S962 Comparing Cortiment® and Prednisone in Ulcerative Colitis: A Population-based Study of Outcomes
Bibliographic record
Abstract
Introduction: In August 2016 Cortiment® was approved for use in ulcerative colitis (UC) patients in Canada, but not approved for reimbursement; the Canadian Agency for Drugs and Technology in Health cited no comparable benefit for its use over other approved UC medications. Real-world data comparing Cortiment® to other UC medications is limited, especially during the COVID-19 pandemic where the use of steroids is counter-indicated for COVID-19-related outcomes. Methods: Using population-based data from Alberta Canada, two cohorts were compared: 1. Cortiment® (all patients dispensed Cortiment® with a diagnostic code for UC [ICD-9-CM: 556.X; ICD-10-CA: K51.X] from August 1, 2016 to October 31, 2019; and, 2. Prednisone (UC patients identified through a validated algorithm and dispensed a >30 day supply or >500mg in 24 hours of prednisone [ATC: H02AB07] or prednisolone [ATC: H02AB06] from April 1, 2016 to October 31, 2019). Both cohorts were followed to identify hospitalizations (all, IBD-related, or IBD-specific), IBD-surgery, or infections (i.e., pneumonia, c.diff, sepsis, tuberculosis) that occurred within 6 or 12 months from the first dispensing of either medication. Cox-proportional hazard models were created to assess outcomes between the two groups (using age and sex as possible modifiers/confounders and assessing the proportional hazard assumption of each model), Kaplan-Meier survival curves were created, and Poisson regression (or negative binomial) used to assess the Average Monthly Percentage Change (AMPC) with associated 95% confidence intervals (CI). Results: The Cortiment® cohort had 917 patients and the Prednisone cohort had 2,404 patients. Over the study period, dispensing of prednisone significantly decreased (AMPC: -2.53% [CI: -2.85, -2.21]) while Cortiment® remained stable (AMPC: 0.86% [CI: -0.04, 1.78]). Dispensing of Cortiment® significantly decreased the hazard of hospitalization (all types, except surgery) at 12 months as compared to prednisone, and significantly decreased the hazard of individuals acquiring an infection at both 6 and 12 months (Table 1 and Figure 1). Conclusion: The use of Cortiment® in a real-world setting lead to fewer deleterious outcomes as compared to prednisone, and its use during a pandemic should be preferred, especially when it’s counterpart (prednisone/prednisolone) can exacerbate negative COVID-19-related outcomes.Table 1.: Description of Cortiment and Prednisone Cohorts; and, Results from Cox Proportional Hazard Models Comparing Cortiment and Prednisone Cohorts for all Outcomes at 6-months and 1-year Bold & Italic = Significant; N: number; IBD: Inflammatory Bowel Disease; HR: Hazard Ratio; CI: Confidence Interval; [*] : Sex Modification; [¥] : Proportional Hazards Assumption violated with the inclusion of age or sex in the model. Therefore, model does not include either.; [□]: Sex Adjusted; [£] : Age-Adjusted and Sex modification; [ᵝ] : Age- and Sex-AdjustedFigure 1.: Kaplan-Meier Survival Curves of 1-year Outcomes: A) All Hospitalizations; B) IBD-Related Hospitalizations; C) IBD-Specific Hospitalizations; and, D) Any Infection. [Dashed Line: Cortiment Cohort; Solid Line: Prednisone/Prednisolone Cohort; IBD: Inflammatory Bowel Disease]
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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 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".