Cargando…

Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials

BACKGROUND: The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn’s disease (CD) in the main trial displayed a close to significant difference favouring...

Descripción completa

Detalles Bibliográficos
Autores principales: Jørgensen, Kristin K., Goll, Guro L., Sexton, Joe, Bolstad, Nils, Olsen, Inge C., Asak, Øivind, Berset, Ingrid P., Blomgren, Ingrid M., Dvergsnes, Katrine, Florholmen, Jon, Frigstad, Svein O., Henriksen, Magne, Hagfors, Jon, Huppertz-Hauss, Gert, Haavardsholm, Espen A., Klaasen, Rolf A., Moum, Bjørn, Noraberg, Geir, Prestegård, Ulf, Rydning, Jan H., Sagatun, Liv, Seeberg, Kathrine A., Torp, Roald, Vold, Cecilia, Warren, David J., Ystrøm, Carl M., Lundin, Knut E. A., Kvien, Tore, Jahnsen, Jørgen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7519917/
https://www.ncbi.nlm.nih.gov/pubmed/32965617
http://dx.doi.org/10.1007/s40259-020-00438-7
_version_ 1783587669152890880
author Jørgensen, Kristin K.
Goll, Guro L.
Sexton, Joe
Bolstad, Nils
Olsen, Inge C.
Asak, Øivind
Berset, Ingrid P.
Blomgren, Ingrid M.
Dvergsnes, Katrine
Florholmen, Jon
Frigstad, Svein O.
Henriksen, Magne
Hagfors, Jon
Huppertz-Hauss, Gert
Haavardsholm, Espen A.
Klaasen, Rolf A.
Moum, Bjørn
Noraberg, Geir
Prestegård, Ulf
Rydning, Jan H.
Sagatun, Liv
Seeberg, Kathrine A.
Torp, Roald
Vold, Cecilia
Warren, David J.
Ystrøm, Carl M.
Lundin, Knut E. A.
Kvien, Tore
Jahnsen, Jørgen
author_facet Jørgensen, Kristin K.
Goll, Guro L.
Sexton, Joe
Bolstad, Nils
Olsen, Inge C.
Asak, Øivind
Berset, Ingrid P.
Blomgren, Ingrid M.
Dvergsnes, Katrine
Florholmen, Jon
Frigstad, Svein O.
Henriksen, Magne
Hagfors, Jon
Huppertz-Hauss, Gert
Haavardsholm, Espen A.
Klaasen, Rolf A.
Moum, Bjørn
Noraberg, Geir
Prestegård, Ulf
Rydning, Jan H.
Sagatun, Liv
Seeberg, Kathrine A.
Torp, Roald
Vold, Cecilia
Warren, David J.
Ystrøm, Carl M.
Lundin, Knut E. A.
Kvien, Tore
Jahnsen, Jørgen
author_sort Jørgensen, Kristin K.
collection PubMed
description BACKGROUND: The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn’s disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested. OBJECTIVE: The aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials. PATIENTS AND METHODS: The 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period. RESULTS: The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient’s and physician’s global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events. CONCLUSION: Efficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC. TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02148640. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40259-020-00438-7) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-7519917
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-75199172020-10-13 Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials Jørgensen, Kristin K. Goll, Guro L. Sexton, Joe Bolstad, Nils Olsen, Inge C. Asak, Øivind Berset, Ingrid P. Blomgren, Ingrid M. Dvergsnes, Katrine Florholmen, Jon Frigstad, Svein O. Henriksen, Magne Hagfors, Jon Huppertz-Hauss, Gert Haavardsholm, Espen A. Klaasen, Rolf A. Moum, Bjørn Noraberg, Geir Prestegård, Ulf Rydning, Jan H. Sagatun, Liv Seeberg, Kathrine A. Torp, Roald Vold, Cecilia Warren, David J. Ystrøm, Carl M. Lundin, Knut E. A. Kvien, Tore Jahnsen, Jørgen BioDrugs Original Research Article BACKGROUND: The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn’s disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested. OBJECTIVE: The aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials. PATIENTS AND METHODS: The 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period. RESULTS: The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient’s and physician’s global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events. CONCLUSION: Efficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC. TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02148640. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40259-020-00438-7) contains supplementary material, which is available to authorized users. Springer International Publishing 2020-09-23 2020 /pmc/articles/PMC7519917/ /pubmed/32965617 http://dx.doi.org/10.1007/s40259-020-00438-7 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Original Research Article
Jørgensen, Kristin K.
Goll, Guro L.
Sexton, Joe
Bolstad, Nils
Olsen, Inge C.
Asak, Øivind
Berset, Ingrid P.
Blomgren, Ingrid M.
Dvergsnes, Katrine
Florholmen, Jon
Frigstad, Svein O.
Henriksen, Magne
Hagfors, Jon
Huppertz-Hauss, Gert
Haavardsholm, Espen A.
Klaasen, Rolf A.
Moum, Bjørn
Noraberg, Geir
Prestegård, Ulf
Rydning, Jan H.
Sagatun, Liv
Seeberg, Kathrine A.
Torp, Roald
Vold, Cecilia
Warren, David J.
Ystrøm, Carl M.
Lundin, Knut E. A.
Kvien, Tore
Jahnsen, Jørgen
Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials
title Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials
title_full Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials
title_fullStr Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials
title_full_unstemmed Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials
title_short Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials
title_sort efficacy and safety of ct-p13 in inflammatory bowel disease after switching from originator infliximab: exploratory analyses from the nor-switch main and extension trials
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7519917/
https://www.ncbi.nlm.nih.gov/pubmed/32965617
http://dx.doi.org/10.1007/s40259-020-00438-7
work_keys_str_mv AT jørgensenkristink efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT gollgurol efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT sextonjoe efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT bolstadnils efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT olseningec efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT asakøivind efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT bersetingridp efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT blomgreningridm efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT dvergsneskatrine efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT florholmenjon efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT frigstadsveino efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT henriksenmagne efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT hagforsjon efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT huppertzhaussgert efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT haavardsholmespena efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT klaasenrolfa efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT moumbjørn efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT noraberggeir efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT prestegardulf efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT rydningjanh efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT sagatunliv efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT seebergkathrinea efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT torproald efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT voldcecilia efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT warrendavidj efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT ystrømcarlm efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT lundinknutea efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT kvientore efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials
AT jahnsenjørgen efficacyandsafetyofctp13ininflammatoryboweldiseaseafterswitchingfromoriginatorinfliximabexploratoryanalysesfromthenorswitchmainandextensiontrials