Non-interventional PASS to investigate the risk of mortality in MS-patients treated with alemtuzumab
Description
- Alemtuzumab (LEMTRADA®), a highly efficacious disease modifying therapy (HE-DMT), is a monoclonal antibody indicated for the treatment of relapsing remitting multiple sclerosis (RRMS) in patients with high disease activity despite prior treatment with at least one other disease modifying therapy (DMT) and rapid disease progression. In Germany, Alemtuzumab was approved in September 2013. Patients receive treatment with Alemtuzumab as a series of infusions.
In 2019, new cumulative safety data were assessed by the pharmacovigilance risk assessment committee (PRAC) of the European Medicines Agency (EMA). From these data, several safety concerns were identified, such as cardiovascular adverse events (temporally associated with infusion) and additional autoimmune events. Furthermore, and most outstanding, the risk of fatal events associated with exposure to Alemtuzumab was identified as a safety concern. Differences in mortality rates from clinical trials (0.17 per 100 patient-years) and post-marketing data (0.42 per 100 patient-years) raised this concern, but existing data was deemed to be insufficient to evaluate whether there was an increased risk of mortality associated with exposure to Alemtuzumab.
Therefore, EMA obligated the market authorization holder of Alemtuzumab, Sanofi, to conduct a post-approval safety study (PASS) to assess the risk of mortality in patients treated with Alemzumab compared to patient treated with HE-DMTs other than Alemtuzumab. The German Pharmacoepidemiological Research Database (GePaRD), together with the Danish multiple sclerosis (MS) registry (DMSR), the Swedish MS registry (SMSR), the Czech MS registry (ReMuS), the Belgian social security database (AIM-IMA) and a three academic-clinical MS centers in England and Wales (University Hospital of Wales in Cardiff, Cambridge University Hospitals in Cambridge, and Derriford Hospital/Plymouth University in Plymouth) will contribute date to this PASS. The study is coordinated by the International Prevention Research Institute (iPRI) in Lyon, France. An interim study report was submitted in Q4 2022, the final report is planned for Q3 2024.
Funding period
- Begin: June 2021
End: December 2024
Sponsor
- Pharmaceutical industry