INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
INTRODUCTION: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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Joanna Lem; Muhammad Younus; Jalal A Aram; Shahrzad Moosavi; Klaus Freivogel; Anne Lewis; Rachel E Sobel Journal: Pharmaceut Med Date: 2019-04