Novartis Pharma KK, Tokyo, Japan.
Creativ-Ceutical, Kraków, Poland.
Int J Hematol. 2021 Aug;114(2):152-163. doi: 10.1007/s12185-021-03149-z. Epub 2021 Apr 13.
This real-world study in Japan assessed the long-term safety of persistent use of eltrombopag compared to corticosteroids. Overall, 1887 patients with primary immune thrombocytopenia were included in the study cohort, based on hospital claims data. Eltrombopag was frequently used as a second- or third-line therapy (monotherapy: 13.1% and 25.7%; combination: 24.39% and 16.52%, respectively). The risk of bleeding was approximately 30% lower in the eltrombopag group (as monotherapy and in combination with other drugs including corticosteroids) than the corticosteroid group (hazard ratio, 0.66; 95% confidence interval, 0.45-0.96). Results from univariate and multivariate Cox models indicated that patients aged ≥ 60 years, male patients and patients who received the drugs for peptic ulcer or gastroesophageal reflux disease have a higher risk of cerebral haemorrhage or gastrointestinal bleeding. Surgeries were more common among patients on corticosteroids compared to patients on eltrombopag (39.1% vs 34.6%, P = 0.004), while splenectomies were very rare. There was no significant difference in the costs of scheduled, emergency, or any type of hospitalisations between the exposure groups. The risk of infections, cataracts, and thrombosis did not differ between the exposure groups.
这项在日本开展的真实世界研究评估了依鲁替尼持续使用与皮质类固醇相比的长期安全性。根据医院索赔数据，该研究队列纳入了 1887 例原发性免疫性血小板减少症患者。依鲁替尼常用于二线或三线治疗（单药治疗：13.1%和 25.7%；联合治疗：24.39%和 16.52%）。依鲁替尼组（包括单药治疗和与皮质类固醇等其他药物联合治疗）出血风险比皮质类固醇组降低约 30%（风险比，0.66；95%置信区间，0.45-0.96）。单变量和多变量 Cox 模型的结果表明，年龄≥60 岁、男性以及因消化性溃疡或胃食管反流病接受治疗的患者发生脑出血或胃肠道出血的风险更高。皮质类固醇组患者接受手术治疗的比例高于依鲁替尼组（39.1% vs 34.6%，P=0.004），而脾切除术则非常罕见。两组暴露患者的计划住院、急诊或任何类型的住院费用均无显著差异。两组暴露患者的感染、白内障和血栓形成风险无差异。
