PMID- 30002864
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220321
IS  - 2054-4774 (Print)
IS  - 2054-4774 (Electronic)
IS  - 2054-4774 (Linking)
VI  - 5
IP  - 1
DP  - 2018
TI  - 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).
PG  - e000212
LID - 10.1136/bmjgast-2018-000212 [doi]
LID - e000212
AB  - OBJECTIVE: GO-COLITIS aimed to measure the effectiveness of subcutaneous 
      golimumab in tumour necrosis factor-alpha 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.
FAU - Probert, Christopher Sj
AU  - Probert CS
AUID- ORCID: 0000-0003-4550-0239
AD  - Department of Cellular and Molecular Physiology, University of Liverpool, 
      Liverpool, UK.
FAU - Sebastian, Shaji
AU  - Sebastian S
AD  - IBD Unit, Hull and East Yorkshire Hospitals NHS Trust Hull, Hull, Kingston upon 
      Hull, UK.
FAU - Gaya, Daniel R
AU  - Gaya DR
AD  - Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK.
FAU - Hamlin, P John
AU  - Hamlin PJ
AD  - Department of Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
FAU - Gillespie, Gillian
AU  - Gillespie G
AD  - Medical Affairs, MSD UK, Hoddesdon, UK.
FAU - Rose, Anita
AU  - Rose A
AD  - Medical Affairs, MSD UK, Hoddesdon, UK.
FAU - Tate, Helen
AU  - Tate H
AD  - New House Farm, Purton End, Saffron Walden, UK.
FAU - Wheeler, Colin
AU  - Wheeler C
AD  - Medical Affairs, MSD UK, Hoddesdon, UK.
FAU - Irving, Peter M
AU  - Irving PM
AD  - Department of Gastroenterology, Guy's and St. Thomas' NHS Foundation Trust, 
      London, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT02092285
PT  - Journal Article
DEP - 20180707
PL  - England
TA  - BMJ Open Gastroenterol
JT  - BMJ open gastroenterology
JID - 101660690
PMC - PMC6038835
OTO - NOTNLM
OT  - Ibd
OT  - tnf-alpha
OT  - ulcerative colitis
COIS- 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.
EDAT- 2018/07/14 06:00
MHDA- 2018/07/14 06:01
PMCR- 2018/07/07
CRDT- 2018/07/14 06:00
PHST- 2018/04/17 00:00 [received]
PHST- 2018/05/16 00:00 [revised]
PHST- 2018/05/25 00:00 [accepted]
PHST- 2018/07/14 06:00 [entrez]
PHST- 2018/07/14 06:00 [pubmed]
PHST- 2018/07/14 06:01 [medline]
PHST- 2018/07/07 00:00 [pmc-release]
AID - bmjgast-2018-000212 [pii]
AID - 10.1136/bmjgast-2018-000212 [doi]
PST - epublish
SO  - BMJ Open Gastroenterol. 2018 Jul 7;5(1):e000212. doi: 
      10.1136/bmjgast-2018-000212. eCollection 2018.