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A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis

Authors :
Dong Hyuk Sheen
Piotr Wiland
Francisco Fidencio Cons-Molina
Pavel Shesternya
Chang Hee Suh
Paweł Hrycaj
Dae Hyun Yoo
Mie Jin Lim
Marina Stanislav
Taek Sang Kwon
Seung Cheol Shim
Won Park
Eun Young Lee
Volodymyr Kovalenko
Sebastião Cezar Radominski
Leysan Myasoutova
Sang Joon Lee
Sławomir Jeka
Sung Young Lee
Francisco G. Medina-Rodriguez
Jung Yoon Choe
Source :
Annals of the Rheumatic Diseases
Publication Year :
2016
Publisher :
BMJ, 2016.

Abstract

ObjectiveTo 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.MethodsIn 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 (AUC0–last) and maximum serum concentration after second infusion (Cmax). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24.Results103 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% (AUC0–last: 97.7% (90% CI 89.2% to 107.0%); Cmax: 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.ConclusionsCT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety.Trial registration numberNCT01534884.

Details

ISSN :
14682060 and 00034967
Volume :
76
Database :
OpenAIRE
Journal :
Annals of the Rheumatic Diseases
Accession number :
edsair.doi.dedup.....03f610d3c8ed44de14bd3f78aaa29379
Full Text :
https://doi.org/10.1136/annrheumdis-2016-209540