| Title: |
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) |
| Authors: |
Probert, CSJ; Sebastian, S; Gaya, DR; Hamlin, PJ; Gillespie, G; Rose, A; Tate, H; Wheeler, C; Irving, PM; Probert, C; Gaya, D; 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, I; Shaw, I; Steed, H; Butterworth, J; Robinson, A; Mawdsley, J; Creed, T; Cummings, F; GO-COLITIS Study Grp |
| Publisher Information: |
BMJ Publishing Group |
| Publication Year: |
2018 |
| Collection: |
St George's University of London: Repository |
| Description: |
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 |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
2054-4774 |
| Relation: |
https://openaccess.sgul.ac.uk/id/eprint/110765/1/e000212.full.pdf; Probert, CSJ; Sebastian, S; Gaya, DR; Hamlin, PJ; Gillespie, G; Rose, A; Tate, H; Wheeler, C; Irving, PM; Probert, C; et al. Probert, CSJ; Sebastian, S; Gaya, DR; Hamlin, PJ; Gillespie, G; Rose, A; Tate, H; Wheeler, C; Irving, PM; 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, I; Shaw, I; Steed, H; Butterworth, J; Robinson, A; Mawdsley, J; Creed, T; Cummings, F; GO-COLITIS Study Grp (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 (1). e000212. ISSN 2054-4774 https://doi.org/10.1136/bmjgast-2018-000212 SGUL Authors: Pollok, Richard Charles G |
| Availability: |
https://openaccess.sgul.ac.uk/id/eprint/110765/; https://openaccess.sgul.ac.uk/id/eprint/110765/1/e000212.full.pdf |
| Rights: |
cc_by_nc_4 |
| Accession Number: |
edsbas.FE5B6CEF |
| Database: |
BASE |