Cutroneo Paola M, Isgrò Valentina, Russo Alessandra, Ientile Valentina, Sottosanti Laura, Pimpinella Giuseppe, Conforti Anita, Moretti Ugo, Caputi Achille P, Trifirò Gianluca
Department of Clinical and Experimental Medicine, Unit of Clinical Pharmacology, University of Messina, Torre Biologica, Policlinico Universitario, Via Consolare Valeria, Gazzi, 98125, Messina, Italy,
Drug Saf. 2014 Nov;37(11):961-70. doi: 10.1007/s40264-014-0224-1.
Biologicals are important treatment options for various chronic diseases. After the introduction of the first biosimilars, animated debate arose in the scientific community about the actual benefit-risk profile of these drugs. In this context, a comparative safety evaluation of biologicals and biosimilars in clinical practice is warranted.
We identified all suspected adverse drug reactions (ADRs) concerning biological/biosimilars (excluding vaccines, toxins, blood derivatives, and radio-pharmaceuticals), and further classified them into mechanistic classes. We described the frequency of biological/biosimilar class- and compound-specific ADRs by system organ class (SOC) and type of reporter. We also separately explored the traceability of biologicals and biosimilar-related ADR reports.
Overall 171,201 ADR reports were collected during the observation period; 9,601 (5.6 %) of these concerned biologicals. Biological-related reports were mainly issued by hospital-based physicians (78.7 %). Most of these reports involved monoclonal antibodies and fusion proteins (66.3 %). Reported ADRs were mainly 'skin and subcutaneous tissue disorders' (21 %), 'general and administration site disorders' (17 %), and 'gastrointestinal disorders' (13.6 %). In terms of traceability, 94.8 % of biological-related reports included an identifiable product name, whilst only 8.6 % indicated the corresponding batch number. Regarding biosimilars, 298 reports were identified, with a low proportion indicating drug ineffectiveness (10.1 %).
Most ADRs attributed to biologicals are 'skin and subcutaneous tissue disorders'. Anticancer monoclonal antibodies are most frequently associated with ADRs. A low proportion of ADR reports concern biosimilars.
生物制品是多种慢性病的重要治疗选择。在首批生物类似药上市后，科学界就这些药物的实际获益 - 风险状况展开了激烈辩论。在此背景下，有必要在临床实践中对生物制品和生物类似药进行比较安全性评估。
我们识别了所有与生物制品/生物类似药（不包括疫苗、毒素、血液制品和放射性药物）相关的疑似药物不良反应（ADR），并进一步将它们分类为机制类别。我们按系统器官类别（SOC）和报告者类型描述了生物制品/生物类似药类别及化合物特异性ADR的发生频率。我们还分别探讨了生物制品和生物类似药相关ADR报告的可追溯性。
在观察期内共收集到171,201份ADR报告；其中9,601份（5.6%）与生物制品有关。与生物制品相关的报告主要由医院医生出具（78.7%）。这些报告大多涉及单克隆抗体和融合蛋白（66.3%）。报告的ADR主要为“皮肤和皮下组织疾病”（21%）、“全身及给药部位疾病”（17%）和“胃肠道疾病”（13.6%）。在可追溯性方面，94.8%的生物制品相关报告包含可识别的产品名称，而只有8.6%标明了相应的批次号。关于生物类似药，识别出298份报告，其中表明药物无效的比例较低（10.1%）。
大多数归因于生物制品的ADR为“皮肤和皮下组织疾病”。抗癌单克隆抗体与ADR的关联最为频繁。涉及生物类似药的ADR报告比例较低。
