Multiple Sclerosis

WASHINGTON, DC—Drinking coffee may be associated with a lower risk of developing multiple sclerosis (MS), according to a study presented at the American Academy of Neurology’s 67th Annual Meeting. “Caffeine intake has been associated with a reduced risk of Parkinson’s and Alzheimer’s diseases, and our study shows that coffee intake may also protect against MS, supporting the idea that the drug may have protective effects for the brain,” said study author Ellen Mowry, MD, MCR, of Johns Hopkins University School of Medicine in Baltimore.

For the study, researchers looked at two population-based case–control studies—a Swedish study of 1,629 patients with MS and 2,807 healthy controls, and a Kaiser Permanente Northern California study of 1,159 patients with MS and 1,172 healthy controls. The studies characterized coffee consumption among patients with MS one and five years before MS symptoms began (as well as 10 years before MS symptoms began in the Swedish study) and compared it with coffee consumption of people who did not have MS at similar time periods. The study also accounted for other factors such as age, sex, smoking, BMI, and sun exposure habits.

The Swedish study found that compared with people who drank at least six cups of coffee per day during the year before symptoms appeared, those who did not drink coffee had about a one and a half times increased risk of developing MS. Drinking large amounts of coffee five or 10 years before symptoms started was similarly protective.

In the US study, people who did not drink coffee were also about one and a half times more likely to develop the disease than those who drank four or more cups of coffee per day in the year before symptoms started to develop the disease.

“Caffeine should be studied for its impact on relapses and long-term disability in MS as well,” said Dr. Mowry.

The study was supported by the Swedish Medical Research Council; the Swedish Research Council for Health, Working Life and Welfare; the Knut and Alice Wallenberg, AFA, and Swedish Brain Foundations; the Swedish Association for Persons with Neurological Disabilities; and the U.S. National Institute of Neurological Disorders and Stroke, the National Institute of Environmental Health Sciences, and the National Institute on Aging.

WASHINGTON, DC—Drinking coffee may be associated with a lower risk of developing multiple sclerosis (MS), according to a study presented at the American Academy of Neurology’s 67th Annual Meeting. “Caffeine intake has been associated with a reduced risk of Parkinson’s and Alzheimer’s diseases, and our study shows that coffee intake may also protect against MS, supporting the idea that the drug may have protective effects for the brain,” said study author Ellen Mowry, MD, MCR, of Johns Hopkins University School of Medicine in Baltimore.

For the study, researchers looked at two population-based case–control studies—a Swedish study of 1,629 patients with MS and 2,807 healthy controls, and a Kaiser Permanente Northern California study of 1,159 patients with MS and 1,172 healthy controls. The studies characterized coffee consumption among patients with MS one and five years before MS symptoms began (as well as 10 years before MS symptoms began in the Swedish study) and compared it with coffee consumption of people who did not have MS at similar time periods. The study also accounted for other factors such as age, sex, smoking, BMI, and sun exposure habits.

The Swedish study found that compared with people who drank at least six cups of coffee per day during the year before symptoms appeared, those who did not drink coffee had about a one and a half times increased risk of developing MS. Drinking large amounts of coffee five or 10 years before symptoms started was similarly protective.

In the US study, people who did not drink coffee were also about one and a half times more likely to develop the disease than those who drank four or more cups of coffee per day in the year before symptoms started to develop the disease.

“Caffeine should be studied for its impact on relapses and long-term disability in MS as well,” said Dr. Mowry.

The study was supported by the Swedish Medical Research Council; the Swedish Research Council for Health, Working Life and Welfare; the Knut and Alice Wallenberg, AFA, and Swedish Brain Foundations; the Swedish Association for Persons with Neurological Disabilities; and the U.S. National Institute of Neurological Disorders and Stroke, the National Institute of Environmental Health Sciences, and the National Institute on Aging.

WASHINGTON, DC—Drinking coffee may be associated with a lower risk of developing multiple sclerosis (MS), according to a study presented at the American Academy of Neurology’s 67th Annual Meeting. “Caffeine intake has been associated with a reduced risk of Parkinson’s and Alzheimer’s diseases, and our study shows that coffee intake may also protect against MS, supporting the idea that the drug may have protective effects for the brain,” said study author Ellen Mowry, MD, MCR, of Johns Hopkins University School of Medicine in Baltimore.

For the study, researchers looked at two population-based case–control studies—a Swedish study of 1,629 patients with MS and 2,807 healthy controls, and a Kaiser Permanente Northern California study of 1,159 patients with MS and 1,172 healthy controls. The studies characterized coffee consumption among patients with MS one and five years before MS symptoms began (as well as 10 years before MS symptoms began in the Swedish study) and compared it with coffee consumption of people who did not have MS at similar time periods. The study also accounted for other factors such as age, sex, smoking, BMI, and sun exposure habits.

The Swedish study found that compared with people who drank at least six cups of coffee per day during the year before symptoms appeared, those who did not drink coffee had about a one and a half times increased risk of developing MS. Drinking large amounts of coffee five or 10 years before symptoms started was similarly protective.

In the US study, people who did not drink coffee were also about one and a half times more likely to develop the disease than those who drank four or more cups of coffee per day in the year before symptoms started to develop the disease.

“Caffeine should be studied for its impact on relapses and long-term disability in MS as well,” said Dr. Mowry.

The study was supported by the Swedish Medical Research Council; the Swedish Research Council for Health, Working Life and Welfare; the Knut and Alice Wallenberg, AFA, and Swedish Brain Foundations; the Swedish Association for Persons with Neurological Disabilities; and the U.S. National Institute of Neurological Disorders and Stroke, the National Institute of Environmental Health Sciences, and the National Institute on Aging.

WASHINGTON, DC—A new study suggests that an investigational drug for multiple sclerosis (MS) may repair myelin, according to a study presented at the American Academy of Neurology’s 67th Annual Meeting. “This study, for the first time, provides biological evidence of repair of damaged myelin in the human brain and advances the field of neuroreparative therapies,” said study lead author Diego Cadavid, MD, a Senior Director at Biogen Idec in Cambridge, Massachusetts.

The phase 2 study involved 82 patients who had their first incident of acute optic neuritis. All participants were treated with high dose steroids and randomly selected with equal probability to receive either the experimental antibody, called anti-LINGO-1, or a placebo once every four weeks, for a total of six doses. Participants were assessed every four weeks for six months and at a final visit at eight months. The drug’s effectiveness in repairing myelin was evaluated by comparing the recovery of the optic nerve latency in the damaged eye at six and eight months to the normal unaffected eye at the start of the study.

