S979 A Nationwide Comparison of Ozanimod and Upadacitinib Adverse Events in Ulcerative Colitis Patients: A Pharmacovigilance Investigation
Bibliographic record
Abstract
Introduction: In the past decade, new biologics emerged for the treatment of ulcerative colitis (UC). Limited head-to-head trials of efficacy and safety profiles are available for these medications. Currently, the treatment of UC with biologics often stems from opinion-based algorithms, insurance coverage, and the clinical experience of gastroenterologists. In this study, we analyze a nationwide patient cohort in establishing a stratified safety profile with respect to ozanimod and upadacitinib. Methods: The US Food and Drug Administration’s Adverse Event Reports System (FAERS) data is a quarterly updated database which was queried primarily for ozanimod and upadacitinib in UC on February 5, 2023. The adverse events of infection and infestations, vascular, neuromusculoskeletal and skin with subcutaneous disorders were selectively considered to compare for the desired drugs. Analysis was performed using reported odds ratios (ROR) with 95% confidence interval (CI) and statistical significance P < 0.05. Results: A dataset of 768 adverse event cases were reported with ozanimod and upadacitinib in UC. 358 (46.6%) patients were male. There was no significant difference between rates of hospitalization between both drugs. Patients treated with ozanimod had significantly reduced risk of infectious complications compared to those patients being treated with upadacitinib [RR 0.52, 95% CI 0.38-0.73, P < 0.001] with common infections being nasopharyngitis, pneumonia, Clostridioides difficile gastroenteritis, urinary tract infection and sinusitis. However, patients treated with ozanimod had a significantly higher risk of vascular adverse events compared to those treated with upadacitinib [RR 5.38, 95% CI 2.00-14.50, P < 0.001] with hemorrhage being highest. Risk of neuromusculoskeletal complications is higher with ozanimod compared to those on upadacitinib [RR 1.43, 95% CI 1.07-1.92, P < 0.05] with most common events of headache, dizziness, back pain, and arthralgia. In addition, there was a significantly reduced risk of skin and subcutaneous tissue adverse reactions in patients on ozanimod compared to those on upadacitinib [RR 0.33, 95% CI 0.21-0.52, P < 0.001]. Incorporating gender and age did not yield any statistical significance. Conclusion: Compared to UC patients being treated with upadacitinib, UC patients being treated with ozanimod had a significantly increased risk of vascular and neuromusculoskeletal complications and a significantly reduced risk of infections and skin and subcutaneous adverse reactions (Figure 1).Figure 1.: Risk Ratio of Reported Events in Ozanimod vs Upadacitinib in Ulcerative Colitis.
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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 | 0.005 | 0.012 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.001 | 0.003 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".