Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine

Johanna Elin Gehin, Guro Løvik Goll, Marthe Kirkesæther Brun, Meghna Jani, Nils Bolstad, Silje Watterdal Syversen

Research output: Contribution to journalArticlepeer-review


Biologic drugs have greatly improved treatment outcomes of inflammatory joint diseases (IJDs), but a substantial proportion of patients either do not respond to treatment or lose response over time. Drug immunogenicity, manifested as formation of anti-drug antibodies (ADAb), constitute a significant clinical problem. ADAb influence the pharmacokinetics of the drug, are associated with reduced clinical efficacy, and increased risk of adverse events such as infusion reactions. The prevalence of ADAb differ among drugs and diseases, and detection of ADAb also depends on assay format. Most data exist for the tumor necrosis factor alpha inhibitors infliximab and adalimumab, with a frequency of ADAb ranging from 10-60% across studies. Measurement of ADAb and serum drug levels, therapeutic drug monitoring (TDM), has been suggested as a strategy to optimize therapy with biologic drugs. Although the recent randomized clinical Norwegian Drug Monitoring (NOR-DRUM) trials show promise towards a personalized medicine prescribing approach by TDM, several challenges remain. A plethora of assay formats, with widely differing properties, is currently used for measuring ADAb. Comparing results between different assays and laboratories is difficult, which complicates development of cut-offs necessary for guidelines and implementation of ADAb measurements in clinical practice. With the possible exception of infliximab, limited data on clinical relevance and cost-effectiveness exist to support TDM as a routine clinical strategy to monitor biologic drugs in IJDs. The aim of this review is to provide an overview of the characteristics and prevalence of ADAb, predisposing factors to ADAb formation, commonly used assessment methods, clinical consequences of ADAb, and the potential implications of ADAb assessments for everyday treatment of IJDs.
Original languageEnglish
Publication statusAccepted/In press - 27 Sept 2022


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