Experience of Mass Switching to Biosimilar Drugs in Patients with Immune-Mediated Inflammatory Rheumatic Diseases: Effectiveness and Safety, Intercambiosim Project

Abstract

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Objective: To evaluate the efficacy and safety of biosimilars in the treatment of immune-mediated inflammatory rheumatic diseases. Materials and methods: Retrospective observational and descriptive study of patients with immune mediated inflammatory rheumatic disease. Patients who had switched from a biological drug to biosimilar anti TNF and rituximab, for at least 24 weeks were included. Statistical tests such as the chi-square and Mann-Whitney U tests were used to assess the independence of categorical and numerical variables, respectively. Results: 364 patients were selected. 29.95% of patients discontinued treatment with the bio similar: inefficacy in 87 patients (52 with primary failure and 35 with secondary failure), adverse effects in 18 patients and 4 patients discontinued it by their own decision. The mean disease activity at the beginning of the medication switch was 1.73 (± 0.93) in ASDAS, 8.73 (± 12.20) in DAPSA, and 2.60 (± 1.20) in DAS28, while at 24 weeks after the switch, the mean activity was 1.79 in ASDAS, 8.39 in DAPSA, and 2.62 in DAS28. Discussion: It was observed that 29.95% of the participants had to discontinue the use of the biosimilar drug, mainly due to its lack of efficacy, which exceeds the average reported in the current literature. Only 18 patients experienced some type of adverse effect. Conclusion: Our data obtained in a real-life setting suggest that biosimilar drugs can be considered an effective and safe option in the treatment of inflammatory rheumatic diseases. However, it is important to note that there is a significant rate of discontinuation of biosimilar use.