The main finding of the study focused on the latency of the visual evoked potential (VEP). The results showed that patients treated with anti-LINGO-1 who did not miss more than one dose (per protocol population) had significantly improved conduction, as measured by latency recovery, compared with people who received the placebo. At six months, those who received the drug improved on average by 7.55 milliseconds, or 34%, compared with placebo. The effect continued to eight months with an average improvement of 9.13 milliseconds or 41% over placebo.

In addition, the percentage of subjects whose VEP latency in the affected eye recovered to normal or nearly normal (ie, within 10% of that of the normal eye) more than doubled from 26% on placebo to 53% on the drug.

A substudy using an exploratory method of measuring latency called multifocal VEP revealed similar treatment effects. “More studies are needed to evaluate whether these changes lead to clinical improvement,” said Dr. Cadavid. A second study of anti-LINGO-1 in patients with MS is ongoing.

The study was supported by Biogen Idec.

WASHINGTON, DC—A new study suggests that an investigational drug for multiple sclerosis (MS) may repair myelin, according to a study presented at the American Academy of Neurology’s 67th Annual Meeting. “This study, for the first time, provides biological evidence of repair of damaged myelin in the human brain and advances the field of neuroreparative therapies,” said study lead author Diego Cadavid, MD, a Senior Director at Biogen Idec in Cambridge, Massachusetts.

The phase 2 study involved 82 patients who had their first incident of acute optic neuritis. All participants were treated with high dose steroids and randomly selected with equal probability to receive either the experimental antibody, called anti-LINGO-1, or a placebo once every four weeks, for a total of six doses. Participants were assessed every four weeks for six months and at a final visit at eight months. The drug’s effectiveness in repairing myelin was evaluated by comparing the recovery of the optic nerve latency in the damaged eye at six and eight months to the normal unaffected eye at the start of the study.

The main finding of the study focused on the latency of the visual evoked potential (VEP). The results showed that patients treated with anti-LINGO-1 who did not miss more than one dose (per protocol population) had significantly improved conduction, as measured by latency recovery, compared with people who received the placebo. At six months, those who received the drug improved on average by 7.55 milliseconds, or 34%, compared with placebo. The effect continued to eight months with an average improvement of 9.13 milliseconds or 41% over placebo.

In addition, the percentage of subjects whose VEP latency in the affected eye recovered to normal or nearly normal (ie, within 10% of that of the normal eye) more than doubled from 26% on placebo to 53% on the drug.

A substudy using an exploratory method of measuring latency called multifocal VEP revealed similar treatment effects. “More studies are needed to evaluate whether these changes lead to clinical improvement,” said Dr. Cadavid. A second study of anti-LINGO-1 in patients with MS is ongoing.

The study was supported by Biogen Idec.

WASHINGTON, DC—A new study suggests that an investigational drug for multiple sclerosis (MS) may repair myelin, according to a study presented at the American Academy of Neurology’s 67th Annual Meeting. “This study, for the first time, provides biological evidence of repair of damaged myelin in the human brain and advances the field of neuroreparative therapies,” said study lead author Diego Cadavid, MD, a Senior Director at Biogen Idec in Cambridge, Massachusetts.

The phase 2 study involved 82 patients who had their first incident of acute optic neuritis. All participants were treated with high dose steroids and randomly selected with equal probability to receive either the experimental antibody, called anti-LINGO-1, or a placebo once every four weeks, for a total of six doses. Participants were assessed every four weeks for six months and at a final visit at eight months. The drug’s effectiveness in repairing myelin was evaluated by comparing the recovery of the optic nerve latency in the damaged eye at six and eight months to the normal unaffected eye at the start of the study.

The main finding of the study focused on the latency of the visual evoked potential (VEP). The results showed that patients treated with anti-LINGO-1 who did not miss more than one dose (per protocol population) had significantly improved conduction, as measured by latency recovery, compared with people who received the placebo. At six months, those who received the drug improved on average by 7.55 milliseconds, or 34%, compared with placebo. The effect continued to eight months with an average improvement of 9.13 milliseconds or 41% over placebo.

In addition, the percentage of subjects whose VEP latency in the affected eye recovered to normal or nearly normal (ie, within 10% of that of the normal eye) more than doubled from 26% on placebo to 53% on the drug.

A substudy using an exploratory method of measuring latency called multifocal VEP revealed similar treatment effects. “More studies are needed to evaluate whether these changes lead to clinical improvement,” said Dr. Cadavid. A second study of anti-LINGO-1 in patients with MS is ongoing.

The study was supported by Biogen Idec.

WASHINGTON – Treatment with daclizumab high-yield process, a first-in-class interleukin-2 immunomodulator administered subcutaneously once a month, was significantly more effective on various outcomes in relapsing-remitting multiple sclerosis than was interferon beta-1a therapy during 96-144 weeks of treatment in the international DECIDE study.

The efficacy of daclizumab high-yield process (DAC HYP) was consistently superior to once-weekly intramuscular interferon (IFN) beta-1a “across key clinical, radiographic, and patient-reported MS outcome measures,” with a 45% reduction in the annualized relapse rate over that period, Dr. Ludwig Kappos said at the annual meeting of the American Academy of Neurology.

DAC HYP “has the potential to be a new once-monthly treatment option for patients with relapsing MS,” said Dr. Kappos, chair of neurology at University Hospital Basel and one of the DECIDE study investigators. Dr. Kappos serves as chair of the study’s advisory committee.

Treatment was associated with an increased risk of infections, cutaneous adverse effects, and hepatic enzyme abnormalities, which he said were “manageable with standard monitoring and medical interventions.”

DAC HYP is a humanized monoclonal antibody that selectively blocks the high-affinity interleukin-2 (IL-2) receptor subunit (CD25), which is expressed at high levels on T cells that are abnormally activated in MS. The biological effects of CD25 blockade include the inhibition of activated T cell responses and “normalization of lymphoid tissue inducer cell numbers,” he said.

The DECIDE study randomized 919 patients to treatment with 150 mg of DAC HYP administered subcutaneously once every 4 weeks and 922 patients to treatment with 30 mcg of IFN beta-1a (Avonex) administered intramuscularly once a week. Mean age of the patients was 36 years, 68% were women, and they had been diagnosed with MS for a mean of 5 years. Patients in both groups had had a similar mean number of relapses within the previous year (0.7-0.8); 21% had highly active MS, and 41% had been on disease-modifying treatments previously; their mean Expanded Disability Status Scale (EDSS) score was 1.2-1.3.

