Combination therapy provides similar clinical benefit as single drug treatment in MS
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 MS (RRMS), were more effective in combination than as monotherapies. The results showed that while combination therapy was no better than monotherapy, patients who took combination therapy had a reduction in new lesions on MRI scan.
"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 clinical benefit greater than those taking a single agent. There was no substantial improvement in neurological function in participants in the combination therapy group. They also found that GA alone was superior to IFN alone in reducing relapse rates. 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 combination therapy 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 trials."
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.
Journal reference: Annals of Neurology
Provided by The Mount Sinai Hospital
- Common MS drugs taken together do not reduce relapse risk Mar 11, 2013 | not rated yet | 0
- Mount Sinai researchers present critical MS data at American Academy of Neurology meeting Apr 14, 2011 | not rated yet | 0
- Combination therapy including antibiotics may be beneficial for multiple sclerosis Dec 10, 2007 | not rated yet | 0
- Study examines fingolimod therapy in patients with multiple sclerosis Jul 02, 2012 | not rated yet | 0
- Widely prescribed multiple sclerosis treatment with interferon beta may not slow progression of disease: study Jul 17, 2012 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013 From pressure-volume curve of the lung and chest wall (attached photo), I don't understand why would the elastic recoil pressure of the lung is...
If you became brain-dead, would you want them to pull the plug?
May 17, 2013 I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
Ratio of Hydrogen of Oxygen in Dessicated Animal Protein
May 13, 2013 As an experiment, for the past few months I've been consuming at least one portion of Jell-O or unflavored Knox gelatin per day. I'm 64, in very...
Alcohol and acetaminophen
May 13, 2013 Edit: sorry for the typo in the title , can't edit I looked around on google quite a bit and it's very hard to find precise information on the...
Marie Curie's leukemia
May 13, 2013 Does anyone know what might be the cause of Marie Curie's cancer
- More from Physics Forums - Medical Sciences
More news stories
While Huntington's disease (HD) is currently incurable, the HD research community anticipates that new disease-modifying therapies in development may slow or minimize disease progression. The success of HD research depends ...
Neuroscience 45 minutes ago | not rated yet | 0
Study shows premature birth interrupts vital brain development processes leading to reduced cognitive abilities
Researchers from King's College London have for the first time used a novel form of MRI to identify crucial developmental processes in the brain that are vulnerable to the effects of premature birth. This new study, published ...
Neuroscience 3 hours ago | not rated yet | 0 |
While the effects of acute stroke have been widely studied, brain damage during the subacute phase of stroke has been a neglected area of research. Now, a new study by the University of South Florida reports that within a ...
Neuroscience 5 hours ago | not rated yet | 0 |
Over the past few decades, neuroscientists have made much progress in mapping the brain by deciphering the functions of individual neurons that perform very specific tasks, such as recognizing the location ...
Neuroscience 8 hours ago | 4.8 / 5 (6) | 0 |
For combat veterans suffering from post-traumatic stress disorder, 'fear circuitry' in the brain never rests
Chronic trauma can inflict lasting damage to brain regions associated with fear and anxiety. Previous imaging studies of people with post-traumatic stress disorder, or PTSD, have shown that these brain regions can over-or ...
Neuroscience May 18, 2013 | 5 / 5 (1) | 0 |
(Medical Xpress)—A research team, led by Jeremy Barr, a biology post-doctoral fellow, unveils a new immune system that protects humans and animals from infection.
13 seconds ago | not rated yet | 0 |
University of Minnesota Medical School researchers from the Masonic Cancer Center, University of Minnesota, in partnership with the University's Brain Tumor Program, have developed a new mouse model of malignant peripheral ...
46 minutes ago | not rated yet | 0 |
Turns out, that old "practice makes perfect" adage may be overblown. New research led by Michigan State University's Zach Hambrick finds that a copious amount of practice is not enough to explain why people ...
56 minutes ago | 5 / 5 (2) | 0 |
Older prostate cancer patients with other underlying health conditions should think twice before committing to surgery or radiation therapy for their cancer, according to a multicenter study led by researchers in the UCLA ...
42 minutes ago | not rated yet | 0 |
A new diagnostic test for a worm infection that can lead to severe enlargement and deformities of the legs and genitals is far more sensitive than the currently used test, according to results of a field ...
43 minutes ago | not rated yet | 0 |
Study shows that women who smoke during pregnancy increase the risk of both obesity and gestational diabetes in their da
Women who smoke during pregnancy increase the risk of both obesity and gestational diabetes, in their daughters, concludes research published in Diabetologia, the journal of the European Association for the Study of Diabet ...
27 minutes ago | not rated yet | 0