Effects of BG-12 (dimethyl fumarate) on health-related quality of life in patients with relapsing–remitting multiple sclerosis: findings from the CONFIRM study

Abstract

Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with symptoms adversely affecting many aspects of everyday living. BG-12 (dimethyl fumarate) demonstrated significant efficacy in the phase III studies DEFINE and CONFIRM in patients with relapsing–remitting MS. In CONFIRM, HRQoL was worse in patients with greater disability at baseline, and who relapsed during the study, and improved with BG-12 treatment. Mean Short Form-36 Physical Component Summary scores for BG-12 increased over 2 years and scores for placebo decreased. Coupled with clinical and neuroradiological benefits, these HRQoL results further support BG-12 as an effective oral treatment for relapsing MS.

Keywords

Multiple sclerosis relapsing–remitting BG-12 dimethyl fumarate quality of life glatiramer acetate randomized controlled trial

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References

Turpin

Carroll

Cassidy

. Deterioration in the health-related quality of life of persons with multiple sclerosis: The possible warning signs. Mult Scler 2007; 13: 1038–1045.

Goldman Consensus Group. The Goldman Consensus statement on depression in multiple sclerosis. Mult Scler 2005; 11: 328–337.

Rudick

Miller

Clough

. Quality of life in multiple sclerosis. Comparison with inflammatory bowel disease and rheumatoid arthritis. Arch Neurol 1992; 49: 1237–1242.

Gold

Kappos

Arnold

. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012; 367: 1098–1107.

Fox

Miller

Phillips

. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012; 367: 1087–1097.

Ware

Jr.

SF-36 health survey update. Spine 2000; 25: 3130–3139.

Ware

Jr Gandek

Kosinski

. The equivalence of SF-36 summary health scores estimated using standard and country-specific algorithms in 10 countries: Results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol 1998; 51: 1167–1170.

Rudick

Miller

Hass

. Health-related quality of life in multiple sclerosis: Effects of natalizumab. Ann Neurol 2007; 62: 335–346.

Miller

Weinstock-Guttman

Bourdette

. Change in quality of life in patients with relapsing-remitting multiple sclerosis over 2 years in relation to other clinical parameters: Results from a trial of intramuscular interferon {beta}-1a. Mult Scler 2011; 17: 734–742.

10.

National Institute of Clinical Excellence (NICE). Fingolimod for the treatment of highly active relapsing-remitting multiple sclerosis. Available at: National Institute of Clinical Excellence (NICE).

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