The study ended when the last patient had been treated for 2 years. In both arms, 29%-30% discontinued treatment, and adverse events were higher in the DAC HYP-treated group (14% vs. 9%).

During 96-144 weeks, the annualized relapse rate – the primary endpoint – was 0.393 among those on IFN beta-1a, vs. 0.216 among those on DAC HYP, a 45% reduction that was highly statistically significant (P < .0001), Dr. Kappos said.

Secondary endpoints included the proportion who remained relapse free, which was higher among those on DAC HYP at different points during the study (including 73% vs. 59% at week 96, and 67% vs. 51% at week 144). The risk of relapse was reduced by 41% (P < .0001).

Other secondary endpoints were MRI-defined lesions at week 96: The number of new or newly enlarging T2 hyperintense lesions at that point was reduced by 54%, compared with IFN beta-1a (P < .0001). There were similar reductions in new T1 hypointense lesions (black holes), which were reduced by 52% (P < .0001), and in gadolinium-enhancing lesions, which were reduced by 65% (P < .0001). There was a significant effect of treatment on brain volume over time, which was possible to detect because the study was so large, Dr. Kappos said.

At 3 months, the risk of progression was reduced by 16% among those on DAC HYP, compared with those on IFN beta-1a (P = .16), a favorable effect, although not statistically significant. At 6 months, the risk was reduced by 27% (P = .033), Dr. Kappos reported. The proportion of patients with a clinically meaningful worsening in patient-reported physical impact of MS (defined by at least a 7.5 point drop on the MSIS-29 PHYS) was reduced by 24% over those on IFN beta-1a, which was not statistically significant.

The incidence of any type of adverse event was 91% in both groups, and infections, cutaneous events, and hepatic abnormalities were more common among those treated with DAC HYP. Serious adverse events were higher among those on DAC HYP (24% vs. 21%); when MS relapses were excluded, the rate was 15% vs. 10%. Treatment discontinuations due to an adverse event, other than an MS relapse, was 14% among those on DAC HYP vs. 9% of those on IFN beta-1a. There were five deaths, one in a patient on the study drug and four among those on the comparator.

The rate of infectious adverse events was higher among those on DAC HYP (65% vs. 57%), as was the rate of serious infectious adverse events (4% vs. 2%). Cutaneous events were more common among those on DAC HYP (37% vs. 19%), as were serious cutaneous adverse events (2% vs. less than 1%).

Dr. Kappos said that hepatic abnormalities were more common among those on DAC HYP, but were reversible. The rate of ALT/AST greater than five times the upper limit of normal (ULN) was 6% among those on the DAC HYP vs. 3% among those on IFN beta-1a; but the rate of ALT greater than three times the ULN and total bilirubin more than twice the ULN was less than 1% in each group. There was one case that met the “Hy’s law” criteria in each group.

Biogen Idec and AbbVie Biotherapeutics funded the study. Dr. Kappos disclosed that University Hospital Basel has received research support from steering committee/consulting fees, and speakers fees from pharmaceutical companies that include Biogen.

emechcatie@frontlinemedcom.com

WASHINGTON – Treatment with daclizumab high-yield process, a first-in-class interleukin-2 immunomodulator administered subcutaneously once a month, was significantly more effective on various outcomes in relapsing-remitting multiple sclerosis than was interferon beta-1a therapy during 96-144 weeks of treatment in the international DECIDE study.

The efficacy of daclizumab high-yield process (DAC HYP) was consistently superior to once-weekly intramuscular interferon (IFN) beta-1a “across key clinical, radiographic, and patient-reported MS outcome measures,” with a 45% reduction in the annualized relapse rate over that period, Dr. Ludwig Kappos said at the annual meeting of the American Academy of Neurology.

DAC HYP “has the potential to be a new once-monthly treatment option for patients with relapsing MS,” said Dr. Kappos, chair of neurology at University Hospital Basel and one of the DECIDE study investigators. Dr. Kappos serves as chair of the study’s advisory committee.

Treatment was associated with an increased risk of infections, cutaneous adverse effects, and hepatic enzyme abnormalities, which he said were “manageable with standard monitoring and medical interventions.”

DAC HYP is a humanized monoclonal antibody that selectively blocks the high-affinity interleukin-2 (IL-2) receptor subunit (CD25), which is expressed at high levels on T cells that are abnormally activated in MS. The biological effects of CD25 blockade include the inhibition of activated T cell responses and “normalization of lymphoid tissue inducer cell numbers,” he said.

The DECIDE study randomized 919 patients to treatment with 150 mg of DAC HYP administered subcutaneously once every 4 weeks and 922 patients to treatment with 30 mcg of IFN beta-1a (Avonex) administered intramuscularly once a week. Mean age of the patients was 36 years, 68% were women, and they had been diagnosed with MS for a mean of 5 years. Patients in both groups had had a similar mean number of relapses within the previous year (0.7-0.8); 21% had highly active MS, and 41% had been on disease-modifying treatments previously; their mean Expanded Disability Status Scale (EDSS) score was 1.2-1.3.

The study ended when the last patient had been treated for 2 years. In both arms, 29%-30% discontinued treatment, and adverse events were higher in the DAC HYP-treated group (14% vs. 9%).

During 96-144 weeks, the annualized relapse rate – the primary endpoint – was 0.393 among those on IFN beta-1a, vs. 0.216 among those on DAC HYP, a 45% reduction that was highly statistically significant (P < .0001), Dr. Kappos said.

Secondary endpoints included the proportion who remained relapse free, which was higher among those on DAC HYP at different points during the study (including 73% vs. 59% at week 96, and 67% vs. 51% at week 144). The risk of relapse was reduced by 41% (P < .0001).

Other secondary endpoints were MRI-defined lesions at week 96: The number of new or newly enlarging T2 hyperintense lesions at that point was reduced by 54%, compared with IFN beta-1a (P < .0001). There were similar reductions in new T1 hypointense lesions (black holes), which were reduced by 52% (P < .0001), and in gadolinium-enhancing lesions, which were reduced by 65% (P < .0001). There was a significant effect of treatment on brain volume over time, which was possible to detect because the study was so large, Dr. Kappos said.

