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dc.contributor.authorProbert, Christopher SJ
dc.contributor.authorSebastian, Shaji
dc.contributor.authorGaya, Daniel R
dc.contributor.authorHamlin, P John
dc.contributor.authorGillespie, Gillian
dc.contributor.authorRose, Anita
dc.contributor.authorTate, Helen
dc.contributor.authorWheeler, Colin
dc.contributor.authorIrving, Peter M
dc.contributor.authorProbert, C
dc.contributor.authorGaya, D
dc.contributor.authorSebastian, S
dc.contributor.authorHart, A
dc.contributor.authorIrving, P
dc.contributor.authorAhmad, T
dc.contributor.authorPollok, R
dc.contributor.authorOrchard, T
dc.contributor.authorArasaradnam, R
dc.contributor.authorIqbal, T
dc.contributor.authorJohnson, M
dc.contributor.authorKaser, A
dc.contributor.authorAllen, P
dc.contributor.authorGordon, J
dc.contributor.authorPreston, C
dc.contributor.authorShenderey, R
dc.contributor.authorHoque, S
dc.contributor.authorBloom, S
dc.contributor.authorAnsari, A
dc.contributor.authorMowat, C
dc.contributor.authorHamlin, J
dc.contributor.authorArnott, I
dc.contributor.authorShaw, I
dc.contributor.authorSteed, H
dc.contributor.authorButterworth, J
dc.contributor.authorRobinson, A
dc.contributor.authorMawdsley, J
dc.contributor.authorCreed, T
dc.contributor.authorCummings, F
dc.contributor.authorGrp, GO-COLITIS Study
dc.date.accessioned2021-11-04T14:26:54Z
dc.date.available2021-11-04T14:26:54Z
dc.date.issued2018-07-07
dc.identifier.citationProbert CS, Sebastian S, Gaya DR On behalf of the GO-COLITIS Study Group, et al. (2018) Golimumab induction and maintenance for moderate to severe ulcerative colitis: results from GO-COLITIS (Golimumab: a Phase 4, UK, open label, single arm study on its utilization and impact in ulcerative Colitis)BMJ Open Gastroenterology, 5:e000212. doi: 10.1136/bmjgast-2018-000212en
dc.identifier.issn2054-4774en
dc.identifier.pmid30002864 (pubmed)
dc.identifier.doi10.1136/bmjgast-2018-000212en
dc.identifier.urihttp://hdl.handle.net/2436/624434
dc.description© 2018 The Authors. Published by BMJ. This is an open access article available under a Creative Commons licence. The published version can be accessed at the following link on the publisher’s website:http://dx.doi.org/10.1136/ bmjgast-2018-000212en
dc.description.abstractGO-COLITIS aimed to measure the effectiveness of subcutaneous golimumab in tumour necrosis factor-α antagonist-naive patients with moderate to severe ulcerative colitis (UC) despite conventional treatment.GO-COLITIS was an open label, single arm, phase 4 study with a pragmatic design which reflected UK clinical practice. Adult patients were eligible if diagnosed with UC ≥3 months, partial Mayo score (PMS) 4-9. Patients received subcutaneous golimumab induction (200 mg initially and 100 mg at week 2) followed at week 6 by 50 mg or 100 mg (depending on weight) every 4 weeks until week 54 with a 12-week follow-up. Efficacy was measured by PMS at baseline, week 6, 30, 54 and 66. Health-related quality of life (HRQoL; Inflammatory Bowel Disease Questionnaire (IBDQ) and EuroQol Group 5 Dimensions Health Questionnaire (EQ-5D)) was assessed at baseline, week 6 and week 54. All safety adverse events (AEs) were recorded.207 patients were enrolled and 205 received golimumab (full analysis set (FAS)205). At week 6, 68.8% (95% CI 62.0% to 75.1%) and 38.5% (95% CI 31.8% to 45.6%) of patients were in response and remission, respectively, using PMS. At the end of the induction phase, 140/141 patients in clinical response continued into the maintenance phase (Maintenance FAS). Sustained clinical response through week 54 was achieved in 51/205 (24.9%) of the FAS205 population and 51/140 (36.4%) of the Maintenance FAS population. Statistically significant improvements from baseline to week 6 were observed for the IBDQ total score and for each IBDQ domain score (bowel symptoms, emotional function, systemic symptoms and social function), as well as the EQ-5D index score and associated visual analogue scale score (p<0.0001). Improvement of HRQoL was sustained through week 54. Serious AEs leading to treatment discontinuation occurred in 8.8% of patients.In this study measuring patient-reported outcomes in patients with moderate to severe UC, golimumab induced and maintained response as measured by PMS and significantly improved quality of life measures.NCT02092285; 2013-004583-56.en
dc.description.sponsorshipGO-COLITIS was sponsored by MSD UK, Hoddesdon, UK.en
dc.formatapplication/pdfen
dc.languageeng
dc.language.isoenen
dc.publisherBMJen
dc.rightsLicence for published version: Creative Commons Attribution-NonCommercial 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.subjectIbden
dc.subjectTNF-alphaen
dc.subjectulcerative colitisen
dc.titleGolimumab induction and maintenance for moderate to severe ulcerative colitis: results from GO-COLITIS (Golimumab: a Phase 4, UK, open label, single arm study on its utilization and impact in ulcerative Colitis)en
dc.typeJournal articleen
dc.identifier.eissn2054-4774
dc.identifier.journalBMJ Open Gastroenterologyen
dc.date.updated2020-09-09T23:09:12Z
dc.contributor.institutionDepartment of Cellular and Molecular Physiology, University of Liverpool, Liverpool, UK.
pubs.place-of-publicationEngland
dc.date.accepted2018-05-25
rioxxterms.funderMSD UK, Hoddesdon, UKen
rioxxterms.identifier.projectUOW04112021HSen
rioxxterms.versionVoRen
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by-nc/4.0/en
rioxxterms.licenseref.startdate2021-11-04en
dc.source.volume5
dc.source.issue1
dc.source.beginpagee000212
dc.description.versionPublished version
refterms.dateFCD2021-11-04T14:26:42Z
refterms.versionFCDVoR
refterms.dateFOA2021-11-04T14:26:56Z


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Licence for published version: Creative Commons Attribution-NonCommercial 4.0 International
Except where otherwise noted, this item's license is described as Licence for published version: Creative Commons Attribution-NonCommercial 4.0 International