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Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology
Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database
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Overview
Paper Summary
Conflicts of Interest
Identified Weaknesses
Rating Explanation
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Paper Summary
Paperzilla title
JAK Inhibitors: Infections, Blood Clots, and Maybe Cancer? (But Don't Worry Too Much About Your Heart)
This study found JAK inhibitors were associated with increased reporting of infections, embolism/thrombosis, neoplasms, and gastrointestinal perforations. While some of these were already known, it raises further concerns about malignancies and gastrointestinal issues, though major cardiovascular events were not significantly associated.
Possible Conflicts of Interest
Aurelien Amiot received consulting fees and travel accommodations from Pfizer. Pascal Claudepierre reported receiving personal fees from Abbvie, Pfizer, Roche-Chugai Bristol-Myers Squibb, MSD, UCB, Novartis, Janssen, Lilly, Celgene.
Identified Weaknesses
Under-reporting and Limited Verification
Under-reporting of events and limited verification of clinical/laboratory data weaken the reliability of reported adverse events.
Limitations of Spontaneous Reporting
Spontaneous reporting cannot accurately estimate the prevalence or incidence of adverse events, limiting the generalizability of findings.
Lack of Case-Causality Assessment
Lack of case-causality assessment makes it difficult to establish a definitive link between JAK inhibitors and reported events.
Missing Data
Missing data, particularly regarding time to onset and patient characteristics, hinders a comprehensive understanding of adverse event profiles.
Limitations of Hierarchical Analysis
The hierarchical analysis method may miss potential signals at deeper levels, leading to incomplete safety assessments.
Lack of Subgroup Analyses
Lack of subgroup analyses by duration or patient characteristics limits understanding of risk factors and adverse event profiles.
Rating Explanation
The study provides valuable insights into the safety profile of JAK inhibitors using a large pharmacovigilance database. However, several methodological limitations, including under-reporting, lack of case-causality assessment, and missing data, prevent stronger conclusions. The identified conflicts of interest also warrant consideration.
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Topic Hierarchy
File Information
Original Title:
Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database
File Name:
s41598-022-10777-w.pdf
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File Size:
2.79 MB
Uploaded:
July 14, 2025 at 11:27 AM
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