Subcutaneous Infliximab, CT-P13 SC: A Profile of Its Use in the EU

医学 英夫利昔单抗 生物仿制药 溃疡性结肠炎 银屑病性关节炎 强直性脊柱炎 类风湿性关节炎 银屑病 炎症性肠病 内科学 疾病 皮肤病科 胃肠病学
作者
Matt Shirley
出处
期刊:Clinical Drug Investigation [Adis, Springer Healthcare]
卷期号:41 (12): 1099-1107 被引量:4
标识
DOI:10.1007/s40261-021-01093-8
摘要

CT-P13 (Remsima®; Inflectra®), a biosimilar of reference infliximab (Remicade®), provides a useful alternative for patients requiring infliximab therapy and, as with other biosimilar agents, has the potential to reduce treatment costs. Furthermore, the availability of CT-P13 in a subcutaneous formulation (CT-P13 SC), with the possibility (after adequate training) of self-administration at home, has the potential to both improve patient convenience and reduce the burden on the healthcare system. The initial approval of CT-P13 SC, for use in the treatment of rheumatoid arthritis in adults, was based on the findings of a randomised, double-blind phase I/III trial which demonstrated the non-inferiority of CT-P13 SC administered once every 2 weeks to intravenous CT-P13 (CT-P13 IV) administered once every 8 weeks in reducing disease activity in patients with active rheumatoid arthritis. Subsequently, based on pharmacokinetic data in patients with inflammatory bowel disease, CT-P13 SC has also been approved in the EU for use in the treatment of Crohn's disease, ulcerative colitis and, by extrapolation, ankylosing spondylitis, psoriatic arthritis and psoriasis, in adults.Biosimilars are biological medical agents that are designed to closely replicate a reference medicine while potentially reducing treatment costs. CT-P13 (Remsima®; Inflectra®) in the intravenous formulation (CT-P13 IV) is a biosimilar of reference infliximab (Remicade®) and is approved in the EU for use in the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis in adults and Crohn’s disease and ulcerative colitis in children aged ≥ 6 years. Unlike reference infliximab, CT-P13 is now also available in a formulation that can be administered by subcutaneous injection (CT-P13 SC). CT-P13 SC is approved for use in adults (only) in all indications as for CT-P13 IV, with approval based on clinical trials which showed that the subcutaneous formulation has non-inferior efficacy to CT-P13 IV in the treatment of rheumatoid arthritis and has non-inferior pharmacokinetics to the intravenous formulation in patients with inflammatory bowel disease. In conclusion, CT-P13 SC provides a useful alternative for adult patients requiring infliximab therapy and, with the possibility of self-administration at home, has the potential both to improve patient convenience and to reduce the burden on the healthcare system.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
anna发布了新的文献求助10
1秒前
CodeCraft应助Lu采纳,获得10
2秒前
2秒前
2秒前
Bressanone发布了新的文献求助10
3秒前
妙蛙完成签到,获得积分10
4秒前
5秒前
111111111发布了新的文献求助10
6秒前
妙蛙发布了新的文献求助10
8秒前
9秒前
爱笑紫菜发布了新的文献求助30
11秒前
11秒前
12秒前
李爱国应助111111111采纳,获得10
12秒前
tay发布了新的文献求助10
13秒前
科研通AI5应助ffff采纳,获得10
14秒前
过氧化氢发布了新的文献求助30
16秒前
感动黄豆发布了新的文献求助10
17秒前
钱宇成发布了新的文献求助10
17秒前
YJ888发布了新的文献求助10
17秒前
vincen91完成签到,获得积分10
21秒前
Leach完成签到 ,获得积分10
22秒前
长乐完成签到,获得积分10
23秒前
FashionBoy应助院士人启动采纳,获得10
27秒前
28秒前
28秒前
AptRank完成签到,获得积分10
29秒前
量子星尘发布了新的文献求助10
29秒前
焦糖布丁的滋味完成签到,获得积分10
29秒前
30秒前
隐形的觅波完成签到 ,获得积分10
31秒前
儒雅南风完成签到 ,获得积分10
32秒前
小马甲应助科研通管家采纳,获得10
33秒前
打打应助科研通管家采纳,获得10
33秒前
科研通AI5应助科研通管家采纳,获得10
33秒前
Orange应助科研通管家采纳,获得10
33秒前
Bio应助科研通管家采纳,获得30
33秒前
慕青应助科研通管家采纳,获得10
33秒前
33秒前
在水一方应助科研通管家采纳,获得10
33秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989115
求助须知:如何正确求助?哪些是违规求助? 3531367
关于积分的说明 11253688
捐赠科研通 3269986
什么是DOI,文献DOI怎么找? 1804868
邀请新用户注册赠送积分活动 882078
科研通“疑难数据库(出版商)”最低求助积分说明 809105