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Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database

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Resumen del artículo

Título de Paperzilla
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.

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Scientists found that some medicines, called JAK inhibitors, were linked to people getting more infections, blood clots, cancer, or even tiny holes in their stomach. It's like these medicines might sometimes cause other problems.

Posibles conflictos de intereses

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.

Limitaciones identificadas

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.

Explicación de la calificación

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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Información del archivo

Título original: Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database
Subido: 14 jul 2025, 11:27:02
Privacidad: Público