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Low Golimumab trough levels at week 6 are associated with poor clinical, endoscopic and histological outcomes in ulcerative colitis patients: pharmacokinetic and pharmacodynamic sub-analysis of the evolution study

2019-11Journal article Restricted access
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dc.contributor.authorMagro, F.
dc.contributor.authorLopes, S.
dc.contributor.authorSilva, M.
dc.contributor.authorCoelho, R.
dc.contributor.authorPortela, F.
dc.contributor.authorBranquinho, D.
dc.contributor.authorCorreia, L.
dc.contributor.authorFernandes, S.
dc.contributor.authorCravo, M.
dc.contributor.authorCaldeira, Paulo
dc.contributor.authorSousa, Helena Tavares
dc.contributor.authorPatita, M.
dc.contributor.authorLago, P.
dc.contributor.authorRamos, J.
dc.contributor.authorAfonso, J.
dc.contributor.authorRedondo, I.
dc.contributor.authorMachado, P.
dc.contributor.authorCornillie, F.
dc.contributor.authorLopes, J.
dc.contributor.authorCarneiro, F.
dc.date.accessioned2020-07-24T10:51:03Z
dc.date.available2020-07-24T10:51:03Z
dc.date.issued2019-11
dc.description.abstractBackground and Aims: Golimumab has an established exposure-response relationship in patients with ulcerative colitis [UC]. However, the association of serum golimumab trough levels [TL] with objective markers of disease activity, such as endoscopic and histological activity scores and concentrations of biomarkers, remains less understood. This report describes the relationship of serum golimumab TL at the end of the induction period [Week 6] with clinical, endoscopic, histological, and biomarker parameters. Methods: This was an open-label, uncontrolled, prospective and interventional study. Moderate to severely active UC patients naive to biologic therapy were treated with golimumab. Serum golimumab TL and faecal calprotectin levels were measured at baseline [Week 0 of induction] and Week 6. Results: A total of 34 patients completed the induction phase [Week 6] and were included in this analysis. Overall, 47.1% and 14.7% of patients achieved clinical response and remission with significantly higher serum golimumab TL in patients with early response or remission [3.7 mu g/mL vs 1.3 mu g/mL, p = 0.0013; and 3.1 mu g/mL vs 1.7 mu g/mL, p = 0.0164, respectively]. In addition, golimumab TL were significantly higher in patients achieving histological remission [4.2 mu g/mL vs 1.7 mu g/mL, p = 0.0049]. Week 6 golimumab TL were inversely correlated with the total Mayo score [rs = -0.546; p = 0.0008], the Mayo endoscopic subscore [rs = -0.381; p = 0.0262], the Geboes histological activity score [rs = -0.464; p = 0.0057], and faecal calprotectin levels [rs = -0.497; p = 0.0044]. Conclusions: A higher early exposure to golimumab is associated with a better objective response in active UC patients and appears to drive the outcome at Week 6.
dc.description.sponsorshipMSD Portugal [MK8259-22]
dc.description.versioninfo:eu-repo/semantics/publishedVersion
dc.identifier.doi10.1093/ecco-jcc/jjz071
dc.identifier.issn1873-9946
dc.identifier.urihttp://hdl.handle.net/10400.1/14191
dc.language.isoeng
dc.peerreviewedyes
dc.publisherOxford University Press
dc.subjectInduction
dc.subjectTherapy
dc.subjectDisease
dc.subjectGolimumab
dc.subjectTrough levels
dc.subjectUlcerative colitis
dc.titleLow Golimumab trough levels at week 6 are associated with poor clinical, endoscopic and histological outcomes in ulcerative colitis patients: pharmacokinetic and pharmacodynamic sub-analysis of the evolution study
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage1393
oaire.citation.issue11
oaire.citation.startPage1387
oaire.citation.titleJournal of Crohn's and Colitis
oaire.citation.volume13
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
rcaap.rightsrestrictedAccess
rcaap.typearticle
relation.isAuthorOfPublication3def3720-8982-4c46-801d-af640d508b59
relation.isAuthorOfPublication6b1d11dd-486f-4fb3-b41f-02e1cf6a5c2e
relation.isAuthorOfPublication.latestForDiscovery3def3720-8982-4c46-801d-af640d508b59

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