%0 Journal Article
%A Bishton, Mark
%A Marshall, Scott
%A Harchowal, Jatinder
%A Salles, Gilles
%A Golfier, Camille
%A Tucci, Alessandra
%A Fernández, Alicia Rodriguez
%A Sanchez Blanco, Jose Javier
%A Bocchia, Monica
%A Kim, SooKyoung
%A Lee, Young Nam
%A Zinzani, Pier Luigi
%T 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.
%D 2022
%U http://hdl.handle.net/10668/22028
%X 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.
%K biosimilar pharmaceuticals
%K chronic
%K infusion
%K intravenous
%K lymphocytic leukemia
%K lymphoma
%K non-Hodgkin
%K rituximab
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