Department of Pharmaceutical Outcomes and Policy, College of Pharmacy.
Center for Drug Evaluation and Safety, University of Florida, Gainesville.
J Manag Care Spec Pharm. 2023 Feb;29(2):119-127. doi: 10.18553/jmcp.2023.29.2.119.
Real-world evidence on the comparative effectiveness of pegfilgrastim biosimilars compared with the originator product is limited. To compare the risk of febrile neutropenia (FN) among users of pegfilgrastim biosimilars (pegfilgrastim-jmdb and pegfilgrastim-cbqv) and the originator product. A retrospective cohort study was conducted using 2019 IBM MarketScan databases to assess comparative effectiveness of pegfilgrastim originator and biosimilars for prevention of FN among patients receiving myelosuppressive chemotherapy. Patients with cancer, including breast, lung, colorectal, esophageal and gastric, pancreatic, prostate, ovarian, and non-Hodgkin lymphomas, initiating myelosuppressive chemotherapy courses were selected. We further selected patients who used pegfilgrastim originator and biosimilars within 3 days of chemotherapy completion. FN-associated hospitalizations were measured by diagnosis codes. After 1:1 propensity score matching, we used equivalence (with a margin of 6%) hypothesis tests to compare FN-related hospitalization risk in the first cycle and across all cycles between biosimilars and originator users. A total of 2,045 patients were included, of which 445 (21.8%) used pegfilgrastim-jmdb, 636 (31.1%) used pegfilgrastim-cbqv, and 964 (47.1%) used pegfilgrastim originator. After matching, 13 out of 445 originator users and 17 out of 445 pegfilgrastim-jmdb users developed FN after the first chemotherapy cycle (risk difference was 0.9%; < 0.001 for equivalence test indicating statistical equivalence). After matching, 14 out of 633 originator users and 16 out of 633 pegfilgrastim-cbqv users developed FN (risk difference was 0.32%; < 0.001 for equivalence test indicating statistical equivalence). Results across all cycles (including the first cycle) were consistent with that in the first cycle. In this real-world study of patients with cancer receiving myelosuppressive chemotherapy, there was no difference in FN risk between patients receiving pegfilgrastim originator and biosimilars in the first cycle and across all cycles. These results add further to the current evidence on pegfilgrastim biosimilars and support wider adoption of pegfilgrastim biosimilars among payers, providers, and patients. Future studies assessing the tolerability, side effects, and other safety issues of pegfilgrastim biosimilars are needed.
在现实世界中，关于培非格司亭生物类似药与原研产品的比较疗效的证据有限。本研究旨在比较培非格司亭生物类似药（培非格司亭-jmdb 和培非格司亭-cbqv）和原研产品在使用中的发热性中性粒细胞减少症（FN）风险。
采用 2019 年 IBM MarketScan 数据库进行回顾性队列研究，评估了培非格司亭原研产品和生物类似药在接受骨髓抑制性化疗的患者中预防 FN 的比较疗效。纳入了患有癌症（包括乳腺癌、肺癌、结直肠癌、食管癌和胃癌、胰腺癌、前列腺癌、卵巢癌和非霍奇金淋巴瘤）并开始接受骨髓抑制性化疗的患者。我们进一步选择了在化疗完成后 3 天内使用培非格司亭原研产品和生物类似药的患者。FN 相关住院治疗由诊断代码测量。在进行 1:1 倾向评分匹配后，我们使用等效性（边际为 6%）假设检验比较了生物类似药和原研产品使用者在第一个周期和所有周期中 FN 相关住院治疗风险。
共纳入 2045 例患者，其中 445 例（21.8%）使用培非格司亭-jmdb，636 例（31.1%）使用培非格司亭-cbqv，964 例（47.1%）使用培非格司亭原研产品。匹配后，在第一个化疗周期后，有 13 例（13/445）原研产品使用者和 17 例（17/445）培非格司亭-jmdb 使用者发生 FN（风险差异为 0.9%；等效性检验<0.001，表明具有统计学等效性）。匹配后，在第一个化疗周期后，有 14 例（14/633）原研产品使用者和 16 例（16/633）培非格司亭-cbqv 使用者发生 FN（风险差异为 0.32%；等效性检验<0.001，表明具有统计学等效性）。所有周期（包括第一个周期）的结果与第一个周期一致。
在这项接受骨髓抑制性化疗的癌症患者的真实世界研究中，在第一个周期和所有周期中，接受培非格司亭原研产品和生物类似药的患者 FN 风险无差异。这些结果进一步增加了关于培非格司亭生物类似药的现有证据，并支持支付者、提供者和患者更广泛地采用培非格司亭生物类似药。需要进一步研究评估培非格司亭生物类似药的耐受性、副作用和其他安全性问题。
J Manag Care Spec Pharm. 2025-7
J Manag Care Spec Pharm. 2021-9
JAMA Oncol. 2018-12-1
Zotero 插件