AB1053 Adverse effects and their consequences in patients with chronic inflammatory arthropathies in treatment with biological therapy
Authors: N. Martinez-Lopez De Castro, A. Martín-Vila, M. Alvarez-Payero, M. Samartín-Ucha, G. Piñeiro-Corrales, J.M. Pego-Reigosa
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> The introduction of biological therapies (BT) for the treatment of chronic inflammatory arthropathies (CIA) has improved the prognosis of these diseases and the quality of life of patients. However, the safety of these drugs in the long term continues to be an aspect of interest. <h3>Objectives</h3> This study aims to review the safety of BT in patients with CIA and the consequences of these adverse effects for patients and the health system under daily clinical practice conditions. <h3>Methods</h3> A descriptive, observational and retrospective study was performed. All patients with CIA: rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) who started BT (abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, tocilizumab and ustekinumab) from January 2009 to January 2017 in the Rheumatology Department of the Sanitary Area of Vigo (Spain) were included. Demographic variables (age, sex), variables related to CIA and their comorbidities: clinical and analytical data (CRP, ESR, haemoglobin, DAS and BASDAI) and years of disease evolution and variables about BT: concomitant treatment (glucocorticoids, methotrexate and leflunomide), persistence, adherence and number of lines were collected. Variables about the adverse effects (AEs) of BT: type and clinical consequence, requirement for additional visits to the Rheumatology clinic, visits to the Emergency Department or need for hospital admission was also collected. <h3>Results</h3> Three hundred sixty-two patients and 478 BT lines (250 lines in patients with RA, 119 with AS and 109 with PsA) were analysed (mean ±SD of BT lines: 1.7±1.1 per patient). In 301 (63.0%) BT lines, some AEs occurred. In total, 683 AEs were detected (0.57 AEs per patient and year of treatment). The most frequent types of AEs were: bacterial infection (0.39 events per year of BT), viral infections (0.04 events per year of BT), fungal infections (0.04 events per year of BT), reactions related to the administration of BT (0.03 events per year of BT) and cardiovascular alterations (0.02 events per year of BT). Certolizumab and abatacept were the drugs that were more associated with bacterial infections: 0.82 and 0.69 per year of BT, respectively. Infliximab was the BT that was less associated with bacterial infections: 0.24 per year of BT. There were 7 deaths in probable relation with the AEs (4 bacterial infections, 1 cardiovascular event and 2 solid tumours). The AEs caused 71 hospital admissions (668 days of hospital stay), 113 hospital emergency room visits and 42 urgent visits to the Rheumatology Department. Sixty percent of the AE were managed from Primary Care without having to go to the hospital. The AEs caused a definitive interruption of BT in 51 episodes and a switch to a different BT in 52 episodes. <h3>Conclusions</h3> In our setting, patients with CIA on BT have an incidence of 0.57 AE per patient and year of BT. Infection (particularly bacterial) is the most frequent AE. Although more than 50% of these AEs are managed from Primary Care, they imply a high consumption of hospital resources. <h3>Disclosure of Interest</h3> None declared