POS0659 REAL WORD EXPERIENCE WITH TOFACITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS: AN INTERIM ANALYSIS FROM A FRENCH PROSPECTIVE OBSERVATIONAL STUDY DeFacTo
Authors: C. Gaujoux-Viala, A. Basch, S. Lassoued, F. Coury-Lucas, M. Kessouri, N. Mammar, T. Lequerre, C. Salliot
Journal: Annals of the Rheumatic Diseases (2021)

Background: Tofacitinib is an oral JAK inhibitor indicated for moderate to severe active rheumatoid arthritis (RA). Objectives: To present baseline patients characteristics and effectiveness data at 6 months of DeFacTo real life study (“I De ntification of Fa ctors predictive of To facitinib’s survival”). Methods: DeFacTo is an observational, open-label, prospective, multi-center, national study designed to evaluate the predictive factors of tofacitinib’s survival in patients with moderate-to-severe active rheumatoid arthritis according to the SmPC [1] . Here we present the 1st interim results involving a descriptive analysis of the 221 patients included between January 2019 and March 2020 (POP1). Effectiveness results at 6 months of 145 patients having ≥ 6 months follow-up (POP2) are also described. Results: The baseline characteristics of the POP1 patients (n = 221) were: 78.3% women with a mean age (± SD) of 60.4 ± 11.1 years, disease duration of 12.0 ± 9.8 years, TJC: 7.3 ± 5.7 and SJC: 5.1 ± 4.7; 44.0% of patients had erosions, 79.5% were RF+ and 75.9% were ACPA+. The mean CRP was 15.3 ± 21.8 mg/l, the ESR at one hour was 28.7 ± 23.6 mm, DAS28-4 CRP was 4.6 ± 1.0, DAS28-4 ESR was 4.9 ± 1.1 and the FACIT-Fatigue score was 27.6 ± 11.3. A total of 97.3% of patients had been previously treated by ≥1 csDMARD (mean number 1.9 ± 1.0) and 66.1% by b/tsDMARDs (mean number 2.9 ± 2.5), tofacitinib was prescribed as monotherapy (without csDMARD) in 49.3% of patients. The characteristics of the POP2 patients were similar to those of POP1. At 6 months in POP2, 29 patients have discontinued their treatment with tofacitinib. The results showed a decrease from baseline in inflammatory markers (CRP from 14.2±17.1 to 4.7±4.2 mg/l), pain (Pain VAS from 58.3±23.4 to 27.6±22.1) and DAS28 activity scores with 23% of patients in DAS28-CRP remission and 36% of patients in DAS28-CRP LDA (figure 1). This interim analysis didn’t identifyany new safety findings (Table 1). Conclusion: Preliminary results from this prospective observational study on the use of tofacitinib in patients suffering with RA in France indicate that its effectiveness and safety are similar to those found in the clinical studies [1-3] . In this study, tofacitinib was prescribed as monotherapy (without csDMARD) in more than 49% of cases. References: [1] European Medicines Agency, Tofacitnibi SmPc (summary of product characteristics). [2] Burmester G et al. Lancet. 2013; 381: 451-460. [3] Fleischman R et al. Lancet 2017; 390: 457-6. [4] Wollenhaupt et al. Arthritis Research &amp; Therapy (2019) 21:89 Figure 1. Patients with LDA or remission at baseline and 6 months Table 1. Safety data Tolerability, n patients (% ) &lt;65 years, n = 132 ≥ 65 years, n = 86 Total n = 218 AE 56 (42.4 ) 33 (38.4 ) 89 (40.8 ) Serious AE 8 (6.1 ) 5 (5.8 ) 13 (6.0 ) Herpes Zoster 4 (3.0 ) 2 (2.3 ) 6 (2.8 ) Infection 27 (20.5 ) 15 (17.4 ) 42 (19.3 ) Severe infection 2 (1.5 ) 2 (2.3 ) 4 (1.8 ) Acknowledgements: To all investigators involved in this study. Disclosure of Interests: Cécile 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; 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, 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