Visible Analytics, Oxford, OX2 0DP, UK.
Kyowa Kirin, Payor Value and Patient Access, Marlow, SL7 1HZ, UK.
J Comp Eff Res. 2023 Oct;12(10):e230017. doi: 10.57264/cer-2023-0017. Epub 2023 Aug 29.
Due to extensive treatment switching in the MAVORIC trial, lack of UK regulatory licence for the comparator, overall survival (OS) with mogamulizumab was compared with patients with previously treated advanced mycosis fungoides/Sézary syndrome (MF/SS) in real-world setting. Data were from the Hospital Episode Statistics database (all patients in NHS secondary care system in 2009-2019). Patients were selected according to trial inclusion criteria, then trial and HES samples were matched on selected variables with significant imbalance. The analysis indicated significant improvement in OS for mogamulizumab treatment compared with UK clinical practice (hazard ratio: 0.36, 95% CI: 0.24, 0.53). Results suggest an OS advantage for patients with advanced MF/SS treated with mogamulizumab in MAVORIC trial compared with UK clinical practice.
由于 MAVORIC 试验中广泛的治疗转换,缺乏对照药物在英国的监管许可,因此在真实世界环境中,莫格利珠单抗的总生存期(OS)与先前接受过治疗的晚期蕈样真菌病/塞扎里综合征(MF/SS)患者进行了比较。数据来自医院住院统计数据库(2009 年至 2019 年 NHS 二级保健系统中的所有患者)。根据试验纳入标准选择患者,然后根据具有显著不平衡的选定变量对试验和 HES 样本进行匹配。分析表明,与英国临床实践相比,莫格利珠单抗治疗在 OS 方面有显著改善(风险比:0.36,95%CI:0.24,0.53)。结果表明,与英国临床实践相比,接受莫格利珠单抗治疗的晚期 MF/SS 患者在 MAVORIC 试验中的 OS 有优势。