日本人悪性リンパ腫患者におけるリツキシマブの先行バイオ医薬品とバイオ後続品の有効性・安全性の評価

抄録

Biosimilars are products that are equivalent to original bio-pharmaceuticals. The use of biosimilars increases medical access to useful treatments, improves the quality of treatment, and reduces costs. The inclusion criteria for the rituximab biosimilar clinical trials were limited to patients with follicular lymphoma, and an analysis of the efficacy and safety of this drug in clinical practice was needed. We compared the efficacy and safety of rituximab and the rituximab biosimilar. We reviewed the characteristics of patients who received rituximab or rituximab biosimilar for treating malignant lymphoma from January 2018 to October 2018. To measure the efficacy and safety of each drug, we evaluated the overall response rate and the side effects that correspond to important identified risks, respectively. Of the 71 patients who received chemotherapy during the study period, 29 and 42 patients used rituximab and rituximab biosimilar, respectively. The overall response rate was 78％ in the rituximab group and 86％ in the rituximab biosimilar group (P = 0.37). Adverse events were observed in 93％ and 95％ of the rituximab and rituximab biosimilar groups, respectively, whereas the frequency of infusion-related reaction was 20％ and 24％ in the rituximab and rituximab biosimilar groups, respectively. In the rituximab biosimilar group, one patient died from gastrointestinal perforation. In this study, the efficacy and safety of the treatments for malignant lymphoma using rituximab and rituximab biosimilar were considered equivalent. Since this study was a short-term survey, we will perform further studies on progression-free survival and safety assessment for long-term treatments.