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Detection of anti-infliximab antibodies is impacted by antibody titer, infliximab level and IgG4 antibodies: a systematic comparison of three different assays

2016-07Journal article Open access
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dc.contributor.authorAfonso, Joana
dc.contributor.authorLopes, Susana
dc.contributor.authorGonçalves, Raquel
dc.contributor.authorCaldeira, Paulo
dc.contributor.authorLago, Paula
dc.contributor.authorSousa, Helena Tavares
dc.contributor.authorRamos, Jaime
dc.contributor.authorGonçalves, Ana Rita
dc.contributor.authorMinistro, Paula
dc.contributor.authorRosa, Isadora
dc.contributor.authorVieira, Ana Isabel
dc.contributor.authorCoelho, Rosa
dc.contributor.authorTavares, Patrícia
dc.contributor.authorSoares, João
dc.contributor.authorSousa, Ana Lúcia
dc.contributor.authorCarvalho, Diana
dc.contributor.authorSousa, Paula
dc.contributor.authorSilva, João Pereira da
dc.contributor.authorMeira, Tânia
dc.contributor.authorFerreira, Filipa Silva
dc.contributor.authorDias, Cláudia Camila
dc.contributor.authorChowers, Yehuda
dc.contributor.authorBen-Horin, Shomron
dc.contributor.authorMagro, Fernando
dc.date.accessioned2017-04-07T15:55:46Z
dc.date.available2017-04-07T15:55:46Z
dc.date.issued2016-07
dc.description.abstractBackground: There is scant information on the accuracy of different assays used to measure anti-infliximab antibodies (ADAs), especially in the presence of detectable infliximab (IFX). We thus aimed to evaluate and compare three different assays for the detection of IFX and ADAs and to clarify the impact of the presence of circulating IFX on the accuracy of the ADA assays.Methods: Blood samples from 79 ulcerative colitis (UC) patients treated with infliximab were assessed for IFX levels and ADAs using three different assays: an in-house assay and two commercial kits, Immundiagnostik and Theradiag. Sera samples with ADAs and undetectable levels of IFX were spiked with exogenous IFX and analyzed for ADAs.Results: The three assays showed 81-96% agreement for the measured IFX level. However, the in-house assay and Immundiagnostik assays detected ADAs in 34 out of 79 samples, whereas Theradiag only detected ADAs in 24 samples. Samples negative for ADAs with Theradiag, but ADA-positive in both the in-house and Immundiagnostik assays, were positive for IFX or IgG4 ADAs. In spiking experiments, a low concentration of exogenous IFX (5 mu g/ml) hampered ADA detection with Theradiag in sera samples with ADA levels of between 3 and 10 mu g/ml. In the Immundiagnostik assay detection interference was only observed at concentrations of exogenous IFX higher than 30 mu g/ml. However, in samples with high levels of ADAs (> 25 mu g/ml) interference was only observed at IFX concentrations higher than 100 mu g/ml in all three assays. Binary (IFX/ADA) stratification of the results showed that IFX+/ADA and IFX-/ADAs + were less influenced by the assay results than the double-positive (IFX+/ADAs+) and double-negative (IFX-/ADAs-) combination.Conclusions: All three methodologies are equally suitable for measuring IFX levels. However, erroneous therapeutic decisions may occur when patients show double-negative (IFX-/ADAs) or double-positive (IFX+/ADAs+) status, since agreement between assays is significantly lower in these circumstances.
dc.identifier.doi10.1177/1756283X16658223
dc.identifier.issn1756-283X
dc.identifier.urihttp://hdl.handle.net/10400.1/9216
dc.language.isoeng
dc.peerreviewedyes
dc.publisherSAGE Publications
dc.relation.isbasedonWOS:000393291500003
dc.subjectAnti-infliximab antibodies
dc.subjectAnti-Infliximab antibody methodologies
dc.subjectInfliximab trough levels
dc.subjectTherapeutic drug monitoring
dc.titleDetection of anti-infliximab antibodies is impacted by antibody titer, infliximab level and IgG4 antibodies: a systematic comparison of three different assays
dc.typejournal article
dspace.entity.typePublication
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/5876-PPCDTI/EXPL%2FIVC-PEC%2F1302%2F2013/PT
oaire.citation.endPage794
oaire.citation.issue6
oaire.citation.startPage781
oaire.citation.titleTherapeutic Advances in Gastroenterology
oaire.citation.volume9
oaire.fundingStream5876-PPCDTI
person.familyNameCaldeira
person.familyNameSousa
person.givenNamePaulo
person.givenNameHelena Tavares
person.identifier.ciencia-id1112-F0B2-19A3
person.identifier.ciencia-idCF1F-1163-1C4A
person.identifier.orcid0000-0002-2404-6295
person.identifier.orcid0000-0002-6626-205X
project.funder.identifierhttp://doi.org/10.13039/501100001871
project.funder.nameFundação para a Ciência e a Tecnologia
rcaap.rightsopenAccess
rcaap.typearticle
relation.isAuthorOfPublication3def3720-8982-4c46-801d-af640d508b59
relation.isAuthorOfPublication6b1d11dd-486f-4fb3-b41f-02e1cf6a5c2e
relation.isAuthorOfPublication.latestForDiscovery6b1d11dd-486f-4fb3-b41f-02e1cf6a5c2e
relation.isProjectOfPublication65392e8c-c247-4390-bccf-91bb5109dda8
relation.isProjectOfPublication.latestForDiscovery65392e8c-c247-4390-bccf-91bb5109dda8

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