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用贝兰他单抗莫福汀治疗的多发性骨髓瘤患者的真实世界特征和结局:一项德国索赔数据研究。

Real-world characteristics and outcomes of patients with multiple myeloma treated with belantamab mafodotin: a German claims data study.

作者信息

Luna Jaime, d'Estrube Tim, Jacobsen Andreas, Lehne Moritz, Wellmann-Pichler Birgit, Mevius Antje, Dornig Sabine

机构信息

Cytel Inc, Berlin, Germany.

GSK, London, UK.

出版信息

Ann Hematol. 2025 May 31. doi: 10.1007/s00277-025-06427-6.

Abstract

In the DREAMM-2 trial, belantamab mafodotin (belamaf) monotherapy demonstrated clinical activity and a manageable safety profile in pretreated patients with relapsed/refractory multiple myeloma (RRMM). Real-world evidence on this patient population is scarce. This study describes real-world baseline characteristics, ocular events, and time-to-event outcomes of patients with RRMM before, during, and after belamaf treatment between August 1, 2020, and March 31, 2023, in Germany based on anonymized health insurance claims data. In the overall cohort (N = 31), the median age was 66 years and all patients had received several MM therapies prior to treatment with belamaf. Of the patients included in the pre-belamaf (n = 31), belamaf (n = 31), and post-belamaf (n = 22) treatment periods, 10 (32.3%), 16 (51.6%), and 15 (68.2%) had at least one recorded ophthalmological visit, respectively. Keratitis was the most frequent among ocular diagnoses of interest across all three study periods. During the belamaf treatment period, seven (22.6%) patients had one or more incident ocular diagnoses of interest, the most frequent being corneal-related events. In the overall cohort, the real-world progression-free survival and overall survival were 4.3 months (95% confidence interval [CI] 2.4-7.7) and 12.3 months (95% CI 6.9-not evaluable), respectively. Our data emphasize the importance of ocular supportive care during belamaf treatment in real-world clinical practice. Our findings also highlight that RRMM remains an aggressive disease with a poor prognosis.

摘要

在DREAMM-2试验中,贝兰他单抗莫福汀(belamaf)单药治疗在复发/难治性多发性骨髓瘤(RRMM)的预处理患者中显示出临床活性和可控的安全性。关于这一患者群体的真实世界证据很少。本研究基于匿名的医疗保险理赔数据,描述了2020年8月1日至2023年3月31日期间德国RRMM患者在接受belamaf治疗前、治疗期间和治疗后的真实世界基线特征、眼部事件和事件发生时间结局。在整个队列(N = 31)中,中位年龄为66岁,所有患者在接受belamaf治疗前均接受过多种MM治疗。在纳入belamaf治疗前(n = 31)、belamaf治疗期间(n = 31)和belamaf治疗后(n = 22)的患者中,分别有10例(32.3%)、16例(51.6%)和15例(68.2%)至少有一次记录的眼科就诊。在所有三个研究期间,角膜炎是所有感兴趣的眼部诊断中最常见的。在belamaf治疗期间,7例(22.6%)患者有一次或多次感兴趣的新发眼部诊断,最常见的是与角膜相关的事件。在整个队列中,真实世界的无进展生存期和总生存期分别为4.3个月(95%置信区间[CI] 2.4 - 7.7)和12.3个月(95% CI 6.9 - 不可评估)。我们的数据强调了在真实世界临床实践中belamaf治疗期间眼部支持治疗的重要性。我们的研究结果还突出表明,RRMM仍然是一种侵袭性疾病,预后较差。

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