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Effects of delayed-release dimethyl fumarate on MRI measures in the phase 3 CONFIRM study
David H Miller1, Robert J Fox2, J Theodore Phillips2
1From the Departments of Neuroinflammation (D.H.M., C.A.M.W.-K., D.J.T., D.G.M.) and Brain Repair and Rehabilitation (T.A.Y.), NMR Research Unit, Queen Square Multiple Sclerosis Centre; University College London Institute of Neurology (D.H.M., C.A.M.W.-K., D.J.T., D.G.M., T.A.Y.), UK; Mellen Center for Multiple Sclerosis Treatment and Research (R.J.F.), Cleveland Clinic, OH; Multiple Sclerosis Program (J.T.P.), Baylor Institute for Immunology Research, Dallas, TX; St. Vincent's University Hospital (M.H.), Elm Park, Donnybrook, Dublin, Ireland; Department of Neurology (E.H.), First Faculty of Medicine, Charles University, Prague, Czech Republic; Virginia Mason Medical Center (M.K.), Seattle, WA; CircleScience (M.G.), Tytherington, UK; and Biogen Idec Incorporated (M.Y., R.Z., V.V., K.T.D.), Weston, MA. david.h.miller@ucl.ac.uk.
Objective:
To evaluate the effects of oral delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on MRI lesion activity and load, atrophy, and magnetization transfer ratio (MTR) measures from the Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis (CONFIRM) study.
Methods:
CONFIRM was a 2-year, placebo-controlled study of the efficacy and safety of DMF 240 mg twice (BID) or 3 times daily (TID) in 1,417 patients with relapsing-remitting multiple sclerosis (RRMS); subcutaneous glatiramer acetate 20 mg once daily was included as an active reference comparator. The number and volume of T2-hyperintense, T1-hypointense, and gadolinium-enhancing (Gd+) lesions, as well as whole brain volume and MTR, were assessed in 681 patients (MRI cohort).
Results:
DMF BID and TID produced significant and consistent reductions vs placebo in the number of new or enlarging T2-hyperintense lesions and new nonenhancing T1-hypointense lesions after 1 and 2 years of treatment and in the number of Gd+ lesions at week 24, year 1, and year 2. Lesion volumes were also significantly reduced. Reductions in brain atrophy and MTR changes with DMF relative to placebo did not reach statistical significance.
Conclusions:
The robust effects on MRI active lesion counts and total lesion volume in patients with RRMS demonstrate the ability of DMF to exert beneficial effects on inflammatory lesion activity in multiple sclerosis, and support DMF therapy as a valuable new treatment option in RRMS.
Classification Of Evidence:
This study provides Class I evidence of reduction in brain lesion number and volume, as assessed by MRI, over 2 years of delayed-release DMF treatment.
Insights
Delayed-release dimethyl fumarate (DMF) significantly reduced active MRI lesions and lesion volume in relapsing-remitting multiple sclerosis (RRMS) patients over two years. These findings support DMF as a valuable treatment option for RRMS inflammatory activity.
Area of Science:
- Neurology
- Immunology
- Radiology
Background:
- Multiple Sclerosis (MS) is a chronic inflammatory disease affecting the central nervous system.
- Relapsing-remitting MS (RRMS) is the most common form, characterized by distinct attacks and remissions.
- Dimethyl fumarate (DMF) is an oral therapy used for treating RRMS.
Purpose of the Study:
- To evaluate the efficacy of oral delayed-release dimethyl fumarate (DMF) on MRI-assessed disease activity and burden in RRMS.
- To assess the impact of DMF on lesion activity, lesion load, brain atrophy, and magnetization transfer ratio (MTR).
Main Methods:
- The CONFIRM study was a 2-year, placebo-controlled trial involving 1,417 RRMS patients.
- Patients received delayed-release DMF (240 mg BID or TID) or placebo, with glatiramer acetate as an active comparator.
- MRI outcomes, including lesion counts, volumes, brain atrophy, and MTR, were assessed in a subset of 681 patients.
Main Results:
- DMF significantly reduced the number of new/enlarging T2 lesions and new non-enhancing T1 lesions compared to placebo at 1 and 2 years.
- DMF also significantly decreased the number of gadolinium-enhancing lesions and total lesion volume.
- No statistically significant reductions in brain atrophy or MTR changes were observed with DMF versus placebo.
Conclusions:
- Delayed-release DMF demonstrates robust efficacy in reducing active MRI lesions and total lesion volume in RRMS patients.
- These findings support DMF's role in managing inflammatory activity in RRMS.
- DMF is a valuable therapeutic option for patients with RRMS.
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