<P><B>Objective</B></P><P>To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis fact...
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https://www.riss.kr/link?id=A107509347
Yoo, Dae Hyun ; Suh, Chang-Hee ; Shim, Seung Cheol ; Jeka, Slawomir ; Cons-Molina, Francisco Fidencio ; Hrycaj, Pawel ; Wiland, Piotr ; Lee, Eun Young ; Medina-Rodriguez, Francisco G ; Shesternya, Pavel ; Radominski, Sebastiao ; Stanislav, Marina ; Kovalenko, Volodymyr ; Sheen, Dong Hyuk ; Myasoutova, Leysan ; Lim, Mie Jin ; Choe, Jung-Yoon ; Lee, Sang Joon ; Lee, Sung Young ; Kwon, Taek Sang ; Park, Won
2017
-
SCI,SCIE,SCOPUS
학술저널
566-570(5쪽)
0
상세조회0
다운로드다국어 초록 (Multilingual Abstract)
<P><B>Objective</B></P><P>To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis fact...
<P><B>Objective</B></P><P>To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents.</P><P><B>Methods</B></P><P>In this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration–time curve from time zero to last quantifiable concentration (AUC<SUB>0–last</SUB>) and maximum serum concentration after second infusion (C<SUB>max</SUB>). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24.</P><P><B>Results</B></P><P>103 patients were assigned to CT-P10 and 51 to RTX. The 90% CIs for the ratio of geometric means (CT-P10/RTX) for both primary endpoints were within the bioequivalence range of 80%–125% (AUC<SUB>0–last</SUB>: 97.7% (90% CI 89.2% to 107.0%); C<SUB>max</SUB>: 97.6% (90% CI 92.0% to 103.5%)). Pharmacodynamics and efficacy were comparable between groups. Antidrug antibodies were detected in 17.6% of patients in each group at week 24. CT-P10 and RTX displayed similar safety profiles.</P><P><B>Conclusions</B></P><P>CT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety.</P><P><B>Trial registration number</B></P><P>NCT01534884.</P>