| アブストラクト | Background/Objectives: Pharmacovigilance studies typically evaluate adverse events as isolated drug-event pairs, potentially overlooking symptoms and functional impairments reported concurrently within the same case. We investigated co-reported adverse event patterns for tofacitinib and upadacitinib in patients with rheumatoid arthritis (RA). Methods: FAERS reports submitted between 2004 and 2025 were included if tofacitinib or upadacitinib was recorded as the primary suspect drug for RA. Disproportionality analysis was integrated with three co-occurrence network approaches, Bayesian network analysis, and time-to-onset (TTO) analysis. Methotrexate served as an indication-matched comparator. Network analyses were stratified by reporter and submission type, and TTO was reassessed for the common 2019-2025 period. FAERS signals were also compared descriptively with Canada Vigilance data. Results: We identified 57,438 tofacitinib-related and 29,869 upadacitinib-related reports, yielding 316 and 413 positive Preferred Term signals, respectively. In the tofacitinib networks, fatigue was consistently associated with pain, mood-related terms, treatment experience, and gastrointestinal and infectious events. Upadacitinib reports exhibited a distinct pattern, with falls, pain, functional limitations, and injuries occupying central positions. Reduced grip strength, decreased joint range of motion, and loss of personal independence formed a recurrent functional cluster. Methotrexate networks were primarily organized around disease-activity terms. The median reported TTO was 34 days for tofacitinib and 115 days for upadacitinib; corresponding values for the 2019-2025 period were 59 and 115 days, respectively. These intervals should not be interpreted as true onset latency or as established hazard patterns. Conclusions: Co-reporting analysis yielded insights beyond individual disproportionality signals. Tofacitinib reports were predominantly characterized by fatigue and associated symptoms, whereas upadacitinib reports more prominently featured functional limitations, falls, and injuries. |
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| 組織名 | Jiangsu Key Laboratory of Innovative Drug Research and Development for Mental and;Neurological Diseases, China Pharmaceutical University, 639 Longmian Avenue,;Nanjing 211198, China.;Department of Biostatistics, School of Public Health, Nanjing Medical University,;Nanjing 211166, China. |
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