POS0478 THE EFFECT OF CORTICOSTEROIDS ON THE RISK OF SERIOUS ADVERSE EVENTS IN RHEUMATOID ARTHRITIS: A SIMULATING A RANDOMIZED CONTROLLED TRIAL USING DATA FROM THE BIOBADABRASIL COHORT

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Background: Corticosteroids have been associated with higher risk of adverse outcomes in rheumatoid arthritis (RA) patients in several previous cohort studies [1, 3]. Few of these studies evaluated the effect of corticosteroids on the risk of total serious adverse events or total severe outcomes [1, 2]. However, randomized controlled trials have failed to show increased risk of serious adverse events (SAEs) with the use of corticosteroids in RA [4]. We are not aware of any previous studies evaluating the effects of corticosteroids on the overall safety of treatment in our specific setting. Objectives: To evaluate the risk of total SAEs related to the use of corticosteroids in Brazilian rheumatoid arthritis (RA) patients, simulating the conditions of a randomized controlled trial (RCT). Methods: BiobadaBrasil is a multicentric registry-based cohort study of Brazilian patients with rheumatic diseases starting a new conventional synthetic (cs-) disease modifying anti-rheumatic drug (DMARD), or their first biologic DMARD (b-DMARD)/Janus kinase inhibitor. The present analysis includes RA patients (recruited from Jan 2009 to Oct 2019) followed-up over one or multiple (up to six) courses therapy (latest date of follow-up, Nov 19, 2019). A treatment course is defined as a period during which the medication scheme does not change, except for dose adjustments. The primary outcome was the incidence of SAEs of any type. A SAE was defined as a condition that causes death or is life threatening, leads to inpatient hospitalization or prolongation of an existing one, or causes important or persistent disability or a congenital abnormality/birth defect; pregnancy was included among SAEs. The secondary outcomes were the incidence of adverse events (AEs) of any type, fatal AEs, total and serious infections, total and serious glycemic control related AEs, total and serious cardiovascular AEs, treatment interruption for any reason (except remission or pregnancy), interruption due to adverse events, and interruption of therapy due to inefficacy. Propensity scores for the use of corticosteroids were generated using logistic regression, including as independent variables all available clinical and demographic features of the patients. We then used inverse probability of treatment weighting (IPTW), which simulates the conditions of a RCT, to calculate the weight of each case. Weights were truncated at the 1st and 99th percentiles to reduce the influence of outliers in the results. After that, we used weighted negative binomial regression models with generalized estimating equations (considering that patients could have up to six courses of treatment) to calculate the propensity score adjusted incidence rate ratios (aIRRs). Analyses were performed using SPSS for Windows 20.0. Results: In total, 1671 RA patients (2891 treatment courses, 2335 of these on b-DMARDs or Janus kinase inhibitors), making-up 8944 patient-years [PY] of follow-up, were enrolled. Corticosteroid were used in 76.5% of treatment courses. IPTW produced pseudo samples of treatment courses (divided according use or not of corticosteroids) with good comparability, with maximal standardized differences of 0.08 in covariates. The overall incidence of SAE was 8.4/100 PY. There was a significant difference in the risk of SAEs (the primary outcome) with the use of corticosteroids (aIRR=1.34, 95% CI: 1.03−1.75, P=0.031). There was also increased risk of total AEs (1.20, 1.05−1.36, P=0.009), total (1.87, 1.15−3.05, P=0.012) and serious cardiovascular (2.43, 1.20−4.94, P=0.014) events, and treatment interruption due to any cause (1.25, 1.09−1.43, P=0.001; see the Figure 1) with corticosteroids. The risk of fatal AEs, total and serious infections, total and serious glycemic control related AEs, interruption due to AEs and due to inefficacy were not significantly increased with use of corticosteroids (Figure 1). Figure 1 Conclusion: In the present study, simulating the conditions of a RCT and performed in a large sample of Brazilian patients with RA on treatment with cs- and b-DMARDs, we observed a higher risk of SAEs and cardiovascular AEs with the use of corticosteroids. Treatment interruption was also more frequent with the use of corticosteroids. REFERENCES: [1] Roubille C, et al. Rheumatology (Oxford) 2021;60(8):3738-3746. [2] Saag KG, et al. Am J Med 1994;96(2):115-23. [3] Wilson JC, et al. Arthritis Care Res (Hoboken) 2019;71(4):498-511. [4] Burmester GR, et al. Lancet 2020;396(10246):267-276. Acknowledgements: NIL . Disclosure of Interests: None declared . © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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