Short summary

The overall objective of this study is to describe the effectiveness and safety of alemtuzumab in a population based real life setting. The study will include a sub-analysis of disease activity among patients receiving alemtuzumab early in the disease course as compared to escalation treatment in subjects with high disease activity. It is based on registerdata from the Danish Multiple Sclerosis Registry.

Rationale

Alemtuzumab (Lemtrada) is a humanized monoclonal antibody licensed for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Lemtrada® received EMA approval for treatment of MS in 2013 and since then 211 patients with highly active RRMS has been treated with alemtuzumab in Denmark. Among Danish MS neurologists there is a genereal perception, that during the last couple of years, alemtuzumab treatment has in general been initiated earlier in the patient's disease course as compared to the first couple of years after launch.

Description of the cohort

Included in the study are all relapsing-remitting multiple sclerosis patients where treatment with alemtuzumab was initiated since December 2013 until Jan 2019. These are adults, mixed men and women.

Data and biological material

Register data only.

Publications associated with the project

Department of Neurology, Odense University Hospital

• Professor Zsolt Illes

Department of Public Health, Epidemiology, Biostatistics and Biodemography, University of Southern Denmark

• Professor Jacob Hjelmborg
• Associate professor Birgit Debrabant

The Danish Multiple Sclerosis Registry

• Associate professor Melinda Magyari