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Alemtuzumab treatment in Denmark: A national study based on the Danish Multiple Sclerosis Registry
Asta Theodorsdottir1, Birgit Debrabant2, Melinda Magyari3
1Department 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.
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.
