What is known and objective: 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.
Methods: 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.
Results and discussion: 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.
What is new and conclusion: 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.
Keywords: biosimilar; efficacy; follicular lymphoma; meta-analysis; rituximab; safety.
© 2022 John Wiley & Sons Ltd.