AB0363 SAFETY OF JAK INHIBITORS IN PATIENTS WITH ARTHRITIS RHEUMATOID UNDER REAL-LIFE CONDITIONS
Authors: M. L. Velloso Feijoo, N. Cid Boza, M. J. Pérez
Journal: Annals of the Rheumatic Diseases (2020)

Background: Efficacy and safety profile of new JAK inhibitors have been properly defined by several clinical trials, being tested in many patients with Arthritis Reumatoid. However, real-life conditions studies play an important role in order to know JAK inhibitors behaviour in safety. Objectives: To describe adverse events of JAK inhibitors in patients with Arthritis Rheumatoid and asses the survival in relation to adverse events. Methods: Observational, descriptive, retrospective design performed in patients with Arthritis Reumatoid in follow-up by the Rheumatology department of the Hospital de Valme until January 2019. Demographic and clinical data related to safety has been collected Results: 58 patients were included with a mean age of 57,77 ± 10,78 years. Mean time from diagnosis was 8,7 ± 6,54 years, female predominance (75%). Mean ASDAS at the beginningof JAK inhibitor treatment was 4,76 ± 0,93. Regarding the determination of FR and CCCP 69% and was positive in both cases. Baricitinib was the treatment chosen in 13 patients (22.4%), and Tofacitinib in 45 patients (77.6%). Regarding associated treatments: 84.5% was under low-dose steroids theraphy; 77.6% was under combined therapy with at least 1 DMARD; 15.5% with two of them. Metotrexato was used in 53,4% of patients, leflunomide in 19%, hydroxycloroquine in 13.8%, sulfasalazyne in 12.1%. 72,4% have been before under at least one biologic treatment (frequently antiTNF), 41,1% one of them, 15.5% two of them, 12.1% three and 1.7% four before starting Jak inhibitor therapy. Adverse events has been observed in 17 patients (13 from de Tofacitinib group -28.8%-, and 4 in the Baricitinib group -30.76%). The most common advers events were: herpes zoster infections (4 patients in Tofacitinib group), respiratory infections (3), urinary infections (2), cutaneous (3), caphalea (1), legs oedema (2), toxic hepatitis in 1 patient of Baricitinib group; pulmonary thromboembolism was observed in 1 patient of Tofacitinib group, and atrial fibrillation in other patients of that group. Treatment was interrupted in 24 of 58 patients (mean time 8.92 ± 5.14 months), 16 from Tofacitinib group (35.5% of patients with Tofacitinib) and 8 from Baricitinib group (61.15% of patients with Tofacitinib). In Tofacitinib group, 10 patients stopped therapy for inefficacy reasons and 6 for advers effects related. In Baricitinib group, 5 due to inefficacy, 2 to adverse effects and 1 to clinical remission. Conclusion: Main adverse effect were mild-moderate infections (involving in-hospital treatment only in one Barictinib group patient). One pulmonary thromboembolism has been detected in a hypertensive 70 years old patient, supporting the recent recommendation of avoiding these drugs in patients over 65 or with cardiovascular risk factors. It is remarkable low survival results due to inefficacy, that could be related to clinical profile of refractory patients in our study, and/or to the small sample that we describe. Disclosure of Interests: None declared