AB0428 Preferences in the use of biologic drugs and adverse events in patients with rheumatic disease from a national biologics registry in mÉxico
Authors: D. Xibillé, S. Carrillo, S. Sicsik, F. Irazoque, A. Ramos, S. Durán, M. Saavedra, L. Barile, G. Olvera
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> National registries of biologic drugs have proven to be valuable tools in following patients with rheumatic disease and some outcomes in real-life situations. <h3>Objectives</h3> The objective of this study was to describe Mexican Rheumatologists' preferences when treating patients with biologic drugs and to analyse factors associated to the use of this therapy. <h3>Methods</h3> Data from patients undergoing biologic treatment in México is gathered into the BIOBADAMEX online database, which is part of the BIOBADAMERICA initiative and based on the BIOBADASER Phase 3 platform. Phase 3 in México started gathering patient data in <sup>April 2016</sup> and to date has information on 216 patients. The database collects information such as gender, age, diagnosis, disease duration, biologic treatment, DMARD treatment, concomitant therapy, motives for discontinuation of biologics, comorbidities, adverse event (AE) severity, infection site and germ involved. Descriptive statistics were applied on the data collected from April 2016 to January 2018. <h3>Results</h3> We analysed data on the use of 267 biologic treatments in 216 patients. Most of them receive biologic therapy through socialised medical insurance programs which may have led to bias. 89.1% of patients were female, mean age 49±15.2 (4–85) years, 42.5% belonging to the &lt;50 group. 69.9% of patients in the registry have RA, 12.5% AS and 5.5% PsA. Mean disease duration is 11±8.9 (0–58) years. The most commonly used biologic overall is Abatacept (15.3%), followed by Adalimumab (13.8%), Tocilizumab (11.2%), Certolizumab (10.1%), Golimumab (8.6%), Rituximab (8.2%), Etanercept biosimilar (7.4%), Etanercept (6.3%), Infliximab (4.1%) and Benlystia (1.1%). All others, including JAK inhibitors, are used in &lt;1% of patients. The preference for first biologic drug was Etanercept (32.4%), followed by Adalimumab (12%), Infliximab (8.3%), Rituximab and Tocilizumab (5.5% each) and Abatacept (2.7%). Most treatments were stopped due to lack of efficacy (60.4%), disease remission (7.4%), other causes (20.1%), AE (4.4%), with the rest of the causes each affecting &lt;5% of patients. The most commonly used DMARD were Methotrexate (49.8%), steroids (33.3%) and leflunomide (23.2%). Comorbidities were present in 87 patients (40%), the most common being Hypertension (13.4%), Diabetes (7.8%) and Dyslipidemia (6.9%). Non-lymphoma neoplasms were reported in 1.3%. 25% of AE were considered serious but most (70%) were mild. Only 6 patients reported infections with the most common sites being the skin (33.3%), urinary tract (16.6%) and middle-ear (16.6%). The causal germ was often undetermined (60%). <h3>Conclusions</h3> When using biologic drugs, TNF inhibitors are the most commonly used initial mechanism of action for the treatment of rheumatic diseases in the BIOBADAMEX registry. Upon treatment failure, patients undergo a switch to another mechanism of action, mainly using Abatacept. Adverse events and infections related to the use of biologics are infrequent, but 40% of patients present chronic comorbidities. <h3>Disclosure of Interest</h3> D. Xibillé Speakers bureau: Abbvie, Pfizer, BMS, S. Carrillo Speakers bureau: Abbvie, Pfizer, BMS, Roche, S. Sicsik Speakers bureau: Roche, Pfizer, BMS, F. Irazoque Speakers bureau: Abbvie, Pfizer, BMS, Roche, A. Ramos: None declared, S. Durán: None declared, M. Saavedra: None declared, L. Barile Speakers bureau: Abbvie, Pfizer, BMS, Roche, G. Olvera: None declared