TRUST - A Study to Evaluate an Integrated Approach for Optimized Patient Management in Multiple Sclerosis Patients Treated with Natalizumab - First Analysis of Baseline Data (P2.147)

Objective: The prospective, non-interventional study TRUST is conducted to investigate: (1) Efficiency of natalizumab (Tysabri®) compared to other DMTs under real-life circumstances and (2) impact of patient-management approaches on outcome of RRMS-patients in Germany. This analysis encompasses baseline data from the first 427 patients. Background: Natalizumab provides rapid and strong control of MS-activity with long-term disease stability. However, its use is hampered by the risk of developing PML and close monitoring is required to optimize benefit/risk considerations. Currently, there is no uniform patient management approach for risk-stratification and the benefit of a systematic approach is largely unknown. Design/Methods: This ongoing study will enrol 1260 RRMS-patients treated with natalizumab for >=12 months. Observation time is 3 years. Endpoints include clinical, subclinical and patient reported outcomes, and patient-management strategies in clinical routine. Results: In total, baseline-data from 427 patients (70.2[percnt] female, mean age±SD 39.4±9.9 years) were evaluated. Mean (±SD) MS-duration was 9.9±6.0 years and MRI was performed in 84.8[percnt] over the last 12 months before study start. 50[percnt] of patients were JCV-antibody positive. 91[percnt] of patients had been treated with other DMTs and had there after received 39 natalizumab infusions (median) prior study start. Based on the retrospective analysis in these patients receiving natalizumab for >=12 months prior to study entry, mean ARR (95[percnt]CI) decreased from 2.17 (2.01-2.34) to 0.17 (0.14-0.21) (p<0,0001). Mean EDSS-score at baseline was 2.9±1.8. Conclusions: In this first analysis of baseline data of patients entering TRUST, the observed reduction of disease activity under natalizumab treatment prior study entry is consistent with other cohort studies. By comparing clinical data from patients continuing vs those discontinuing natalizumab over 3 years and exploring patient management pathways in a high-risk cohort, TRUST is expected to provide insight into individual benefit/risk considerations and decision making in clinical practice. Study supported by: Biogen Disclosure: Dr. Ziemssen has received personal compensation for activities with Bayer Schering Pharma, Biogen Idec, EMD Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis, Teva Pharmaceutical, and Almirall. Prof. Gass received personal compensation from activities with Biogen Idec and Novartis. Dr. Limmroth has received personal compensation for activities with Bayer Pharmaceuticals Inc., Biogen Idec, Novartis, Roche Diagnostics Corp., Sanofi-Aventis Pharmaceuticals Inc., and Teva Neuroscience. Dr. Bayas has received personal compensation for activities with Merck Serono, Biogen-Idec, Novartis and Sanofi/Genzyme as a speaker/consultant. Dr. Haas has received personal compensation for activities with Bayer Schering, Teva Aventis, Merck Serono, Biogen Idec, Allergan Inc., Octapharma as a consultant. Dr. Linker has nothing to disclose. Dr. Maurer has received personal compensation for activities with Bayer HealthCare, Genzyme, Biogen, Novartis, TEVA, EMD Serono, Sanofi-Aventis, and Roche. Dr. Stangel has received personal compensation for activities with Bayer HealthCare. Dr. Tackenberg has received personal compensation for activities with Bayer Pharmaceuticals Corp., Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Dr. Tackenberg has received research support. Dr. Wuerfel has received research support from Biogen Idec and Novartis. Dr. Meergens has received personal compensation for activities with Biogen as an employee. Dr. Harlin has received personal compensation for activities with Biogen as an employee. Dr. Hartung has received personal compensation for activities with from Bayer, Biogen, GeNeuro, Genzyme as speaker, committee member, consultant.