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Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product

PURPOSE: To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center. PATIENTS AND METHODS: In April 2014, patients attending our rheumatology service for infliximab infusions were switched from referenc...

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Autores principales: Abdalla, Abuelmagd, Byrne, Niamh, Conway, Richard, Walsh, Thomas, Mannion, Geraldine, Hanly, Michael, O’Sullivan, Miriam, Curran, Ann Maria, Carey, John J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5349501/
https://www.ncbi.nlm.nih.gov/pubmed/28331376
http://dx.doi.org/10.2147/OARRR.S124975
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author Abdalla, Abuelmagd
Byrne, Niamh
Conway, Richard
Walsh, Thomas
Mannion, Geraldine
Hanly, Michael
O’Sullivan, Miriam
Curran, Ann Maria
Carey, John J
author_facet Abdalla, Abuelmagd
Byrne, Niamh
Conway, Richard
Walsh, Thomas
Mannion, Geraldine
Hanly, Michael
O’Sullivan, Miriam
Curran, Ann Maria
Carey, John J
author_sort Abdalla, Abuelmagd
collection PubMed
description PURPOSE: To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center. PATIENTS AND METHODS: In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval. RESULTS: Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9), mean disease duration 14.79 years (9.7), median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3) months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (p=0.043, 0.001 respectively). There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7%) patients discontinued the biosimilar infliximab. CONCLUSION: Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost.
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spelling pubmed-53495012017-03-22 Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product Abdalla, Abuelmagd Byrne, Niamh Conway, Richard Walsh, Thomas Mannion, Geraldine Hanly, Michael O’Sullivan, Miriam Curran, Ann Maria Carey, John J Open Access Rheumatol Original Research PURPOSE: To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center. PATIENTS AND METHODS: In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval. RESULTS: Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9), mean disease duration 14.79 years (9.7), median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3) months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (p=0.043, 0.001 respectively). There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7%) patients discontinued the biosimilar infliximab. CONCLUSION: Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost. Dove Medical Press 2017-03-07 /pmc/articles/PMC5349501/ /pubmed/28331376 http://dx.doi.org/10.2147/OARRR.S124975 Text en © 2017 Abdalla et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Abdalla, Abuelmagd
Byrne, Niamh
Conway, Richard
Walsh, Thomas
Mannion, Geraldine
Hanly, Michael
O’Sullivan, Miriam
Curran, Ann Maria
Carey, John J
Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
title Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
title_full Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
title_fullStr Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
title_full_unstemmed Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
title_short Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
title_sort long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5349501/
https://www.ncbi.nlm.nih.gov/pubmed/28331376
http://dx.doi.org/10.2147/OARRR.S124975
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