Dimethyl Fumarate Therapy Reduces Relapse Rates in Early Multiple Sclerosis
The ESTEEM study included 3075 patients who were newly prescribed dimethyl fumarate to manage relapsing-remitting multiple sclerosis.
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Treatment of real-world patients with multiple sclerosis showed that early initiation of dimethyl fumarate significantly reduced annualized relapse rates compared with no treatment or prior treatment with other disease-modifying therapies. This research was presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis 2018, held October 10-12, 2018, in Berlin, Germany.
The authors of this post-hoc interim analysis of the ongoing ESTEEM study sought to evaluate the real-world efficacy of delayed-release dimethyl fumarate in patients with multiple sclerosis who had been treated within 3 years of diagnosis, treated with only 1 prior interferon-beta/glatiramer acetate, or who were treatment-naive.
The ESTEEM study included 3075 patients who were newly prescribed dimethyl fumarate to manage relapsing-remitting multiple sclerosis. Efficacy outcomes were measured using annualized relapse rates, which were obtained using a repeated-measure negative binomial model. Relapse rates were assessed for the overall population, newly diagnosed patients with no prior treatment and who initiated dimethyl fumarate within 1 year of diagnosis (n=770), early multiple sclerosis patients who initiated dimethyl fumarate within 3 years of diagnosis (n=1291), and patients who switched treatment from interferon-beta/glatiramer acetate to dimethyl fumarate (n=1915).
The results showed that 73% of patients enrolled in ESTEEM were receiving treatment at the time of the interim analysis. The investigators followed these patients for a median 13 months. For each subgroup, unadjusted annualized relapse rates for the year before starting dimethyl fumarate therapy were compared with those for the 24 months post dimethyl fumarate initiation: overall population, 0.8 (95% CI, 0.78-0.83) vs 0.15 (95% CI, 0.14-0.16); newly diagnosed patients, 1.12 (95% CI, 1.07-1.17) vs 0.17 (95% CI, 0.14-0.21); early multiple sclerosis patients, 1.03 (95% CI, 0.99-1.08) vs 0.17 (95% CI, 0.14-0.19); and patients who switched treatments, 0.69 (95% CI, 0.65-0.73) vs 0.16 (95% CI, 0.14-0.17). This represents an 81% lower relapse rate for the overall population (85% for newly diagnosed patients, 84% for early patients, and 77% for patients who switched therapies).
For patients with multiple sclerosis, annualized relapse rates were significantly reduced after treatment with dimethyl fumarate compared with the period before treatment initiation. The researchers concluded that these findings confirm the real-world effectiveness of dimethyl fumarate for treatment of multiple sclerosis early in the disease course.
Disclosures: Multiple authors declare associations with the pharmaceutical industry. Please see original reference for a full list of authors' disclosures.
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Macdonell R, Giles K, Balashov K, et al. Real-world efficacy of delayed-release dimethyl fumarate in early multiple sclerosis: interim results from ESTEEM. Presented at: 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. October 10-12, 2018; Berlin, Germany. Poster P595.