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The safety and clinical effectiveness of rapid infusion with CT‐P10 in patients with non‐Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non‐interventional post‐authorization safety study in Europe

Rapid infusion (RI) of the rituximab biosimilar CT‐P10 is currently only an approved treatment regimen for the treatment of rheumatoid arthritis. Although both CT‐P10 and reference rituximab are known to be frequently administered using a RI regimen (≤90 min) in clinical practice, published data on...

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Autores principales: Bishton, Mark, Marshall, Scott, Harchowal, Jatinder, Salles, Gilles, Golfier, Camille, Tucci, Alessandra, Fernández, Alicia Rodriguez, Sanchez Blanco, Jose Javier, Bocchia, Monica, Kim, SooKyoung, Lee, Young Nam, Zinzani, Pier Luigi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9545983/
https://www.ncbi.nlm.nih.gov/pubmed/35168291
http://dx.doi.org/10.1002/hon.2978
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author Bishton, Mark
Marshall, Scott
Harchowal, Jatinder
Salles, Gilles
Golfier, Camille
Tucci, Alessandra
Fernández, Alicia Rodriguez
Sanchez Blanco, Jose Javier
Bocchia, Monica
Kim, SooKyoung
Lee, Young Nam
Zinzani, Pier Luigi
author_facet Bishton, Mark
Marshall, Scott
Harchowal, Jatinder
Salles, Gilles
Golfier, Camille
Tucci, Alessandra
Fernández, Alicia Rodriguez
Sanchez Blanco, Jose Javier
Bocchia, Monica
Kim, SooKyoung
Lee, Young Nam
Zinzani, Pier Luigi
author_sort Bishton, Mark
collection PubMed
description Rapid infusion (RI) of the rituximab biosimilar CT‐P10 is currently only an approved treatment regimen for the treatment of rheumatoid arthritis. Although both CT‐P10 and reference rituximab are known to be frequently administered using a RI regimen (≤90 min) in clinical practice, published data on the safety of RI of CT‐P10 in patients with NHL and CLL are limited. Hence, this study collected real‐world safety and effectiveness data on RI‐CT‐P10 from the medical records of 196 patients with NHL or CLL in 10 European centers, 6 months after the date of the first RI (index date); the infusion‐related reaction (IRR) rate was compared to previously published data. Ten percent (95% confidence interval 6%–15%; n = 20/196) of patients experienced an infusion‐related reaction (IRR) on day 1–2 post‐index, which was not significantly different (p = 0.45) to the IRR rate for rituximab described in a previous meta‐analysis (8.8%). During the observation period, 2% of patients experienced grade 3–5 IRRs and 85% (n = 166) experienced an adverse event (non‐IRR). The most common reason for discontinuation of first‐line CT‐P10 was planned treatment completion (81%; n = 158). Complete response and partial response to CT‐P10 was observed in 74% (n = 142/192) and 22% (n = 42/192) of patients, respectively. The results of this real‐world study demonstrate that the safety and effectiveness profile of RI‐CT‐P10 is similar to RI of reference rituximab and therefore support the current use of RI‐CT‐P10 in patients with NHL and CLL.
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spelling pubmed-95459832022-10-14 The safety and clinical effectiveness of rapid infusion with CT‐P10 in patients with non‐Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non‐interventional post‐authorization safety study in Europe Bishton, Mark Marshall, Scott Harchowal, Jatinder Salles, Gilles Golfier, Camille Tucci, Alessandra Fernández, Alicia Rodriguez Sanchez Blanco, Jose Javier Bocchia, Monica Kim, SooKyoung Lee, Young Nam Zinzani, Pier Luigi Hematol Oncol Original Articles Rapid infusion (RI) of the rituximab biosimilar CT‐P10 is currently only an approved treatment regimen for the treatment of rheumatoid arthritis. Although both CT‐P10 and reference rituximab are known to be frequently administered using a RI regimen (≤90 min) in clinical practice, published data on the safety of RI of CT‐P10 in patients with NHL and CLL are limited. Hence, this study collected real‐world safety and effectiveness data on RI‐CT‐P10 from the medical records of 196 patients with NHL or CLL in 10 European centers, 6 months after the date of the first RI (index date); the infusion‐related reaction (IRR) rate was compared to previously published data. Ten percent (95% confidence interval 6%–15%; n = 20/196) of patients experienced an infusion‐related reaction (IRR) on day 1–2 post‐index, which was not significantly different (p = 0.45) to the IRR rate for rituximab described in a previous meta‐analysis (8.8%). During the observation period, 2% of patients experienced grade 3–5 IRRs and 85% (n = 166) experienced an adverse event (non‐IRR). The most common reason for discontinuation of first‐line CT‐P10 was planned treatment completion (81%; n = 158). Complete response and partial response to CT‐P10 was observed in 74% (n = 142/192) and 22% (n = 42/192) of patients, respectively. The results of this real‐world study demonstrate that the safety and effectiveness profile of RI‐CT‐P10 is similar to RI of reference rituximab and therefore support the current use of RI‐CT‐P10 in patients with NHL and CLL. John Wiley and Sons Inc. 2022-03-17 2022-08 /pmc/articles/PMC9545983/ /pubmed/35168291 http://dx.doi.org/10.1002/hon.2978 Text en © 2022 Celltrion Healthcare. Hematological Oncology published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Bishton, Mark
Marshall, Scott
Harchowal, Jatinder
Salles, Gilles
Golfier, Camille
Tucci, Alessandra
Fernández, Alicia Rodriguez
Sanchez Blanco, Jose Javier
Bocchia, Monica
Kim, SooKyoung
Lee, Young Nam
Zinzani, Pier Luigi
The safety and clinical effectiveness of rapid infusion with CT‐P10 in patients with non‐Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non‐interventional post‐authorization safety study in Europe
title The safety and clinical effectiveness of rapid infusion with CT‐P10 in patients with non‐Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non‐interventional post‐authorization safety study in Europe
title_full The safety and clinical effectiveness of rapid infusion with CT‐P10 in patients with non‐Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non‐interventional post‐authorization safety study in Europe
title_fullStr The safety and clinical effectiveness of rapid infusion with CT‐P10 in patients with non‐Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non‐interventional post‐authorization safety study in Europe
title_full_unstemmed The safety and clinical effectiveness of rapid infusion with CT‐P10 in patients with non‐Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non‐interventional post‐authorization safety study in Europe
title_short The safety and clinical effectiveness of rapid infusion with CT‐P10 in patients with non‐Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non‐interventional post‐authorization safety study in Europe
title_sort safety and clinical effectiveness of rapid infusion with ct‐p10 in patients with non‐hodgkin's lymphoma or chronic lymphocytic leukemia: a retrospective non‐interventional post‐authorization safety study in europe
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9545983/
https://www.ncbi.nlm.nih.gov/pubmed/35168291
http://dx.doi.org/10.1002/hon.2978
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