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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.

2019-10-28Clinical trial Open 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, P
dc.contributor.authorSousa, H T
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.accessioned2025-07-15T11:19:52Z
dc.date.available2025-07-15T11:19:52Z
dc.date.issued2019-10-28
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 naïve 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 μg/mL vs 1.3 μg/mL, p = 0.0013; and 3.1 μg/mL vs 1.7 μg/mL, p = 0.0164, respectively]. In addition, golimumab TL were significantly higher in patients achieving histological remission [4.2 μg/mL vs 1.7 μg/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.eng
dc.identifier.citationJ Crohns Colitis . 2019;13(11):1387-1393.
dc.identifier.doi10.1093/ecco-jcc/jjz071.
dc.identifier.pmid30989180
dc.identifier.urihttp://hdl.handle.net/10400.17/5108
dc.language.isoeng
dc.peerreviewedyes
dc.publisherOxford University Press
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectHSAC GAS
dc.subjectAdult
dc.subjectFemale
dc.subjectHumans
dc.subjectAntibodies
dc.subjectMonoclonal / administration & dosage*
dc.subjectMonoclonal / blood*
dc.subjectBiomarkers / analysis
dc.subjectC-Reactive Protein / analysis
dc.subjectColitis
dc.subjectUlcerative / drug therapy*
dc.subjectUlcerative / pathology
dc.subjectDose-Response Relationship
dc.subjectDrug
dc.subjectDrug Administration Schedule
dc.subjectDrug Therapy
dc.subjectCombination
dc.subjectEndoscopy
dc.subjectGastrointestinal
dc.subjectFeces / chemistry
dc.subjectGastrointestinal Agents / administration & dosage
dc.subjectGastrointestinal Agents / blood
dc.subjectGlucocorticoids / therapeutic use
dc.subjectImmunosuppressive Agents / therapeutic use
dc.subjectLeukocyte L1 Antigen Complex / analysis
dc.subjectMale
dc.subjectPortugal
dc.subjectProspective Studies
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.eng
dc.typeclinical trial
dspace.entity.typePublication
oaire.citation.endPage1393
oaire.citation.issue11
oaire.citation.startPage1387
oaire.citation.titleJournal of Crohn's & Colitis
oaire.citation.volume13
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85

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