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Commercial, clinical trial assays for Remicade show strong agreement
HONOLULU — Commercially available assays for determining Remicade concentrations and antibodies were found to have strong agreement with assays used by Janssen in the clinical development of Remicade for inflammatory bowel disease, according to a poster presented at ACG 2015.
Investigators evaluated Remicade (infliximab, Janssen) concentrations and antibodies to infliximab results found by assays developed by Janssen and used in clinical trials, and compared them with results from FDA- or EMA-validated commercial assays developed by KU Leuven, Sanquin Diagnostic Services, LabCorp and Dynacare. Janssen prepared blinded samples and shipped them to each laboratory for testing.
Intra-class correlations relative to Janssen’s infliximab assay were all considered “excellent,” with 0.931 (95% CI, 0.88-0.96) for Dynacare, 0.96 (95% CI, 0.93-0.977) for KU Leuven, 0.971 (95% CI, 0.949-0.977) for LabCorp and 0.895 (95% CI, 0.821-0.939) for Sanquin.
Most assays measuring antibodies to infliximab had “excellent” to “outstanding” correlation with Janssen’s “drug tolerant” assay, with no statistically significant difference between any method.
“The strong agreement reported here between the comparator assays and the Janssen drug-tolerant assay provides support to clinicians in their use of these commercial assays, and for understanding their patients’ [infliximab] and [antibodies to infliximab] results relative to published data from clinical studies of Remicade,” the researchers wrote. – by Adam Leitenberger
Reference:
Marini J, et al. Abstract P1063. Presented at: ACG 2015; Oct. 19-21, 2015; Honolulu, HI.
Disclosures: This study was funded by Janssen.