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Disproportionality analysis of upadacitinib-related adverse events in inflammatory bowel disease using the FDA
Shiyi Wang1, Xiaojian Wang2, Jing Ding1
1Department of Gastroenterology, Ningbo Hospital of Traditional Chinese Medicine, Affiliated to Zhejiang Chinese Medical University, Ningbo, China.
Background:
Upadacitinib, a Janus kinase inhibitor, has been increasingly used over the past few years to treat moderate to severe ulcerative colitis and Crohn's disease in patients who are insufficiently responsive or intolerant to tumor necrosis factor (TNF) antibodies, demonstrating notable clinical efficacy. The long-term safety of upadacitinib in extensive populations remains unexplored. This study evaluates upadacitinib-related adverse events (AEs) utilizing data from the US Food and Drug Administration Adverse Event Reporting System (FAERS).
Methods:
We employed disproportionality analyses, including the proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM) algorithms to identify signals of upadacitinib-associated AEs for treating inflammatory bowel disease (IBD).
Results:
From a total of 7,037,004 adverse event reports sourced from the FAERS database, 37,822 identified upadacitinib as the primary suspect drug in adverse drug events (ADEs), including 1,917 reports specifically related to the treatment of inflammatory bowel disease (IBD). The most commonly reported AEs were acne, product residue present, haematochezia, frequent bowel movements, flatulence, blood cholesterol increased, aligning with clinical trial outcomes. Notably, significant but unexpected AEs, such as rosacea, proctalgia, polyp, were also reported. Subgroup analysis indicated that the most prevalent AEs among the elderly included pulmonary embolism, cataract, and sepsis, whereas the 18-65 age group most frequently reported acne, abdominal pain, and nasopharyngitis. The median onset time for AEs related to upadacitinib was 41.00 days (interquartile range [IQR] 10-141.5 days), with the majority occurring within 3 months of treatment initiation (n = 269, 66.09%), particularly in the first month (n = 171, 42.01%).
Conclusion:
Our findings affirm clinical observations and reveal potential new AE signals for upadacitinib, underscoring the need for prospective clinical studies to verify these results and clarify their clinical relevance. This study contributes valuable evidence for ongoing safety evaluations of upadacitinib.
Insights
Upadacitinib, a Janus kinase inhibitor, shows efficacy for inflammatory bowel disease but has potential safety concerns. This study identified common and unexpected adverse events (AEs) in patients, highlighting the need for further clinical research.
Area of Science:
- Pharmacovigilance
- Gastroenterology
- Drug Safety
Background:
- Upadacitinib is a Janus kinase inhibitor used for moderate to severe ulcerative colitis and Crohn's disease.
- Its efficacy is established in patients unresponsive to TNF antibodies, but long-term safety data in broad populations are limited.
- This study investigates upadacitinib-related adverse events (AEs) using real-world data.
Purpose of the Study:
- To evaluate the safety profile of upadacitinib in patients with inflammatory bowel disease (IBD).
- To identify potential adverse events (AEs) associated with upadacitinib treatment using post-marketing surveillance data.
- To compare real-world AE signals with known clinical trial outcomes.
Main Methods:
- Utilized disproportionality analyses (PRR, ROR, BCPNN, EBGM) on US FDA Adverse Event Reporting System (FAERS) data.
- Analyzed 7,037,004 adverse event reports, focusing on 1,917 cases where upadacitinib was the suspect drug for IBD.
- Conducted subgroup analyses based on age.
Main Results:
- Common AEs included acne, product residue, and hematochezia, consistent with clinical trials.
- Unexpected AEs such as rosacea, proctalgia, and polyps were identified.
- Elderly patients showed higher rates of pulmonary embolism, cataract, and sepsis; younger adults reported more acne and nasopharyngitis.
- Most AEs occurred within 3 months of treatment initiation.
Conclusions:
- Findings confirm known side effects and suggest novel AE signals for upadacitinib in IBD.
- Highlights the importance of ongoing pharmacovigilance for upadacitinib.
- Recommends prospective studies to validate these real-world safety findings.
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