Incidence of hypertension and proteinuria in patients treated with bevacizumab versus bevacizumab biosimilar

Abstract

83 Background: Biosimilar products are proven to have no clinically meaningful differences in terms of safety and effectiveness with the reference product, however, to our knowledge, there is limited comparative analysis regarding adverse events for the bevacizumab biosimilars and the reference product. The purpose of this study was to evaluate the incidence of hypertension and proteinuria in patients treated with reference versus biosimilar bevacizumab to potentially streamline clinical management. Methods: A retrospective study was conducted with data consisting of gastrointestinal cancer patients who initiated either reference bevacizumab or biosimilar bevacizumab between January 2019 and July 2020 at Roswell Park Comprehensive Cancer Center. For the primary composite endpoint, Electronic Health Records were searched for the presence or absence of hypertension and proteinuria, as well as time to event analysis. In patients treated with bevacizumab biosimilar, demographics, hypertension and proteinuria related risk factors, bevacizumab containing chemotherapy regimen, and bevacizumab dosing were also identified to assess the risk association with hypertension and proteinuria. Results: 75 patients were included with 42 patients received bevacizumab and 33 patients received bevacizumab biosimilar. Hypertension occurred in 52.4% of reference bevacizumab group versus 36.4% of bevacizumab biosimilar group. Median time to hypertension is 84 days (bevacizumab) versus 24.5 days (bevacizumab biosimilar) following the first treatment (p= 0.0064). Proteinuria developed in 35.7% of reference bevacizumab patients compared to 30% of bevacizumab biosimilar patients. Median onset of proteinuria was 213 days (bevacizumab) versus 53.5 days (bevacizumab biosimilar) (p= 0.0022). In patients with a history of hypertension or underlying renal dysfunction, there was an increased risk of further hypertension and proteinuria, respectively. Conclusions: Higher risk of hypertension and proteinuria was associated with the bevacizumab reference product group, although not statistically significant. A shorter onset of hypertension and proteinuria was associated with the bevacizumab biosimilar group. Our results need further validation in larger cohorts, especially due to the more recent implementation of bevacizumab biosimilar products. [Table: see text]