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Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score–Matched Analysis from the Korean College of Rheumatology Biologics Registry

BACKGROUND: Long-term, real-world data are required to support the use of CT-P13 in chronic conditions such as ankylosing spondylitis. However, real-world evidence may be influenced by selection bias, which can confound outcomes. The aim of the current analysis was to confirm the long-term comparabi...

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Autores principales: Kim, Hyoun-Ah, Lee, Eunyoung, Lee, Sun-Kyung, Park, Yong-Beom, Shin, Kichul
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7391390/
https://www.ncbi.nlm.nih.gov/pubmed/32696266
http://dx.doi.org/10.1007/s40259-020-00432-z
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author Kim, Hyoun-Ah
Lee, Eunyoung
Lee, Sun-Kyung
Park, Yong-Beom
Shin, Kichul
author_facet Kim, Hyoun-Ah
Lee, Eunyoung
Lee, Sun-Kyung
Park, Yong-Beom
Shin, Kichul
author_sort Kim, Hyoun-Ah
collection PubMed
description BACKGROUND: Long-term, real-world data are required to support the use of CT-P13 in chronic conditions such as ankylosing spondylitis. However, real-world evidence may be influenced by selection bias, which can confound outcomes. The aim of the current analysis was to confirm the long-term comparability of CT-P13 and reference infliximab treatment in patients with ankylosing spondylitis, using propensity score matching to adjust for baseline differences between groups. METHODS: A propensity score–matching analysis was conducted on data from patients with ankylosing spondylitis in the Korean College of Rheumatology Biologics registry who received CT-P13 or reference infliximab. Drug retention, reasons for biologic therapy changes or discontinuation, and efficacy parameters were analyzed overall and by treatment line with up to 4 years of follow-up. Adverse events were recorded for each treatment group. RESULTS: Propensity score matching was effective in matching 124 CT-P13–treated and 124 reference infliximab-treated patients. Median treatment duration and drug retention were similar between CT-P13 and reference infliximab. Three-year retention rates (95% confidence interval [CI]) were 64.2% (53.5–73.0) for CT-P13 and 55.6% (42.9–66.6) for reference infliximab. Overall, 17.1% (CT-P13) and 29.3% (reference infliximab) of patients discontinued biologic therapy, and 20.0% (CT-P13) and 15.2% (reference infliximab) changed biologic therapy. Efficacy assessments were generally similar between groups; both treatments were well tolerated. CONCLUSIONS: Propensity score–matching analysis confirmed that CT-P13 treatment was not associated with significant differences in drug retention, treatment duration, most efficacy parameters, or safety versus reference infliximab in Korean patients with ankylosing spondylitis, building evidence for the long-term comparability of these treatments. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01965132. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40259-020-00432-z) contains supplementary material, which is available to authorized users.
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spelling pubmed-73913902020-08-12 Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score–Matched Analysis from the Korean College of Rheumatology Biologics Registry Kim, Hyoun-Ah Lee, Eunyoung Lee, Sun-Kyung Park, Yong-Beom Shin, Kichul BioDrugs Original Research Article BACKGROUND: Long-term, real-world data are required to support the use of CT-P13 in chronic conditions such as ankylosing spondylitis. However, real-world evidence may be influenced by selection bias, which can confound outcomes. The aim of the current analysis was to confirm the long-term comparability of CT-P13 and reference infliximab treatment in patients with ankylosing spondylitis, using propensity score matching to adjust for baseline differences between groups. METHODS: A propensity score–matching analysis was conducted on data from patients with ankylosing spondylitis in the Korean College of Rheumatology Biologics registry who received CT-P13 or reference infliximab. Drug retention, reasons for biologic therapy changes or discontinuation, and efficacy parameters were analyzed overall and by treatment line with up to 4 years of follow-up. Adverse events were recorded for each treatment group. RESULTS: Propensity score matching was effective in matching 124 CT-P13–treated and 124 reference infliximab-treated patients. Median treatment duration and drug retention were similar between CT-P13 and reference infliximab. Three-year retention rates (95% confidence interval [CI]) were 64.2% (53.5–73.0) for CT-P13 and 55.6% (42.9–66.6) for reference infliximab. Overall, 17.1% (CT-P13) and 29.3% (reference infliximab) of patients discontinued biologic therapy, and 20.0% (CT-P13) and 15.2% (reference infliximab) changed biologic therapy. Efficacy assessments were generally similar between groups; both treatments were well tolerated. CONCLUSIONS: Propensity score–matching analysis confirmed that CT-P13 treatment was not associated with significant differences in drug retention, treatment duration, most efficacy parameters, or safety versus reference infliximab in Korean patients with ankylosing spondylitis, building evidence for the long-term comparability of these treatments. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01965132. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40259-020-00432-z) contains supplementary material, which is available to authorized users. Springer International Publishing 2020-07-21 2020 /pmc/articles/PMC7391390/ /pubmed/32696266 http://dx.doi.org/10.1007/s40259-020-00432-z 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
Kim, Hyoun-Ah
Lee, Eunyoung
Lee, Sun-Kyung
Park, Yong-Beom
Shin, Kichul
Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score–Matched Analysis from the Korean College of Rheumatology Biologics Registry
title Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score–Matched Analysis from the Korean College of Rheumatology Biologics Registry
title_full Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score–Matched Analysis from the Korean College of Rheumatology Biologics Registry
title_fullStr Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score–Matched Analysis from the Korean College of Rheumatology Biologics Registry
title_full_unstemmed Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score–Matched Analysis from the Korean College of Rheumatology Biologics Registry
title_short Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score–Matched Analysis from the Korean College of Rheumatology Biologics Registry
title_sort retention rate and efficacy of the biosimilar ct-p13 versus reference infliximab in patients with ankylosing spondylitis: a propensity score–matched analysis from the korean college of rheumatology biologics registry
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7391390/
https://www.ncbi.nlm.nih.gov/pubmed/32696266
http://dx.doi.org/10.1007/s40259-020-00432-z
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