Clinical Utility of Antihuman Lambda Chain-based Enzyme-linked Immunosorbent Assay (ELISA) Versus Double Antigen ELISA for the Detection of Anti-infliximab Antibodies

Background: Anti-infliximab antibodies (ATIs) are associated with lower serum infliximab (IFX) trough levels and diminished clinical response. The current most prevalent method for detection of ATI is a double-antigen (DA) enzyme-linked immunosorbent assay (ELISA) utilizing IFX for ligand and detection antibody. Serum IFX interferes with ATI measurement in this method. An alternative ELISA using antihuman lambda chain (AHLC) antibody for ATI detection may be less amenable to this interference. The aim of our study was to compare the performance of AHLC-ATI versus DA-ATI for prediction of clinical response and evaluate the clinical significance of positive ATI in the presence of detectable IFX levels in IFX-treated inflammatory bowel disease (IBD) patients.

Methods: In all, 63 patients' sera were analyzed for IFX levels and antibody levels by AHLC and DA. The results were compared with the clinical response to IFX. Percentage of patients with IFX+ATI+ status among IFX-treated patients and the clinical outcome of IFX+ATI+ patients were assessed.

Results: ATIs were demonstrated in 22/63 (34.9%) and 18/63 (28.5%) sera of patients by AHLC and DA assay, respectively (P = 0.6). Detectable ATI and in IFX was detected in four patients (6.3%) by AHLC but not by DA assay. IFX+ATI+ status was documented in 8.7% of available sera and was associated with a trend for loss of response.

Conclusions: AHLC and DA ELISA are equally effective for ATI detection in patients with undetectable serum IFX. AHLC ELISA detects ATI in some patients with detectable serum IFX. This IFX+ATI+ status may be a harbinger of evolving loss of response to the drug.