Effects of delayed-release dimethyl fumarate on MRI measures in the phase 3 CONFIRM study(314 views) Miller DH, Fox RJ, Phillips JT, Hutchinson M, Havrdova E, Kita M, Wheeler-kingshott CA, Tozer DJ, Macmanus DG, Yousry TA, Goodsell M, Yang M, Zhang R, Viglietta V, Dawson KT
From 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.
References: Not available.
Effects of delayed-release dimethyl fumarate on MRI measures in the phase 3 CONFIRM study
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.
Effects of delayed-release dimethyl fumarate on MRI measures in the phase 3 CONFIRM study
No results.
Effects of delayed-release dimethyl fumarate on MRI measures in the phase 3 CONFIRM study
Kim YH, Shin SW, Pellicano R, Fagoonee S, Choi IJ, Kim YI, Park B, Choi JM, Kim SG, Choi J, Park JY, Oh S, Yang HJ, Lim JH, Im JP, Kim JS, Jung HC, Ponzetto A, Figura N, Malfertheiner P, Choi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, Park B, Nam BH, Bae SE, Choi KD, Choe J, Kim SO, Na HK, Choi JY, Ahn JY, Jung KW, Lee J, Kim DH, Chang HS, Song HJ, Lee GH, Jung HY, Seta T, Takahashi Y, Noguchi Y, Shikata S, Sakai T, Sakai K, Yamashita Y, Nakayama T, Leja M, Park JY, Murillo R, Liepniece-karele I, Isajevs S, Kikuste I, Rudzite D, Krike P, Parshutin S, Polaka I, Kirsners A, Santare D, Folkmanis V, Daugule I, Plummer M, Herrero R, Tsukamoto T, Nakagawa M, Kiriyama Y, Toyoda T, Cao X, Corral JE, Mera R, Dye CW, Morgan DR, Lee YC, Lin JT, Garcia Martin R, Matia Cubillo A, Lee SH, Park JM, Han YM, Ko WJ, Hahm KB, Leontiadis GI, Ford AC, Ichinose M, Sugano K, Jeong M, Park JM, Han YM, Park KY, Lee DH, Yoo JH, Cho JY, Hahm KB, Bang CS, Baik GH, Shin IS, Kim JB, Suk KT, Yoon JH, Kim YS, Kim DJ * Helicobacter pylori Eradication for Prevention of Metachronous Recurrence after Endoscopic Resection of Early Gastric Cancer(548 views) N Engl J Med (ISSN: 0028-4793, 0028-4793linking, 1533-4406electronic), 2015 Jun; 30642104201566393291: 749-756. Impact Factor:59.558 ViewExport to BibTeXExport to EndNote