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
Bibliographic record
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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".