AB0437 SAFETY OF JAK INHIBITORS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN CONDITIONS OF DAILY CLINICAL PRACTICE
Authors: Natalia Cid Boza, ML Velloso Feijoo, Nahia Plaza, Jose Luis Marenco
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> Efficacy and safety of the new JAK inhibitors is supported by phase I, II and III studies with a large number of patients included in the follow-up, although it is of vital importance behavior of new molecules in routine clinical practice, and until now we still have few clinical data. <h3>Objectives:</h3> To describe the adverse effects observed, as well as the income Hospitals and description of them during treatment with JAK inhibitors in a series of patients with RA. <h3>Methods:</h3> This is a retrospective descriptive study in patients with RA treated with JAK inhibitors in follow-up by the Rheumatology Unit of Virgen de Valme Hospital. We included demographic, related to the disease and treatment and security variables. <h3>Results:</h3> We included 31 patients with rheumatoid arthritis with a mean age of 57.58 ± 11.31 years and mean time of evolution of the disease of 9.42 ± 6.62 years, 61.3% positive FR and 61.3% ACPA positive. The female sex represents 74.2% of the sample. The mean of the baseline DAS28 was 4.90 ± 0.95. Regarding the treatment analysis initiated 12 patients (38.7%) receive baricitinib and 19 (61.3%) tofacitinib. 93.5% were in treatment with steroids at low doses and 80.64% in treatment combined with at least 1 associated DMARD (75% baricitinib group, 84.2% tofacitib group). The subanalysis of concomitant treatment reveals that up to 31.5% of patients undergoing treatment with tofacitinib initiated treatment with ≥2 FAMEs. 61.3% of patients had previously received at least one biological drug, among which the antiTNFs stand out for their frequency; 31.5% with one biological, 9.7% with 2 previous biologicals and 16.5% had used three. A total of 14 adverse effects were recorded in 10 of the 31 patients which are described below: baricitinib group a total of 6 events (50%); 1 toxic hepatitis, 1 respiratory infection, 2 cases of urinary tract infection, 1 case of canker sores, and 1 cold sore. Tofacitinib group a total of 8 events (42.1%): 2 cases of Herpes zoster, 1 case of headache and dizziness, 2 perianal abscesses and 1 abscess submandibular There were 3 hospital admissions with independence of its relationship with the treatment analyzed; barcitinib group: 1 patient with upper respiratory tract infection and decompensated heart failure, 1 patient with toxic hepatitis. Tofacitinib group: 1 patient with post-traumatic humerus fracture. <h3>Conclusion:</h3> The main side effect observed was infection, in general mild-moderate that only motivated hospital admission in a patient in treatment with barcitinib due to decompensation of its pathology base. Stresses the development of uncomplicated perianal abscess in 2 patients on treatment with tofacitinib, one of them with perianal fistula known, and a recurrence of submental abscess in a patient with antecedent of repetition abscesses in said location. I only know observed elevated transaminases in a patient undergoing treatment with baricitinib showing in general an optimal hepatic safety profile. No primary cardiovascular events of interest have been recorded, neoplasms or other gastrointestinal events. Everything described, considering the high rate of concomitant treatment with steroids at low doses (93.5%) and up to 80.64% of patients in treatment with at least 1 concomitant DMARD. <h3>References</h3> [1] Caporali R, Zavaglia D : Real-world experience with tofacitinib for treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2018 Aug 29. [2] Fleischmann R, Mysler E, Hall S Et Al.: Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet 2017; 390: 457-68. [3] Smolen JS, Genovese MC, Takeuchi T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment [published online September 15, 2018]. J Rheumatol. <h3>Disclosure of Interests:</h3> Natalia Cid Boza: None declared, ML Velloso Feijoo: None declared, NAHIA PLAZA: None declared, Jose Luis Marenco Speakers bureau: abbie, pfizer, novartis, janmsen