P307. Safety, efficacy, and pharmacokinetics of golimumab in patients with moderately to severely Active ulcerative colitis: PURSUIT-SC long-term extension
Bibliographic record
Abstract
Methods: All consecutive active, non-operated UC patients treated with VDZ in France from June to December 2014 were assessed.From June to September 2014, VDZ was available through a centralised pre-approval programme piloted by the French regulatory agency (ANSM).After its approval by ANSM (reimbursement of the drug by social services is still pending), recruitment was extended until December 2014.Patients received VDZ (at a dose of 300 mg) at weeks 0, 2, and 6 as induction therapy and then every 8 weeks.Patients who did not respond to VDZ induction therapy at week 6 could receive VDZ 300 mg every 4 weeks.Patients were evaluated prospectively through W52.Remission was defined as a partial Mayo score < 2. Response was defined as a reduction in the partial Mayo score of at least 3 points and a decrease of at least 30% from baseline.C-reactive protein, as well as safety, was ascertained.Results: In total, 121 patients (67 males, median age: 40.4 IQR [29.7-55.2]years) were included in 33 centres.Median disease duration was 6.5 [3.8-11.4]years; 115 (95%) patients were previously treated with immunosuppressants and 116 (96%) with at least 1 anti-TNF.At baseline, median total Mayo score was 9 (IQR 8-12) and mean CRP level was 19.4 ± 21.1 mg/L.Steroid-free response rates at W14, W22, and W30 were 50%, 50%, and 54%, respectively; the steroid-free remission rates at W14, W22, and W30 were 36%, 39%, and 39%, respectively.At W14, the mean decrease of partial Mayo score and CRP level was 2.5 ± 2.8 (p < 0.001) and 3.8 ± 22.5 (p = 0.02), respectively.At W14, adverse events were reported in 22 ( 18%) patients and consisted of opportunistic infection (n = 13, including nasopharyngitis [n = 6], upper respiratory tract infection [n = 4], Clostridium difficile superinfection [n = 1], cholecystitis [n = 1], and tuberculosis [n = 1]), cutaneous reaction (n = 5), paraesthesia (n = 2), strokes (n = 1), and deep venous thrombosis (n = 1). Conclusions:In this first real-life experience cohort of patients with refractory UC, vedolizumab-induced steroid-free clinical remission in one-third of the cases at W14, with an acceptable safety profile.The efficacy of VDZ remained stable through W30 and will be assessed in January 2016 through W52.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".