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...

Descripción completa

Detalles Bibliográficos
Autores principales: Chopra, Arvind, Khadke, Nagnath, Saluja, Manjit, Kianifard, Toktam, Venugopalan, Anuradha, Gharia, Mihir
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