S978 A Nationwide Comparison of Risankizumab-rzaa, Vedolizumab, and Adalimumab on Infection and Neuromusculoskeletal Adverse Events in Crohn’s Disease Patients: A Pharmacovigilance Investigation
Bibliographic record
Abstract
Introduction: Crohn’s disease (CD) is chronic inflammation of the gut mucosa due to dysregulated immune responses. Biologics, a novel therapy revolutionized CD management. However, these medications have not been without adverse reactions, and comprehensive patient education is thereby imperative when starting it. In this study, we investigate the adverse events associated with the biologic agents risankizumab-rzaa, adalimumab, and vedolizumab in a nationwide cohort of CD patients. Methods: The US Food and Drug Administration’s Adverse Event Reports System (FAERS) was queried for risankizumab-rzaa, vedolizumab and adalimumab in CD on February 5, 2023. Patient demographics were recorded along with rates of infection and neuromusculoskeletal adverse reactions on these drugs. Analysis was performed using reported odds ratios (ROR) with 95% confidence interval (CI) and statistical significance P < 0.05. Results: A dataset of 93,056 reported adverse event cases of CD patients treated with risankizumab-rzaa, vedolizumab and adalimumab until December 31, 2022, was extracted from the FAERS database. 34,647 (37.2%) patients were male. Patients on vedolizumab were 1.56 times more likely to be hospitalized than those on adalimumab [95% CI 1.50-1.58, P < 0.05]. Whereas patients on risankizumab-rzaa were significantly 44% less likely to be hospitalized than those on adalimumab [95% CI 0.40-0.77, P < 0.05]. The risk of contracting an infection was 1.35 times higher for patients on vedolizumab than those on adalimumab [95% CI 1.31-1.40, P < 0.001]. Notably the risk for nervous system disorders was almost twice as high for patients on risankizumab than those on adalimumab [OR 1.97, 95% CI 1.57-2.47, P < 0.001]. Incorporating musculoskeletal adverse events, patients on risankizumab had 1.69 times a risk of developing a neuromusculoskeletal disorder over those patients on adalimumab [95% CI 1.46-1.97, P < 0.001]. There was no statistical significance between rates of neuromusculoskeletal adverse reactions between patients on vedolizumab and those on adalimumab. Incorporating gender and age did not yield any statistical significance (Figure 1). Conclusion: Patients with Crohn’s disease on risankizumab-rzaa had significantly higher rates of neuromusculoskeletal adverse events but less hospitalization than patients with CD being treated with adalimumab while patients with CD on vedolizumab have significantly higher rates of infections and hospitalization than patients with CD on adalimumab.Figure 1.: A) Risk Ratio of Reported Events in Risankizumab-rzaa vs Adalimumab in Crohn’s Disease; B) Risk Ratio of Reported Events in Vedolizumab vs Adalimumab in Crohn’s Disease.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.003 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| 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".