| アブストラクト | BACKGROUND: The use of JAK inhibitors (JAKis) is growing in dermatology with approvals for atopic dermatitis, alopecia areata, plaque psoriasis, and psoriatic arthritis. This study aimed to evaluate infectious adverse events (iAEs) associated with abrocitinib, baricitinib, deucravacitinib, ritlecitinib, tofacitinib, and upadacitinib. METHODS: Data were retrieved from the FDA Adverse Event Reporting System (FAERS) via the open-source AERSMine platform (version:2025-04-16; Cincinnati Children's Hospital Medical Center, USA). Reports from 2004Q1 to 2024Q2 were screened under the MedDRA System Organ Class "Infections and Infestations". The analysis encompassed all indications, not only dermatologic use. Disproportionality metrics including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Information Component (IC) were calculated. RESULTS: Tofacitinib had the highest number of iAE reports (n=68,669), followed by upadacitinib (n=17,822). Most reports involved females and those aged 25-65, except baricitinib, which was more frequent in >/=66. Disproportionality analysis revealed sex- and age-related differences in iAE risk, with male sex generally associated with lower risk. Pediatric patients (0-14 years) had an elevated iAE risk with abrocitinib and upadacitinib, while older adults (>/=66) showed increased risk with baricitinib and tofacitinib. Commonly reported iAEs included COVID-19, herpes zoster, nasopharyngitis, influenza, urinary tract infection, pneumonia, and sinusitis. Each JAKi was associated with distinct high-signal iAEs. CONCLUSION: This is the most comprehensive real-world analysis of iAEs linked to oral JAKis. While infection risks varied across agents, both common and rare but serious events were identified. Findings highlight the importance of individualized monitoring and preventive strategies, and reinforce the value of post-marketing surveillance in ensuring safe JAKi use. |
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