FRI0124 EFFICACY AND SAFETY OF BARICITINIB AND TOFACITINIB IN RHEUMATOID ARTHRITIS: DATA FROM REAL-WORLD
Authors: R. Gonzalez Mazario, J. J. Fragio-Gil, E. Grau García, M. De la Rubia Navarro, C. Pávez Perales, S. Leal Rodriguez, J. Ivorra Cortés, R. Negueroles Albuixech, L. Gonzalez Puig, J. E. Oller Rodríguez, C. Alcañiz Escandell, E. Vicens Bernabeu, I. Chalmeta Verdejo, I. Martínez Cordellat, F. M. Ortiz Sanjuan, C. Nájera Herranz, I. Cánovas Olmos, A. J. Cañada Martinez, J. A. Román Ivorra
Journal: Annals of the Rheumatic Diseases (2020)

Background: Oral targeted synthetic disease modifying anti-rheumatic drugs (DMARDs) including baricitinib and tofacitinib (JAKi), are the latest addition to the therapeutic options for rheumatoid arthritis (RA). Objectives: To assess and compare the efficacy and safety of Baricitinib and Tofacitinib in RA patients in real life. Methods: An observational longitudinal retrospective study was performed including RA patients who fulfilled the ACR/EULAR 2010 criteria and initiated treatment with Baricitinib or Tofacitinib from September 2017 to January 2020. Demographic, clinical and laboratory parameters and adverse events were collected. Infection was considered severe if it implied hospitalization. Statistical analysis was performed with R software (3.6.1) which consist in Bayesian lineal regression models including monotonic effect and Kaplan-Meier survival curves. Results: 98 patients were included. Basal characteristics are exposed in table 1. Table 1. Basal characteristics Baricitinib n=32 Tofacitinib n= 66 Female sex 96,88% 84,85% Age 53,2 (13,1) 55,4 (13,4) Disease evolution (years) 12,6 (9,1) 14,4 (8,6) Monotherapy 14 (21,21%) 20 (30,3%) DMARD Metotrexate 13 (40,63%) 24 (36,36%) Leflunomide 4 (12,5%) 10 (15,15%) Hydroxychloroquine 1 (3,7%) 2 (3,03%) Glucocorticoids 22 (68,75%) 48 (72,73%) First indication 6 (18,75%) 22 (33,33%) After bDMARD failure 24 (75%) 44 (66,67%) In both groups, a significative reduction of disease activity scores was noted (graphics 1 and 2). Any difference between both treatments was detected in terms of efficacy even in first line, after bDMARD failure, in monotherapy nor combined therapy. Safety data are exposed in table 2 and neither was detected any statistical difference. In 2 of the cases of herpes zoster infection developed postherpetc neuralgia. Definitive discontinuation was registered in 23 cases (23,45%) accounting 6 (6,12%) for intolerance symptoms such as dizziness, nausea or headache (4 with Tofacitinib and 2 in Baricitinib group). Table 2. Safety data Baricitinib n=32 Tofacitinib n=66 Temporary interruption 24 (75%) 50 (75,75%) Adverse reaction 8 (25 %) 17 (25.75%) Infections 22 (68,75%) 46 (69,69%) Serious infections 3 (9,37%) 5 (7,57%) Herpes Zoster 2 (6,25%) 2 (3,03%) Permanent discontinuation 9 (28,13%) 14 (28,2%) Intolerance 2 (6,25) 8 (12,12%) Primary failure 1 (3,13%) 2 (3,03%) Secondary failure 5 (15,63%) 3 (4,54%) Infections 1 (3,13) 1 (1,51%) Drug survival 23 (71,87%) 52 (78,78%) Survival analysis did not showed any difference between groups. Conclusion: Baricitinib and Tofacitinib are both comparable in terms of efficacy and safety in real world conditions. Graphic 1. Evolution of DAS28 Graphic 2. Evolution of HAQ Disclosure of Interests: None declared