Combination therapy provides similar clinical benefit as single drug treatment in MS

March 11, 2013

People with multiple sclerosis (MS) who were treated with combination therapy did not see significant clinical benefit over those treated with single drug therapy, but combination therapy did reduce the development of new lesions, according to an international research team led by The Mount Sinai Medical Center. The findings, part of the largest-ever MS trial sponsored by the National Institutes of Health, are published in the March 11 issue of Annals of Neurology.

In the Phase III CombiRx trial, researchers led by Fred Lublin, MD, of The Mount Sinai Medical Center, sought to determine if Glatiramer Acetate (GA) and Interferon Beta-1a (IFN), the two most commonly-prescribed drugs for relapsing-remitting (RRMS), were more effective in combination than as monotherapies. The results showed that while combination therapy was no better than , patients who took combination therapy had a reduction in new lesions on .

"This is the first NIH-sponsored, multi-center, comparative trial evaluating the benefits of both combination therapy and monotherapy in MS," said lead author Fred Lublin, MD, Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at The Mount Sinai Medical Center. "The study is the first to show that a combination trial is feasible in MS, to compare a combination to established monotherapy, and to provide comparative efficacy data for two commonly-prescribed drugs."

The research team enrolled 1,008 participants from 68 sites to receive IFN plus GA (499), IFN alone (250), or GA alone (259), with 30µg IFN administered intramuscularly weekly and/or 20 mg of GA injected daily. The groups were followed for three years to assess if the combination therapy reduced MS relapse rates.

While combining IFN and GA was safe and effective, patients taking this regimen did not see greater than those taking a single agent. There was no substantial improvement in in participants in the combination therapy group. They also found that GA alone was superior to IFN alone in reducing . MRI findings also suggested that the IFN plus GA together were better in reducing new lesions and total lesion accumulation than either drug alone.

"While there was no substantial clinical benefit of over monotherapy, we will continue to monitor these patients to see if the reduction in MRI lesion translates into a future clinical benefit," said Dr. Lublin. "The CombiRx study also provides a large dataset to analyze different aspects of the disease, such as potential biomarkers for prognosis and response to therapy."

The National Institute of Neurological Disorders and Stroke (NINDS) provided funding for the CombiRx clinical trial (grant #UO1NS045719 and R21NS41986), which will continue to evaluate the cohort for four more years.

"The investigators were successful in implementing a clinical trial comparing the effectiveness of a two-drug combination to treatment with a single drug," said Petra Kaufmann, MD, MSc, Associate Director for Clinical Research, NINDS. "The trial answered an important question to the MS community: The results did not show a clinical benefit in people taking two drugs rather than one drug. In addition to answering this question, the trial has resulted in valuable clinical and imaging observations that can help researchers to better understand the course of MS and that can inform the planning of future ."

The NINDS describes MS as a neuroinflammatory disease, which affects the central nervous system by attacking myelin, a substance found in nerve fibers, and causing lesions. NINDS estimates that up to 350,000 individuals in the U.S. have MS, which affects twice as many women as men, with most symptoms appearing between the ages of 20 and 40. Experts believe this complex autoimmune disease may be caused by genetic and environmental factors.

Explore further: Common MS drugs taken together do not reduce relapse risk

Related Stories

Common MS drugs taken together do not reduce relapse risk

March 11, 2013
A recent clinical trial found that interferonβ-1a (INF) and glatiramer acetate (GA), two of the most commonly prescribed drugs for multiple sclerosis (MS), provide no additional clinical benefit when taken together. While ...

Mount Sinai researchers present critical MS data at American Academy of Neurology meeting

April 14, 2011
Researchers from Mount Sinai School of Medicine will present several key studies at the American Academy of Neurology (AAN) annual meeting, including research providing critical insight into the prognosis and clinical treatment ...

Study examines fingolimod therapy in patients with multiple sclerosis

July 2, 2012
The medication fingolimod reduced inflammatory lesion activity and reduced brain volume loss in patients with multiple sclerosis who participated in a two-year placebo-controlled clinical trial and were assessed by magnetic ...

Widely prescribed multiple sclerosis treatment with interferon beta may not slow progression of disease: study

July 17, 2012
Researchers with the UBC Hospital MS Clinic and Brain Research Centre at Vancouver Coastal Health and the University of British Columbia have published important data in the Journal of the American Medical Association (JAMA) ...

New MS drug proves effective where others have failed

October 31, 2012
A drug which 'reboots' a person's immune system has been shown to be an effective treatment for multiple sclerosis (MS) patients who have already failed to respond to the first drug with which they were treated (a 'first-line' ...

Recommended for you

Scientists discover powerful potential pain reliever

August 16, 2017
A team of scientists led by chemists Stephen Martin and James Sahn at The University of Texas at Austin have discovered what they say is a powerful pain reliever that acts on a previously unknown pain pathway. The synthetic ...

Scientists use magnetic fields to remotely stimulate brain—and control body movements

August 16, 2017
Scientists have used magnetism to activate tiny groups of cells in the brain, inducing bodily movements that include running, rotating and losing control of the extremities—an achievement that could lead to advances in ...

Scientists give star treatment to lesser-known cells crucial for brain development

August 16, 2017
After decades of relative neglect, star-shaped brain cells called astrocytes are finally getting their due. To gather insight into a critical aspect of brain development, a team of scientists examined the maturation of astrocytes ...

Researchers discover fundamental pathology behind ALS

August 16, 2017
A team led by scientists at St. Jude Children's Research Hospital and Mayo Clinic has identified a basic biological mechanism that kills neurons in amyotrophic lateral sclerosis (ALS) and in a related genetic disorder, frontotemporal ...

The nerve-guiding 'labels' that may one day help re-establish broken nervous connections

August 16, 2017
Scientists have identified a large group of biological 'labels' that guide nerves to ensure they make the correct connections and control different parts of the body. Although their research was conducted with fruit flies, ...

Navigation and spatial memory—new brain region identified to be involved

August 16, 2017
Navigation in mammals including humans and rodents depends on specialized neural networks that encode the animal's location and trajectory in the environment, serving essentially as a GPS, findings that led to the 2014 Nobel ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.