IL-6R Inhibitors and Gastrointestinal Perforations: A Pharmacovigilance Study and a Predicting Nomogram DOI Creative Commons
Shupeng Zou, Mengling Ouyang, Qian Cheng

и другие.

Biomedicines, Год журнала: 2024, Номер 12(12), С. 2860 - 2860

Опубликована: Дек. 17, 2024

Objective IL-6R inhibitors are widely used in many inflammation-related diseases, especially so during the COVID-19 pandemic. However, their relationship with gastrointestinal perforations (GIPs) has been reported more and more. We comprehensively analyzed association GIPs from United States FDA Adverse Event Reporting System (FAERS). Methods: A disproportionate analysis was to quantify signals of caused by using two algorithms, we assessed risk logistic regression analysis. also established a prediction model GIPs. Results: identified 994 cases (tocilizumab sarilumab) FAERS database. The were significant, including tocilizumab (reporting odds ratio [ROR] 6.86, 95%CI 6.43–7.31) sarilumab (ROR 4.03, 2.83–5.73). Duodenal perforation had strongest (n = 312; ROR 19.45, 17.33–21.83; IC025 3.72) 14; 9.57, 5.66–16.17; 1.92). median time near 60 days. In total, 71% occurred within first six months after treatment. After excluding missing data, found that independent factors included female (OR 1.52, 1.16–1.98), ≥40 years 5.63, 1.78–17.78), glucocorticoids 1.37, 1.10–1.72), nonsteroidal anti-inflammatory drugs (NSAIDs, OR 3.46, 2.77–4.32). showed good discrimination clinical applicability both training (AUC, 0.73) validation 0.75) sets. Conclusions: may increase GIPs, female, middle-aged patients, inhibitors, NSAIDs, glucocorticoids. Therefore, suggest these associated reactions should be considered

Язык: Английский

IL-6R Inhibitors and Gastrointestinal Perforations: A Pharmacovigilance Study and a Predicting Nomogram DOI Creative Commons
Shupeng Zou, Mengling Ouyang, Qian Cheng

и другие.

Biomedicines, Год журнала: 2024, Номер 12(12), С. 2860 - 2860

Опубликована: Дек. 17, 2024

Objective IL-6R inhibitors are widely used in many inflammation-related diseases, especially so during the COVID-19 pandemic. However, their relationship with gastrointestinal perforations (GIPs) has been reported more and more. We comprehensively analyzed association GIPs from United States FDA Adverse Event Reporting System (FAERS). Methods: A disproportionate analysis was to quantify signals of caused by using two algorithms, we assessed risk logistic regression analysis. also established a prediction model GIPs. Results: identified 994 cases (tocilizumab sarilumab) FAERS database. The were significant, including tocilizumab (reporting odds ratio [ROR] 6.86, 95%CI 6.43–7.31) sarilumab (ROR 4.03, 2.83–5.73). Duodenal perforation had strongest (n = 312; ROR 19.45, 17.33–21.83; IC025 3.72) 14; 9.57, 5.66–16.17; 1.92). median time near 60 days. In total, 71% occurred within first six months after treatment. After excluding missing data, found that independent factors included female (OR 1.52, 1.16–1.98), ≥40 years 5.63, 1.78–17.78), glucocorticoids 1.37, 1.10–1.72), nonsteroidal anti-inflammatory drugs (NSAIDs, OR 3.46, 2.77–4.32). showed good discrimination clinical applicability both training (AUC, 0.73) validation 0.75) sets. Conclusions: may increase GIPs, female, middle-aged patients, inhibitors, NSAIDs, glucocorticoids. Therefore, suggest these associated reactions should be considered

Язык: Английский

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