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PTU-070 Patient-Reported Quality of Life During Golimumab Induction for Moderate to Severe Ulcerative Colitis in the United Kingdom: Results from The Go-Colitis Study
  1. P Irving1,
  2. C Probert2,
  3. D Gaya3,
  4. PJ Hamlin4,
  5. S Sebastian5,
  6. G Gillespie6,
  7. H Tate6,
  8. C Wheeler6
  1. 1Guy’s and St. Thomas’ Hospitals, London
  2. 2University of Liverpool, Liverpool
  3. 3Glasgow Royal Infirmary, Glasgow
  4. 4Leeds Teaching Hospitals Trust, Leeds
  5. 5Hull & East Yorkshire NHS Trust, Hull
  6. 6MSD UK, Hoddesdon, UK

Abstract

Introduction Consistent relief of symptoms is among the most important attributes considered by patients with ulcerative colitis (UC) when selecting a therapy.1 GO-COLITIS (NCT02092285; 2013–004583-56) is a UK phase 4, multicentre, open-label, single-arm trial of golimumab (GLM) for the treatment of moderate to severe UC. Here, we report the results of an analysis of patient-reported quality of life (QoL) at the end of the GLM induction phase.

Methods Anti-TNF naive patients (≥18 y) with UC ≥ 3 months and with moderate to severe disease (partial Mayo score 4–9 or full Mayo score 6–12) at baseline, Mayo rectal bleeding subscore ≥1, and endoscopy subscore ≥2 (if full Mayo was used) were included. Patients received subcutaneous GLM on day 0 (200 mg) and day 14 (100 mg) during the 6 week induction phase, followed by GLM 50 or 100 mg every 4 weeks during the 48 week maintenance phase with 12 week follow-up, in line with the Summary of Product Characteristics. Patients completed the Inflammatory Bowel Disease Questionnaire (IBDQ) and EuroQoL Group 5 Dimensions Health Questionnaire (EQ-5D) at baseline and at week 6 during GLM induction. Data were summarised descriptively.

Results 205 patients were enrolled (mean [range] age, 39.3 [18–79] years; male, n = 123 [60%]). All patients received one or two doses of induction GLM. Statistically significant improvements from baseline to induction week 6 (mean [SD]) were observed for IBDQ total score (Baseline: 115.9 (32.4); week 6: 161.9 (38.2); change from baseline of 45.2 [37.4] (p < 0.0001), as well as the individual IBDQ domains of bowel symptoms, emotional function, systemic symptoms, and social function (all p < 0.0001). In addition, significant improvements in the EQ-5D index score (0.1 [0.2]; p < 0.0001) and health state visual analogue scale (VAS) (15.6 [26.6]; p < 0.0001) were observed

Conclusion During the GLM induction phase of the GO-COLITIS study, patients with moderate to severe UC experienced significant improvements from baseline in disease-specific QoL, including bowel symptoms, emotional function, systemic symptoms, and social function, as well as generic QoL.

Reference 1 GreyGray JR, et al. Aliment Pharmacol Ther 2009;29:1114–1120.

Disclosure of Interest P. Irving Grant/research support from: MSD, Takeda, Consultant for: Abbvie, Warner Chilcott, Takeda, MSD, Vifor Pharma, Pharmacosmos, Topivert, Genentech, Hospira, Speaker bureau with: Abbvie, Falk Pharma, Ferring, MSD, Shire, Takeda, Warner Chilcott, Johnson and Johnson, C. Probert Consultant for: Abbvie, MSD, Napp, Takeda, Speaker bureau with: Abbvie, Ferring, Falk Pharma, MSD, Shire, Takeda, Conflict with: Abbvie, Falk Pharma, MSD, Shire, Takeda, D. Gaya Speaker bureau with: Abbvie, Falk Pharma, Ferring, MSD, Shire, Takeda, Vifor, Conflict with: Abbvie, Falk Pharma, MSD, Shire, Takeda, Vifor, P. Hamlin Speaker bureau with: Abbvie, Ferring, MSD, Takeda, Warner Chilcott, Tillots, Conflict with: Abbvie, Falk Pharma, MSD, Tillotts, S. Sebastian Grant/research support from: Abbvie, Ferring, Warner Chilcott, Johnson and Johnson, Consultant for: Falk Pharma, Ferring, MSD, Takeda, Vifor, Warner Chilcott, Speaker bureau with: Abbvie, Takeda, Warner Chilcott, G. Gillespie Shareholder of: MSD UK, Conflict with: Employment: MSD UK, H. Tate Consultant for: MSD UK, C. Wheeler Shareholder of: MSD UK, Conflict with: Employment: MSD UK

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