At 3 months, the risk of progression was reduced by 16% among those on DAC HYP, compared with those on IFN beta-1a (P = .16), a favorable effect, although not statistically significant. At 6 months, the risk was reduced by 27% (P = .033), Dr. Kappos reported. The proportion of patients with a clinically meaningful worsening in patient-reported physical impact of MS (defined by at least a 7.5 point drop on the MSIS-29 PHYS) was reduced by 24% over those on IFN beta-1a, which was not statistically significant.

The incidence of any type of adverse event was 91% in both groups, and infections, cutaneous events, and hepatic abnormalities were more common among those treated with DAC HYP. Serious adverse events were higher among those on DAC HYP (24% vs. 21%); when MS relapses were excluded, the rate was 15% vs. 10%. Treatment discontinuations due to an adverse event, other than an MS relapse, was 14% among those on DAC HYP vs. 9% of those on IFN beta-1a. There were five deaths, one in a patient on the study drug and four among those on the comparator.

The rate of infectious adverse events was higher among those on DAC HYP (65% vs. 57%), as was the rate of serious infectious adverse events (4% vs. 2%). Cutaneous events were more common among those on DAC HYP (37% vs. 19%), as were serious cutaneous adverse events (2% vs. less than 1%).

Dr. Kappos said that hepatic abnormalities were more common among those on DAC HYP, but were reversible. The rate of ALT/AST greater than five times the upper limit of normal (ULN) was 6% among those on the DAC HYP vs. 3% among those on IFN beta-1a; but the rate of ALT greater than three times the ULN and total bilirubin more than twice the ULN was less than 1% in each group. There was one case that met the “Hy’s law” criteria in each group.

Biogen Idec and AbbVie Biotherapeutics funded the study. Dr. Kappos disclosed that University Hospital Basel has received research support from steering committee/consulting fees, and speakers fees from pharmaceutical companies that include Biogen.

emechcatie@frontlinemedcom.com

WASHINGTON – Treatment with daclizumab high-yield process, a first-in-class interleukin-2 immunomodulator administered subcutaneously once a month, was significantly more effective on various outcomes in relapsing-remitting multiple sclerosis than was interferon beta-1a therapy during 96-144 weeks of treatment in the international DECIDE study.

The efficacy of daclizumab high-yield process (DAC HYP) was consistently superior to once-weekly intramuscular interferon (IFN) beta-1a “across key clinical, radiographic, and patient-reported MS outcome measures,” with a 45% reduction in the annualized relapse rate over that period, Dr. Ludwig Kappos said at the annual meeting of the American Academy of Neurology.

DAC HYP “has the potential to be a new once-monthly treatment option for patients with relapsing MS,” said Dr. Kappos, chair of neurology at University Hospital Basel and one of the DECIDE study investigators. Dr. Kappos serves as chair of the study’s advisory committee.

Treatment was associated with an increased risk of infections, cutaneous adverse effects, and hepatic enzyme abnormalities, which he said were “manageable with standard monitoring and medical interventions.”

DAC HYP is a humanized monoclonal antibody that selectively blocks the high-affinity interleukin-2 (IL-2) receptor subunit (CD25), which is expressed at high levels on T cells that are abnormally activated in MS. The biological effects of CD25 blockade include the inhibition of activated T cell responses and “normalization of lymphoid tissue inducer cell numbers,” he said.

The DECIDE study randomized 919 patients to treatment with 150 mg of DAC HYP administered subcutaneously once every 4 weeks and 922 patients to treatment with 30 mcg of IFN beta-1a (Avonex) administered intramuscularly once a week. Mean age of the patients was 36 years, 68% were women, and they had been diagnosed with MS for a mean of 5 years. Patients in both groups had had a similar mean number of relapses within the previous year (0.7-0.8); 21% had highly active MS, and 41% had been on disease-modifying treatments previously; their mean Expanded Disability Status Scale (EDSS) score was 1.2-1.3.

The study ended when the last patient had been treated for 2 years. In both arms, 29%-30% discontinued treatment, and adverse events were higher in the DAC HYP-treated group (14% vs. 9%).

During 96-144 weeks, the annualized relapse rate – the primary endpoint – was 0.393 among those on IFN beta-1a, vs. 0.216 among those on DAC HYP, a 45% reduction that was highly statistically significant (P < .0001), Dr. Kappos said.

Secondary endpoints included the proportion who remained relapse free, which was higher among those on DAC HYP at different points during the study (including 73% vs. 59% at week 96, and 67% vs. 51% at week 144). The risk of relapse was reduced by 41% (P < .0001).

Other secondary endpoints were MRI-defined lesions at week 96: The number of new or newly enlarging T2 hyperintense lesions at that point was reduced by 54%, compared with IFN beta-1a (P < .0001). There were similar reductions in new T1 hypointense lesions (black holes), which were reduced by 52% (P < .0001), and in gadolinium-enhancing lesions, which were reduced by 65% (P < .0001). There was a significant effect of treatment on brain volume over time, which was possible to detect because the study was so large, Dr. Kappos said.

At 3 months, the risk of progression was reduced by 16% among those on DAC HYP, compared with those on IFN beta-1a (P = .16), a favorable effect, although not statistically significant. At 6 months, the risk was reduced by 27% (P = .033), Dr. Kappos reported. The proportion of patients with a clinically meaningful worsening in patient-reported physical impact of MS (defined by at least a 7.5 point drop on the MSIS-29 PHYS) was reduced by 24% over those on IFN beta-1a, which was not statistically significant.

The incidence of any type of adverse event was 91% in both groups, and infections, cutaneous events, and hepatic abnormalities were more common among those treated with DAC HYP. Serious adverse events were higher among those on DAC HYP (24% vs. 21%); when MS relapses were excluded, the rate was 15% vs. 10%. Treatment discontinuations due to an adverse event, other than an MS relapse, was 14% among those on DAC HYP vs. 9% of those on IFN beta-1a. There were five deaths, one in a patient on the study drug and four among those on the comparator.

The rate of infectious adverse events was higher among those on DAC HYP (65% vs. 57%), as was the rate of serious infectious adverse events (4% vs. 2%). Cutaneous events were more common among those on DAC HYP (37% vs. 19%), as were serious cutaneous adverse events (2% vs. less than 1%).

Dr. Kappos said that hepatic abnormalities were more common among those on DAC HYP, but were reversible. The rate of ALT/AST greater than five times the upper limit of normal (ULN) was 6% among those on the DAC HYP vs. 3% among those on IFN beta-1a; but the rate of ALT greater than three times the ULN and total bilirubin more than twice the ULN was less than 1% in each group. There was one case that met the “Hy’s law” criteria in each group.

