Cargando…

P66 Adalimumab originator versus biosimilar in children and young people with JIA

INTRODUCTION/BACKGROUND: Biosimilar therapies are considered to have comparable efficacy to their originators and prescribing is encouraged in the UK for significant cost-savings to the NHS. However, real-world evidence comparing originators and biosimilars is limited, particularly in children and y...

Descripción completa

Detalles Bibliográficos
Autores principales: Kearsley-Fleet, Lianne, Jain, Sarthak, Baildam, Eileen, Beresford, Michael W, Douglas, Sharon, Foster, Helen E, Southwood, Taunton R, Hyrich, Kimme L
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9515880/
http://dx.doi.org/10.1093/rap/rkac067.066
_version_ 1784798588254027776
author Kearsley-Fleet, Lianne
Jain, Sarthak
Baildam, Eileen
Beresford, Michael W
Douglas, Sharon
Foster, Helen E
Southwood, Taunton R
Hyrich, Kimme L
author_facet Kearsley-Fleet, Lianne
Jain, Sarthak
Baildam, Eileen
Beresford, Michael W
Douglas, Sharon
Foster, Helen E
Southwood, Taunton R
Hyrich, Kimme L
author_sort Kearsley-Fleet, Lianne
collection PubMed
description INTRODUCTION/BACKGROUND: Biosimilar therapies are considered to have comparable efficacy to their originators and prescribing is encouraged in the UK for significant cost-savings to the NHS. However, real-world evidence comparing originators and biosimilars is limited, particularly in children and young people. The objective of this analysis was to compare the effectiveness of the anti-TNF adalimumab originator and a biosimilar in the treatment of JIA in children and young people, by comparing change in disease activity after six months. DESCRIPTION/METHOD: This analysis included children and young people with JIA from the Biologics for Children with Rheumatic Diseases (BCRD) study. Data are collected at the point of starting biologic therapy, and after 6 months, including patient demographics, biologic therapy, and disease activity. Patients were included if they were starting adalimumab (originator or biosimilar) as their first biologic. Patients with follow-up data at 6 months were assessed for outcomes at 6 months. Change in Juvenile Arthritis Disease Activity Score (JADAS-71) from baseline to 6 months was calculated and compared between therapies using linear regression. Multivariable logistical regression was used to compare remission (JADAS-71 ≤1) at 6 months between therapies. Both regression models were adjusted for baseline characteristics at the start of biologic therapy: age, gender, disease duration, ILAR category, history of uveitis, number of comorbidities (0/1/2+), and JADAS-71. Multiple imputation was used to account for missing data. DISCUSSION/RESULTS: A total of 457 patients were registered starting adalimumab as their first biologic: 413 on originator, 44 on biosimilar (Table). Of these, 63% were female, median age at start of therapy was 11 years old (IQR 6, 14), and median disease duration was 2 years (IQR 1, 5). The majority of patients had RF-negative polyarticular JIA (29%), persistent oligoarticular (20%) or extended oligoarticular JIA (18%). There were 47% of patients who had a history of uveitits when starting biologic therapy, and 68% reported at least one comorbidity. Baseline characters were similar between both therapies. There were 429 patients with follow-up data after six months of treatment: 393 on originator and 36 on biosimliar. The median JADAS-71 improved by -4.4 (IQR -9.9, -0.2) with no difference seen between the originator and the biosimilar patients (adjusted b-coefficient: -0.4; 95% CI -2.6, 1.8; p = 734). There were 36% of patients in remission, with no difference between the two therapies (odds ratio 1.2; 95% CI 0.5, 2.9; p = 0.543). KEY LEARNING POINTS/CONCLUSION: There was no significant difference in disease activity response between children and young people with JIA treated with adalimumab originator versus biosimilar. These results support that the adalimumab biosimilar is similar in effectiveness to the originator in treating JIA, although more research is needed regarding safety and tolerability.
format Online
Article
Text
id pubmed-9515880
