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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)

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Inflammatory bowel disease
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)
  1. Christopher SJ Probert1,
  2. Shaji Sebastian2,
  3. Daniel R Gaya3,
  4. P John Hamlin4,
  5. Gillian Gillespie5,
  6. Anita Rose5,
  7. Helen Tate6,
  8. Colin Wheeler5,
  9. Peter M Irving7
  10. On behalf of the GO-COLITIS Study Group
  1. 1 Department of Cellular and Molecular Physiology, University of Liverpool, Liverpool, UK
  2. 2 IBD Unit, Hull and East Yorkshire Hospitals NHS Trust Hull, Hull, Kingston upon Hull, UK
  3. 3 Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK
  4. 4 Department of Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  5. 5 Medical Affairs, MSD UK, Hoddesdon, UK
  6. 6 New House Farm, Purton End, Saffron Walden, UK
  7. 7 Department of Gastroenterology, Guy’s and St. Thomas’ NHS Foundation Trust, London, UK
  1. Correspondence to Dr Christopher SJ Probert; chris.probert{at}liverpool.ac.uk

Abstract

Objective 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.

Design 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.

Results 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.

Conclusion 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.

Trial registration number NCT02092285; 2013-004583-56.

  • ulcerative colitis
  • tnf-alpha
  • Ibd

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjgast-2018-000212

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    Footnotes

    • Contributors CSJP, SS, GG, HT, CW and PMI contributed to the design of the study. CSJP, SS, DRG, PJH and PMI collected the data. PJH, GG, AR, HT and CW analysed the data and all authors contributed to the interpretation of the data. CSJP wrote the article and all authors critically reviewed and approved the final version of the manuscript.

    • Funding GO-COLITIS was sponsored by MSD UK, Hoddesdon, UK.

    • Competing interests CSJP acted as a paid advisor to MSD, Abbvie, Dr Falk, Ferring, Janssen, Napp, Pfizer, Shield, Takeda and Vifor and Dr Falk. Study grants received from Shield. SS holds research grants from Takeda, AbbVie, Warner Chilcott, Ferring, Biohit and Celgene, served on the advisory boards of Takeda, AbbVie, Merck, Ferring, Pharmacocosmos, Warner Chilcott, Janssen, Falk Pharma, Biohit, TriGenix, Cellgene and Tillots Pharma and has received speakers fees from AbbVie, Warner Chilcott, Janssen, Takeda, Tillots Pharma and Falk Pharma. DRG received speaker honoraria/travel grants from MSD, Abbvie, Ferring,Janssen, Vifor, Tillots and Dr Falk. PJH served as a speaker for Abbvie, Ferring, Janssen, MSD, Takeda, Tillotts,Warner Chilcott. GG and AR are employees (and shareholders) of MSD. HT carried out statistical consultancy work for MSD as an independent statistician. CW was an employee of MSD. PI received honoraria for acting in an advisory capacity for or speaking on behalf of Abbvie, MSD, Takeda, Janssen, Falk, Ferring, Shire, Tillotts, VH2, Topivert, Pfizer, Lilly and Samsung Bioepis. Research grants received from Takeda, MSD and Janssen.

    • Patient consent Not required.

    • Ethics approval The study protocol and its amendments (8259-032-03) were approved by an independent ethics committee (Committee North West – Liverpool Central of the National Research Ethics Service) and the Medicines and Healthcare Products Regulatory Agency.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Additional data available on request. Please direct enquiries to Colin Wheeler (colin@southwoodresearch.com).

    • Collaborators The participating investigators for the GO-COLITIS Study Group were: C Probert, Royal Liverpool Hospital, Liverpool, UK (PI); D Gaya, Glasgow Royal Infirmary, Glasgow, UK; S Sebastian, Hull Royal Infirmary, Hull, UK; A Hart, St Mark’s Hospital, London, UK; P Irving, St Thomas' Hospital, London, UK; T Ahmad, Royal Devon and Exeter, Exeter, Devon; UK; R Pollok, St George’s Hospital, London, UK; T Orchard, St Marys Hospital, London, UK, R Arasaradnam, University Hospital Coventry, Coventry, UK; T Iqbal, Queen Elizabeth Hospital, Birmingham, UK; M Johnson, Luton and Dunstable University Hospital, Luton, UK; A Kaser, Addenbrooke’s Hospital, Cambridge, UK; P Allen, The Ulster Hospital, Belfast, UK; J Gordon, Royal Hampshire County Hospital, Winchester, UK; C Preston, Bradford Royal Infirmary, Bradford, UK; R Shenderey, Airedale General Hospital, Keighley, UK; S Hoque, Whipps Cross University Hospital, London, UK; S Bloom, University College Hospital, London, UK; A Ansari, East Surrey Hospital, Redhill, UK; C Mowat, Medical Research Institute, Ninewells hospital, Dundee, UK; J Hamlin, St James’s Hospital, Leeds, UK; I Arnott, Western General Hospital, Edinburgh, UK; I Shaw, Gloucester Royal Hospital, Gloucester, UK; H Steed, Royal Wolverhampton hospital, Wolverhampton, UK; J Butterworth, Royal Shrewsbury Hospital, Shrewsbury, UK; A Robinson, Salford Royal NHS Foundation Trust, Salford, UK; J Mawdsley, West Middlesex University Hospital, Isleworth, UK; T Creed, Bristol Royal Infirmary, Bristol, UK; F Cummings, Southampton General Hospital, Southampton, UK.