Kashima Shin, Sawada Koji, Moriichi Kentaro, Fujiya Mikihiro
Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, 2-1 Midorigaoka-Higashi, Asahikawa 078-8510, Hokkaido, Japan.
Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.
Ther Adv Drug Saf. 2022 May 24;13:20420986221100118. doi: 10.1177/20420986221100118. eCollection 2022.
Inflammatory bowel diseases (IBDs) are chronic immune disorders of unclear etiology. Tumor necrosis factor (TNF) inhibitors are effective for IBD treatment and are cost-effective because they reduce hospital admissions and are associated with fewer surgery requirements and a better quality of life in IBD patients. A large number of clinical trials of infliximab biosimilar (CT-P13) have suggested that the administration of biosimilars provides high efficacy and safety similar to that of the originators, with a lower cost, so switching from the original to a biosimilar is considered an acceptable treatment. While several abnormalities of blood examination have been observed in patients with CT-P13 administration, no cases of drug-induced liver injury (DILI) caused by CT-P13 has been reported. A 23-year-old woman had been diagnosed with Crohn's disease and was treated with original infliximab (O-IFX) for 9 years. She developed severe jaundice 1 month after switching from O-IFX to CT-P13. Serologic tests of autoimmune and hepatitis viruses were negative, and ultrasonography, computed tomography, and magnetic resonance cholangiopancreatography revealed no abnormalities. A liver biopsy showed prominent pericentral canalicular cholestasis, without features of steatosis or sclerosing cholangitis, which was consistent with drug-induced cholestasis. The cholestasis improved 10 weeks after the discontinuation of CT-P13, and no DILI redeveloped even after re-switching from CT-P13 to O-IFX. This is the first report of DILI due to switching from O-IFX to CT-P13. While the efficacy and safety of CT-P13 are considered equal to those of O-IFX, clinicians need to be alert for certain severe DILIs when switching from O-IFX to CT-P13 with careful monitoring and appropriate treatment.
Inflammatory bowel disease (IBD) is characterized by chronic inflammation of the entire gastrointestinal tract, although its etiology has largely been unclear. Tumor necrosis factor (TNF) inhibitors are effective for IBD treatment and are cost-effective because they reduce hospital admissions and are associated with fewer surgery requirements and a better quality of life in IBD patients. A biological medicinal product that contains a version of the active substance of an already authorized biological medicinal product. Biosimilars of TNF inhibitors, such as CT-P13, are thought to possess equal efficacy and safety to the original with a lower cost, so switching from the original to a biosimilar considered an acceptable treatment. While several serious adverse reactions of TNF inhibitors have been reported, drug-induced liver injury (DILI) is uncommon, and liver dysfunction due to the administration of CT-P13 has not been reported in IBD patients. We herein report the first case of DILI due to CT-P13 after switching from original infliximab (O-IFX) in a patient with Crohn's disease. While the efficacy and safety of CT-P13 are considered equal to those of O-IFX, clinicians need to be alert for certain severe DILIs when switching from O-IFX to CT-P13 with careful monitoring and appropriate treatment.
炎症性肠病（IBD）是病因不明的慢性免疫紊乱疾病。肿瘤坏死因子（TNF）抑制剂对IBD治疗有效且具有成本效益，因为它们可减少住院次数，降低IBD患者的手术需求，并改善生活质量。大量英夫利昔单抗生物类似药（CT-P13）的临床试验表明，使用生物类似药具有与原研药相似的高疗效和安全性，且成本更低，因此从原研药转换为生物类似药被认为是一种可接受的治疗方式。虽然在使用CT-P13的患者中观察到了一些血液检查异常，但尚未有CT-P13导致药物性肝损伤（DILI）的病例报告。一名23岁女性被诊断为克罗恩病，使用原研英夫利昔单抗（O-IFX）治疗9年。从O-IFX转换为CT-P13 1个月后，她出现了严重黄疸。自身免疫和肝炎病毒的血清学检查均为阴性，超声、计算机断层扫描和磁共振胰胆管造影均未发现异常。肝脏活检显示中央静脉周围胆小管胆汁淤积明显，无脂肪变性或硬化性胆管炎特征，符合药物性胆汁淤积。停用CT-P13 10周后胆汁淤积改善，即使从CT-P13再次转换回O-IFX，也未再次发生DILI。这是首例因从O-IFX转换为CT-P13导致DILI的报告。虽然CT-P13的疗效和安全性被认为与O-IFX相当，但临床医生在从O-IFX转换为CT-P13时需要警惕某些严重的DILI，要仔细监测并给予适当治疗。
炎症性肠病（IBD）的特征是整个胃肠道的慢性炎症，但其病因在很大程度上尚不清楚。肿瘤坏死因子（TNF）抑制剂对IBD治疗有效且具有成本效益，因为它们可减少住院次数，降低IBD患者的手术需求，并改善生活质量。生物制品是一种含有已获授权生物制品活性物质版本的药品。TNF抑制剂的生物类似药，如CT-P13，被认为具有与原研药同等的疗效和安全性且成本更低，因此从原研药转换为生物类似药被认为是一种可接受的治疗方式。虽然已经报告了TNF抑制剂的几种严重不良反应，但药物性肝损伤（DILI）并不常见，IBD患者中尚未有因使用CT-P13导致肝功能障碍的报告。我们在此报告了首例克罗恩病患者从原研英夫利昔单抗（O-IFX）转换为CT-P13后发生DILI的病例。虽然CT-P13的疗效和安全性被认为与O-IFX相当，但临床医生在从O-IFX转换为CT-P13时需要警惕某些严重的DILI，要仔细监测并给予适当治疗。
