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RISS 인기검색어
- 검색키워드
- 저자 : Radominski, Seb (검색결과 2 건)
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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, Seb H. K. Lewis 2017 Annals of the rheumatic diseases Vol.76 No.3
<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>
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Yoo, Dae Hyun,Suh, Chang-Hee,Shim, Seung Cheol,Jeka, Slawomir,Molina, Francisco Fidencio Cons,Hrycaj, Pawel,Wiland, Piotr,Lee, Eun Young,Medina-Rodriguez, Francisco G.,Shesternya, Pavel,Radominski, Se Springer International Publishing 2017 BioDrugs Vol.31 No.4
<P><B>Background</B></P><P>CT-P10 is a biosimilar of innovator rituximab (RTX), a biological therapy used to treat patients with rheumatoid arthritis (RA) who have responded inadequately to anti-tumor necrosis factor agents.</P><P><B>Objective</B></P><P>Our objective was to compare the clinical profile of CT-P10 versus RTX in patients with RA who received up to two courses of treatment and were followed for up to 72 weeks.</P><P><B>Methods</B></P><P>In this multicenter double-blind phase I study, patients were randomized 2:1 to receive CT-P10 1000 mg or RTX 1000 mg at weeks 0 and 2. Based on disease activity, patients could receive a second course of treatment between weeks 24 and 48. Efficacy endpoints, including mean change from baseline in Disease Activity Score using 28 joints (DAS28), safety, immunogenicity, pharmacokinetics, and pharmacodynamics were evaluated.</P><P><B>Results</B></P><P>In total, 154 patients were randomized to CT-P10 or RTX (<I>n</I> = 103 and 51, respectively); 137 (<I>n</I> = 92 and 45) completed the first course of treatment, of whom 83 (<I>n</I> = 60 and 23) were re-treated. Improvements from baseline in all efficacy endpoints were highly similar between the CT-P10 and RTX groups over both treatment courses. At week 24 after the second course, mean change from week 0 of the first course in DAS28 erythrocyte sedimentation rate was −2.47 and −2.04 for CT-P10 and RTX, respectively, (<I>p</I> = 0.1866) and in DAS28 C-reactive protein was −2.32 and −2.00, respectively (<I>p</I> = 0.3268). The proportion of patients positive for antidrug antibodies at week 24 after the second treatment course was 20.0% and 21.7% in the CT-P10 and RTX groups, respectively. The safety profile of CT-P10 was comparable to that of RTX, and pharmacokinetic and pharmacodynamic properties were similar.</P><P><B>Conclusions</B></P><P>In patients with RA, efficacy, safety, and other clinical data were comparable between CT-P10 and RTX after up to two courses of treatment over 72 weeks.</P><P>(ClinicalTrials.gov identifier NCT01534884).</P><P><B>Electronic supplementary material</B></P><P>The online version of this article (doi:10.1007/s40259-017-0232-7) contains supplementary material, which is available to authorized users.</P>
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