2020
DOI: 10.1208/s12248-020-00518-0
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Comparison of the ELISA and ECL Assay for Vedolizumab Anti-drug Antibodies: Assessing the Impact on Pharmacokinetics and Safety Outcomes of the Phase 3 GEMINI Trials

Abstract: Vedolizumab immunogenicity has been assessed using an enzyme-linked immunosorbent assay (ELISA) with a ~ 0.5 μg/mL drug interference, which may underestimate on-drug immunogenicity. We aimed to compare immunogenicity results between ELISA and the new drug-tolerant electrochemiluminescence (ECL) assay (and the two versions of neutralizing assays, drug-sensitive versus drug-tolerant). The ECL assay drug tolerance is ~ 100 times higher than that of the ELISA (≥ 50 μg/mL vs. 0.5 μg/mL with a 500 ng/mL positive con… Show more

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Cited by 15 publications
(15 citation statements)
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“…21 The development of ADAs has been associated with an increased risk of infusion reactions, particularly with anti-tumor necrosis factor therapy. 22,23 In contrast, consistent with previous reports, 12,18 50/227 [22.0%]). Altogether, these results suggest a low impact of immunogenicity on vedolizumab safety in inflammatory bowel disease.…”
Section: Discussionsupporting
confidence: 91%
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“…21 The development of ADAs has been associated with an increased risk of infusion reactions, particularly with anti-tumor necrosis factor therapy. 22,23 In contrast, consistent with previous reports, 12,18 50/227 [22.0%]). Altogether, these results suggest a low impact of immunogenicity on vedolizumab safety in inflammatory bowel disease.…”
Section: Discussionsupporting
confidence: 91%
“…Although vedolizumab clinical efficacy was not explored in this post hoc analysis, real‐world data support the conclusion that ADAs do not appear to play a major role in vedolizumab efficacy, 24 even in patients who discontinue and later restart vedolizumab treatment 25,26 . This is further supported by previously published results 27 and that low‐titer ADA positive status (10‐50 titer values) had minimal effect on the pharmacokinetics of vedolizumab, 18 whereas higher‐titer ADAs (≥250 titer values) affect vedolizumab clearance 28 . Additionally, a recent report suggested that immunogenicity was not a primary driver of vedolizumab treatment failure 24 …”
Section: Discussionsupporting
confidence: 80%
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