Biogen Idec and AbbVie Biotherapeutics funded the study. Dr. Kappos disclosed that University Hospital Basel has received research support from steering committee/consulting fees, and speakers fees from pharmaceutical companies that include Biogen.

emechcatie@frontlinemedcom.com

The Consortium of Multiple Sclerosis Centers (CMSC) Task Force has updated its standardized MRI protocol and clinical guidelines for the diagnosis and follow-up of MS. The revision to the 2006 MRI protocols include the following changes:

• an emphasis on 3D sequences of brain MRI

• a specific monitoring protocol for progressive multifocal leukoencephalopathy (PML)

• an optional orbit MRI protocol for severe optic neuritis

Key changes to the 2006 clinical guidelines include:

• specific timing for using brain MRIs to monitor response to disease-modifying therapies

• timing of brain MRIs for PML surveillance

• inclusion of radiologic isolated syndrome

The updated guidelines also include new evidence regarding the value of MRI changes in determining treatment effectiveness.

Citation: 2015 Revised CMSC MRI Protocol and Guidelines. CMSC website. http://c.ymcdn.com/sites/www.mscare.org/resource/collection/9C5F19B9-3489-48B0-A54B-623A1ECEE07B/MRIprotocol2015.pdf. Updated April 2015. Accessed April 10, 2015.

The Consortium of Multiple Sclerosis Centers (CMSC) Task Force has updated its standardized MRI protocol and clinical guidelines for the diagnosis and follow-up of MS. The revision to the 2006 MRI protocols include the following changes:

• an emphasis on 3D sequences of brain MRI

• a specific monitoring protocol for progressive multifocal leukoencephalopathy (PML)

• an optional orbit MRI protocol for severe optic neuritis

Key changes to the 2006 clinical guidelines include:

• specific timing for using brain MRIs to monitor response to disease-modifying therapies

• timing of brain MRIs for PML surveillance

• inclusion of radiologic isolated syndrome

The updated guidelines also include new evidence regarding the value of MRI changes in determining treatment effectiveness.

Citation: 2015 Revised CMSC MRI Protocol and Guidelines. CMSC website. http://c.ymcdn.com/sites/www.mscare.org/resource/collection/9C5F19B9-3489-48B0-A54B-623A1ECEE07B/MRIprotocol2015.pdf. Updated April 2015. Accessed April 10, 2015.

The Consortium of Multiple Sclerosis Centers (CMSC) Task Force has updated its standardized MRI protocol and clinical guidelines for the diagnosis and follow-up of MS. The revision to the 2006 MRI protocols include the following changes:

• an emphasis on 3D sequences of brain MRI

• a specific monitoring protocol for progressive multifocal leukoencephalopathy (PML)

• an optional orbit MRI protocol for severe optic neuritis

Key changes to the 2006 clinical guidelines include:

• specific timing for using brain MRIs to monitor response to disease-modifying therapies

• timing of brain MRIs for PML surveillance

• inclusion of radiologic isolated syndrome

The updated guidelines also include new evidence regarding the value of MRI changes in determining treatment effectiveness.

Citation: 2015 Revised CMSC MRI Protocol and Guidelines. CMSC website. http://c.ymcdn.com/sites/www.mscare.org/resource/collection/9C5F19B9-3489-48B0-A54B-623A1ECEE07B/MRIprotocol2015.pdf. Updated April 2015. Accessed April 10, 2015.

A biomarker of Epstein-Barr virus, infectious mononucleosis, and smoking are environmental factors associated with multiple sclerosis (MS) that have the strongest consistent evidence, according to an umbrella review of 44 meta-analyses.

The review included 416 primary studies of different risk factors and MS, including vaccinations, comorbidities, surgeries, environmental agents, and biomarkers. Of those, only 3 had strong enough sample sizes to make consistent associations:

• IgG seropositivity for Epstein-Barr virus nuclear antigen (EBNA) (odds ratio [OR], 4.46)

• infectious mononucleosis (OR, 2.17)

• smoking (OR, 1.52)

The study authors conclude that more data from better-designed studies are needed to establish robust associations.

Citation: Belbasis L, Bellou V, Evangelou E, Ioannidis JP, Tzoulaki I. Environmental risk factors and multiple sclerosis: an umbrella review of systematic reviews and meta-analyses. Lancet Neurol. 2015;14(3):263-273. doi: 10.1016/S1474-4422(14)70267-4.

A biomarker of Epstein-Barr virus, infectious mononucleosis, and smoking are environmental factors associated with multiple sclerosis (MS) that have the strongest consistent evidence, according to an umbrella review of 44 meta-analyses.

The review included 416 primary studies of different risk factors and MS, including vaccinations, comorbidities, surgeries, environmental agents, and biomarkers. Of those, only 3 had strong enough sample sizes to make consistent associations:

• IgG seropositivity for Epstein-Barr virus nuclear antigen (EBNA) (odds ratio [OR], 4.46)

• infectious mononucleosis (OR, 2.17)

• smoking (OR, 1.52)

The study authors conclude that more data from better-designed studies are needed to establish robust associations.

Citation: Belbasis L, Bellou V, Evangelou E, Ioannidis JP, Tzoulaki I. Environmental risk factors and multiple sclerosis: an umbrella review of systematic reviews and meta-analyses. Lancet Neurol. 2015;14(3):263-273. doi: 10.1016/S1474-4422(14)70267-4.

A biomarker of Epstein-Barr virus, infectious mononucleosis, and smoking are environmental factors associated with multiple sclerosis (MS) that have the strongest consistent evidence, according to an umbrella review of 44 meta-analyses.

The review included 416 primary studies of different risk factors and MS, including vaccinations, comorbidities, surgeries, environmental agents, and biomarkers. Of those, only 3 had strong enough sample sizes to make consistent associations:

• IgG seropositivity for Epstein-Barr virus nuclear antigen (EBNA) (odds ratio [OR], 4.46)

• infectious mononucleosis (OR, 2.17)

• smoking (OR, 1.52)

The study authors conclude that more data from better-designed studies are needed to establish robust associations.

Citation: Belbasis L, Bellou V, Evangelou E, Ioannidis JP, Tzoulaki I. Environmental risk factors and multiple sclerosis: an umbrella review of systematic reviews and meta-analyses. Lancet Neurol. 2015;14(3):263-273. doi: 10.1016/S1474-4422(14)70267-4.

