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Quality of life outcomes with BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: the DEFINE study.
Mult Scler. 2014 Feb; 20(2):243-52.MS

Abstract

BACKGROUND

Oral BG-12 (dimethyl fumarate), approved for the treatment of the relapsing forms of MS, has demonstrated clinical efficacy with an acceptable safety profile in the Phase III "Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting Multiple Sclerosis (RRMS)" (DEFINE) and "Comparator and an Oral Fumarate in RRMS" (CONFIRM) studies.

OBJECTIVES

To evaluate the health-related quality of life (HRQoL) impairment that is associated with RRMS and to assess the effects of BG-12 on HRQoL in the DEFINE study.

METHODS

Patients with RRMS were randomized to BG-12 240 mg twice (BID) or three times (TID) daily, or placebo, for 2 years. HRQoL was assessed by the Short Form-36 (SF-36), global assessment of well-being visual analog scale and the EuroQol-5D.

RESULTS

In the 1237 patients from DEFINE, HRQoL impairment was greatest in patients who had higher disability scores and in those who had experienced relapse. Change in SF-36 physical component summary scores during 2 years' treatment significantly favored BG-12 over placebo (both doses: p < 0.001). We saw similar benefits in other measures of functioning and general well-being as early as Week 24. These benefits were maintained during the study.

CONCLUSIONS

Our results add to evidence for a negative impact of RRMS on HRQoL and they demonstrate the benefits of BG-12 on HRQoL measures, which coupled with significant clinical efficacy, further support its use as a new treatment for RRMS.

Authors+Show Affiliations

Departments of Neurology and Biomedicine, University Hospital Basel, Switzerland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24150779

Citation

Kappos, Ludwig, et al. "Quality of Life Outcomes With BG-12 (dimethyl Fumarate) in Patients With Relapsing-remitting Multiple Sclerosis: the DEFINE Study." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 20, no. 2, 2014, pp. 243-52.
Kappos L, Gold R, Arnold DL, et al. Quality of life outcomes with BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: the DEFINE study. Mult Scler. 2014;20(2):243-52.
Kappos, L., Gold, R., Arnold, D. L., Bar-Or, A., Giovannoni, G., Selmaj, K., Sarda, S. P., Agarwal, S., Zhang, A., Sheikh, S. I., Seidman, E., & Dawson, K. T. (2014). Quality of life outcomes with BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: the DEFINE study. Multiple Sclerosis (Houndmills, Basingstoke, England), 20(2), 243-52. https://doi.org/10.1177/1352458513507817
Kappos L, et al. Quality of Life Outcomes With BG-12 (dimethyl Fumarate) in Patients With Relapsing-remitting Multiple Sclerosis: the DEFINE Study. Mult Scler. 2014;20(2):243-52. PubMed PMID: 24150779.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quality of life outcomes with BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: the DEFINE study. AU - Kappos,Ludwig, AU - Gold,Ralf, AU - Arnold,Douglas L, AU - Bar-Or,Amit, AU - Giovannoni,Gavin, AU - Selmaj,Krzysztof, AU - Sarda,Sujata P, AU - Agarwal,Sonalee, AU - Zhang,Annie, AU - Sheikh,Sarah I, AU - Seidman,Emily, AU - Dawson,Katherine T, Y1 - 2013/10/22/ PY - 2013/10/24/entrez PY - 2013/10/24/pubmed PY - 2014/9/25/medline KW - BG-12 KW - DEFINE KW - dimethyl fumarate KW - multiple sclerosis KW - quality of life KW - randomized controlled trial KW - relapsing–remitting multiple sclerosis SP - 243 EP - 52 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult Scler VL - 20 IS - 2 N2 - BACKGROUND: Oral BG-12 (dimethyl fumarate), approved for the treatment of the relapsing forms of MS, has demonstrated clinical efficacy with an acceptable safety profile in the Phase III "Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting Multiple Sclerosis (RRMS)" (DEFINE) and "Comparator and an Oral Fumarate in RRMS" (CONFIRM) studies. OBJECTIVES: To evaluate the health-related quality of life (HRQoL) impairment that is associated with RRMS and to assess the effects of BG-12 on HRQoL in the DEFINE study. METHODS: Patients with RRMS were randomized to BG-12 240 mg twice (BID) or three times (TID) daily, or placebo, for 2 years. HRQoL was assessed by the Short Form-36 (SF-36), global assessment of well-being visual analog scale and the EuroQol-5D. RESULTS: In the 1237 patients from DEFINE, HRQoL impairment was greatest in patients who had higher disability scores and in those who had experienced relapse. Change in SF-36 physical component summary scores during 2 years' treatment significantly favored BG-12 over placebo (both doses: p < 0.001). We saw similar benefits in other measures of functioning and general well-being as early as Week 24. These benefits were maintained during the study. CONCLUSIONS: Our results add to evidence for a negative impact of RRMS on HRQoL and they demonstrate the benefits of BG-12 on HRQoL measures, which coupled with significant clinical efficacy, further support its use as a new treatment for RRMS. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/24150779/Quality_of_life_outcomes_with_BG_12__dimethyl_fumarate__in_patients_with_relapsing_remitting_multiple_sclerosis:_the_DEFINE_study_ L2 - https://journals.sagepub.com/doi/10.1177/1352458513507817?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -