AB0452 Biological therapy adverse events in biobadaguay registry. (12th June 2018) - Franco, M.
Abstract : Background: BIOBADAGUAY is the Paraguayan/Uruguayan registry of adverse events (AE) in patients with inflammatory rheumatic conditions under biologic therapy (BT) Objectives: To determine the frequency and severity of AE in patients under BT from the BIOBADAGUAY registry Methods: Prospective, observational study of undetermined length to verify the efficacy, safety and survival of the BT. The methodology applied is available at https//biobadaguay.ser.es. For the present study epidemiological and clinical variables, BT, type and severity of AE were analysed. The incidence rate (IR) was calculated as the total number of adverse events per 1000 patients/year and the incidence rate ratio (IRR) was analysed using the Poisson regression model. Results: 778 BT were analysed (56.6% adalimumab, 23.7% etanercept, 9.6% tocilizumab, 5.7% rituximab, 3.5%infliximabm, 0.5%golimumab, 0.38%infliximab biosimilar, 0.13% abatacept). In these, 330 AE were observed, 256 (77.6%) mild and 74 (24.4%) severe. The global IR of AE was 143.9 (95% CI, 128.8–160.8) and 32.6 (95% CI, 25.3–40.5), 111.6 (95% CI, 98.4–126.2) for severe and mild respectively. Infection was the most frequent AE in 175 (53.0%) and 39 (22.3%) of them were severe. Infection's IR was 76.3 (95% CI, 65.4–88.5), 59.3 (95% CI, 49.76–70.2) and 17.0 (95% CI, 12.1–23.3) for global, severe and mild respectively. Out of the 39 severe AE, respiratory infections were the most frequent in 43.6% of the cases. 5 tuberculosis, 6 malignancies and 6 deaths were observed. When analysing the IR according to diagnosis, Idiopathic Juvenile Arthritis (JIA) was associated with a higher IR of global AE when comparing to the other diagnosis (IRR=2.3 [95% CI, 1.6–3.4] p=4.27 × 10–6). RA diagnosis was significantly associated with a higher risk of severe AE (IRR=2.20 [95% CI, 1.2–4.1] p=1.17 × 10–2). tocilizumab was significantly associated with a higher incidence of global AE, (IRR=2.69 [95% CI, 1.90–3.82] p=3.13 × 10–8) and severe ones (IRR=3.34 [95% CI, 1.81–6.1] p=1.10 × 10–4). Adalimumab was significantly associated with a lower rate of global AE(IRR=0.6 [95% CI, 0.4–0.8] p=1.86 × 10–4). Conclusions: AE were mild in general and infections were the most frequent. In the present study, it was found that JIA and treatment with tocilizumab presented a higher IRR of AE while RA presented a higher rate of severe AE. Disclosure of Interest: None declared