Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial

MAbs
Won ParkDae Hyun Yoo

Abstract

This multinational, randomized, double-blind trial, (ClinicalTrials.gov identifier NCT02149121) was designed to demonstrate equivalence in pharmacokinetics and efficacy between CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA). Adults with active RA were treated with CT-P10, United States-sourced RTX (US-RTX; Rituxan®), or European Union-sourced RTX (EU-RTX; MabThera®) at weeks 0 and 2. The co-primary pharmacokinetic endpoints were area under the serum concentration-time curve (AUC) from time zero to last measurable concentration (AUC0-last), AUC from time zero to infinity (AUC0-∞), and maximum concentration (Cmax) after two infusions. The primary efficacy endpoint was change from baseline to week 24 in Disease Activity Score using 28 joints-C-reactive protein (DAS28-CRP). Pharmacodynamics, immunogenicity, and safety were also assessed. 372 patients were randomly assigned to CT-P10 (n = 161) or RTX (n = 211 [US-RTX, n = 151; EU-RTX, n = 60]). For the co-primary pharmacokinetic endpoints, 90% confidence intervals (CI) for ratios of geometric means (CT-P10/US-RTX, CT-P10/EU-RTX or EU-RTX/US-RTX) all fell within the equivalence margin of 80-125%. Adjusted least squares (LS) mean (standard error) chang...Continue Reading

References

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Citations

Feb 6, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Chang-Hee SuhSung Young Lee
Mar 6, 2019·Future Oncology·Nadia HarbeckAndriy Krendyukov
Aug 2, 2019·Clinical Rheumatology·Soheil TavakolpourArash Jafarieh
Sep 13, 2019·Expert Opinion on Biological Therapy·Wojciech JurczakChristian Buske
Sep 10, 2019·Expert Opinion on Biological Therapy·Ju-Yang JungChang-Hee Suh
Aug 24, 2019·Future Oncology·Mark VerrillJavier Cortes
Jul 7, 2020·Leukemia & Lymphoma·Wojciech Jurczak, Monika Długosz-Danecka
Sep 22, 2019·Drugs·Pier Luigi ZinzaniGiuseppe Curigliano
Nov 14, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Vibeke StrandJohn D Isaacs
Sep 6, 2020·Internal and Emergency Medicine·Omer Karadag, Emine Duran
Jul 1, 2020·Future Oncology·Pilar Nava-ParadaChadi Nabhan
Aug 26, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Soohyun LeeEunYoung Kim
Oct 6, 2020·Expert Opinion on Drug Metabolism & Toxicology·Dae Hyun YooWon Park
Mar 18, 2021·Scientific Reports·Silvana A M UrruAnnalisa Campomori

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Methods Mentioned

BETA
ESR

Clinical Trials Mentioned

NCT01534884
NCT02149121

Software Mentioned

SAS
Phoenix WinNonlin

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