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A real-world disproportionality analysis of mesalazine data mining of the public version of FDA adverse event
Mingdi Liu1, Liting Gu1, Yuning Zhang1
1Key Laboratory of Pathobiology, Ministry of Education, Jilin University, Changchun, Jilin, China.
Abstract:
Background: Mesalazine, a preparation of 5-aminosalicylic acid, is a medication widely used in clinical practice as a first-line therapy in the treatment of mild and moderate inflammatory bowel disease. However, the long-term safety of mesalazine in large sample population was unknown. The current study was to assess mesalazine -related adverse events of real-world through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio the Bayesian confidence propagation neural network and the multi-item gamma Poisson shrinker (MGPS) algorithms were employed to quantify the signals of mesalazine -associated AEs. Results: Out of 14,149,980 reports collected from the FDA Adverse Event Reporting System database, 24,284 reports of mesalazine -associated AEs were identified. A total of 170 significant disproportionality preferred terms conforming to the four algorithms simultaneously were retained. The most common AEs included colitis ulcerative, diarrhoea, condition aggravated, crohn's disease, fatigue, abdominal pain, nausea, haematochezia, which were corresponding to those reported in the specification and clinical trials. Unexpected significant AEs as dizziness, drug ineffective, drug hypersensitivity, infection, off label use, weight decreased, decreased appetite, arthralgia, rash might also occur. The median onset time of mesalazine -related AEs was 1,127 days (interquartile range [IQR] 1,127-1,674 days), and most of the cases occurred 2 years later (n = 610, 70.93%) and within the first 1 month (n = 89, 10.35%) after mesalazine initiation. Conclusion: Results of our study were consistent with clinical observations. We also found potential new and unexpected AEs signals for mesalazine, suggesting prospective clinical studies were needed to confirm these results and illustrate their relationship. Our results could provide valuable evidence for further safety studies of mesalazine.
Insights
This study analyzed real-world data on mesalazine adverse events (AEs). While confirming known side effects, it identified potential new safety signals for mesalazine, requiring further investigation.
Area of Science:
- Pharmacovigilance
- Gastroenterology
- Drug Safety
Background:
- Mesalazine (5-aminosalicylic acid) is a first-line treatment for mild to moderate inflammatory bowel disease.
- Long-term safety data for mesalazine in large populations remained largely unknown.
- Real-world adverse event (AE) assessment is crucial for understanding drug safety profiles.
Purpose of the Study:
- To assess mesalazine-related adverse events using real-world data.
- To identify potential new safety signals associated with mesalazine therapy.
- To provide evidence for future mesalazine safety studies.
Main Methods:
- Data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).
- Disproportionality analyses using Reporting Odds Ratio (ROR), Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Multi-item Gamma Poisson Shrinker (MGPS).
- Identification of significant disproportionality preferred terms across four algorithms.
Main Results:
- 24,284 mesalazine-associated AEs were identified from over 14 million reports.
- Common AEs included ulcerative colitis, diarrhea, aggravated condition, Crohn's disease, fatigue, abdominal pain, nausea, and hematochezia.
- Unexpected signals included dizziness, ineffective drug, hypersensitivity, infection, off-label use, weight loss, decreased appetite, arthralgia, and rash, with median onset around 1,127 days.
Conclusions:
- Study findings align with existing clinical observations of mesalazine safety.
- Potential new and unexpected AE signals for mesalazine were identified.
- Prospective studies are recommended to confirm these novel findings and elucidate their clinical significance.
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