Psychiatric comorbidity, particularly depression and anxiety, is common in multiple sclerosis. A systematic review of 118 studies found the prevalence of psychiatric disorders as follows:

• depression, 23%

• anxiety, 22%

• alcohol abuse, 15%

• bipolar disorder, 6%

• psychosis, 4%

• substance abuse, 3%

The study authors note that developing a consistent approach to measuring psychiatric comorbidity would enhance future studies.

Citation: Marrie RA, Reingold S, Cohen J, et al. The incidence and prevalence of psychiatric disorders in multiple sclerosis: A systematic review. Mult Scler. 2015;21(3):305-317.

Commentary: Multiple sclerosis disease impact is classically gauged by physical disability characterized by neurological examination findings from EDSS. White matter disconnection impacts more than just walking, coordination, and vision, however. This very important review clearly demonstrates the high incidence of psychiatric disorders — specifically anxiety and depression — in patients with MS, not only at presentation but the increasing incidence over time. Mood can impact reported fatigue, employment, quality of life, and adherence to medications. The MS clinician no longer can entirely focus on relapse and MRI, but must evaluate and address mood-related problems in MS care to provide quality care and effective intervention of not only symptoms but long-term disease management as well.   –Mark Gudesblatt, MD, Medical Director of the Comprehensive MS Care Center at South Shore Neurologic Associates in Islip, NY

Psychiatric comorbidity, particularly depression and anxiety, is common in multiple sclerosis. A systematic review of 118 studies found the prevalence of psychiatric disorders as follows:

• depression, 23%

• anxiety, 22%

• alcohol abuse, 15%

• bipolar disorder, 6%

• psychosis, 4%

• substance abuse, 3%

The study authors note that developing a consistent approach to measuring psychiatric comorbidity would enhance future studies.

Citation: Marrie RA, Reingold S, Cohen J, et al. The incidence and prevalence of psychiatric disorders in multiple sclerosis: A systematic review. Mult Scler. 2015;21(3):305-317.

Commentary: Multiple sclerosis disease impact is classically gauged by physical disability characterized by neurological examination findings from EDSS. White matter disconnection impacts more than just walking, coordination, and vision, however. This very important review clearly demonstrates the high incidence of psychiatric disorders — specifically anxiety and depression — in patients with MS, not only at presentation but the increasing incidence over time. Mood can impact reported fatigue, employment, quality of life, and adherence to medications. The MS clinician no longer can entirely focus on relapse and MRI, but must evaluate and address mood-related problems in MS care to provide quality care and effective intervention of not only symptoms but long-term disease management as well.   –Mark Gudesblatt, MD, Medical Director of the Comprehensive MS Care Center at South Shore Neurologic Associates in Islip, NY

Psychiatric comorbidity, particularly depression and anxiety, is common in multiple sclerosis. A systematic review of 118 studies found the prevalence of psychiatric disorders as follows:

• depression, 23%

• anxiety, 22%

• alcohol abuse, 15%

• bipolar disorder, 6%

• psychosis, 4%

• substance abuse, 3%

The study authors note that developing a consistent approach to measuring psychiatric comorbidity would enhance future studies.

Citation: Marrie RA, Reingold S, Cohen J, et al. The incidence and prevalence of psychiatric disorders in multiple sclerosis: A systematic review. Mult Scler. 2015;21(3):305-317.

Commentary: Multiple sclerosis disease impact is classically gauged by physical disability characterized by neurological examination findings from EDSS. White matter disconnection impacts more than just walking, coordination, and vision, however. This very important review clearly demonstrates the high incidence of psychiatric disorders — specifically anxiety and depression — in patients with MS, not only at presentation but the increasing incidence over time. Mood can impact reported fatigue, employment, quality of life, and adherence to medications. The MS clinician no longer can entirely focus on relapse and MRI, but must evaluate and address mood-related problems in MS care to provide quality care and effective intervention of not only symptoms but long-term disease management as well.   –Mark Gudesblatt, MD, Medical Director of the Comprehensive MS Care Center at South Shore Neurologic Associates in Islip, NY

Comorbidity with multiple sclerosis can impact diagnosis, disability progression, and quality of life, but there are substantial gaps in epidemiological knowledge of comorbidities, according to a systematic review of 249 studies that found a wide variability in study designs and reporting.

Researchers quantitatively assessed population-based studies and found:

• The 5 most prevalent comorbidities were depression, anxiety, hypertension, hyperlipidemia, and chronic lung disease.

• The most prevalent autoimmune diseases were thyroid disease and psoriasis.

• The most prevalent cancers were cervical, breast, and digestive system cancers.

Citation: Marrie RA, Cohen J, Stuve O, et al. A systematic review of the incidence and prevalence of comorbidity in multiple sclerosis: overview. Mult Scler. 2015;21(3):263-281.

Comorbidity with multiple sclerosis can impact diagnosis, disability progression, and quality of life, but there are substantial gaps in epidemiological knowledge of comorbidities, according to a systematic review of 249 studies that found a wide variability in study designs and reporting.

Researchers quantitatively assessed population-based studies and found:

• The 5 most prevalent comorbidities were depression, anxiety, hypertension, hyperlipidemia, and chronic lung disease.

• The most prevalent autoimmune diseases were thyroid disease and psoriasis.

• The most prevalent cancers were cervical, breast, and digestive system cancers.

Citation: Marrie RA, Cohen J, Stuve O, et al. A systematic review of the incidence and prevalence of comorbidity in multiple sclerosis: overview. Mult Scler. 2015;21(3):263-281.

Comorbidity with multiple sclerosis can impact diagnosis, disability progression, and quality of life, but there are substantial gaps in epidemiological knowledge of comorbidities, according to a systematic review of 249 studies that found a wide variability in study designs and reporting.

Researchers quantitatively assessed population-based studies and found:

• The 5 most prevalent comorbidities were depression, anxiety, hypertension, hyperlipidemia, and chronic lung disease.

• The most prevalent autoimmune diseases were thyroid disease and psoriasis.

• The most prevalent cancers were cervical, breast, and digestive system cancers.

Citation: Marrie RA, Cohen J, Stuve O, et al. A systematic review of the incidence and prevalence of comorbidity in multiple sclerosis: overview. Mult Scler. 2015;21(3):263-281.

Several factors associated with worsening in timed 25-foot walk (T25FW) scores and other clinical indicators may be used to predict clinically significant change in patients with multiple sclerosis, according to an analysis of 1,544 patients.

