Rosé Mathieu, Bourahla Intissar, Ghiddi Alessandro, Al-Akabawi Assem, Chan Edmond, Toussi Massoud
IQVIA, Courbevoie, France.
Janssen-Cilag Italy, Milan, Italy.
Adv Ther. 2021 May;38(5):2284-2293. doi: 10.1007/s12325-021-01685-y. Epub 2021 Mar 16.
Daratumumab, a monoclonal antibody targeting CD38, is approved to treat multiple myeloma. Red blood cells express low levels of CD38, which can result in a false-positive antibody screen in daratumumab-treated patients. Educational materials were developed to inform healthcare professionals (HCPs) and blood transfusion management department personnel (BTMDP) about this risk and recommended measures to mitigate that risk. Materials were distributed in European countries where daratumumab was commercially available. This post-authorization safety study was designed to evaluate whether HCPs and BTMDP understood the materials.
An anonymous, cross-sectional, non-interventional, web-based survey was distributed in 12 European countries. Four key questions were identified, for which a correct answer from at least 80% of respondents was considered indicative of satisfactory effectiveness.
A total of 408 participants completed the questionnaires (62.3% (n = 254) HCPs and 37.7% (n = 154) BTMDP). Responses were consistent between groups. All respondents were aware of the educational materials (the first key question) and at least 80% correctly answered three of the four key questions. A key question regarding which blood typing test(s) daratumumab interferes with did not achieve satisfactory effectiveness (60% correct responses). In a weighted analysis, 79% of respondents correctly identified the recommended measures for daratumumab-treated patients requiring transfusion. This was attributed to an error in the survey's German translation; in a sensitivity analysis, 90% of participants correctly responded to this question.
Results suggest that participants were aware of the educational materials, the risk of daratumumab interference with blood testing, and recommended measures to mitigate that risk.
达雷妥尤单抗是一种靶向CD38的单克隆抗体,已被批准用于治疗多发性骨髓瘤。红细胞表达低水平的CD38,这可能导致在接受达雷妥尤单抗治疗的患者中出现抗体筛查假阳性。已编写教育材料,告知医疗保健专业人员(HCP)和输血管理部门人员(BTMDP)有关此风险以及降低该风险的推荐措施。这些材料已在达雷妥尤单抗有商业供应的欧洲国家分发。这项上市后安全性研究旨在评估HCP和BTMDP是否理解这些材料。
在12个欧洲国家开展了一项基于网络的匿名横断面非干预性调查。确定了四个关键问题,至少80%的受访者给出正确答案被视为有效性令人满意。
共有408名参与者完成了问卷(62.3%(n = 254)为HCP,37.7%(n = 154)为BTMDP)。两组之间的回答一致。所有受访者都知晓这些教育材料(第一个关键问题),并且至少80%的人正确回答了四个关键问题中的三个。关于达雷妥尤单抗会干扰哪种血型检测的一个关键问题未达到令人满意的有效性(正确回答率为60%)。在加权分析中,79%的受访者正确识别了针对需要输血的达雷妥尤单抗治疗患者的推荐措施。这归因于调查德语翻译中的一个错误;在敏感性分析中,90%的参与者正确回答了这个问题。
结果表明参与者知晓教育材料、达雷妥尤单抗干扰血液检测的风险以及降低该风险的推荐措施。