OC-003 Efficacy and Safety of Golimumab Induction for Moderate to Severe Ulcerative Colitis in the United Kingdom: Results from the Go-Colitis Study
Bibliographic record
Abstract
Introduction Induction and maintenance of clinical response is a treatment goal for ulcerative colitis (UC). GO-COLITIS (NCT02092285; 2013–004583-56) is a UK phase 4, multicentre, open-label, single-arm trial evaluating the efficacy of golimumab (GLM) in induction and maintenance of clinical response in patients with moderate to severe UC. We report the results of an interim analysis of clinical response 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 Mayo score 6–12) at baseline, Mayo rectal bleeding subscore ≥1, and Mayo endoscopy subscore ≥2 (if full Mayo was used) were included. Patients received SC 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. Clinical response and remission were summarised descriptively at the end of week 6. Clinical response was defined as decrease in partial Mayo score of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding score ≤1. Patients without scores were considered nonresponders. Clinical remission was defined as partial Mayo score ≤2 and no individual Mayo subscore >1. Results 205 patients were enrolled (mean [range] age, 39.3 [18–79] years; male, n = 123 [60%]). The mean baseline (SD) partial Mayo score was 6.4 (1.4). All patients received one or two doses of induction GLM. Clinical responses occurred in 141/205 patients (response rate, 68.8%; 95% CI, 62.0%–75.1%). Clinical remission occurred in 79/205 patients (remission rate, 38.5%; 95% CI, 31.8%–45.6%). The mean (SD) change from baseline in partial Mayo score (n = 198) was –3.2 (2.4). AEs (any cause) occurred in 37 (18%) patients. Serious AEs occurred in 17 (8%) patients: UC flare/worsening (n = 11), accidental overdose (n = 2), anaphylaxis (n = 1), constipation (n = 1), rectal fissure (n = 1), and respiratory tract infection (n = 1). Eight patients (4%) discontinued due to serious AEs. There were no fatal AEs. Conclusion During the GLM induction phase of GO-COLITIS, 68.8% of patients had a partial Mayo response and were eligible to continue to the 48 week maintenance phase. AEs were consistent with previous observations; no new safety signals were identified. Disclosure of Interest C. Probert Consultant for: Abbvie, MSD, Napp, Takeda, Speaker bureau with: Abbvie, Falk, Ferring, MSD, Shire, Takeda, Conflict with: Abbvie, Falk, MSD, Shire, Takeda, D. Gaya Speaker bureau with: Abbvie, Falk, Ferring, MSD, Shire, Takeda, Vifor, Conflict with: Abbvie, Falk, Ferring, MSD, Shire, Takeda, Vifor, P. Hamlin Speaker bureau with: Abbvie, Ferring, MSD, Takeda, Tillotts, Warner Chilcott, Conflict with: Abbvie, Falk, MSD, Tillotts, P. Irving Grant/research support from: MSD, Takeda, Consultant for: Abbvie, MSD, Takeda, Warner Chilcott, Vifor Pharma. Pharmacosmos, Topivert, Genentech, Hospira, Speaker bureau with: Abbvie, Falk Pharma, Ferring, MSD, Takeda, Warner Chilcott, Johnson and Johnson, Shire, S. Sebastian Grant/research support from: Abbvie, Ferring, Warner Chilcott, Consultant for: Falk Pharma, Ferring, MSD, Takeda, Warner Chilcott, Vifor Pharma, 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 | 0.003 |
| 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 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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".