Investigators reviewed patients who experienced a 20% or greater worsening in T25FW, and found the following factors related to disease progression:

• lower baseline Multiple Sclerosis Performance Scales (MSPS) scores

• sex, baseline T25FW, and time since diagnosis

• Patient Health Questionaire-9 (PHQ9) scores

The disease course time to worsening was significantly shorter for secondary progressive compared to relapsing-remitting disease.

Citation: Miller DM, Thompson NR, Cohen JA, et al. Factors associated with clinically significant increased walking time in multiple sclerosis: results of a survival analysis of short-term follow-up data from a clinical database. Mult Scler. 2015;21(4):457-465. doi: 10.1177/1352458514544536.

Several factors associated with worsening in timed 25-foot walk (T25FW) scores and other clinical indicators may be used to predict clinically significant change in patients with multiple sclerosis, according to an analysis of 1,544 patients.

Investigators reviewed patients who experienced a 20% or greater worsening in T25FW, and found the following factors related to disease progression:

• lower baseline Multiple Sclerosis Performance Scales (MSPS) scores

• sex, baseline T25FW, and time since diagnosis

• Patient Health Questionaire-9 (PHQ9) scores

The disease course time to worsening was significantly shorter for secondary progressive compared to relapsing-remitting disease.

Citation: Miller DM, Thompson NR, Cohen JA, et al. Factors associated with clinically significant increased walking time in multiple sclerosis: results of a survival analysis of short-term follow-up data from a clinical database. Mult Scler. 2015;21(4):457-465. doi: 10.1177/1352458514544536.

Several factors associated with worsening in timed 25-foot walk (T25FW) scores and other clinical indicators may be used to predict clinically significant change in patients with multiple sclerosis, according to an analysis of 1,544 patients.

Investigators reviewed patients who experienced a 20% or greater worsening in T25FW, and found the following factors related to disease progression:

• lower baseline Multiple Sclerosis Performance Scales (MSPS) scores

• sex, baseline T25FW, and time since diagnosis

• Patient Health Questionaire-9 (PHQ9) scores

The disease course time to worsening was significantly shorter for secondary progressive compared to relapsing-remitting disease.

Citation: Miller DM, Thompson NR, Cohen JA, et al. Factors associated with clinically significant increased walking time in multiple sclerosis: results of a survival analysis of short-term follow-up data from a clinical database. Mult Scler. 2015;21(4):457-465. doi: 10.1177/1352458514544536.

The first generic formulation of the multiple sclerosis drug glatiramer acetate has been approved by the Food and Drug Administration, despite efforts by Copaxone manufacturer Teva to delay the approval of a generic version of the drug.

But it is unclear when the generic will be available.

The approved generic, in a 20 mg/mL daily injection, is manufactured by Sandoz, the FDA announced in a statement issued on April 16. The statement was accompanied by a letter from the FDA denying Teva’s citizen’s petition requesting that the FDA not approve generic versions of the drug “unless and until” certain conditions were met, including the conduct of extensive studies showing generic versions are bioequivalent to Copaxone. This was the eighth petition submitted by Teva, according to the FDA’s letter.

The FDA’s statement announcing the approval said that the agency “applies the same rigorous and reliable standards to evaluate all generic drug products. As needed, the agency requires appropriate information to demonstrate sameness for complex active ingredients, such as glatiramer acetate. For this approval, FDA scientists established a thorough scientific approach for demonstrating active ingredient sameness that takes into consideration the complexity of glatiramer acetate.”

Before approval of this product, “given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement.

In a statement, Sandoz said it will market the generic form as Glatopa. A spokesperson said that the company cannot comment on plans for launching Glatopa.

In January, the U.S. Supreme Court overturned a federal circuit court’s judgment that had said that a patent for Copaxone 20 mg/mL was invalid because Teva’s listing of the molecular weight of its active ingredient as “5 to 9 kilodaltons” was fatally indefinite, sending it back to the U.S. Court of Appeals for the Federal Circuit for further review.

“Given the pending decision from the U.S. Court of Appeals for the Federal Circuit, any companies that launch a generic version of Copaxone would do so at risk,” a Teva spokesperson said in response to a request for a comment.

Approved in 1996, glatiramer acetate is indicated for relapsing forms of MS; the 20 mg/mL dose is administered once a day. Teva also markets a 40 mg/mL dose that is administered three times a week.

emechcatie@frontlinemedcom.com

The first generic formulation of the multiple sclerosis drug glatiramer acetate has been approved by the Food and Drug Administration, despite efforts by Copaxone manufacturer Teva to delay the approval of a generic version of the drug.

But it is unclear when the generic will be available.

The approved generic, in a 20 mg/mL daily injection, is manufactured by Sandoz, the FDA announced in a statement issued on April 16. The statement was accompanied by a letter from the FDA denying Teva’s citizen’s petition requesting that the FDA not approve generic versions of the drug “unless and until” certain conditions were met, including the conduct of extensive studies showing generic versions are bioequivalent to Copaxone. This was the eighth petition submitted by Teva, according to the FDA’s letter.

The FDA’s statement announcing the approval said that the agency “applies the same rigorous and reliable standards to evaluate all generic drug products. As needed, the agency requires appropriate information to demonstrate sameness for complex active ingredients, such as glatiramer acetate. For this approval, FDA scientists established a thorough scientific approach for demonstrating active ingredient sameness that takes into consideration the complexity of glatiramer acetate.”

Before approval of this product, “given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement.

In a statement, Sandoz said it will market the generic form as Glatopa. A spokesperson said that the company cannot comment on plans for launching Glatopa.

In January, the U.S. Supreme Court overturned a federal circuit court’s judgment that had said that a patent for Copaxone 20 mg/mL was invalid because Teva’s listing of the molecular weight of its active ingredient as “5 to 9 kilodaltons” was fatally indefinite, sending it back to the U.S. Court of Appeals for the Federal Circuit for further review.

“Given the pending decision from the U.S. Court of Appeals for the Federal Circuit, any companies that launch a generic version of Copaxone would do so at risk,” a Teva spokesperson said in response to a request for a comment.

Approved in 1996, glatiramer acetate is indicated for relapsing forms of MS; the 20 mg/mL dose is administered once a day. Teva also markets a 40 mg/mL dose that is administered three times a week.

emechcatie@frontlinemedcom.com

The first generic formulation of the multiple sclerosis drug glatiramer acetate has been approved by the Food and Drug Administration, despite efforts by Copaxone manufacturer Teva to delay the approval of a generic version of the drug.

But it is unclear when the generic will be available.

