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

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...

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Autores principales: Park, Won, Božić-Majstorović, Ljubinka, Milakovic, Dragana, Berrocal Kasay, Alfredo, El-Khouri, Elias Chalouhi, Irazoque-Palazuelos, Fedra, Molina, Francisco Fidencio Cons, Shesternya, Pavel, Miranda, Pedro, Medina-Rodriguez, Francisco G., Wiland, Piotr, Jeka, Slawomir, Chavez-Corrales, Jose, Garmish, Olena, Linde, Thomas, Rekalov, Dmytro, Hrycaj, Pawel, Krause, Andreas, Fomina, Natalia, Piura, Olena, Abello-Banfi, Mauricio, Suh, Chang-Hee, Shim, Seung Cheol, Lee, Sang Joon, Lee, Sung Young, Kim, Sung Hwan, Yoo, Dae Hyun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6152436/
https://www.ncbi.nlm.nih.gov/pubmed/30010481
http://dx.doi.org/10.1080/19420862.2018.1487912
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author Park, Won
Božić-Majstorović, Ljubinka
Milakovic, Dragana
Berrocal Kasay, Alfredo
El-Khouri, Elias Chalouhi
Irazoque-Palazuelos, Fedra
Molina, Francisco Fidencio Cons
Shesternya, Pavel
Miranda, Pedro
Medina-Rodriguez, Francisco G.
Wiland, Piotr
Jeka, Slawomir
Chavez-Corrales, Jose
Garmish, Olena
Linde, Thomas
Rekalov, Dmytro
Hrycaj, Pawel
Krause, Andreas
Fomina, Natalia
Piura, Olena
Abello-Banfi, Mauricio
Suh, Chang-Hee
Shim, Seung Cheol
Lee, Sang Joon
Lee, Sung Young
Kim, Sung Hwan
Yoo, Dae Hyun
author_facet Park, Won
Božić-Majstorović, Ljubinka
Milakovic, Dragana
Berrocal Kasay, Alfredo
El-Khouri, Elias Chalouhi
Irazoque-Palazuelos, Fedra
Molina, Francisco Fidencio Cons
Shesternya, Pavel
Miranda, Pedro
Medina-Rodriguez, Francisco G.
Wiland, Piotr
Jeka, Slawomir
Chavez-Corrales, Jose
Garmish, Olena
Linde, Thomas
Rekalov, Dmytro
Hrycaj, Pawel
Krause, Andreas
Fomina, Natalia
Piura, Olena
Abello-Banfi, Mauricio
Suh, Chang-Hee
Shim, Seung Cheol
Lee, Sang Joon
Lee, Sung Young
Kim, Sung Hwan
Yoo, Dae Hyun
author_sort Park, Won
collection PubMed
description 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 (AUC(0–last)), AUC from time zero to infinity (AUC(0–∞)), and maximum concentration (C(max)) 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) change from baseline in DAS28-CRP at week 24 was −2.13 (0.175) for CT-P10 and −2.09 (0.176) for RTX. The 95% CI (−0.29, 0.21) of the estimated treatment difference between CT-P10 and RTX (−0.04) was entirely within the efficacy equivalence margin of ±0.5. Pharmacodynamics, immunogenicity, and safety profiles were similar for CT-P10 and RTX. The pharmacokinetics of CT-P10, US-RTX, and EU-RTX were equivalent. CT-P10 and RTX were also equivalent in terms of efficacy and displayed similar pharmacodynamic, immunogenicity, and safety profiles up to week 24.
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spelling pubmed-61524362018-09-26 Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial Park, Won Božić-Majstorović, Ljubinka Milakovic, Dragana Berrocal Kasay, Alfredo El-Khouri, Elias Chalouhi Irazoque-Palazuelos, Fedra Molina, Francisco Fidencio Cons Shesternya, Pavel Miranda, Pedro Medina-Rodriguez, Francisco G. Wiland, Piotr Jeka, Slawomir Chavez-Corrales, Jose Garmish, Olena Linde, Thomas Rekalov, Dmytro Hrycaj, Pawel Krause, Andreas Fomina, Natalia Piura, Olena Abello-Banfi, Mauricio Suh, Chang-Hee Shim, Seung Cheol Lee, Sang Joon Lee, Sung Young Kim, Sung Hwan Yoo, Dae Hyun MAbs Report 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 (AUC(0–last)), AUC from time zero to infinity (AUC(0–∞)), and maximum concentration (C(max)) 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) change from baseline in DAS28-CRP at week 24 was −2.13 (0.175) for CT-P10 and −2.09 (0.176) for RTX. The 95% CI (−0.29, 0.21) of the estimated treatment difference between CT-P10 and RTX (−0.04) was entirely within the efficacy equivalence margin of ±0.5. Pharmacodynamics, immunogenicity, and safety profiles were similar for CT-P10 and RTX. The pharmacokinetics of CT-P10, US-RTX, and EU-RTX were equivalent. CT-P10 and RTX were also equivalent in terms of efficacy and displayed similar pharmacodynamic, immunogenicity, and safety profiles up to week 24. Taylor & Francis 2018-07-16 /pmc/articles/PMC6152436/ /pubmed/30010481 http://dx.doi.org/10.1080/19420862.2018.1487912 Text en © 2018 The Author(s). Published with license by Taylor & Francis. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.
spellingShingle Report
Park, Won
Božić-Majstorović, Ljubinka
Milakovic, Dragana
Berrocal Kasay, Alfredo
El-Khouri, Elias Chalouhi
Irazoque-Palazuelos, Fedra
Molina, Francisco Fidencio Cons
Shesternya, Pavel
Miranda, Pedro
Medina-Rodriguez, Francisco G.
Wiland, Piotr
Jeka, Slawomir
Chavez-Corrales, Jose
Garmish, Olena
Linde, Thomas
Rekalov, Dmytro
Hrycaj, Pawel
Krause, Andreas
Fomina, Natalia
Piura, Olena
Abello-Banfi, Mauricio
Suh, Chang-Hee
Shim, Seung Cheol
Lee, Sang Joon
Lee, Sung Young
Kim, Sung Hwan
Yoo, Dae Hyun
Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial
title Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial
title_full Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial
title_fullStr Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial
title_full_unstemmed Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial
title_short Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial
title_sort comparison of biosimilar ct-p10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled phase 3 trial
topic Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6152436/
https://www.ncbi.nlm.nih.gov/pubmed/30010481
http://dx.doi.org/10.1080/19420862.2018.1487912
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