Contributions
Abstract: EP1630
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: In real-world comparative effectiveness studies of relapsing-remitting multiple sclerosis (RRMS) patients, including claims data and registries, treatment with delayed-release dimethyl fumarate (DMF) compared with fingolimod (FTY) for up to 2 years was associated with no statistically significant differences in relapse outcomes.
Objectives: To report the real-world effectiveness of DMF compared with FTY in RRMS patients (pts) at 12 months.
Methods: EFFECT (NCT02776072) was an observational, multicentre, international, retrospective, single time point, medical record review study undertaken to evaluate the effectiveness of DMF and other disease-modifying therapies (DMTs). Pt eligibility criteria included: age ≥18 years, diagnosis of RRMS, treatment naïve or 1 prior DMT (interferon or glatiramer acetate [GA]), initiation of DMT treatment after December 2010, and ≥12 months of medical record data following DMT initiation. Endpoints included Kaplan-Meier estimated proportion of pts relapsed at 12 months and annualized relapse rate (ARR). Substantive baseline covariates were used in estimating propensity score. The data were divided into
4 strata using quartiles of propensity score. After assessing for balance in baseline covariates between treatment groups, Kaplan-Meier estimates and estimate of treatment effects were pooled across strata of propensity score.
Results: Of the 826 DMF and 785 FTY pts enrolled at sites in 17 countries, 816 and 781 pts, respectively, were included in the full analysis set. Treatment groups were balanced after propensity score stratification. At 12 months, 86% of DMF-treated patients and 94% of FTY-treated patients remained on therapy. In the trimmed full analysis set, the estimated proportion of DMF pts that relapsed at 12 months was 12% compared with 13% for FTY pts; hazard ratio (95%, CI) 1.07 (0.78, 1.46; p=0.6926). At 12 months after treatment initiation, the adjusted ARR ratio (95% CI) was 1.09 (0.80, 1.49; p=0.5754) for pts treated with DMF compared to FTY.
Conclusions: Over 12 months, treatment with DMF versus FTY was associated with no statistically significant difference on relapse outcomes.
Supported by: Biogen
Disclosure:
Sloane J: Consulting fees: Biogen, Genentech, Genzyme, Teva
Phillips JT: Served as a consultant for Acorda, Biogen, Genentech, Genzyme, Merck Serono, Roche, and Sanofi.
Calkwood J: Consulting fees: advisory, consultancy, and speaker activities for Acorda, Biogen, EMD Serono, Genzyme, Novartis, Roche, and Teva. Research grants: Biogen, Celegene, Genzyme, Novartis, and Roche.
Van der Walt: Consulting fees: advisory boards for Merck, Novartis and travel honoraria from Biogen, Merck, Novartis, and Teva.
Min J: Contractor for Biogen
Okwuokenye M: Employee of and holds stock/stock options in Biogen
Taylor C: Employee of and holds stock/stock options in Biogen
Abstract: EP1630
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: In real-world comparative effectiveness studies of relapsing-remitting multiple sclerosis (RRMS) patients, including claims data and registries, treatment with delayed-release dimethyl fumarate (DMF) compared with fingolimod (FTY) for up to 2 years was associated with no statistically significant differences in relapse outcomes.
Objectives: To report the real-world effectiveness of DMF compared with FTY in RRMS patients (pts) at 12 months.
Methods: EFFECT (NCT02776072) was an observational, multicentre, international, retrospective, single time point, medical record review study undertaken to evaluate the effectiveness of DMF and other disease-modifying therapies (DMTs). Pt eligibility criteria included: age ≥18 years, diagnosis of RRMS, treatment naïve or 1 prior DMT (interferon or glatiramer acetate [GA]), initiation of DMT treatment after December 2010, and ≥12 months of medical record data following DMT initiation. Endpoints included Kaplan-Meier estimated proportion of pts relapsed at 12 months and annualized relapse rate (ARR). Substantive baseline covariates were used in estimating propensity score. The data were divided into
4 strata using quartiles of propensity score. After assessing for balance in baseline covariates between treatment groups, Kaplan-Meier estimates and estimate of treatment effects were pooled across strata of propensity score.
Results: Of the 826 DMF and 785 FTY pts enrolled at sites in 17 countries, 816 and 781 pts, respectively, were included in the full analysis set. Treatment groups were balanced after propensity score stratification. At 12 months, 86% of DMF-treated patients and 94% of FTY-treated patients remained on therapy. In the trimmed full analysis set, the estimated proportion of DMF pts that relapsed at 12 months was 12% compared with 13% for FTY pts; hazard ratio (95%, CI) 1.07 (0.78, 1.46; p=0.6926). At 12 months after treatment initiation, the adjusted ARR ratio (95% CI) was 1.09 (0.80, 1.49; p=0.5754) for pts treated with DMF compared to FTY.
Conclusions: Over 12 months, treatment with DMF versus FTY was associated with no statistically significant difference on relapse outcomes.
Supported by: Biogen
Disclosure:
Sloane J: Consulting fees: Biogen, Genentech, Genzyme, Teva
Phillips JT: Served as a consultant for Acorda, Biogen, Genentech, Genzyme, Merck Serono, Roche, and Sanofi.
Calkwood J: Consulting fees: advisory, consultancy, and speaker activities for Acorda, Biogen, EMD Serono, Genzyme, Novartis, Roche, and Teva. Research grants: Biogen, Celegene, Genzyme, Novartis, and Roche.
Van der Walt: Consulting fees: advisory boards for Merck, Novartis and travel honoraria from Biogen, Merck, Novartis, and Teva.
Min J: Contractor for Biogen
Okwuokenye M: Employee of and holds stock/stock options in Biogen
Taylor C: Employee of and holds stock/stock options in Biogen