The approved generic, in a 20 mg/mL daily injection, is manufactured by Sandoz, the FDA announced in a statement issued on April 16. The statement was accompanied by a letter from the FDA denying Teva’s citizen’s petition requesting that the FDA not approve generic versions of the drug “unless and until” certain conditions were met, including the conduct of extensive studies showing generic versions are bioequivalent to Copaxone. This was the eighth petition submitted by Teva, according to the FDA’s letter.

The FDA’s statement announcing the approval said that the agency “applies the same rigorous and reliable standards to evaluate all generic drug products. As needed, the agency requires appropriate information to demonstrate sameness for complex active ingredients, such as glatiramer acetate. For this approval, FDA scientists established a thorough scientific approach for demonstrating active ingredient sameness that takes into consideration the complexity of glatiramer acetate.”

Before approval of this product, “given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement.

In a statement, Sandoz said it will market the generic form as Glatopa. A spokesperson said that the company cannot comment on plans for launching Glatopa.

In January, the U.S. Supreme Court overturned a federal circuit court’s judgment that had said that a patent for Copaxone 20 mg/mL was invalid because Teva’s listing of the molecular weight of its active ingredient as “5 to 9 kilodaltons” was fatally indefinite, sending it back to the U.S. Court of Appeals for the Federal Circuit for further review.

“Given the pending decision from the U.S. Court of Appeals for the Federal Circuit, any companies that launch a generic version of Copaxone would do so at risk,” a Teva spokesperson said in response to a request for a comment.

Approved in 1996, glatiramer acetate is indicated for relapsing forms of MS; the 20 mg/mL dose is administered once a day. Teva also markets a 40 mg/mL dose that is administered three times a week.

emechcatie@frontlinemedcom.com

WASHINGTON, DC—Women with multiple sclerosis (MS) may have lower levels of important antioxidant and anti-inflammatory nutrients, such as folate from food and vitamin E, than healthy people, according to a study presented at the American Academy of Neurology’s 67th Annual Meeting.

For the study, researchers identified 27 Caucasian women with MS and compared them to 30 healthy Caucasian women between the ages of 18 and 60 and with BMI of less than or equal to 30 kg/m2. Participants reported on their diet and nutrition over the previous year prior to starting vitamin D supplementation.

On average, the women who had MS had lower levels of the following five nutrients with antioxidant or anti-inflammatory properties: food folate, vitamin E, magnesium, lutein-zeaxanthin, and quercetin. For food folate, the women with MS had average intake of 244 mg, while the healthy women had an average intake of 321 mg. The recommended daily allowance is 400 mg.

For magnesium, the women with MS had average intake of 254 mg, while the healthy women met the recommended daily allowance of 320 mg with an average of 321 mg. The women with MS also had a lower average percentage of their calories from fat than the healthy participants.

“Since MS is a chronic inflammatory disorder, having enough nutrients with anti-inflammatory properties may help prevent the disease or reduce the risk of attacks for those who already have MS,” said study author Sandra D. Cassard, ScD, of Johns Hopkins University in Baltimore. “Antioxidants are also critical to good health and help reduce the effects of other types of damage that can occur on a cellular level and contribute to neurologic diseases like MS. Whether the nutritional differences that we identified in the study are a cause of MS or a result of having it is not yet clear.”

The study was supported by the National Institute of Neurological Disorders and Stroke.

WASHINGTON, DC—Women with multiple sclerosis (MS) may have lower levels of important antioxidant and anti-inflammatory nutrients, such as folate from food and vitamin E, than healthy people, according to a study presented at the American Academy of Neurology’s 67th Annual Meeting.

For the study, researchers identified 27 Caucasian women with MS and compared them to 30 healthy Caucasian women between the ages of 18 and 60 and with BMI of less than or equal to 30 kg/m2. Participants reported on their diet and nutrition over the previous year prior to starting vitamin D supplementation.

On average, the women who had MS had lower levels of the following five nutrients with antioxidant or anti-inflammatory properties: food folate, vitamin E, magnesium, lutein-zeaxanthin, and quercetin. For food folate, the women with MS had average intake of 244 mg, while the healthy women had an average intake of 321 mg. The recommended daily allowance is 400 mg.

For magnesium, the women with MS had average intake of 254 mg, while the healthy women met the recommended daily allowance of 320 mg with an average of 321 mg. The women with MS also had a lower average percentage of their calories from fat than the healthy participants.

“Since MS is a chronic inflammatory disorder, having enough nutrients with anti-inflammatory properties may help prevent the disease or reduce the risk of attacks for those who already have MS,” said study author Sandra D. Cassard, ScD, of Johns Hopkins University in Baltimore. “Antioxidants are also critical to good health and help reduce the effects of other types of damage that can occur on a cellular level and contribute to neurologic diseases like MS. Whether the nutritional differences that we identified in the study are a cause of MS or a result of having it is not yet clear.”

The study was supported by the National Institute of Neurological Disorders and Stroke.

WASHINGTON, DC—Women with multiple sclerosis (MS) may have lower levels of important antioxidant and anti-inflammatory nutrients, such as folate from food and vitamin E, than healthy people, according to a study presented at the American Academy of Neurology’s 67th Annual Meeting.

For the study, researchers identified 27 Caucasian women with MS and compared them to 30 healthy Caucasian women between the ages of 18 and 60 and with BMI of less than or equal to 30 kg/m2. Participants reported on their diet and nutrition over the previous year prior to starting vitamin D supplementation.

On average, the women who had MS had lower levels of the following five nutrients with antioxidant or anti-inflammatory properties: food folate, vitamin E, magnesium, lutein-zeaxanthin, and quercetin. For food folate, the women with MS had average intake of 244 mg, while the healthy women had an average intake of 321 mg. The recommended daily allowance is 400 mg.

For magnesium, the women with MS had average intake of 254 mg, while the healthy women met the recommended daily allowance of 320 mg with an average of 321 mg. The women with MS also had a lower average percentage of their calories from fat than the healthy participants.

“Since MS is a chronic inflammatory disorder, having enough nutrients with anti-inflammatory properties may help prevent the disease or reduce the risk of attacks for those who already have MS,” said study author Sandra D. Cassard, ScD, of Johns Hopkins University in Baltimore. “Antioxidants are also critical to good health and help reduce the effects of other types of damage that can occur on a cellular level and contribute to neurologic diseases like MS. Whether the nutritional differences that we identified in the study are a cause of MS or a result of having it is not yet clear.”

The study was supported by the National Institute of Neurological Disorders and Stroke.