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

作者：Liu Yang, Zhiwei Zheng, Na Li, Bin Zheng, Maobai Liu, Hongfu Cai · 发表于：Journal of Clinical Pharmacy and Therapeutics · 年份：2022 · DOI：10.1111/jcpt.13799 · 被引用次数：9 · 研究领域：Biosimilars and Bioanalytical Methods、Lymphoma Diagnosis and Treatment、Cancer Immunotherapy and Biomarkers

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.