09 May Diroximel Fumarate in Patients With Relapsing-remitting Multiple Sclerosis: Interim Efficacy and Safety Results From the Phase 3 EVOLVE-MS-1 Study
MedicalResearch.com Interview with:
Douglas Arnold, MD
The Montreal Neurological Institute & Hospital
Montreal, QC, Canada
MedicalResearch.com: What is the background for this study?
Response: Diroximel fumarate (DRF) is a novel oral fumarate, with a distinct chemical structure that is being developed for relapsing forms of multiple sclerosis (MS). It is hypothesized that the distinct chemical structure of DRF may elicit less localized irritation in the gastrointestinal (GI) tract, potentially leading to improved GI tolerability. Diroximel fumarate is expected to have similar efficacy as dimethyl fumarate (marketed as TECFIDERA®), as both are converted to equivalent levels of monomethyl fumarate in the body. The EVOLVE-MS-1 study is primarily evaluating the safety of DRF and also exploring efficacy endpoints.
MedicalResearch.com: What are the main findings?
Response: New interim safety results from the ongoing pivotal EVOLVE-MS-1 study that included 696 patients in the analysis showed that adverse events (AEs) were reported in 84.6% of patients; in most patients, AEs were mild or moderate in severity. GI AEs occurred in 30.9% of patients. The AEs led to discontinuation for 6.3% of patients and less than 1% of patients discontinued DRF due to GI AEs.
Serious AEs occurred in 7.5% of patients; 0.3% of patients had serious infections; no serious opportunistic infections, including progressive multifocal leukoencephalopathy
(PML), have been reported to date. Four (< 1%) patients permanently discontinued treatment due to lymphopenia.
New interim data explored the effectiveness of diroximel fumarate on clinical and radiological measures of disease activity in people with relapsing MS, particularly in newly diagnosed patients, after approximately one year of follow up.
Exploratory results show that diroximel fumarate significantly reduced annualized relapse rate (ARR) by 79 percent over one year in the overall study population, and by 82 percent in newly diagnosed patients compared to baseline. Diroximel fumarate also reduced the mean number of gadolinium-enhancing (Gd+) lesions compared to baseline by 77 percent in the total population and by 96 percent in newly diagnosed patients.
MedicalResearch.com: What should readers take away from your report?
Response: Diroximel fumarate shows potential as a new meaningful option for patients with relapsing multiple sclerosis. Newly diagnosed patients had notable improvements in ARR and Gd+ lesion count.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The GI tolerability profile of diroximel fumarate as compared to dimethyl fumarate is not yet understood; however, a head-to-head study called EVOLVE-MS-2 is currently ongoing and results are expected later this year.
MedicalResearch.com: Is there anything else you would like to add?
Response: Multiple sclerosis is a heterogeneous, chronic disease – we welcome new therapeutic options to help address our patients’ changing needs throughout the course of their disease.
This study was supported by Biogen and Alkermes.
Citation: AAN 2019 abstract
April 09, 2019; 92 (15 Supplement) MAY 7, 2019
Diroximel Fumarate (DRF) in Patients With Relapsing-Remitting Multiple Sclerosis: Interim Efficacy and Safety Results From the Phase 3 EVOLVE-MS-1 Study (P3.2-060)
Douglas L. Arnold, Christopher LaGanke, Dragana Obradovic, Mark Gudesblatt, Lili Yang, Catherine Miller, Richard Leigh-Pemberton, Maria Lopez-Bresnahan, Boris Kandinov, Jerry S. Wolinsky
First published April 9, 2019
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