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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.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.pmid30002864 (pubmed)
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: 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.rightsLicence for published version: Creative Commons Attribution-NonCommercial 4.0 International
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.journalBMJ Open Gastroenterologyen
dc.contributor.institutionDepartment of Cellular and Molecular Physiology, University of Liverpool, Liverpool, UK.
rioxxterms.funderMSD UK, Hoddesdon, UKen
dc.description.versionPublished version

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Licence for published version: Creative Commons Attribution-NonCommercial 4.0 International
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