Iannone Florenzo, Conti Fabrizio, Cauli Alberto, Farina Alberto, Caporali Roberto
Rheumatology Unit, Department of Emergency and Organ Transplantation, Università Degli Studi Di Bari Aldo Moro, Bari, Italy.
Rheumatology Unit, Department of Clinical, Internal, Anesthetic and Cardiovascular Sciences, Sapienza Università di Roma, Rome, Italy.
J Inflamm Res. 2022 Jun 1;15:3259-3267. doi: 10.2147/JIR.S240593. eCollection 2022.
The first subcutaneous (SC) formulation of infliximab CT-P13 has been authorized for the treatment of rheumatoid arthritis (RA) in Europe in 2019. Later, in 2020, approved indications were extended also to ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease (CD) and ulcerative colitis (UC). The present review provides summary of the key features of SC infliximab, with particular focus on pharmacokinetic profile, clinical development program in comparison with the intravenous (IV) formulation, and the latest evidence in the literature. We conclude that SC infliximab represents a new and promising approach in the treatment of patients with RA, offering an optimized clinical profile and a more practical option in comparison to the IV formulation. Nevertheless, SC formulation can improve the use of national health systems resources (e.g., through the time of healthcare workers not having to supervise infusions) and facilitate social distancing measures during the COVID-19 pandemic, as the patient can self-inject the medicine at home without going to the hospital. The limitations of the SC infliximab are mainly due to the limited experience of use in clinical practice and the absence of long-term drug retention data.
英夫利昔单抗CT-P13的首个皮下(SC)制剂于2019年在欧洲获批用于治疗类风湿性关节炎(RA)。后来,在2020年,其获批适应症又扩展至强直性脊柱炎、银屑病关节炎、银屑病、克罗恩病(CD)和溃疡性结肠炎(UC)。本综述总结了皮下注射英夫利昔单抗的关键特性,特别关注其药代动力学特征、与静脉注射(IV)制剂相比的临床开发项目以及文献中的最新证据。我们得出结论,皮下注射英夫利昔单抗是治疗类风湿性关节炎患者的一种新的且有前景的方法,与静脉注射制剂相比,它具有优化的临床特征且是一种更实用的选择。尽管如此,皮下注射制剂可以改善国家卫生系统资源的利用(例如,通过减少医护人员监督输液的时间),并在2019冠状病毒病大流行期间便于采取社交距离措施,因为患者可以在家自行注射药物而无需前往医院。皮下注射英夫利昔单抗的局限性主要是由于临床实践中的使用经验有限以及缺乏长期药物留存数据。