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-95158802022-09-28 P66 Adalimumab originator versus biosimilar in children and young people with JIA Kearsley-Fleet, Lianne Jain, Sarthak Baildam, Eileen Beresford, Michael W Douglas, Sharon Foster, Helen E Southwood, Taunton R Hyrich, Kimme L Rheumatol Adv Pract Posters INTRODUCTION/BACKGROUND: Biosimilar therapies are considered to have comparable efficacy to their originators and prescribing is encouraged in the UK for significant cost-savings to the NHS. However, real-world evidence comparing originators and biosimilars is limited, particularly in children and young people. The objective of this analysis was to compare the effectiveness of the anti-TNF adalimumab originator and a biosimilar in the treatment of JIA in children and young people, by comparing change in disease activity after six months. DESCRIPTION/METHOD: This analysis included children and young people with JIA from the Biologics for Children with Rheumatic Diseases (BCRD) study. Data are collected at the point of starting biologic therapy, and after 6 months, including patient demographics, biologic therapy, and disease activity. Patients were included if they were starting adalimumab (originator or biosimilar) as their first biologic. Patients with follow-up data at 6 months were assessed for outcomes at 6 months. Change in Juvenile Arthritis Disease Activity Score (JADAS-71) from baseline to 6 months was calculated and compared between therapies using linear regression. Multivariable logistical regression was used to compare remission (JADAS-71 ≤1) at 6 months between therapies. Both regression models were adjusted for baseline characteristics at the start of biologic therapy: age, gender, disease duration, ILAR category, history of uveitis, number of comorbidities (0/1/2+), and JADAS-71. Multiple imputation was used to account for missing data. DISCUSSION/RESULTS: A total of 457 patients were registered starting adalimumab as their first biologic: 413 on originator, 44 on biosimilar (Table). Of these, 63% were female, median age at start of therapy was 11 years old (IQR 6, 14), and median disease duration was 2 years (IQR 1, 5). The majority of patients had RF-negative polyarticular JIA (29%), persistent oligoarticular (20%) or extended oligoarticular JIA (18%). There were 47% of patients who had a history of uveitits when starting biologic therapy, and 68% reported at least one comorbidity. Baseline characters were similar between both therapies. There were 429 patients with follow-up data after six months of treatment: 393 on originator and 36 on biosimliar. The median JADAS-71 improved by -4.4 (IQR -9.9, -0.2) with no difference seen between the originator and the biosimilar patients (adjusted b-coefficient: -0.4; 95% CI -2.6, 1.8; p = 734). There were 36% of patients in remission, with no difference between the two therapies (odds ratio 1.2; 95% CI 0.5, 2.9; p = 0.543). KEY LEARNING POINTS/CONCLUSION: There was no significant difference in disease activity response between children and young people with JIA treated with adalimumab originator versus biosimilar. These results support that the adalimumab biosimilar is similar in effectiveness to the originator in treating JIA, although more research is needed regarding safety and tolerability. Oxford University Press 2022-09-28 /pmc/articles/PMC9515880/ http://dx.doi.org/10.1093/rap/rkac067.066 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Posters
Kearsley-Fleet, Lianne
Jain, Sarthak
Baildam, Eileen
Beresford, Michael W
Douglas, Sharon
Foster, Helen E
Southwood, Taunton R
Hyrich, Kimme L
P66 Adalimumab originator versus biosimilar in children and young people with JIA
title P66 Adalimumab originator versus biosimilar in children and young people with JIA
title_full P66 Adalimumab originator versus biosimilar in children and young people with JIA
title_fullStr P66 Adalimumab originator versus biosimilar in children and young people with JIA
title_full_unstemmed P66 Adalimumab originator versus biosimilar in children and young people with JIA
title_short P66 Adalimumab originator versus biosimilar in children and young people with JIA
title_sort p66 adalimumab originator versus biosimilar in children and young people with jia
topic Posters
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9515880/
http://dx.doi.org/10.1093/rap/rkac067.066
work_keys_str_mv AT kearsleyfleetlianne p66adalimumaboriginatorversusbiosimilarinchildrenandyoungpeoplewithjia
AT jainsarthak p66adalimumaboriginatorversusbiosimilarinchildrenandyoungpeoplewithjia
AT baildameileen p66adalimumaboriginatorversusbiosimilarinchildrenandyoungpeoplewithjia
AT beresfordmichaelw p66adalimumaboriginatorversusbiosimilarinchildrenandyoungpeoplewithjia
AT douglassharon p66adalimumaboriginatorversusbiosimilarinchildrenandyoungpeoplewithjia
AT fosterhelene p66adalimumaboriginatorversusbiosimilarinchildrenandyoungpeoplewithjia
AT southwoodtauntonr p66adalimumaboriginatorversusbiosimilarinchildrenandyoungpeoplewithjia
AT hyrichkimmel p66adalimumaboriginatorversusbiosimilarinchildrenandyoungpeoplewithjia