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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)

Probert, Christopher SJ
; 
Sebastian, Shaji
; 
Gaya, Daniel R
; 
Hamlin, P John
; 
Gillespie, Gillian
; 
Rose, Anita
; 
Tate, Helen
; 
Wheeler, Colin
; 
Irving, Peter M
; 
Probert, C
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Authors
Probert, Christopher SJ
 Sebastian, Shaji
 Gaya, Daniel R
 Hamlin, P John
 Gillespie, Gillian
 Rose, Anita
 Tate, Helen
 Wheeler, Colin
 Irving, Peter M
 Probert, C
 Gaya, D
 Sebastian, S
 Hart, A
 Irving, P
 Ahmad, T
 Pollok, R
 Orchard, T
 Arasaradnam, R
 Iqbal, T
 Johnson, M
 Kaser, A
 Allen, P
 Gordon, J
 Preston, C
 Shenderey, R
 Hoque, S
 Bloom, S
 Ansari, A
 Mowat, C
 Hamlin, J
 Arnott, Ian
 Shaw, I
 Steed, Helen
 Butterworth, J
 Robinson, A
 Mawdsley, J
 Creed, T
 Cummings, F
 Grp, GO-COLITIS Study
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Other contributors
Affiliation
Epub Date
Issue Date
2018-07-07
Submitted date
Subjects
Ibd
 TNF-alpha
 ulcerative colitis
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Abstract
GO-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.
Citation
Probert 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-2018-000212
Publisher
BMJ
Journal
BMJ Open Gastroenterology
Research Unit
URI
http://hdl.handle.net/2436/624434
DOI
10.1136/bmjgast-2018-000212
PubMed ID
30002864 (pubmed)
PubMed Central ID
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Type
Journal article
Language
en
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-2018-000212
Series/Report no.
ISSN
2054-4774
EISSN
2054-4774
ISBN
ISMN
Gov't Doc #
Sponsors
GO-COLITIS was sponsored by MSD UK, Hoddesdon, UK.
Rights
Licence for published version: Creative Commons Attribution-NonCommercial 4.0 International
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