Asta Theodorsdottir1, Birgit Debrabant2, Melinda Magyari3, Matthias Kant4, Peter V Rasmussen5, Carl-Fredrik Malmberg6, Iver A Norberg6, Victoria Hansen7, Danny Bech8, Mathias F Schmidt9, Karen Schreiber9, Jette L Frederiksen9, Finn Sellebjerg3, Zsolt Illes10. 1. Department of Neurology, Odense University Hospital, Odense, Denmark/Department of Neurology, Hospital Lillebaelt, Kolding, Denmark/Institute of Clinical Research, University of Southern Denmark, Odense, Denmark/OPEN, Odense Patient Data Explorative Network, Odense University Hospital, Odense, Denmark. 2. Department of Public Health, Epidemiology, Biostatistics & Biodemography, University of Southern Denmark, Odense, Denmark. 3. Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Glostrup, Denmark/The Danish Multiple Sclerosis Registry, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Glostrup, Denmark. 4. Department of Neurology, Hospital of Southern Jutland, Sønderborg, Denmark. 5. Department of Neurology, Aarhus University Hospital, Aarhus, Denmark. 6. Department of Neurology, Odense University Hospital, Odense, Denmark. 7. Department of Neurology, Aalborg University Hospital, Aalborg, Denmark. 8. Department of Neurology, Regional Hospital of Viborg, Viborg, Denmark. 9. Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Glostrup, Denmark. 10. Department of Neurology, Odense University Hospital, Odense, Denmark/Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
Abstract
OBJECTIVE: To investigate clinical outcomes in a real-world setting in the complete population-based cohort of alemtuzumab-treated MS patients in Denmark. METHODS: Data were retrieved from The Danish Multiple Sclerosis Registry between 2009 and 2019. Demographic and disease-specific patient parameters related to treatment history, efficacy, and safety outcomes were assessed at baseline and during follow-up visits. RESULTS: A total of 209 patients (78% female) started treatment with alemtuzumab during the study period with 3.1 ± 1.4 years follow-up. After 2 years, 75% of patients were relapse-free compared to 48% the year before alemtuzumab (p < 0.001). The annual number of relapses was reduced by 69% in year 4 compared with the year prior alemtuzumab. More active disease before alemtuzumab increased the annual hazard rate for relapse (HR: 2.88, p < 0.001). The Expanded Disability Status Scale (EDSS) score remained stable or improved in 81% of patients after 2 years. The need for an additional treatment course was associated with higher number of relapses in the year before alemtuzumab (odds ratio (OR) = 1.95, p = 0.001). CONCLUSION: In a country with primarily escalation strategy, relapse rate reduction was maintained for 5 years, and EDSS stabilized/improved in majority of patients. Higher relapse rate 1 year before alemtuzumab increased the odds for additional courses. Novel serious AEs were not observed.
OBJECTIVE: To investigate clinical outcomes in a real-world setting in the complete population-based cohort of alemtuzumab-treated MS patients in Denmark. METHODS: Data were retrieved from The Danish Multiple Sclerosis Registry between 2009 and 2019. Demographic and disease-specific patient parameters related to treatment history, efficacy, and safety outcomes were assessed at baseline and during follow-up visits. RESULTS: A total of 209 patients (78% female) started treatment with alemtuzumab during the study period with 3.1 ± 1.4 years follow-up. After 2 years, 75% of patients were relapse-free compared to 48% the year before alemtuzumab (p < 0.001). The annual number of relapses was reduced by 69% in year 4 compared with the year prior alemtuzumab. More active disease before alemtuzumab increased the annual hazard rate for relapse (HR: 2.88, p < 0.001). The Expanded Disability Status Scale (EDSS) score remained stable or improved in 81% of patients after 2 years. The need for an additional treatment course was associated with higher number of relapses in the year before alemtuzumab (odds ratio (OR) = 1.95, p = 0.001). CONCLUSION: In a country with primarily escalation strategy, relapse rate reduction was maintained for 5 years, and EDSS stabilized/improved in majority of patients. Higher relapse rate 1 year before alemtuzumab increased the odds for additional courses. Novel serious AEs were not observed.