Medical News: MS Drug Slows Inflammation of Brain - in Clinical Context, Multiple Sclerosis from MedPage Today

 

 

MS Drug Slows Inflammation of Brain

This report is part of a 12-month Clinical Context series.

By Michael Smith, North American Correspondent, MedPage Today

Published: July 02, 2012

Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, BSN, RN, Nurse Planner

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Action Points

• Explain that magnetic resonance imaging (MRI) showed a decrease in number of new lesions, volume of lesions, and overall brain volume loss compared with placebo for multiple sclerosis patients treated with fingolimod at two different doses.
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• Note that the patients studied were enrolled in the FREEDOM trial and that this report was of the MRI imaging component.

The multiple sclerosis medication fingolimod (Gilenya) led to "rapid and sustained" reductions in MRI-documented inflammatory lesion activity, researchers reported.
In a two-year randomized trial, the medication also slowed the rate of brain volume loss compared with placebo, according to Ernst-Wilhelm Radue, MD, of University Hospital Basel in Basel, Switzerland, and colleagues.
 

Changes in lesion volume over time also favored the medication rather than placebo, Radue and colleagues reported online in Archives of Neurology.
Combined with previously reported improvements in relapse rates and disability progression, the findings suggest that the drug -- a sphingosine 1–phosphate receptor (S1PR) modulator -- has a "positive impact on long-term disease evolution," the researchers argued.
 

Fingolimod inhibits migration of T cells out of lymph nodes, preventing them from attacking the protective myelin sheaths surrounding nerve fibers. The drug, in an oral formulation of 0.5 milligrams, was approved in 2010 on the basis of its effects on relapse and disability.
The current study looks at magnetic resonance imaging (MRI) of the 1,272 patients who were part of the FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) clinical trial.
 

Participants were randomly assigned to get once-daily fingolimod capsules of 0.5 mg or 1.25 mg, or to placebo and had standardized MRI scans at screening and at 6, 12, and 24 months.
The scans were evaluated for the number and volume of T1 gadolinium-enhancing, T2 hyperintense, and T1 hypointense lesions, Radue and colleagues reported, as well as for the percentage of change in brain volume.
They found:

• Both fingolimod doses significantly reduced (P<0.001) the number of new or newly enlarged T2 lesions over 24 months compared with placebo.
• The reductions reached significance by month 6 and remained significant for the rest of the study.
• Fingolimod patients at either dose also had fewer gadolinium-enhancing lesions and lower lesion volumes at 6, 12 and 24 months than patients treated with placebo (P<0.001 for all).
• Over the 24 months, 21% of placebo patients were completely free from new or newly enlarged T2 lesions, gadolinium-enhancing lesions, or both, compared with 52% and 50.7% of those treated with the high and low doses of fingolimod, respectively (P<0.001).
• Changes in T2 hyperintense and T1 hypointense lesion volume also favored fingolimod over placebo, (P<0.05 for all).
• Both doses of the drug slowed the loss of brain volume compared with placebo (P<0.001) over the whole study period. The improvement was significant by month 6 and was sustained, with relative reductions in brain volume loss, compared with placebo, of 23% to 45% at the various intervals.

The findings "confirm that the efficacy of fingolimod therapy is robust across all MRI end points," the authors argued.

The study was supported by Novartis Pharma AG. Radue reported financial links with Bayer Schering, Biogen Idec, Novartis, Merck Serono, Actelion, and Basilea Pharmaceutica.

Primary source: Archives of Neurology
Source reference:
Radue E-W, et al "Impact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis" Arch Neurol 2012; DOI: 10.1001/archneurol.2012.105.

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Michael Smith
North American Correspondent

North American Correspondent for MedPage Today, is a three-time winner of the Science and Society Journalism Award of the Canadian Science Writers’ Association. After working for newspapers in several parts of Canada, he was the science writer for the Toronto Star before becoming a freelancer in 1994. His byline has appeared in New Scientist, Science, the Globe and Mail, United Press International, Toronto Life, Canadian Business, the Toronto Star, Marketing Computers, and many others. He is based in Toronto, and when not transforming dense science into compelling prose he can usually be found sailing.

Related Article(s):

• Oral MS Drug Wins Approval

   

 Source:
 http://www.medpagetoday.com/clinical-context/MultipleSclerosis/33583

Medical News: MS Drug Slows Inflammation of Brain - in Clinical Context, Multiple Sclerosis from MedPage Today