Daily News for Neuros, Nurses & Savvy MSers: 208,152 Viewers, 8,368 Stories & Studies
Click Here For My Videos, Advice, Tips, Studies and Trials.
Timothy L. Vollmer, MD
Department of Neurology
University of Colorado Health Sciences Center Professor

Co-Director of the RMMSC at Anschutz Medical Center

Medical Director-Rocky Mountain MS Center
Click here to read my columns
Brian R. Apatoff, MD, PhD
Multiple Sclerosis Institute
Center for Neurological Disorders

Associate Professor Neurology and Neuroscience,

Weill Medical College of Cornell University

Clinical Attending in Neurology,
New York-Presbyterian Hospital
You'll get FREE Breaking News Alerts on new MS treatments as they are approved

HERE'S A FEW OF OUR 6000+ Facebook & MySpace FRIENDS
Timothy L. Vollmer M.D.
Department of Neurology
University of Colorado Health Sciences Center
Co-Director of the RMMSC at Anschutz Medical Center
Medical Director-Rocky Mountain MS Center

Click to view 1280 MS Walk photos!

"MS Can Not
Rob You of Joy"
"I'm an Mom has MS and we have a message for everyone."
- Jennifer Hartmark-Hill MD
Beverly Dean

"I've had MS for 2 years...this is the most important advice you'll ever hear."
"This is how I give myself a painless injection."
Heather Johnson

"A helpful tip for newly diagnosed MS patients."
"Important advice on choosing MS medication "
Joyce Moore

This page is powered by Blogger. Isn't yours?



No Evidence of Disease Activity Achieved in MS with Tecfidera (dimethyl fumarate)

Image Source: MEDSCAPE

Post hoc data analysis of the DEFINE and CONFIRM trials showed that a higher percentage of patients with relapsing-remitting multiple sclerosis (RRMS) achieved no evidence of disease activity (NEDA) with delayed-release dimethyl fumarate (DMF) compared with placebo. The results were published in the European Journal of Neurology.1

NEDA is a relatively new composite outcome that is being used more often to measure therapeutic response in MS. NEDA is comprised of 3 factors: no clinical relapse, no disability progression measured by the Expanded Disability Status Scale (EDSS) for 12 weeks, and no evidence of disease activity on magnetic resonance imaging (MRI).

In the phase 3 DEFINE/CONFIRM studies and the long-term extension (ENDORSE) study, treatment with delayed-release DMF demonstrated significant reductions in clinical and neuroradiologic measures compared with placebo in patients with RRMS.

In the current study, Eva Havrdov√°, MD, PhD, of First Faculty of Medicine of Charles University in Prague, Czech Republic, and colleagues conducted a post hoc analysis of integrated data from DEFINE and CONFIRM to assess the ability of DMF to achieve NEDA in patients with RRMS.

Both DEFINE and CONFIRM were parallel multicenter, randomized, double-blind, placebo-controlled trials of DMF for RRMS. Patients enrolled in the trials received DMF 240 mg 2 or 3 times daily, placebo, or glatiramer acetate 20 mg daily in the CONFIRM trial for 2 years.

End points included the percentage of patients who relapsed at 2 years, time to confirmed disability progression for 12 weeks, and new or newly enlarging lesions on brain MRI. For this study, the investigators pooled the data and performed post hoc analysis applying NEDA criteria. Outcomes included clinical NEDA, overall NEDA, and neuroradiologic NEDA.

The intention-to-treat population included 1540, 1072, and 818 participants in the combined data, CONFIRM, and DEFINE trials, respectively. Likewise, analysis of the MRI data included 692, 511, 356 participants, respectively.

The demographics were generally similar, with a mean age of approximately 37, and 70% of participants were women. Participants reported first MS symptoms between 7 to 8 years prior to the study and a mean of 1.3 relapses in the year preceeding the study.

In the intention-to-treat population, more participants achieved clinical NEDA with DMF than placebo over 2 years in the integrated analysis (hazard ratio [HR] 0.61; 95% CI, 0.52-0.72; P <.0001). Likewise, there were more participants who achieved neuroradiologic NEDA in the DMF integrated analysis (HR 0.60; 95% CI, 0.49-0.73; P <.0001). The investigators estimated that DMF treatment was associated with a reduced risk of new or newly enlarging MRI lesions of 40% compared with placebo.

Story Source: The above story is based on materials provided by NEUROLOGYADVISOR
Note: Materials may be edited for content and length


Go to Newer News Go to Older News