Two-Year Relapse Rate in the TOP MS Study: Completer Cohort (P01.132)

Objective: To evaluate characteristics related to 2-year relapse rate for the TOP MS study completer cohort. Background The Therapy Optimization in MS Study (TOP MS) is a prospective, open-label parallel group study of patients who are being treated with disease-modifying therapies (DMT). All of the DMT have been shown to effectively reduce relapse rates. Design/Methods: Potential participants for TOP MS were identified at specialty pharmacies with medication therapy management programs. Signed informed consent forms were returned to the pharmacies, and study enrollment produced log-on instructions for the study website. At baseline and monthly intervals over 24 months, enrolled participants receive reminders to respond to surveys. Self-reported responses are entered directly into the study database. Results: The TOP MS completer cohort consists of 531 subjects with a mean duration of disease of 11.1+9.2 years. Nearly 90% of participants met the criteria for relapsing forms of MS. The 2-year relapse rate for this cohort was 35.3%. Glatiramer acetate was being used by 50.8%, and 49.2% were using interferon-beta at study enrollment. Over two years therapy change occurred for 50 patients (9.4%) and was significantly associated with the number of confirmed relapses (chi 2 = 13.9, df = 2, p = .001). While mean duration of current DMT treatment was 4.3+4.1 years, shorter duration was correlated with more confirmed relapses (p = .004). One-third of the completer cohort had used other DMT prior to starting their current therapy (mean number of previous therapies: 1.3) and number of previous DMT was positively correlated with number of confirmed relapses (p = .001). Disease duration and enrollment DMT were not associated with relapses. Conclusions: The two-year relapse rate in the completer cohort of the TOP MS Study was influenced by change in DMT therapy, time on DMT treatment, and number of previous DMT treatments. Supported by: Teva Pharmaceuticals. Disclosure: Dr. Coyle has received personal compensation for activities with Acorda Therapeutics, Avanir Pharmaceuticals, Bayer Pharmaceuticals Corporation, Biogen Idec, Genzyme Corporation, Novartis, Questcor, Roche Diagnostics Corporation, Sanofi-Aventis Pharmaceuticals, Inc., and Teva Neuroscience. Dr. Coyle has received personal compensation in an editorial capacity for NEURA. Dr. Coyle has received research support from Serono, Inc., Novartis, and Sanofi-Aventis Pharmaceuticals, Inc. Dr. Zwibel has received personal compensation for activities with Serono, Inc., and Teva Neuroscience. Dr. Zwibel has received research support from Teva Neuroscience. Dr. Cohen has received research support from Biogen Idec. Dr. Leist has received personal compensation for activities with EMD Serono, Teva Neuroscience and Bayer.Dr. Leist has received research support from Bayer, EMD Serono and Teva Neuroscience. Dr. Tullman has received personal compensation for activities with Acorda Therapeutics, Biogen Idec, Serono Inc., Novartis, Pfizer Inc., Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Abbott Labortories, Inc. and Vaccinex as a consultant and/or speaker. Dr. Tullman has received research support from Acorda Therapeutics, BioMS, Novartis, and Genentech, Inc. Dr. Markowitz has received personal compensation for activities with Bayer, Teva, EMD-Serono, Biogen Idec, and Eli Lilly. Dr. Hughes has received research support from Teva Neuroscience, Berlex Labratories and Genentech, Inc..