by Yinli Shi, Shuang Guan, Sicun Wang, Muzhi Li, Yanan Yu, Jun Liu, Weibin Yang, Zhong Wang
BackgroundAlthough filgotinib, a selective Janus kinase 1 inhibitor, has been increasingly applied in the treatment of inflammatory diseases, its comprehensive safety profile remains insufficiently characterized. Using data from the FAERS database covering Q1 2014 to Q2 2024, this study attempts to analyze adverse event signals linked to filgotinib and provide guidance for the safe and sensible clinical usage of filgotinib.
MethodsFrom Q1 2014 to Q2 2024, information on adverse drug events (ADEs) associated with filgotinib was gathered. The reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) were among the signal detection methods that were employed for analysis following data normalization.
ResultsFilgotinib was shown to be the main suspected medication in ADE reports, exposing 103 preferred terms (PTs) in 17 system organ classes (SOCs). Infections, gastrointestinal disorders, and musculoskeletal and connective tissue disorders were the most commonly reported adverse effects. Additionally, atrial fibrillation, alopecia, elevated serum creatinine, blood creatinine increased, pulmonary embolism, epididymitis, respiratory failure, and osteopenia were identified as potential disproportionate reporting signals for filgotinib, although these were not listed in the official drug label. Notable significant signals included large intestine erosion (ROR 2186.05, 95%CI(ROR): 1015.94–4703.86, PRR 2176.18, 95%CI(PRR): 1014.64–4667.42), mesenteric arterial occlusion (ROR 1832.17, 95%CI(ROR): 897.68–3739.48, PRR 1822.71, 95%CI(PRR): 896.17–3707.20), repetitive strain injury (ROR 1149.27, 95%CI(ROR): 363.16–3637.01, PRR 1147.05, 95%CI(PRR): 363.24–3622.15), oligoarthritis (ROR 755.02, 95%CI(ROR): 310.74–1834.54, PRR 752.59, 95%CI(PRR): 310.60–1823.51), and periostitis (ROR 676.03, 95%CI(ROR): 319.36–1431.06, PRR 672.98, 95%CI(PRR): 318.97–1419.87). The subgroup analysis identified obvious sex and age-specific trends in filgotinib-related adverse reactions, emphasizing a higher risk of renal disorders in females, a preponderance of gastrointestinal events in males, and age-dependent trends involving mesenteric occlusion, increased serum creatinine, and immunoglobulin reduction.
ConclusionWhile filgotinib demonstrates therapeutic efficacy, it is associated with a range of potential adverse events, underscoring the need for vigilant clinical monitoring. Particular attention should be given to gastrointestinal, cardiovascular, respiratory, and metabolic complications.
The geriatric nutritional risk index (GNRI) predicts adverse outcomes in chronic diseases, but its prognostic value for major adverse limb events (MALE) in elderly patients with peripheral artery disease (PAD) remains unverified; thus, this study aimed to establish the association between GNRI and MALE.
A multicenter, prospective study.
From January 2021 to August 2022, 1200 patients with PAD aged ≥ 60 years were enrolled. Patients were stratified by GNRI value (At-risk group: ≤ 98 vs. No-risk group: > 98). Data were analysed through Kaplan–Meier curves, multivariable Cox regression, restricted cubic spline (RCS) modelling, and subgroup analyses.
Among 1036 completers (13.7% attrition rate), 275 (26.5%) developed MALE during a mean follow-up of 18.9 ± 8.0 months. Kaplan–Meier analysis demonstrated significantly higher MALE incidence in patients in the At-risk group (log-rank p < 0.001). Adjusted Cox models revealed a 45% increased MALE risk in patients in the At-risk group (HR 1.45, 95% CI 1.12–1.86, p = 0.005). RCS identified a non-linear L-shaped relationship (p = 0.006) with inflection at GNRI = 95: Below 95, each 1-unit GNRI increase reduced MALE risk by 9% (HR 0.91, 95% CI 0.88–0.95, p < 0.001), while no significant association existed above 95. Subgroup analyses confirmed consistency across subgroups (all p-interaction > 0.05).
GNRI exhibits a non-linear L-shaped association with MALE risk in elderly patients with PAD, demonstrating critical prognostic utility below the 95 inflection point. Routine GNRI monitoring should be prioritised for patients with GNRI < 95 to guide preventive interventions.
GNRI should be incorporated as a routine risk assessment tool for elderly patients with PAD, with particular vigilance required for those with GNRI < 95. Prioritising nutritional screening and intervention in patients with GNRI < 95 may potentially improve clinical outcomes.
Patients contributed to this study by completing follow-up assessments.
This study followed the STROBE guidelines.
To identify whether cognitive appraisal and coping style have moderating and mediating effects on the relationship between family resilience and quality of life (QoL) in patients with acute leukaemia (AL).
AL is a clonal and aggressive haematological malignancy that requires long-term and continuous therapy, which may negatively influence QoL. Family resilience can be used as a psychosocial resource that may enhance patients' coping processes and QoL.
This cross-sectional descriptive study was conducted among hospitalised patients with AL from June 2022 to June 2023.
A cross-sectional study was performed following the STROBE Statement. Convenience sampling was used in the present study, and 286 patients were recruited from five tertiary Grade A hospitals in Xi'an, China. The questionnaires included the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu), the Cognitive Appraisal of Health Scale (CAHS), the Trait Coping Style Questionnaire (TCSQ) and the Family Hardiness Index (FHI). We used SPSS 26.0 and Hayes' PROCESS macro for data analyses and path coefficients.
The QoL of patients with AL was significantly positively correlated with family resilience and positive coping, and negatively correlated with cognitive appraisal. Cognitive appraisal partially mediated the relationship between family resilience and QoL. Positive coping moderated the relationships between family resilience and cognitive appraisal, and between cognitive appraisal and QoL.
The results revealed that the association between family resilience and QoL was partially mediated by cognitive appraisal and that positive coping moderated this relationship. These findings are meaningful for early interventions that reduce the risk of psychosocial distress and improve QoL in this population.
Nurses should focus on the cognitive appraisal and coping style of AL patients and provide family support and respect to improve their QoL.
This cross-sectional descriptive study was conducted on patients with AL undergoing clinical chemotherapy in Chinese medical facilities.