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

Abuelmagd Abdalla, Niamh Byrne, Richard Conway, Thomas Walsh, Geraldine Mannion, Michael Hanly, Miriam O’Sullivan, Ann Maria Curran, John J Carey Department of Rheumatology, Galway University Hospitals, Galway, Ireland Purpose:...

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Autores principales: Abdalla A, Byrne N, Conway R, Walsh T, Mannion G, Hanly M, O'Sullivan M, Curran AM, Carey JJ
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Lenguaje:EN
Publicado: Dove Medical Press 2017
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Acceso en línea:https://doaj.org/article/0836fca57a1c4dfb9924d297e9233ad3
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spelling oai:doaj.org-article:0836fca57a1c4dfb9924d297e9233ad32021-12-02T02:07:57ZLong-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product1179-156Xhttps://doaj.org/article/0836fca57a1c4dfb9924d297e9233ad32017-03-01T00:00:00Zhttps://www.dovepress.com/long-term-safety-and-efficacy-of-biosimilar-infliximab-among-patients--peer-reviewed-article-OARRRhttps://doaj.org/toc/1179-156XAbuelmagd Abdalla, Niamh Byrne, Richard Conway, Thomas Walsh, Geraldine Mannion, Michael Hanly, Miriam O’Sullivan, Ann Maria Curran, John J Carey Department of Rheumatology, Galway University Hospitals, Galway, Ireland 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. Keywords: biologic therapy, rheumatic diseases, biosimilar exchange, infliximab, adultAbdalla AByrne NConway RWalsh TMannion GHanly MO'Sullivan MCurran AMCarey JJDove Medical PressarticleBiologic therapyRheumatic diseasesBiosimilar exchangeInfliximabAdultDiseases of the musculoskeletal systemRC925-935ENOpen Access Rheumatology: Research and Reviews, Vol Volume 9, Pp 29-35 (2017)
institution DOAJ
collection DOAJ
language EN
topic Biologic therapy
Rheumatic diseases
Biosimilar exchange
Infliximab
Adult
Diseases of the musculoskeletal system
RC925-935
spellingShingle Biologic therapy
Rheumatic diseases
Biosimilar exchange
Infliximab
Adult
Diseases of the musculoskeletal system
RC925-935
Abdalla A
Byrne N
Conway R
Walsh T
Mannion G
Hanly M
O'Sullivan M
Curran AM
Carey JJ
Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
description Abuelmagd Abdalla, Niamh Byrne, Richard Conway, Thomas Walsh, Geraldine Mannion, Michael Hanly, Miriam O’Sullivan, Ann Maria Curran, John J Carey Department of Rheumatology, Galway University Hospitals, Galway, Ireland 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. Keywords: biologic therapy, rheumatic diseases, biosimilar exchange, infliximab, adult
format article
author Abdalla A
Byrne N
Conway R
Walsh T
Mannion G
Hanly M
O'Sullivan M
Curran AM
Carey JJ
author_facet Abdalla A
Byrne N
Conway R
Walsh T
Mannion G
Hanly M
O'Sullivan M
Curran AM
Carey JJ
author_sort Abdalla A
title 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_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_sort long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
publisher Dove Medical Press
publishDate 2017
url https://doaj.org/article/0836fca57a1c4dfb9924d297e9233ad3
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