Pos0084 Safety of Targeted Therapies in Immune Mediated Inflammatory Diseases: Combined Data From Five Countries of Latin America

Background: Biologic and targeted synthetic disease-modifying antirheumatic drugs (ts/bDMARDs) play a pivotal role in the treatment of Immune-mediated inflammatory diseases (IMID). Additionally, in the last few years, biosimilars and generic targeted synthetic (ts) DMARDs have been introduced. Objectives: Determine the frequency and severity of adverse event (AE) of patients under ts/bDMARDs in patients with IMID in four BIOBADA Registries in five Latin American countries. Methods: Data from four BIOBADA Registries from Latin America were collected, including Argentina, Brazil, Mexico, Paraguay, and Uruguay (the last two countries are included at the same registry). For this analysis, those patients with IMID, who had started at least one biological or small molecule drug until October 2023 were included. Results: A total of 12477 patients were included (9170 (73.5%) with ts/bDMARDs and 3307 (26.5%) were controls with conventional disease- modifying drugs, cDMARDs). 76.5% were women, the mean age at treatment initiation was 48.2 ±15.3 years. The most common diagnosis was rheumatoid arthritis with 70,7%, followed by ankylosing spondylitis with 8.4%.19516 treatment cycles were administered. Of the ts/bDMARDs the most frequent were the original TNF inhibitors (anti-TNFo) with 9075 (62,5%), the original Rituximab (RTXo) with 1168 (8%), IL-6 inhibitor with 1198 (8.3%) and the original JAKs inhibitors with 943 (6.5%). A total of 17248 AEs were reported of which 2478 (14.4%) were severe and 145 (0.8%) were mortal (Table 1). 35.9% (7004) of the total number of treatment cycles had at least 1 AE. Infections were the most frequently observed AE with 19.4% (3399), followed by respiratory and thoracic disorders 10.6% (1833), skin disorders 10.4% (1789), among the most frequent. In the multivariate analysis, cycles with IL-6 inhibitors were significantly associated with an increased risk of developing AE (OR= 1.9 IC [95%, 1.6-2.2] p<0.001), as well as with anti-TNFo (OR= 1.5 I [C 95%, 1.4-1.6 ]p<0.001), RTXo (OR= 1.7 [IC 95%, 1.5-2.0] p<0.001) and abatacept (OR= 1.4 [IC 95%, 1.3-1,7] p<0.001) (Figure 1). Also having a longer time of disease evolution at the beginning of the treatment cycle (OR= 1.0 IC 95 [%, 1.01-1.02] p<0.001), arterial hypertension (OR= 1.1 IC [95%, 1.1-1.2] p<0.001) and smoking habit (OR= 1.2 IC [95%, 1.1-1.3] p<0.001) were shown to have the same effect. Conclusion: We describe the real-life safety with targeted therapies in four BIOBADA Registries in five Latin American countries, being comparable to that found in other cohorts REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests: None declared.