P583. Real-world use and effectiveness of golimumab for ulcerative colitis in Canada
Bibliographic record
Abstract
Background: Measurement of trough levels and detection of antidrug antibodies have gained importance in the management of loss of response (LOR) in inflammatory bowel diseases (IBD) patients under anti-tumour necrosis factor (TNF)-alpha therapy.Nevertheless, their role in quiescent IBD is still debated.The aim of this study was to assess predictive value of infliximab trough levels in quiescent IBD under maintenance infliximab therapy.Methods: We conducted a single-centre prospective study enrolling all consecutive IBD patients in clinical remission under maintenance infliximab therapy between January and March 2011.Clinical remission was defined as CDAI < 150 in Crohn's disease (CD) and as a simplified Mayo score < 3 in ulcerative colitis (UC).Trough levels of Infliximab in serum (TLI) and antibodies to Infliximab (ATI) were assessed just before infliximab infusion.Loss of response (LOR) was pragmatically defined by the occurrence of either a therapy optimisation, a switch to another biologic, an intestinal surgery, or an IBD complication.Patients were prospectively monitored between January 2011 and March 2014.C-reactive protein (CRP) levels were collected, and CDAI or simplified Mayo score were calculated at each infliximab infusion.Univariate and multivariate analysis using Cox model were performed to identify predictive factors of LOR.Results: In total, 66 patients with quiescent IBD (29 CD and 37 UC) were included.Average age was 35.5 years [17-86] and sex ratio M / F was 0.94.At baseline, 32 patients had TLI < 3 µg/ ml (IFX-group), and 34 had TLI > 3 µg/ml (IFX+ group).The 2 groups were similar regarding age at IBD onset, gender distribution, smoker status, and IBD clinical features according to the Montreal Classification and concomitant immunosuppressive therapy.ATI were found in 5 (15.1%) patients from the IFX-group but in none of the IFX+ group.LOR was significantly higher in IFX-group when compared with the IFX+ (51.7% vs 22.2%; p = 0.02).Rates of complications, therapy optimisation and surgery requirements were similar in the 2 groups.Multivariate analysis showed that 2 factors were associated with LOR within 3 years: TLI < 3 µg/ ml at baseline (OR = 3.67; IC 95% [1.39-9.69];p = 0.009) and perianal lesions at baseline (OR = 3; IC 95% [1.20-2.46];p = 0.018).Conclusions: This study suggests that low trough levels of infliximab (< 3 µg / ml) in patients with IBD in clinical remission under infliximab maintenance therapy are predictive to a LOR in the medium term.
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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 | 0.000 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.004 | 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".