P310 Patient-reported quality of life during golimumab induction for moderate-to-severe ulcerative colitis in the United Kingdom: results from the GO-COLITIS study
P. Irving*1, C. Probert2, D. R. Gaya3, P. J. Hamlin4, S. Sebastian5, G. Gillespie6, H. Tate6, C. Wheeler6
1Guy’s and St Thomas’ Hospitals, London, United Kingdom, 2University of Liverpool, Liverpool, United Kingdom, 3Glasgow Royal Infirmary, Glasgow, United Kingdom, 4Leeds Teaching Hospitals Trust, Leeds, United Kingdom, 5Hull & East Yorkshire NHS Trust, Hull, United Kingdom, 6MSD UK, Hoddesdon, United Kingdom
Background
Consistent relief of symptoms is amongst the most important attributes considered by patients with ulcerative colitis (UC) when selecting a therapy.1 GO-COLITIS (NCT02092285; 20130–045835–6) is a phase 4, multicentre, open-label, single-arm trial of golimumab (GLM) for the treatment of moderate-to-severe UC in patients in the United Kingdom. We report the results of an analysis of patient-reported quality of life (QoL) at the end of the GLM induction phase.
Methods
Anti-tumour necrosis (TNF)-naïve 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 subs-core ≥ 1, and endoscopy sub-score ≥ 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
In total, 205 patients were enrolled (mean [range] age, 39.3 [18–79] years; male, n = 123 [60%]). All patients received 1 or 2 doses of induction GLM. Mean changes from baseline to induction week 6 in the IBDQ and EQ-5D scales are summarised in the Table. Statistically significant improvements from baseline to week 6 were observed for the IBDQ total score, as well as the individual IBDQ domains of bowel symptoms, emotional function, systemic symptoms, and social function. In addition, significant improvements in the EQ-5D index score and health state visual analogue scale (VAS) were observed.
Table 1. Mean (SD) change from baseline to week 6 in IBDQ and EQ-5D
| n | Baseline | n | Week 6 | n | Change from baselinea | P -value | |
|---|---|---|---|---|---|---|---|
| IBDQ total scoreb | 202 | 115.9 (32.4) | 195 | 161.9 (38.2) | 192 | 45.2 (37.4) | < 0.0001 |
| Bowel symptoms | 204 | 3.7 (1.0) | 195 | 5.2 (1.2) | 195 | 1.5 (1.2) | < 0.0001 |
| Emotional function | 204 | 3.5 (1.2) | 195 | 4.9 (1.3) | 195 | 1.4 (1.3) | < 0.0001 |
| Systemic symptoms | 204 | 3.3 (1.1) | 195 | 4.7 (1.3) | 195 | 1.4 (1.3) | < 0.0001 |
| Social function | 204 | 3.9 (1.6) | 195 | 5.4 (1.5) | 195 | 1.5 (1.6) | < 0.0001 |
| EQ-5D index score | 201 | 0.7 (0.2) | 192 | 0.8 (0.2) | 188 | 0.1 (0.2) | < 0.0001 |
| EQ-5D health state VAS, mm | 195 | 46.9 (22.6) | 194 | 62.7 (25.3) | 184 | 15.6 (26.6) | < 0.0001 |
| aIncreases indicate improvement. P-values calculated using paired t-test | |||||||
| bMeans for all values in each of the 4 IBDQ domains are shown |
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. The degree of improvement in IBDQ total score exceeded the IBDQ increase cut-off (> 20 points) previously identified as representative of a patient-defined improvement in an assessment of UC clinical endpoints.2
References:
[1] Gray JR, Leung E, Scales J. Treatment of ulcerative colitis from the patient’s perspective: a survey of preferences and satisfaction with therapy. Aliment Pharmacol Ther 2009;29(10):1114–20,
[2] Higgins PDR, Schwartz M, Mapili J, et al. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut 2005;54(6):782–88.