A pharmacokinetic evaluation of the rituximab biosimilar CT-P10 in the treatment of rheumatoid arthritis

  • Yoo, Dae Hyun
  • Suh, Chang-Hee
  • Shim, Seung Cheol
  • Lee, Sang Joon
  • Kim, Sung Hyun
  • 외 1명
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초록

Introduction CT-P10 is the first biosimilar of rituximab (RTX) for the treatment of rheumatoid arthritis (RA). The application of valuable biosimilar for the treatment of RA may decrease economic burden of society, and disease activity of RA. Thus, it is worthwhile to identify the economic advantage and further requirement for the proper use of CT-P10 in real world. Areas covered Literature searching was performed to identify suitable references written in English for this review article. Rituximab, biosimilar, CT-P10, and rheumatoid arthritis were used as keywords. Current state of RA treatment, position of RTX in the recommendations for the treatment of RA, current status of RTX biosimilar development were assessed before evaluating CT-P10 itself. Physicochemical property, pharmacokinetic profile through phase I to phase III studies, pharmacodynamics, toxicology data, clinical efficacy, and safety were reviewed Expert opinion As the first biosimilar to originator RTX, CT-P10 may be a useful alternative for the treatment of RA in all indications for originator RTX. In addition, more studies are required to identify long-term effectiveness and safety of CT-P10 in real world. It is also important to find out new indications of CT-P10 and effective mechanisms to lessen nocebo effect against biosimilar including CT-P10.

키워드

CT-P10rituximabbiosimilarrheumatoid arthritispharmacokineticsRANDOMIZED CONTROLLED-TRIALINNOVATOR RITUXIMABDOUBLE-BLINDOPEN-LABELEFFICACYSAFETYMETHOTREXATEMULTICENTERINHIBITIONTHERAPY
제목
A pharmacokinetic evaluation of the rituximab biosimilar CT-P10 in the treatment of rheumatoid arthritis
저자
Yoo, Dae HyunSuh, Chang-HeeShim, Seung CheolLee, Sang JoonKim, Sung HyunPark, Won
DOI
10.1080/17425255.2020.1832082
발행일
2020-12-01
유형
Article
저널명
Expert Opinion on Drug Metabolism and Toxicology
16
12
페이지
1125 ~ 1132