Abstract Details

Title Dimethyl Fumarate Demonstrates Treatment Effectiveness in Patients One Year After Switching From Teriflunomide

Topic Multiple Sclerosis

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

Poster/Presentation
Number 12-005

Background Understanding the effectiveness of switching from platform treatments to DMF can inform treatment strategies, particularly if the reason for switch is due to efficacy reasons, or not.

Objective To describe effectiveness of delayed-release dimethyl fumarate (DMF) for patients with relapsing-remitting multiple sclerosis (RRMS) previously treated with teriflunomide who switched for efficacy or non-efficacy reasons.

Design/Methods Patients most recently treated with teriflunomide in the ongoing ESTEEM (NCT02047097) as of 07 April 2020 and completed PROTEC studies (NCT01930708) were assessed for clinical effectiveness (ARR, PROs) up to 12 months on DMF treatment based on reason for switching (efficacy or non-efficacy). Negative binomial regression was used to estimate ARR and 95% confidence interval (CI). Poisson generalized estimating equations were used to compare unadjusted ARRs 12 months before and after study entry. PROs between baseline and 12 months were compared with a mixed-effect model with random intercept.

Results Overall, 195 patients (ESTEEM, n=184; PROTEC, n=11) switched from teriflunomide to DMF; 79 (40.5%) for efficacy and 116 (59.5%) for non-efficacy reasons. At baseline, efficacy switchers were younger, more likely to be male, and have shorter duration of MS, more MS relapses in the past 12 months, and longer duration of teriflunomide than non-efficacy switchers. For efficacy switchers, mean ARR was 0.232 (95% CI: 0.137–0.391) after up to 12 months of DMF treatment, and significantly decreased by 76% vs the year before study entry (p<0.0001). For non-efficacy switchers, mean ARR was 0.113 (95% CI: 0.061–0.210) after up to 12 months of DMF treatment and significantly decreased by 79% vs the year before study entry (p<0.0001). In both populations, PRO values remained stables from baseline to 12 months of DMF treatment.

Conclusions

DMF is an effective therapeutic strategy for patients previously treated with teriflunomide regardless of if switching for efficacy or non-efficacy reasons.

Study Supported by: Biogen

Authors/Disclosures
Sai L. Shankar, PhD, FAAN (Biogen) PRESENTER	Dr. Shankar has received personal compensation for serving as an employee of Biogen. Dr. Shankar has stock in Biogen.
Kathryn Giles	Kathryn Giles has stock in Synderdisc. The institution of Kathryn Giles has received research support from Biogen.
Richard A. Macdonell, MD, FAAN (Austin Health)	Dr. Macdonell has nothing to disclose.
	No disclosure on file
Phoebe Jiang, PhD	Dr. Jiang has received personal compensation for serving as an employee of Biogen. Dr. Jiang has stock in Biogen.
Seth N. Levin, MD (Biogen)	Dr. Levin has received personal compensation for serving as an employee of Biogen. Dr. Levin has received stock or an ownership interest from Biogen.
Thomas A. Berger, MD (Dept. of Neurology, Medical University of Vienna)	Prof. Berger has received personal compensation in the range of $10,000-$49,999 for serving as a speaker at scientific meetings and participant of local and international advisory boards with various companies producing and markerting treatments for multiple sclerosis (Almirall, Biogen, Biologix, Bionorica, Celgene-BMS, Merck, Novartis, Roche, Sanofi-Genzyme, TG Therapeutics, UCB).