The rate of antidrug antibody formation to biologics used in the treatment of inflammatory bowel disease (IBD) was assessed in a systematic review and meta-analysis published in BioDrugs.
Given that immunogenicity to biologics may contribute to IBD treatment failure, the authors sought to determine the rate of antidrug antibody formation to individual biologic agents. They used multiple databases to gather information on trials that reported on immunogenicity and assessed the evidence using the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) framework.
The meta-analysis included 33 studies involving 5850 patients. The pooled rates for antidrug antibodies were 28.0% for infliximab, 16.0% for natalizumab, 10.9% for certolizumab pegol, 7.5% for adalimumab, 6.2% for ustekinumab, and 3.8% for golimumab. “Pooled [antidrug antibody] rates were 8.4% for vedolizumab and 5.0% for etrolizumab for combo- and monotherapy combined,” the authors reported.
A significant reduction in antidrug antibody positivity was observed with most biologics when patients were treated with combination therapy (risk ratios [RR]: 0.52 [95% CI, 0.44-0.62] for infliximab, 0.31 [95% CI, 0.14-0.69] for adalimumab, 0.29 [95% CI, 0.10-0.83] for golimumab, 0.30 [95% CI, 0.14-0.67] for certolizumab pegol, and 0.20 [95% CI, 0.11-0.39] for natalizumab).
With regard to infliximab, the analysis showed that development of antidrug antibodies was linked to reduced efficacy (RR, 0.75; 95% CI 0.61-0.91) and increased adverse events, specifically higher rates of infusion reactions (RR, 2.36; 95% CI, 1.85-3.01).
As the observed incidence of antibody positivity in an assay may be influenced by many factors including assay methodology, as well as the drug dose and frequency of use, the authors concluded that a true comparison for antidrug antibody rates across biologics is difficult to ascertain.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Bots SJ, Parker CE, Brandse JF, et al. Anti-drug antibody formation against biologic agents in inflammatory bowel disease: a systematic review and meta-analysis. Published online November 19, 2021. BioDrugs. doi.org/10.1007/s40259-021-00507-5