Real-World Clinical Outcomes in Relapsing-Remitting Multiple Sclerosis Patients who Switch from Natalizumab to Delayed-Release Dimethyl Fumarate: A Multicenter, Retrospective, Observational Study (STRATEGY) (P3.293)

OBJECTIVE: Describe a retrospective observational study of relapsing-remitting multiple sclerosis (RRMS) patients who switched from natalizumab to delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) in the real-world setting. Factors potentially associated with treatment outcomes on DMF to be included are patient demographics, disease activity prior to initiating natalizumab or while on natalizumab, duration of washout from natalizumab to DMF, and steroid treatment during washout. BACKGROUND: There is limited information on standardized practices for transitioning patients from natalizumab to DMF. Clinical practices and switch protocols vary, and predictors of favorable treatment outcomes on DMF following natalizumab are not well understood. DESIGN/METHODS: STRATEGY is being performed through a single time point medical chart abstraction without required study visits or procedures. Approximately 500−700 patients from approximately 50 US sites will be enrolled. Key inclusion criteria include age 蠅18 years, RRMS diagnosis (McDonald criteria), at least 12 months of continuous treatment with natalizumab monotherapy prior to initiation of DMF, and initiation of DMF at least 12 months prior to enrollment. Patients are eligible to enroll regardless of current DMF use. Multiple endpoints will be examined, including relapse activity 12 months after initiation of DMF (measured as proportion of patients relapsed, annualized relapse rate, proportion of patients with MS-related hospitalization, and proportion of patients with relapses requiring intravenous steroids); association between disease activity prior to initiating natalizumab or while on natalizumab and relapse activity on DMF; association between washout duration and relapse activity on DMF; and association between steroid use during the washout period and relapse activity while on DMF. RESULTS: STRATEGY is ongoing; results will be reported. CONCLUSIONS: STRATEGY is being conducted to examine potential predictors of treatment response to DMF in RRMS patients who switched from natalizumab. Study Supported by: Biogen Idec Disclosure: Dr. Cohan has received personal compensation for activities with Acorda, Biogen Idec, Novartis, and Sanofi. Dr. Calkwood has received personal compensation for activities with Acorda Therapeutics, Bayer Healthcare, Biogen Idec, EMD Serono, Genzyme, Novartis, Questcor, and Teva as an advisor, consultant, and/or speaker. Dr. LaGanke has received personal compensation for activities with Acorda Therapeutics, Bayer Pharmaceuticals Corp., Biogen Idec, EMD Serono, Novartis, Pfizer Inc., Questcor Diagnostics, Genzyme Corp., Teva Neuroscience, and UCB Pharma. Dr. Tornatore has personal compensation for activities with Biogen Idec, Genzyme Corporation, and Novartis as a consultant and/or speakers bureau member. Dr. Moses has received personal compensation for activities with EMD Serono, Teva Neuroscience, Biogen Idec, Bayer Pharmaceuticals, Novartis, Questcor, Actelion, Genzyme, and Acorda Therapeutics. Dr. Smoot has personal compensation for activities with Acorda Therapeutics, Biogen Idec, EMD Serono, Pfizer Inc., Novartis, and Teva Neuroscience as a consultant. Dr. Mann has received personal compensation for activities with Biogen Idec as an employee. Dr. Meka has received personal compensation for activities with Biogen Idec as an employee. Dr. Okwuokenye has received personal compensation for activities with Biogen Idec as an employee. Dr. Hotermans has received personal compensation for activities with Biogen Idec as an employee. Dr. Meltzer has received personal compensation for activities with Biogen Idec, Inc. as an employee.