TY - JOUR

T1 - Alemtuzumab treatment in Denmark

T2 - A national study based on the Danish Multiple Sclerosis Registry

AU - Theodorsdottir, Asta

AU - Debrabant, Birgit

AU - Magyari, Melinda

AU - Kant, Matthias

AU - Rasmussen, Peter V.

AU - Malmberg, Carl Fredrik

AU - Norberg, Iver A.

AU - Hansen, Victoria

AU - Bech, Danny

AU - Schmidt, Mathias F.

AU - Schreiber, Karen

AU - Frederiksen, Jette L.

AU - Sellebjerg, Finn

AU - Illes, Zsolt

N1 - Publisher Copyright: © The Author(s), 2021.

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - adverse events

KW - Alemtuzumab

KW - CARE-MS

KW - multiple sclerosis

KW - observational study

KW - real-world efficacy

KW - registry

U2 - 10.1177/13524585211003291

DO - 10.1177/13524585211003291

M3 - Journal article

C2 - 33779361

AN - SCOPUS:85103371082

VL - 27

SP - 2254

EP - 2266

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

SN - 1352-4585

IS - 14

ER -