Design of a Non-interventional Study to Establish Effectiveness, Quality of Life, Cognition, Health-Related and Work Capacity Data on Alemtuzumab in Multiple Sclerosis Patients in Germany (TREAT-MS) (P7.281)

OBJECTIVE: To report on the study design and baseline characteristics of enrolled patients in TREAT-MS: a non-interventional long-Term study foR obsErvAtion of Treatment with LEMTRADA® in active relapsing-remitting MS. BACKGROUND: Alemtuzumab, a humanized monoclonal antibody, is licensed in Germany since October 2013 as treatment for patients with active relapsing-remitting multiple sclerosis (RRMS). In 2-year phase 3 studies, alemtuzumab had superior efficacy as compared to subcutaneous interferon beta-1a and durable efficacy over 4 years in an extension study with manageable safety in RRMS patients. DESIGN/METHODS: This non-interventional effectiveness study is a prospective treatment with alemtuzumab in approximately 3000 RRMS patients from neurological clinics and practices. Planned recruitment is until end of 2016. The study comprises a 5-year observation period. The following instruments will be used: Patient-Reported Outcome Indices for Multiple Sclerosis (PRIMUS), EuroQoL EQ-5D™, Work Productivity and Activity Impairment (WPAI), and Symbol Digit Modalities Test (SDMT). The Multiple Sclerosis Documentation System (MSDS) Project Development Group in Dresden adapted the patient management software, "MSDS3D", for use in this study. TREAT-MS will also fulfill a quality assurance function. Risk-management plan measures such as monitoring for thyroid disorders, immune thrombocytopenia and nephropathies, and regular laboratory tests/urinalyses are represented in TREAT-MS and integrated into MSDS3D. RESULTS: Study enrollment began in October 2014. CONCLUSIONS: The TREAT-MS study design and baseline characteristics of patients will be presented. Study Supported by: Genzyme, a Sanofi company Disclosure: Dr. Engelmann has received personal compensation for activities with Genzyme as employee. Dr. Jahn has received personal compensation for activities with Genzyme as an employee. Dr. Leptich has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals as an employee. Dr. Kern has received personal compensation for activities with Teva, Bayer Healthcare, Genzyme, Biogen Idec, and Novartis as a consultant. Dr. Ziemssen has nothing to disclose.