Cargando…
The Long-Term Effects of Short-Period Adalimumab Biosimilar Usage in Ankylosing Spondylitis
Background Cost and drug toxicity frequently deter the long-term use of anti-tumor necrosis factor (TNF) agents in ankylosing spondylitis (AS). Therefore, this study was conducted to observe long-term relief after the short-term administration of an anti-TNF agent. Methodology A one-year, prospectiv...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cureus
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10030650/ https://www.ncbi.nlm.nih.gov/pubmed/36960229 http://dx.doi.org/10.7759/cureus.36444 |
_version_ | 1784910425607897088 |
---|---|
author | Chopra, Arvind Khadke, Nagnath Saluja, Manjit Kianifard, Toktam Venugopalan, Anuradha Gharia, Mihir |
author_facet | Chopra, Arvind Khadke, Nagnath Saluja, Manjit Kianifard, Toktam Venugopalan, Anuradha Gharia, Mihir |
author_sort | Chopra, Arvind |
collection | PubMed |
description | Background Cost and drug toxicity frequently deter the long-term use of anti-tumor necrosis factor (TNF) agents in ankylosing spondylitis (AS). Therefore, this study was conducted to observe long-term relief after the short-term administration of an anti-TNF agent. Methodology A one-year, prospective, interventional, uncontrolled, single-center trial was conducted. There were 50 patients with symptomatic active chronic AS who received rheumatology therapy and were anti-TNF naive. Every two weeks, 40 mg of standard biosimilar adalimumab (Bs-ADA, Exemptia™) was administered subcutaneously for six injections (10 weeks) or to continue with standard follow-up if they did not achieve an Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20) index response by week 12. Standard indicators (Assessment Spondyloarthritis International Society/ASAS and Bath) were used to evaluate progress. In addition, TNF-alpha, interleukin (IL)-6, and IL-17 were tested using a commercially available enzyme-linked immunosorbent assay kit from Bio Legend (Bengaluru, India). Results Patients experienced early and significant improvement in pain, non-steroidal anti-inflammatory drugs (NSAIDs) requirement, function, and several indices (ASAS 20 and 40, ASAS partial remission, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Ankylosing Spondylitis Disease Activity Score) after discontinuing injections. At weeks 12 and 48, 84% and 52% of patients showed ASAS 20 improvement, with 34% and 24% showing ASAS partial remission. Over half of the patients continued to improve and provided proof of concept. Conclusions In difficult-to-treat AS, a 10-week course of biosimilar adalimumab demonstrated significant early improvement that often lasted for 24 weeks. This unconventional method proved to be economically appealing. It merits further confirmation and acceptance, especially in resource-constrained contexts. |
format | Online Article Text |
id | pubmed-10030650 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Cureus |
record_format | MEDLINE/PubMed |
spelling | pubmed-100306502023-03-22 The Long-Term Effects of Short-Period Adalimumab Biosimilar Usage in Ankylosing Spondylitis Chopra, Arvind Khadke, Nagnath Saluja, Manjit Kianifard, Toktam Venugopalan, Anuradha Gharia, Mihir Cureus Internal Medicine Background Cost and drug toxicity frequently deter the long-term use of anti-tumor necrosis factor (TNF) agents in ankylosing spondylitis (AS). Therefore, this study was conducted to observe long-term relief after the short-term administration of an anti-TNF agent. Methodology A one-year, prospective, interventional, uncontrolled, single-center trial was conducted. There were 50 patients with symptomatic active chronic AS who received rheumatology therapy and were anti-TNF naive. Every two weeks, 40 mg of standard biosimilar adalimumab (Bs-ADA, Exemptia™) was administered subcutaneously for six injections (10 weeks) or to continue with standard follow-up if they did not achieve an Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20) index response by week 12. Standard indicators (Assessment Spondyloarthritis International Society/ASAS and Bath) were used to evaluate progress. In addition, TNF-alpha, interleukin (IL)-6, and IL-17 were tested using a commercially available enzyme-linked immunosorbent assay kit from Bio Legend (Bengaluru, India). Results Patients experienced early and significant improvement in pain, non-steroidal anti-inflammatory drugs (NSAIDs) requirement, function, and several indices (ASAS 20 and 40, ASAS partial remission, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Ankylosing Spondylitis Disease Activity Score) after discontinuing injections. At weeks 12 and 48, 84% and 52% of patients showed ASAS 20 improvement, with 34% and 24% showing ASAS partial remission. Over half of the patients continued to improve and provided proof of concept. Conclusions In difficult-to-treat AS, a 10-week course of biosimilar adalimumab demonstrated significant early improvement that often lasted for 24 weeks. This unconventional method proved to be economically appealing. It merits further confirmation and acceptance, especially in resource-constrained contexts. Cureus 2023-03-20 /pmc/articles/PMC10030650/ /pubmed/36960229 http://dx.doi.org/10.7759/cureus.36444 Text en Copyright © 2023, Chopra et al. https://creativecommons.org/licenses/by/3.0/This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Internal Medicine Chopra, Arvind Khadke, Nagnath Saluja, Manjit Kianifard, Toktam Venugopalan, Anuradha Gharia, Mihir The Long-Term Effects of Short-Period Adalimumab Biosimilar Usage in Ankylosing Spondylitis |
title | The Long-Term Effects of Short-Period Adalimumab Biosimilar Usage in Ankylosing Spondylitis |
title_full | The Long-Term Effects of Short-Period Adalimumab Biosimilar Usage in Ankylosing Spondylitis |
title_fullStr | The Long-Term Effects of Short-Period Adalimumab Biosimilar Usage in Ankylosing Spondylitis |
title_full_unstemmed | The Long-Term Effects of Short-Period Adalimumab Biosimilar Usage in Ankylosing Spondylitis |
title_short | The Long-Term Effects of Short-Period Adalimumab Biosimilar Usage in Ankylosing Spondylitis |
title_sort | long-term effects of short-period adalimumab biosimilar usage in ankylosing spondylitis |
topic | Internal Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10030650/ https://www.ncbi.nlm.nih.gov/pubmed/36960229 http://dx.doi.org/10.7759/cureus.36444 |
work_keys_str_mv | AT chopraarvind thelongtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT khadkenagnath thelongtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT salujamanjit thelongtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT kianifardtoktam thelongtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT venugopalananuradha thelongtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT ghariamihir thelongtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT chopraarvind longtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT khadkenagnath longtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT salujamanjit longtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT kianifardtoktam longtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT venugopalananuradha longtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis AT ghariamihir longtermeffectsofshortperiodadalimumabbiosimilarusageinankylosingspondylitis |