhaupt et al. Arthritis Research & Therapy (2019) 21:89 https://doi.org/10.1186/s13075-019-1866-2[2] Kremer et al. ACR Open Rheumatology 2021. DOI 10.1002/acr2.11232