Evaluation of the revised 2013 MS clinical course definitions in the CLIMB real world cohort (P5.190)

OBJECTIVE: To test the performance of revised 2013 clinical course definitions of MS (Neurology 2014; 83:278) in a real world cohort. BACKGROUND: Revised definitions for MS disease course were proposed by the International Advisory Committee on Clinical Trials in MS, to be used for communication, prognostication, design and recruitment for clinical trials. The revisions include relapse rate, imaging and progression. DESIGN/METHODS: The Comprehensive Longitudinal Investigation of MS at Brigham and Women’s Hospital (CLIMB) is a prospective cohort study that includes relapse rate, imaging and disease progression. We evaluated the proportion of patients who met each of the revised definitions at their first visit in years 2010 through 2013, using physician designations based on clinical and MRI data prospectively entered into the CLIMB database (885-1123 patients per year). The majority of patients were on disease modifying therapy. RESULTS: Patients categorized as “active” comprised 0-8.75[percnt] of the clinically isolated syndrome (CIS) category; 88.7-100[percnt] were not active. In the relapsing remitting (RRMS) group, 9.9-12.3[percnt] were active, and 85.1-87.1[percnt] were not active and not progressive. Amongst progressive patients, 55.94-69.7[percnt] were not active and not progressive; 0.6-1.7[percnt] were active but without progression; 29.5-42.7[percnt] were not active but with progression; 0-1.2[percnt] were active and progressive. The relapsing active patients were younger (p<0.001, two sample t-test) and had shorter disease duration that relapsing non-active patients (p=0.001, two sample t-test). Amongst progressive patients, the non-progressive/non-active and progressive/non-active patients did not differ significantly in age, sex, or disease duration. CONCLUSIONS: Using revised definitions, we found approximately 10[percnt] of relapsing patients were active, and 30-40[percnt] progressive patients had disease progression in the CLIMB study. These data are the first test of the revised definitions in a large prospective cohort and will help inform the use of the new definitions in clinical and research settings including clinical trials. Disclosure: Dr. Chitnis has received personal compensation for activities with Biogen Idec and Alexion. Dr. Chitnis has received research support from Merck Serono and Novartis. Dr. Healy has received research support from Merck Serono. Dr. Glanz has received research support from Merck Serono. Dr. Bakshi has received personal compensation for activities with Biogen Idec, Novartis, Sanofi/Genzyme, and Teva Neuroscience as a consultant. Dr. Bove has nothing to disclose. Dr. De Jager has received personal compensation for activities with Teva Neuroscience and Biogen Idec. Dr. De Jager has received research support from Biogen Idec and Sanofi/Genzyme. Dr. Houtchens has received personal compensation for activities with Biogen Idec, Teva Neuroscience, and Novartis Pharmaceuticals. Dr. Kimbrough has nothing to disclose. Dr. Severson has received personal compensation for activities with Biogen Idec and Novartis. Dr. Stankiewicz has received personal compensation for activities with Teva Neuroscience, Questcor Pharmaceuticals, Novartis, and Genzyme Corporation as a consultant. Ms. Stazzone has received personal compensation for activities with Teva Neuroscience, Novartis, and Genzyme Corporation. Dr. Weiner has received personal compensation for activities with Biogen Idec, Novartis, EMD Serono, and Teva Neuroscience.