Contributions
Abstract: P595
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Delayed-release dimethyl fumarate (DMF) demonstrated strong efficacy and a favourable benefit-risk profile in patients with relapsing-remitting multiple sclerosis (RRMS) in clinical studies. ESTEEM (NCT02047097) is an ongoing, 5-year, observational study to characterise the long-term safety and effectiveness of DMF in patients treated in clinical practice.
Objectives: To evaluate the real-world effectiveness of DMF in patients who are treatment naïve, or have been treated within 3 years of diagnosis, or treated with only one prior interferon-beta (IFN)/glatiramer acetate (GA).
Methods: This post-hoc interim analysis of ESTEEM includes patients newly prescribed DMF in routine practice at ~380 sites globally. Annualised relapse rate (ARR) was evaluated in the overall population, as well as newly diagnosed (no prior disease-modifying therapy [DMT] and initiated DMF ≤1 year of diagnosis), early MS (≤1 prior DMT and initiated DMF ≤3 years of diagnosis), and IFN/GA switch (received prior IFN/GA at any time from diagnosis) patients. ARRs were obtained via a repeated-measure negative binomial model.
Results: Enrolled in ESTEEM were 3075 patients; 73% were on-treatment at the time of the interim analysis; median (min-max) follow-up was 13 (0-40) months. The unadjusted ARRs for the 12 months before DMF vs. the 24 months post DMF initiation were as follows: overall population (n=3075), 0.80 (95% confidence interval [CI]: 0.78-0.83) vs. 0.15 (95% CI: 0.14-0.16), representing a 81% lower ARR (P< 0.0001); newly diagnosed patients (n=770), 1.12 (95% CI: 1.07-1.17) vs. 0.17 (95% CI: 0.14-0.21), representing an 85% lower ARR (P< 0.0001); early MS patients (n=1291), 1.03 (95% CI: 0.99-1.08) vs. 0.17 (95% CI: 0.14-0.19), representing an 84% lower ARR (P< 0.0001); and IFN/GA switch patients (n=1915), 0.69 (95% CI: 0.65-0.73) vs. 0.16 (95% CI: 0.14-0.17), representing a 77% lower ARR (P< 0.0001). For reference, in pooled data from the DEFINE/CONFIRM trials, the ARR after 2 years among patients who received placebo (n=771) was 0.37 (95% CI: 0.33-0.42).
Conclusions: After treatment with DMF, ARR at 2 years was significantly reduced compared to the year prior to DMF initiation in patients who were treated with DMF in the real-world setting. These data provide further evidence of real-world effectiveness of DMF in patients who are early in their MS disease course.
Supported by: Biogen
Disclosure: Kathryn Giles: Consulting fees from EMD Serono, honoraria from Genzyme and Biogen
Konstantin Balashov: Speaker fees from Teva, consulting fees from Genzyme, Genetech, and Celgene. Grant/research support from Biogen.
Cynthia C. Jones: Employee of and holds stock/stock options in Biogen
Richard Macdonell: Honoraria from Biogen, Teva, Roche, Merck, Genzyme, and Novartis
Catherine Miller: Employee of and holds stock/stock options in Biogen
Jörg Windsheimer: Honoraria from Teva, Roche, Merck, Genzyme, and Novartis
Fan Wu: Employee of and holds stock/stock options in Biogen
Nicholas J. Everage: Employee of and holds stock/stock options in Biogen
Abstract: P595
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Delayed-release dimethyl fumarate (DMF) demonstrated strong efficacy and a favourable benefit-risk profile in patients with relapsing-remitting multiple sclerosis (RRMS) in clinical studies. ESTEEM (NCT02047097) is an ongoing, 5-year, observational study to characterise the long-term safety and effectiveness of DMF in patients treated in clinical practice.
Objectives: To evaluate the real-world effectiveness of DMF in patients who are treatment naïve, or have been treated within 3 years of diagnosis, or treated with only one prior interferon-beta (IFN)/glatiramer acetate (GA).
Methods: This post-hoc interim analysis of ESTEEM includes patients newly prescribed DMF in routine practice at ~380 sites globally. Annualised relapse rate (ARR) was evaluated in the overall population, as well as newly diagnosed (no prior disease-modifying therapy [DMT] and initiated DMF ≤1 year of diagnosis), early MS (≤1 prior DMT and initiated DMF ≤3 years of diagnosis), and IFN/GA switch (received prior IFN/GA at any time from diagnosis) patients. ARRs were obtained via a repeated-measure negative binomial model.
Results: Enrolled in ESTEEM were 3075 patients; 73% were on-treatment at the time of the interim analysis; median (min-max) follow-up was 13 (0-40) months. The unadjusted ARRs for the 12 months before DMF vs. the 24 months post DMF initiation were as follows: overall population (n=3075), 0.80 (95% confidence interval [CI]: 0.78-0.83) vs. 0.15 (95% CI: 0.14-0.16), representing a 81% lower ARR (P< 0.0001); newly diagnosed patients (n=770), 1.12 (95% CI: 1.07-1.17) vs. 0.17 (95% CI: 0.14-0.21), representing an 85% lower ARR (P< 0.0001); early MS patients (n=1291), 1.03 (95% CI: 0.99-1.08) vs. 0.17 (95% CI: 0.14-0.19), representing an 84% lower ARR (P< 0.0001); and IFN/GA switch patients (n=1915), 0.69 (95% CI: 0.65-0.73) vs. 0.16 (95% CI: 0.14-0.17), representing a 77% lower ARR (P< 0.0001). For reference, in pooled data from the DEFINE/CONFIRM trials, the ARR after 2 years among patients who received placebo (n=771) was 0.37 (95% CI: 0.33-0.42).
Conclusions: After treatment with DMF, ARR at 2 years was significantly reduced compared to the year prior to DMF initiation in patients who were treated with DMF in the real-world setting. These data provide further evidence of real-world effectiveness of DMF in patients who are early in their MS disease course.
Supported by: Biogen
Disclosure: Kathryn Giles: Consulting fees from EMD Serono, honoraria from Genzyme and Biogen
Konstantin Balashov: Speaker fees from Teva, consulting fees from Genzyme, Genetech, and Celgene. Grant/research support from Biogen.
Cynthia C. Jones: Employee of and holds stock/stock options in Biogen
Richard Macdonell: Honoraria from Biogen, Teva, Roche, Merck, Genzyme, and Novartis
Catherine Miller: Employee of and holds stock/stock options in Biogen
Jörg Windsheimer: Honoraria from Teva, Roche, Merck, Genzyme, and Novartis
Fan Wu: Employee of and holds stock/stock options in Biogen
Nicholas J. Everage: Employee of and holds stock/stock options in Biogen