改进注射部位反应从阿达利穆马布转向阿达利穆马布生物类似物LBAL治疗性结肠炎:一个病例报告
Yudai Hirakawa1, Toshihiko Kakiuchi1, Masato Yoshiura1
1Department of Pediatrics, Faculty of Medicine, Saga University, Saga, Japan.
Medicine
|November 4, 2024
概括
一名患有性结肠炎的患者经历了注射部位对阿达利穆马布 (ADA) 的反应. 转换为阿达利穆马布生物类似剂 (LBAL) 解决了这些反应,证明了其作为替代治疗方法的有效性和安全性.
科学领域:
- 免疫学 免疫学 免疫学
- 胃肠病学 胃肠病学
- 药理学 药理学是指药理学的学科.
背景情况:
- 抗瘤亡因子剂阿达利穆马布 (ADA) 治疗炎症性肠道疾病,但由于成本而面临访问限制.
- 生物类药物为原始生物制品提供了类似的替代品,其有效性和安全性的初始数据有限.
研究的目的:
- 评估阿达利穆马布生物仿制剂 (LBAL) 的有效性和安全性,在患有参考产品不良反应的患者中.
- 探索因医疗原因从原始生物转换为生物类似药的潜力.
主要方法:
- 一名15岁的患有类固醇依赖性性结肠炎的患者,耐受维多利祖马布,接受了参考阿达利祖马布 (ADA) 治疗.
- 随着注射部位对ADA参考药物的反应 (发红,胀,) 后,患者被切换为阿达利木马布生物类似物LBAL.
主要成果:
- 患者耐受阿达利穆马布生物仿制LBAL,没有任何局部注射部位反应 (胀,发红,发).
- 胃肠道症状仍然消失,这表明生物类似药治疗的持续有效性.
结论:
- 阿达利穆马布生物仿制LBAL的疗效和安全性与参考ADA相当,为经历不良事件的患者提供了可行的替代方案.
- 由于不良事件而转换为生物类药物需要仔细监测,因为原始药和生物类药物不相同.
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