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Persistence and Safety of Golimumab in Elderly Patients with Rheumatoid Arthritis and Renal Dysfunction in a Real-World Setting

BACKGROUND: The efficacy and safety of golimumab in elderly patients with renal dysfunction are not well evaluated due to the exclusion criteria of clinical trials. OBJECTIVE: To assess the persistence and safety of golimumab in elderly rheumatoid arthritis patients with renal dysfunction. PATIENTS...

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Detalles Bibliográficos
Autores principales: Yokoyama, Seiji, Ishii, Yutaka, Masuda, Junya
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9943813/
https://www.ncbi.nlm.nih.gov/pubmed/36334249
http://dx.doi.org/10.1007/s40801-022-00338-y
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author Yokoyama, Seiji
Ishii, Yutaka
Masuda, Junya
author_facet Yokoyama, Seiji
Ishii, Yutaka
Masuda, Junya
author_sort Yokoyama, Seiji
collection PubMed
description BACKGROUND: The efficacy and safety of golimumab in elderly patients with renal dysfunction are not well evaluated due to the exclusion criteria of clinical trials. OBJECTIVE: To assess the persistence and safety of golimumab in elderly rheumatoid arthritis patients with renal dysfunction. PATIENTS AND METHODS: In this retrospective observational study, we used Japan's nationwide electronic medical records and claims database to identify patients aged 65 years and older who were newly prescribed golimumab for rheumatoid arthritis between July 2011 and June 2018. Patients were divided into three groups according to estimated glomerular filtration rate (eGFR; high, ≥ 90; moderate, ≥ 60, < 90; low, ≥ 30, < 60), and the persistence of golimumab and adverse events were compared between the groups. RESULTS: A total of 423 patients met the eligibility criteria. At 6 months, the persistence rates of golimumab were 62.4%, 63.7% and 67.0% in the high, moderate and low eGFR groups, respectively. In Cox proportional hazards regression analysis, baseline eGFR was not associated with golimumab persistence or adverse events, but concomitant methotrexate and low baseline C-reactive protein (CRP) were associated with longer golimumab persistence. CONCLUSION: Reduced renal function was not associated with continuation of golimumab or incidence of adverse events, suggesting that the persistence of golimumab therapy in patients with rheumatoid arthritis is independent of the baseline level of renal function. On the other hand, concomitant use of methotrexate and low baseline CRP levels were suggested as factors that may affect the persistence of golimumab treatment. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-022-00338-y.
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spelling pubmed-99438132023-02-23 Persistence and Safety of Golimumab in Elderly Patients with Rheumatoid Arthritis and Renal Dysfunction in a Real-World Setting Yokoyama, Seiji Ishii, Yutaka Masuda, Junya Drugs Real World Outcomes Original Research Article BACKGROUND: The efficacy and safety of golimumab in elderly patients with renal dysfunction are not well evaluated due to the exclusion criteria of clinical trials. OBJECTIVE: To assess the persistence and safety of golimumab in elderly rheumatoid arthritis patients with renal dysfunction. PATIENTS AND METHODS: In this retrospective observational study, we used Japan's nationwide electronic medical records and claims database to identify patients aged 65 years and older who were newly prescribed golimumab for rheumatoid arthritis between July 2011 and June 2018. Patients were divided into three groups according to estimated glomerular filtration rate (eGFR; high, ≥ 90; moderate, ≥ 60, < 90; low, ≥ 30, < 60), and the persistence of golimumab and adverse events were compared between the groups. RESULTS: A total of 423 patients met the eligibility criteria. At 6 months, the persistence rates of golimumab were 62.4%, 63.7% and 67.0% in the high, moderate and low eGFR groups, respectively. In Cox proportional hazards regression analysis, baseline eGFR was not associated with golimumab persistence or adverse events, but concomitant methotrexate and low baseline C-reactive protein (CRP) were associated with longer golimumab persistence. CONCLUSION: Reduced renal function was not associated with continuation of golimumab or incidence of adverse events, suggesting that the persistence of golimumab therapy in patients with rheumatoid arthritis is independent of the baseline level of renal function. On the other hand, concomitant use of methotrexate and low baseline CRP levels were suggested as factors that may affect the persistence of golimumab treatment. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-022-00338-y. Springer International Publishing 2022-11-05 /pmc/articles/PMC9943813/ /pubmed/36334249 http://dx.doi.org/10.1007/s40801-022-00338-y Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/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/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research Article
Yokoyama, Seiji
Ishii, Yutaka
Masuda, Junya
Persistence and Safety of Golimumab in Elderly Patients with Rheumatoid Arthritis and Renal Dysfunction in a Real-World Setting
title Persistence and Safety of Golimumab in Elderly Patients with Rheumatoid Arthritis and Renal Dysfunction in a Real-World Setting
title_full Persistence and Safety of Golimumab in Elderly Patients with Rheumatoid Arthritis and Renal Dysfunction in a Real-World Setting
title_fullStr Persistence and Safety of Golimumab in Elderly Patients with Rheumatoid Arthritis and Renal Dysfunction in a Real-World Setting
title_full_unstemmed Persistence and Safety of Golimumab in Elderly Patients with Rheumatoid Arthritis and Renal Dysfunction in a Real-World Setting
title_short Persistence and Safety of Golimumab in Elderly Patients with Rheumatoid Arthritis and Renal Dysfunction in a Real-World Setting
title_sort persistence and safety of golimumab in elderly patients with rheumatoid arthritis and renal dysfunction in a real-world setting
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9943813/
https://www.ncbi.nlm.nih.gov/pubmed/36334249
http://dx.doi.org/10.1007/s40801-022-00338-y
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