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Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing-remitting multiple sclerosis (RRMS).
Mult Scler. 2015 Jan; 21(1):57-66.MS

Abstract

BACKGROUND

Delayed-release dimethyl fumarate (DMF) demonstrated efficacy and safety in the Phase 3 DEFINE and CONFIRM trials.

OBJECTIVE

To evaluate delayed-release DMF in newly diagnosed relapsing-remitting multiple sclerosis (RRMS) patients, in a post-hoc analysis of integrated data from DEFINE and CONFIRM.

METHODS

Patients included in the analysis were diagnosed with RRMS within 1 year prior to study entry and naive to MS disease-modifying therapy.

RESULTS

The newly diagnosed population comprised 678 patients treated with placebo (n = 223) or delayed-release DMF 240 mg BID (n = 221) or TID (n = 234). At 2 years, delayed-release DMF BID and TID reduced the annualized relapse rate by 56% and 60% (both p < 0.0001), risk of relapse by 54% and 57% (both p < 0.0001), and risk of 12-week confirmed disability progression by 71% (p < 0.0001) and 47% (p = 0.0085) versus placebo. In a subset of patients (MRI cohort), delayed-release DMF BID and TID reduced the mean number of new or enlarging T2-hyperintense lesions by 80% and 81%, gadolinium-enhancing lesion activity by 92% and 92%, and mean number of new non-enhancing T1-hypointense lesions by 68% and 70% (all p < 0.0001 versus placebo). Flushing and gastrointestinal events were associated with delayed-release DMF.

CONCLUSION

Delayed-release DMF improved clinical and neuroradiological outcomes relative to placebo in newly diagnosed RRMS patients.

Links

Publisher Full Text
ncbi.nlm.nih.gov
journals.sagepub.com
PMC Free PDF

Authors+Show Affiliations

Gold R
St. Josef Hospital, Ruhr University, Germany ralf.gold@ruhr-uni-bochum.de.
Giovannoni G
Queen Mary University of London, Blizard Institute, Barts and the London School of Medicine and Dentistry, London, UK.
Phillips JT
Multiple Sclerosis Program, Baylor Institute for Immunology Research, Dallas, TX, USA.
Fox RJ
Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.
Zhang A
Biogen Idec, Inc., Cambridge, MA, USA.
Meltzer L
Biogen Idec, Inc., Cambridge, MA, USA.
Kurukulasuriya NC
Biogen Idec, Inc., Cambridge, MA, USA.

MeSH

AdultClinical Trials, Phase III as TopicDelayed-Action PreparationsDimethyl FumarateFemaleFumaratesHumansImmunosuppressive AgentsMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingTreatment Outcome

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24990854

Clinical Trial Links

Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS

Citation

Gold, Ralf, et al. "Efficacy and Safety of Delayed-release Dimethyl Fumarate in Patients Newly Diagnosed With Relapsing-remitting Multiple Sclerosis (RRMS)." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 21, no. 1, 2015, pp. 57-66.
Gold R, Giovannoni G, Phillips JT, et al. Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing-remitting multiple sclerosis (RRMS). Mult Scler. 2015;21(1):57-66.
Gold, R., Giovannoni, G., Phillips, J. T., Fox, R. J., Zhang, A., Meltzer, L., & Kurukulasuriya, N. C. (2015). Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing-remitting multiple sclerosis (RRMS). Multiple Sclerosis (Houndmills, Basingstoke, England), 21(1), 57-66. https://doi.org/10.1177/1352458514537013
Gold R, et al. Efficacy and Safety of Delayed-release Dimethyl Fumarate in Patients Newly Diagnosed With Relapsing-remitting Multiple Sclerosis (RRMS). Mult Scler. 2015;21(1):57-66. PubMed PMID: 24990854.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing-remitting multiple sclerosis (RRMS). AU - Gold,Ralf, AU - Giovannoni,Gavin, AU - Phillips,J Theodore, AU - Fox,Robert J, AU - Zhang,Annie, AU - Meltzer,Leslie, AU - Kurukulasuriya,Nuwan C, Y1 - 2014/07/02/ PY - 2014/7/4/entrez PY - 2014/7/6/pubmed PY - 2015/11/14/medline KW - Delayed-release dimethyl fumarate KW - efficacy KW - multiple sclerosis KW - newly diagnosed KW - safety SP - 57 EP - 66 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult Scler VL - 21 IS - 1 N2 - BACKGROUND: Delayed-release dimethyl fumarate (DMF) demonstrated efficacy and safety in the Phase 3 DEFINE and CONFIRM trials. OBJECTIVE: To evaluate delayed-release DMF in newly diagnosed relapsing-remitting multiple sclerosis (RRMS) patients, in a post-hoc analysis of integrated data from DEFINE and CONFIRM. METHODS: Patients included in the analysis were diagnosed with RRMS within 1 year prior to study entry and naive to MS disease-modifying therapy. RESULTS: The newly diagnosed population comprised 678 patients treated with placebo (n = 223) or delayed-release DMF 240 mg BID (n = 221) or TID (n = 234). At 2 years, delayed-release DMF BID and TID reduced the annualized relapse rate by 56% and 60% (both p < 0.0001), risk of relapse by 54% and 57% (both p < 0.0001), and risk of 12-week confirmed disability progression by 71% (p < 0.0001) and 47% (p = 0.0085) versus placebo. In a subset of patients (MRI cohort), delayed-release DMF BID and TID reduced the mean number of new or enlarging T2-hyperintense lesions by 80% and 81%, gadolinium-enhancing lesion activity by 92% and 92%, and mean number of new non-enhancing T1-hypointense lesions by 68% and 70% (all p < 0.0001 versus placebo). Flushing and gastrointestinal events were associated with delayed-release DMF. CONCLUSION: Delayed-release DMF improved clinical and neuroradiological outcomes relative to placebo in newly diagnosed RRMS patients. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/24990854/Efficacy_and_safety_of_delayed_release_dimethyl_fumarate_in_patients_newly_diagnosed_with_relapsing_remitting_multiple_sclerosis__RRMS__ L2 - https://journals.sagepub.com/doi/10.1177/1352458514537013?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -