Contributions
Abstract: P1160
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: In a post hoc analysis of the CONFIRM study comparing patients (pts) with relapsing-remitting multiple sclerosis (RRMS) treated with delayed-release dimethyl fumarate (DMF) versus glatiramer acetate (GA), DMF was associated with significantly reduced risk of inflammatory disease activity.
Objectives: To report real-world effectiveness results of DMF compared with GA in RRMS pts at 12 months.
Methods: EFFECT (NCT02776072) was a multicentre, international, retrospective, single time point, observational study undertaken to evaluate the effectiveness of DMF and other disease-modifying therapies (DMTs). Pt inclusion criteria included: age ≥18 years, diagnosis of RRMS, treatment naïve or 1 prior DMT (interferon [IFN] or GA; pts in the GA arm were permitted only prior IFN), initiation of DMT after December 2010, and ≥12 months of follow-up data available after DMT initiation. Endpoints included the Kaplan-Meier estimated proportion of pts relapsed at 12 months (primary), and annualized relapse rate (ARR). Substantive baseline covariates were used in estimating propensity score. Quartiles of propensity score were created. After assessing for balance in baseline covariate between treatment groups, Kaplan-Meier estimates and estimate of treatment effects were pooled across strata of propensity score.
Results: Of the 826 DMF-treated pts and 1064 GA-treated pts enrolled at sites from 17 countries, 816 DMF and 1042 GA pts, respectively, were included in the full analysis set. Treatment groups were balanced after propensity score stratification. At 12 months, 14% (117) of DMF-treated and 20% (211) of GA-treated pts had discontinued therapy; the primary reason for discontinuation was tolerability for both DMF (9%) and GA (9%) arms. In the trimmed full analysis set, the estimated proportion of DMF-treated pts that relapsed at 12 months was 11.6% compared with 20.8% for the GA-treated pts (hazard ratio [95% CI] 0.71 [0.54, 0.95]), representing a significant decrease of 29% (DMF vs GA; P=0.0195). At 12 months after treatment initiation, the adjusted ARR ratio was (95% CI) 0.66 (0.50, 0.87), representing a significant decrease of 34% (p=0.0033) for pts treated with DMF versus GA.
Conclusions: Over 12 months, treatment with DMF versus GA was associated with statistically significant higher proportion of relapse-free pts and lower ARR.
Supported by: Biogen
Disclosure:
Chan A: Consulting fees from Bayer, Biogen, Genzyme, Merck, Novartis, Roche, Sanofi-Aventis, Teva Neuroscience, UCB. Research grants from: Biogen, Genzyme, Novartis, and UCB
Cohan S: Consulting fees from advisory boards and steering committees for Biogen, Novartis, Genzyme, and Mallinckrodt; speaker honoraria from Biogen, Novartis, Genzyme, Roche Genentech, and Acorda. Research grants from: Biogen, Opexa, Novartis, Genzyme, Roche, and Mallinckgrodt
Stark J: Dr. Stark has nothing to disclose
Brassat D: Speaker honororia and consulting fees from Bayer, Biogen, Merck, Novartis, Roche and Teva
Okwuokenye M: Employee of and holds stock/stock options in Biogen
Min J: Contractor for Biogen
Taylor C: Employee of and holds stock/stock options in Biogen
Abstract: P1160
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: In a post hoc analysis of the CONFIRM study comparing patients (pts) with relapsing-remitting multiple sclerosis (RRMS) treated with delayed-release dimethyl fumarate (DMF) versus glatiramer acetate (GA), DMF was associated with significantly reduced risk of inflammatory disease activity.
Objectives: To report real-world effectiveness results of DMF compared with GA in RRMS pts at 12 months.
Methods: EFFECT (NCT02776072) was a multicentre, international, retrospective, single time point, observational study undertaken to evaluate the effectiveness of DMF and other disease-modifying therapies (DMTs). Pt inclusion criteria included: age ≥18 years, diagnosis of RRMS, treatment naïve or 1 prior DMT (interferon [IFN] or GA; pts in the GA arm were permitted only prior IFN), initiation of DMT after December 2010, and ≥12 months of follow-up data available after DMT initiation. Endpoints included the Kaplan-Meier estimated proportion of pts relapsed at 12 months (primary), and annualized relapse rate (ARR). Substantive baseline covariates were used in estimating propensity score. Quartiles of propensity score were created. After assessing for balance in baseline covariate between treatment groups, Kaplan-Meier estimates and estimate of treatment effects were pooled across strata of propensity score.
Results: Of the 826 DMF-treated pts and 1064 GA-treated pts enrolled at sites from 17 countries, 816 DMF and 1042 GA pts, respectively, were included in the full analysis set. Treatment groups were balanced after propensity score stratification. At 12 months, 14% (117) of DMF-treated and 20% (211) of GA-treated pts had discontinued therapy; the primary reason for discontinuation was tolerability for both DMF (9%) and GA (9%) arms. In the trimmed full analysis set, the estimated proportion of DMF-treated pts that relapsed at 12 months was 11.6% compared with 20.8% for the GA-treated pts (hazard ratio [95% CI] 0.71 [0.54, 0.95]), representing a significant decrease of 29% (DMF vs GA; P=0.0195). At 12 months after treatment initiation, the adjusted ARR ratio was (95% CI) 0.66 (0.50, 0.87), representing a significant decrease of 34% (p=0.0033) for pts treated with DMF versus GA.
Conclusions: Over 12 months, treatment with DMF versus GA was associated with statistically significant higher proportion of relapse-free pts and lower ARR.
Supported by: Biogen
Disclosure:
Chan A: Consulting fees from Bayer, Biogen, Genzyme, Merck, Novartis, Roche, Sanofi-Aventis, Teva Neuroscience, UCB. Research grants from: Biogen, Genzyme, Novartis, and UCB
Cohan S: Consulting fees from advisory boards and steering committees for Biogen, Novartis, Genzyme, and Mallinckrodt; speaker honoraria from Biogen, Novartis, Genzyme, Roche Genentech, and Acorda. Research grants from: Biogen, Opexa, Novartis, Genzyme, Roche, and Mallinckgrodt
Stark J: Dr. Stark has nothing to disclose
Brassat D: Speaker honororia and consulting fees from Bayer, Biogen, Merck, Novartis, Roche and Teva
Okwuokenye M: Employee of and holds stock/stock options in Biogen
Min J: Contractor for Biogen
Taylor C: Employee of and holds stock/stock options in Biogen