Abstract Details

Title Real-world Efficacy of Delayed-Release Dimethyl Fumarate in Early Multiple Sclerosis: Interim Results from ESTEEM

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-081

Objective Evaluate real-world effectiveness of delayed-release dimethyl fumarate (DMF) in newly diagnosed, early multiple sclerosis (MS), and interferon-beta (IFN)/glatiramer acetate (GA) switch patients in ESTEEM, an ongoing, multinational, 5-year, prospective, non-interventional study.

Background DMF demonstrated strong efficacy and favorable benefit–risk in patients with relapsing-remitting MS (RRMS) in clinical studies.

Design/Methods This post-hoc interim analysis of ESTEEM includes patients newly prescribed DMF in routine practice at ~380 sites. Annualized relapse rate (ARR) was evaluated in the overall population, 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.

Results 3075 patients were enrolled in ESTEEM; 73% on-treatment at interim analysis; median (min-max) follow-up, 13 (0-40) months. Unadjusted ARRs for 12 months before vs. 24 months post DMF 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), 82% 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), 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), 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), 77% lower ARR (P<0.0001). For reference, from DEFINE/CONFIRM pooled data, ARR after 2 years among patients receiving PBO (n=771) was 0.37 (95% CI: 0.33–0.42).

Conclusions

After treatment with DMF, ARR at 2 years was significantly reduced vs. the year prior to DMF initiation in patients treated with DMF in the real-world setting. These data provide further evidence of real-world effectiveness of DMF in patients early in their MS disease course.

Supported by: Biogen

Authors/Disclosures
Kathryn Giles PRESENTER	Kathryn Giles has stock in Synderdisc. The institution of Kathryn Giles has received research support from Biogen.
Konstantin E. Balashov, MD, PhD, FAAN (Department of Neurology, BMC and BUSM)	Dr. Balashov has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech.
Cynthia Jones, PhD	Dr. Jones has received personal compensation for serving as an employee of Biogen. Dr. Jones has received stock or an ownership interest from Biogen.
Richard A. Macdonell, MD, FAAN (Austin Health)	Dr. Macdonell has nothing to disclose.
Catherine Miller	Catherine Miller has received personal compensation for serving as an employee of Biogen. Catherine Miller has received stock or an ownership interest from Biogen.
Joerg Windsheimer, MD	No disclosure on file
Fan Wu, PhD	No disclosure on file
Nicholas J. Everage	No disclosure on file

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