AB0388 FRENCH REAL LIFE SAFETY DATA ON THE USE OF TOFACITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS: OBSERVATIONAL STUDY, DeFacTo

BackgroundTofacitinib, an oral Janus Kinase inhibitor, is indicated in the treatment of adult patients (pts) with active, moderate to severe rheumatoid arthritis (RA).ObjectivesThe objective of this work is to describe the tofacitinib’s safety profile in the DeFacTo study (French prospective observational study).MethodsThe safety profile of tofacitinib was assessed on the basis of interim data from a descriptive analysis of pts having taken at least one dose of tofacitinib in the context of the DeFacTo study.ResultsOf the 313 pts enrolled in the study, 301 had received tofacitinib and were included in the safety analysis. Of these, 276 fulfilled the eligibility criteria and included 219 who had ≥ 1 year follow-up and a mean exposure period of 368 ± 197.1 days. As of 15 March 2021, 122 patients are continuing to take tofacitinib therapy (76 missing prescription data). On inclusion, 77.9% of the 276 pts were females of mean (± SD) age 59.7 ± 11.7 years and a median disease duration of 9.1 years [Q1;Q3: 4.1; 19.2]. A history of cardiovascular disease was found in 12.5% of cases, (4.4% myocardial infraction, 5.5% stroke/transient ischemic attack, 1.5% heart failure and 1.5% peripheral arterial occlusive disease); 5.5% had a history of cancer, 17.5% a prior infection and 46% were smokers/former smokers. Tofacitinib was prescribed in combination with a csDMARD in 58.3% of pts and with corticosteroids in 54.3% of cases. At the cut-off date of 15 March 2021, of the 301 patients, adverse effects (AE) had been reported in 44.9% of cases of which 10.6% were considered serious (SAE). Infections were detected in 18.6% of pts (Table 1).Table 1.Real life safety data for tofacitinib according to ageN, (%)< 65 years (n=190)≥ 65 years (n=110)Total (n=301*)Adverse effect80 (42.1)55 (50.0)135 (44.9)Serious adverse effect16 (8.4)16 (14.5)32 (10.6)Infection33 (17.4)23 (20.9)56 (18.6)Severe infection3 (1.6)4 (3.6)7 (2.3)AE of interest (number of events) Infection Herpes zoster5510 Severe infection Herpes zoster101 Tuberculosis022 Cancer Small-cell carcinoma011 MACE Stroke101 Thromboembolic events Venous thrombosis011Death000*1 patient for whom age is unknown but is counted in the total.ConclusionThese purely descriptive interim results reveal a safety profile for tofacitinib in patients with RA, similar to that 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/acr2.11232AcknowledgementsTo all investigators involved in this study, and all patients included in this studyDisclosure of InterestsCécile Gaujoux-Viala Speakers bureau: AbbVie; Amgen; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Consultant of: AbbVie; Amgen; Boeringhe; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Andre BASCH Speakers bureau: Janssen, Novartis, Amgen, BMS, Abbvie, Lilly, Pfizer, MSD, UCB, Consultant of: Janssen, Novartis, Amgen, BMS, Abbvie, Lilly, Pfizer, MSD, UCB,, Slim Lassoued: None declared, Fabienne COURY-LUCAS Consultant of: AbbVie, Bristol-Myers Squibb, Janssen, Lilly, MSD, Novartis and Pfizer, Grant/research support from: AbbVie, Biogen, Roche Chugai, Pfizer, and UCB,, Meriem Kessouri Shareholder of: Pfizer, Employee of: Pfizer, Nadir Mammar Shareholder of: Pfizer, Employee of: Pfizer, Yves Brault Shareholder of: Pfizer, Employee of: Pfizer, Thierry Lequerre Consultant of: Abbvie, BMS, Boeringher, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Roche – Chugai, Sanofi, UCB,, Carine Salliot Consultant of: Biogen, Lilly, Novartis, Roche Chugai, Pfizer