SB5 shows cross-immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis

• Published in: Therapeutic advances in gastroenterology 2019, Vol.12, p.1756284819891081-1756284819891081
• Main Authors: Goncalves, Joao, Myung, Gihyun, Park, MinJeong, Jeong, Deokyoon, Ghil, Jeehoon
• Format: Article
• Language: English
• Subjects: Gastroenterology; Immunoglobulins; Immunotherapy; Inflammatory bowel disease; Monoclonal antibodies; Original Research; Rheumatoid arthritis; TNF inhibitors
• ISSN: 1756-2848; 1756-283X; 1756-2848
• DOI: 10.1177/1756284819891081

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: 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: 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; p