Efficacy and safety of rituximab biosimilars or reference product as first-line treatment in patients with low-tumour-burden follicular lymphoma: A systematic review and meta-analysis.

Abstract

The role of rituximab in the first-line treatment of low-tumour-burden follicular lymphoma (LTB-FL) has been supported by a large number of data. However, whether rituximab biosimilars have the same efficacy and safety as the reference drug (MabThera) is still controversial. Electronic databases and the ClinicalTrail.gov website were extensively searched using relevant search criteria. The risk of bias of the included studies was assessed using the RoB 2 assessment scale, and the RevMan 5.4 statistical software was used for meta-analysis. A total of 1223 patients were included in four clinical randomized controlled trials. There was no statistical difference in efficacy between biosimilars and MabThera groups (the objective response rate: RR=1.00, 95% CI: 0.93-1.08, p=0.92; the progression-free survival: RR=1.04, 95% CI: 0.96-1.12, p=0.30; the overall survival: RR=1.00, 95% CI: 0.98-1.03, p=0.76; the serious adverse events: RR=1.15, 95% CI: 0.69-1.89, p=0.59; the infusion-related reaction: RR=0.91, 95% CI: 0.77-1.09, p=0.32). In terms of safety, there was also no significant difference between two groups. Our study concluded that the efficacy and safety of rituximab biosimilars in the treatment of LTB-FL are highly similar to those of the original drug.