Rheumatology Research Center, Schlosspark-Klinik Charité, University Medicine Berlin, Berlin, Germany.
Celltrion Healthcare Co., Ltd, Incheon, Republic of Korea.
Clin Drug Investig. 2022 Jun;42(6):477-489. doi: 10.1007/s40261-022-01162-6. Epub 2022 Jun 3.
Subcutaneous infliximab recently received approval for the treatment of various immune-mediated inflammatory diseases in Europe, following pivotal clinical trials in patients with rheumatoid arthritis and inflammatory bowel disease. Subcutaneous infliximab demonstrated an improved pharmacokinetic profile compared with intravenous infliximab: the more stable exposure and increased systemic drug concentrations mean it has been cited as a biobetter. Alongside the pharmacokinetic advantages, potential benefits for efficacy, immunogenicity, and health-related quality-of-life outcomes have been suggested with subcutaneous infliximab. During the coronavirus disease 2019 pandemic, the benefits of subcutaneous over intravenous therapies became apparent: switching from intravenous to subcutaneous infliximab reduced the hospital visit-related healthcare resource burden and potential viral transmission. Clinical advantages observed in pivotal trials are also being seen in the real world. Accumulating experience from four European countries (the UK, Spain, France, and Germany) in patients with rheumatic diseases and inflammatory bowel disease supports clinical trial findings that subcutaneous infliximab is well tolerated, increases serum drug concentrations, and offers maintained or improved efficacy outcomes for patients switching from intravenous infliximab. Initial evidence is emerging with subcutaneous infliximab treatment after intravenous infliximab failure. High patient satisfaction and pharmacoeconomic benefits have also been reported with subcutaneous infliximab. Treatments aligned with patient preferences for the flexibility and convenience of at-home subcutaneous administration could boost adherence and treatment outcomes. Altogether, findings suggest that switching from intravenous to subcutaneous infliximab could be advantageous, and healthcare professionals should be prepared to discuss supporting data as part of shared decision making during patient consultations.
皮下注射英夫利昔单抗最近在欧洲获得批准,用于治疗各种免疫介导的炎症性疾病,此前在类风湿关节炎和炎症性肠病患者中进行了关键性临床试验。与静脉注射英夫利昔单抗相比,皮下注射英夫利昔单抗显示出改善的药代动力学特征:更稳定的暴露和增加的全身药物浓度意味着它被认为是一种生物改良药物。除了药代动力学优势外,皮下注射英夫利昔单抗在疗效、免疫原性和健康相关生活质量结果方面也被认为具有潜在益处。在 2019 年冠状病毒病大流行期间,皮下治疗相对于静脉治疗的益处变得明显:从静脉注射转换为皮下注射英夫利昔单抗可降低与医院就诊相关的医疗资源负担和潜在的病毒传播。在关键性试验中观察到的临床优势也在现实世界中得到体现。来自四个欧洲国家(英国、西班牙、法国和德国)的风湿性疾病和炎症性肠病患者的累积经验支持临床试验结果,即皮下注射英夫利昔单抗耐受性良好,可增加血清药物浓度,并为从静脉注射英夫利昔单抗转换的患者提供维持或改善的疗效结果。在静脉注射英夫利昔单抗失败后,皮下注射英夫利昔单抗的初步证据正在出现。皮下注射英夫利昔单抗也报告了患者满意度高和药物经济学效益。与患者对在家中进行皮下给药的灵活性和便利性的偏好相匹配的治疗方法可以提高依从性和治疗结果。总之,研究结果表明,从静脉注射转换为皮下注射英夫利昔单抗可能具有优势,医护人员应准备好讨论支持数据,作为患者咨询过程中共同决策的一部分。