Contributions
Abstract: P1163
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Delayed-release dimethyl fumarate (DMF) demonstrated strong efficacy and a favourable benefit-risk profile in patients (Pts) with relapsing-remitting multiple sclerosis (RRMS) in clinical studies, including the ESTEEM study (NCT02047097), an ongoing, multinational, 5-yr prospective, non-interventional study.
Objectives: To evaluate the efficacy of DMF in newly diagnosed, early MS, and interferon-beta (IFN) or glatiramer acetate (GA) switch Pts in ESTEEM.
Methods: Eligible Pts treated with newly prescribed DMF under routine clinical care were recruited from ~380 sites globally. The primary objective of the ESTEEM study is to determine serious adverse events (SAEs) and AEs leading to treatment discontinuation. This post hoc analysis evaluated the annualized relapse rate (ARR) in newly diagnosed, early MS, and IFN/GA switch Pts. Newly diagnosed Pts were defined as those having received no prior disease-modifying therapy (DMT) and initiating DMF within 1 year of diagnosis; early MS Pts as those having received ≤1 prior DMT and initiating DMF within 3 years of diagnosis; and IFN/GA switch Pts as those having any prior history of IFN or GA regardless of time from diagnosis. ARRs were obtained by fitting a repeated measure negative binomial model.
Results: In the overall population (n=2011), the unadjusted ARR for the 12 months prior to DMF initiation was 0.79 (95% confidence interval [CI]: 0.75, 0.82) vs. 0.18 (95% CI: 0.15, 0.20) for the 12 months after DMF initiation, representing a 78% lower ARR (P< 0.0001). In newly diagnosed Pts (n=467), the unadjusted ARR for the 12 months prior to DMF initiation was 1.07 (95% CI: 1.00, 1.14) vs. 0.21 (95% CI: 0.16, 0.27) for the 12 months after DMF initiation, representing an 80% lower ARR (P< 0.0001). In early MS Pts (n=814), the unadjusted ARR for the 12 months prior to DMF initiation was 1.03 (95% CI: 0.97, 1.08) vs. 0.18 (95% CI: 0.14, 0.22) for the 12 months after DMF initiation, representing an 83% lower ARR (P< 0.0001). In IFN/GA switch Pts (n=1298), the unadjusted ARR for the 12 months prior to DMF initiation was 0.70 (95% CI: 0.66, 0.75) vs. 0.18 (95% CI: 0.15, 0.21) for the 12 months after DMF initiation, representing a 75% lower ARR (P< 0.0001).
Conclusions: DMF treatment at 12 months was associated with significantly lower ARRs compared to the 12 months prior to DMF in newly diagnosed, early MS, and IFN/GA switch Pts, consistent with findings in the overall ESTEEM population.
Supported by: Biogen
Disclosure:
Supported by: this study was supported by Biogen (Cambridge, MA, USA). Editorial support was provided by Excel Scientific Solutions (Horsham, UK): funding was provided by Biogen.
Nicholas J. Everage: employee of and holds stock/stock options in Biogen
Jerome Hanna: employee of and holds stock/stock options in Biogen
Fan Wu: employee of and holds stock/stock options in Biogen
Catherine Taylor: employee of and holds stock/stock options in Biogen
Konstantin Balashov: grant/research support from Biogen, consultant for Genzyme, and speaker bureau member for Teva
Richard Macdonell: grant/research support from Biogen and advisory boards for Biogen, Genzyme, Merck, Novartis, Roche, and Teva
Jörg Windsheimer: advisory boards for Genzyme, Merck, Novartis, Roche, and Teva
Kathryn Giles: consulting fees from EMD Serono, advisory board for Genzyme, and speakers' bureau and advisory board for Biogen.
Abstract: P1163
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Delayed-release dimethyl fumarate (DMF) demonstrated strong efficacy and a favourable benefit-risk profile in patients (Pts) with relapsing-remitting multiple sclerosis (RRMS) in clinical studies, including the ESTEEM study (NCT02047097), an ongoing, multinational, 5-yr prospective, non-interventional study.
Objectives: To evaluate the efficacy of DMF in newly diagnosed, early MS, and interferon-beta (IFN) or glatiramer acetate (GA) switch Pts in ESTEEM.
Methods: Eligible Pts treated with newly prescribed DMF under routine clinical care were recruited from ~380 sites globally. The primary objective of the ESTEEM study is to determine serious adverse events (SAEs) and AEs leading to treatment discontinuation. This post hoc analysis evaluated the annualized relapse rate (ARR) in newly diagnosed, early MS, and IFN/GA switch Pts. Newly diagnosed Pts were defined as those having received no prior disease-modifying therapy (DMT) and initiating DMF within 1 year of diagnosis; early MS Pts as those having received ≤1 prior DMT and initiating DMF within 3 years of diagnosis; and IFN/GA switch Pts as those having any prior history of IFN or GA regardless of time from diagnosis. ARRs were obtained by fitting a repeated measure negative binomial model.
Results: In the overall population (n=2011), the unadjusted ARR for the 12 months prior to DMF initiation was 0.79 (95% confidence interval [CI]: 0.75, 0.82) vs. 0.18 (95% CI: 0.15, 0.20) for the 12 months after DMF initiation, representing a 78% lower ARR (P< 0.0001). In newly diagnosed Pts (n=467), the unadjusted ARR for the 12 months prior to DMF initiation was 1.07 (95% CI: 1.00, 1.14) vs. 0.21 (95% CI: 0.16, 0.27) for the 12 months after DMF initiation, representing an 80% lower ARR (P< 0.0001). In early MS Pts (n=814), the unadjusted ARR for the 12 months prior to DMF initiation was 1.03 (95% CI: 0.97, 1.08) vs. 0.18 (95% CI: 0.14, 0.22) for the 12 months after DMF initiation, representing an 83% lower ARR (P< 0.0001). In IFN/GA switch Pts (n=1298), the unadjusted ARR for the 12 months prior to DMF initiation was 0.70 (95% CI: 0.66, 0.75) vs. 0.18 (95% CI: 0.15, 0.21) for the 12 months after DMF initiation, representing a 75% lower ARR (P< 0.0001).
Conclusions: DMF treatment at 12 months was associated with significantly lower ARRs compared to the 12 months prior to DMF in newly diagnosed, early MS, and IFN/GA switch Pts, consistent with findings in the overall ESTEEM population.
Supported by: Biogen
Disclosure:
Supported by: this study was supported by Biogen (Cambridge, MA, USA). Editorial support was provided by Excel Scientific Solutions (Horsham, UK): funding was provided by Biogen.
Nicholas J. Everage: employee of and holds stock/stock options in Biogen
Jerome Hanna: employee of and holds stock/stock options in Biogen
Fan Wu: employee of and holds stock/stock options in Biogen
Catherine Taylor: employee of and holds stock/stock options in Biogen
Konstantin Balashov: grant/research support from Biogen, consultant for Genzyme, and speaker bureau member for Teva
Richard Macdonell: grant/research support from Biogen and advisory boards for Biogen, Genzyme, Merck, Novartis, Roche, and Teva
Jörg Windsheimer: advisory boards for Genzyme, Merck, Novartis, Roche, and Teva
Kathryn Giles: consulting fees from EMD Serono, advisory board for Genzyme, and speakers' bureau and advisory board for Biogen.