SB5 shows cross-immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis.
adalimumab
anti-TNF
biologic therapies
biosimilar
inflammatory bowel disease
Journal
Therapeutic advances in gastroenterology
ISSN: 1756-283X
Titre abrégé: Therap Adv Gastroenterol
Pays: England
ID NLM: 101478893
Informations de publication
Date de publication:
2019
2019
Historique:
received:
09
08
2019
accepted:
15
10
2019
entrez:
17
12
2019
pubmed:
17
12
2019
medline:
17
12
2019
Statut:
epublish
Résumé
The primary objective of this study was to analyze the cross-reactivity of antidrug antibodies to reference adalimumab (ADL) and SB5 (adalimumab biosimilar) in patients with inflammatory bowel disease (IBD) or rheumatoid arthritis (RA). Sera from patients with IBD and RA with or without antibodies to adalimumab (ATA+ or ATA-, respectively) were tested for cross-reactivity with SB5 and ADL. Functional inhibition of tumor necrosis factor-α binding was measured. Sera from patients with antibodies to reference infliximab (ATI+) were examined for cross-reactivity to SB5. Sera were tested by enzyme-linked immunosorbent assay. All 30 anti-ADL ATA+ sera from patients with IBD and all 4 anti-SB5 ATA+ sera from patients with RA were cross-reactive with ADL and SB5 (range of mean concentrations: IBD, 20.99-21.31 μg/ml; RA, 16.46-17.48 μg/ml). In general, there was no significant difference between mean ATA titers. A strong correlation was detected in all ATA+ samples (rho = 0.997 to >0.999; ADL and SB5 show cross-immunogenicity in sera from patients with IBD or RA, supporting shared immune-dominant epitopes. ATI+ sera did not cross-react with SB5, suggesting different immunogenic epitopes between infliximab and SB5.
Sections du résumé
BACKGROUND
BACKGROUND
The primary objective of this study was to analyze the cross-reactivity of antidrug antibodies to reference adalimumab (ADL) and SB5 (adalimumab biosimilar) in patients with inflammatory bowel disease (IBD) or rheumatoid arthritis (RA).
METHODS
METHODS
Sera from patients with IBD and RA with or without antibodies to adalimumab (ATA+ or ATA-, respectively) were tested for cross-reactivity with SB5 and ADL. Functional inhibition of tumor necrosis factor-α binding was measured. Sera from patients with antibodies to reference infliximab (ATI+) were examined for cross-reactivity to SB5. Sera were tested by enzyme-linked immunosorbent assay.
RESULTS
RESULTS
All 30 anti-ADL ATA+ sera from patients with IBD and all 4 anti-SB5 ATA+ sera from patients with RA were cross-reactive with ADL and SB5 (range of mean concentrations: IBD, 20.99-21.31 μg/ml; RA, 16.46-17.48 μg/ml). In general, there was no significant difference between mean ATA titers. A strong correlation was detected in all ATA+ samples (rho = 0.997 to >0.999;
CONCLUSIONS
CONCLUSIONS
ADL and SB5 show cross-immunogenicity in sera from patients with IBD or RA, supporting shared immune-dominant epitopes. ATI+ sera did not cross-react with SB5, suggesting different immunogenic epitopes between infliximab and SB5.
Identifiants
pubmed: 31839806
doi: 10.1177/1756284819891081
pii: 10.1177_1756284819891081
pmc: PMC6893927
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1756284819891081Informations de copyright
© The Author(s), 2019.
Déclaration de conflit d'intérêts
Conflict of interest statement: J. Goncalves has received consulting fees from Astra Zeneca, Biogen, Novartis, Pfizer, Samsung Bioepis, and Sandoz. G. Myung, M. Park, D. Jeong, and J. Ghil are employees of Samsung Bioepis Co., Ltd.
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