OP0123 SAFETY PROFILE OF JAK-INHIBITORS VERSUS TNF-INHIBITORS IN REAL-WORLD CLINICAL PRACTICE: DATA FROM A MULTICENTER REGISTER

Autor: M. Freire González, Javier García-González, I. Castrejon, Carlos Sánchez-Piedra, Fernando Sánchez-Alonso, Jose Manuel Blanco, S. Manrique Arija, Miriam Moreno, Eva Perez-Pampin, Blanca Hernández-Cruz, Noemí Busquets
Rok vydání: 2021
Předmět:
Zdroj: Annals of the Rheumatic Diseases. 80:68.1-69
ISSN: 1468-2060
0003-4967
DOI: 10.1136/annrheumdis-2021-eular.2645
Popis: Background:JAK-inhibitors (JAKi) are small molecules emerging as a promising treatment for immune mediated diseases. Data from clinical trials are very promising. But long-term observational studies, with patients with diverse clinical backgrounds are required to confirm safety profile.Objectives:To compare the safety profile of JAKi versus TNF antagonists (anti-TNF) in a multicenter real world dataset.Methods:Data of patients enrolled in BIOBADASER 3.0 up to November 2020 with the start of anti-TNF or JAKi were analysed. Adverse events (AE) were classified according to Meddra dictionary (v19.0). For each group, demographic, clinical variables and ncidence rate ratios of AE per 1000 patients-year (PYs) and 95% confidence interval were estimated.Results:A total of 3,729 patients on anti-TNF (5,306) or JAKi (493) were analyzed. Patients on JAKi were older and with a mean disease duration of 10 years. JAKi were prescribed as first line treatment only in 24% of patients. The main reason of stopping treatment was ineffectiveness (53-59%) followed by adverse events (25-34%) in both groups. Survival during first year was similar between groups.Table 1.Patient characteristics and adverse events by treatment groupAnti-TNFJAKiMean age start of treatment (SD), yrs50.8 (12.6)57.6 (11.9)Female, n (%)3122 (58.8)392 (79.5)Disease duration, median (IQR)7.0 (2.7-13.7)9.9 (4.9-16.8)First line biologic, n (%)2614 (49.3)117 (23.7)Rheumatoid Arthritis1385 (41.1)339 (95.2)Ankylsosing Spondylitis1031 (30.6)1 (0.3)Psoriatic Arthritis957 (28.4)16 (4.5)DAS28-ESR4.3 (1.4)4.7 (1.4)Survival first year (IC 95%)73.3 (71.9-74.6)69.7 (66.0-73.0)Charlson Index, mean (SD)1.9 (1.3)2.3 (1.6)Reason to stop therapy (n)*: Lack of efficacy1534 (53.2)57 (58.8) Adverse event723 (25.1)33 (34.0)Adverse events (AE)*Serious infections14.2 (12.4-16.2)33.2 (19.3-57.3)Herpes zoster5.7 (4.6-7.1)12.8 (5.3-30.7)Tuberculosis0.7 (0.4-1.3)0.0 (0.0-0.0)Malignancy/Neoplasia10.2 (8.7-11.9)15.3 (6.9-34.2)Cardiac events13.9 (12.2-16.0)30.7 (17.4-54.0)GI perforation1.2 (0.8-1.9)10.2 (3.8-27.3)Vascular events9.8 (8.3-11.5)25.6 (13.8-47.5)*Data show the incidence rate ratio per 1000 patient-years (PYs; 95% CI)Conclusion:Serious infections and herpes zoster tend to be more frequent in patients on JAKi. However patients on JAKi were older, presented higher comorbidity and have a longer disease duration.Disclosure of Interests:None declared
Databáze: OpenAIRE
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