Author Topic: (ECTRIMS) Tecfidera better than placebo on composite disability measure  (Read 167 times)

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Offline agate

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From DGNews (DocGuide), November 3, 2015:

Dimethyl Fumarate Is Superior to Placebo on Composite Disability Measure

: Presented at ECTRIMS

By Jill Stein

BARCELONA -- October 8, 2015 -- Delayed-release dimethyl fumarate (DMF) provides significant clinical benefits over placebo on composite measures of clinical disability progression in patients with multiple sclerosis, according to results of an analysis of 2 phase 3 studies presented at the 2015 Annual Meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Amit Bar-Or, MD, Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada, and colleagues assessed the effect of DMF twice daily on composite measures of sustained clinical disability progression in an integrated analysis of the phase 3 DEFINE and CONFIRM studies of relapsing-remitting MS.

While delayed-release DMF significantly reduced the risk of sustained disability progression as assessed by the Expanded Disability Status Scale (EDSS) compared with placebo, EDSS progression alone may not capture all aspects of disability, the authors pointed out in their poster presentation here on October 8.

In fact, EDSS progression is inherently subjective, as it is based on the standard neurological examination, and does not differentiate between different contributors to motor disabilities. In addition, it inadequately captures non-ambulation-related contributors to patient disability such as vision and cognition, particularly in those patients with an EDSS in the range of 4.0 to 4.5, who are fully ambulatory without aid.

In the present study, the researchers tested the use of a functional composite outcome measure that allows for the capture of potentially clinically relevant sustained worsening across multiple neuro-performance components.

The integrated intent-to-treat population included 771 and 769 subjects receiving placebo or DMF twice daily, respectively.

At 2 years, DMF twice daily significantly reduced the risk of 12- or 24-week sustained disability progression on the composite measure, including EDSS or disability as measured by the timed 25-foot walk or 9-hole peg test compared with placebo.

DMF twice daily significantly reduced the risk of disability progression on the full composite, measured by any of the disability outcomes, for 12-week (hazard ratio
= 0.85; P = .0489) or 24-week (HR = 0.79); P = .0231) sustained disability progression compared with placebo.


The researchers observed significant reductions with DMF twice daily compared with placebo in an analysis of 12- or 24-week sustained disability progression including EDSS or the worsening of 1 of the following: timed 25-foot walk; 9-hole peg test for 12-week sustained disability progression only; paced auditory serial addition test; or a visual function test.

Funding for this study was provided by Biogen, Boston, Massachusetts.

[Presentation title: Efficacy of Delayed-Release Dimethyl Fumarate for Relapsing-Remitting Multiple Sclerosis Using a Composite Measure of Disability: Integrated Analysis of the Phase 3 DEFINE and CONFIRM studies Abstract P628]

The article can be seen here.
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SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.