Aims Secukinumab, the first interleukin 17A inhibitor, is widely used to treat immune diseases, including plaque psoriasis, psoriatic arthritis and ankylosing spondylitis. Recently, many studies have reported adverse events associated with secukinumab, including gastrointestinal disorders, infections and infestations, and hypersensitive and nervous system disorders. Objective Here, we aimed to explore the clinical characteristics, outcomes and time to onset of the four main toxicities of secukinumab using post‐marketing data. Methods Our study utilized data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database from 2015 to 2021, using disproportionality analysis. Toxicities were defined based on the standardized Medical Dictionary for Regulatory Activities queries. Two disproportionality methods were used to detect potential signals: information component (IC) and reporting odds ratio (ROR). The signals were defined as ROR025 > 1 and IC025 > 0. Results A total of 73 945 398 records were included in this study, of which 300 665 records were related to secukinumab. Diarrhoea (N = 3538), nasopharyngitis (N = 3458), pruritus (N = 4277) and rash (N = 3270) were the most common adverse events. Inflammatory bowel disease (IC025/ROR025 = 3.25/9.69), genital candidiasis (IC025/ROR025 = 3.46/11.54), dermatitis psoriasiform (IC025/ROR025 = 1.94/4.04) and anosmia (IC025/ROR025 = 1.62/3.17) had the highest IC025 values of all toxicities. The time to onset of the four toxicities was mainly concentrated in the first month. Some patients simultaneously presented with two or more toxicities. Conclusion This pharmacovigilance study systematically explored the four main toxicities of secukinumab and provided new safety signals based on past safety information. Some high‐risk signals need to be given attention.
Background: Severe burn can be accompanied by life-threatening bleeding on some occasions, thus, blood transfusion is often required in these patients during their hospitalization. Therefore, we aimed to examine temporal trends, predictors, and in-hospital outcomes of blood transfusion in these patients in the United States.Methods: The National Inpatient Sample was used to identify severe burn patients between January 2010 and September 2017 in the United States.Trends in the utilization of blood transfusion were analyzed using the Cochran-Armitage trend test. Moreover, propensity score matching (PSM) was employed, and then in-hospital outcomes were compared between these two groups in the matched cohort. Multivariable logistic regressions were further used to validate the results of PSM.Results: Among 27,260 severe burn patients identified during the study period, 2120 patients (7.18%) received blood transfusion. Blood transfusion rates decreased significantly from 9.52% in 2010 to 5.02% in 2017 (p for trend <.001). In the propensity-matched cohort (2120 pairs with and without transfusion), patients transfused were at increased risk of in-hospital mortality (13.3% vs 8.77%, p < .001), overall postoperative complications (88.3% vs 72.59%, p < .001), longer hospital stays (defined as > median hospital stays = 5 d) (73.8% vs 50.6%, p < .001) and increased overall cost (defined as > median overall costs = 30,746) (81.6% vs 57.3%, p < .001). This was also the case for the multivariable analysis. Conclusions: Blood transfusion following severe burn injury may be associated with worse clinical outcomes. The utility for blood transfusion in burn patients warrants further prospective exploration.Chi Peng and Fan Yang contributed equally to this work and are listed as co-first authors.
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