A national, multi-center study in Germany to assess implementation of infusion management, treatment satisfaction and quality of life in MS patients receiving alemtuzumab

Background: Alemtuzumab is an anti-CD52 antibody approved for the treatment of relapsing remitting multiple sclerosis (RRMS). The summary of product characteristics (SmPC) provides recommendations on the adminis-tration of alemtuzumab to prevent or reduce the risk of serious side effects associated with alemtuzumab infu-sion, including myocardial ischemia, hemorrhagic stroke, arterial dissection, and pulmonary alveolar hemorrhage. However, real-world implementation of alemtuzumab infusion management recommendations has not been previously assessed.Methods: Here we provide a large-scale multi-center (in-and outpatient) observational study on alemtuzumab infusion management in daily clinical care in Germany (ALEMLL08025; INFUSE-MS; NIS-no. 364). Parameters of infusion management -including infusion administration, clinical and laboratory monitoring -were assessed, compared between study centers and the occurrence of infusion-associated reactions (IARs) was documented. Moreover, the TSQM and MSIS-29 questionnaires were used to quantify patient satisfaction and health-related quality of life. Results: 140 RRMS patients were enrolled in this study. Alemtuzumab infusion regimes (treatment course 1 and 2) were comparable between infusion sites and in accordance with recommendations by the SmPC. Standardi-zation of infusion management was associated with a satisfactory safety profile. IARs were usually mild, head-ache (13.6%), rash (10.7%), and pyrexia (6.4%) being the most common ones. TSQM and MSIS-29 scores denoted high patient satisfaction and health-related quality of life among RRMS patients treated with alemtuzumab.Conclusion: In conclusion, our results indicate that infusion management of alemtuzumab is highly standardized and in line with the SmPC. Alemtuzumab treatment and implementation of infusion management recommen-dations are associated with a satisfactory safety profile regarding the occurrence of IARs, a high patient satis-faction and health-related quality of life as important indicators for the quality of MS care.