ICYMI Multiple Sclerosis

BARCELONA—Patients with relapsing-remitting multiple sclerosis (MS) who receive daclizumab high-yield process (DAC HYP) for two years have significantly less brain volume loss than patients who receive intramuscular interferon beta-1a for two years, according to research presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The effects of daclizumab, compared with those of interferon beta-1a, are not related to pseudoatrophy during the first 24 weeks of treatment, according to the investigators.

“These results are consistent with other MRI outcomes from DECIDE that showed significantly lower inflammatory and chronic brain MRI lesion activity for DAC HYP, compared with intramuscular interferon beta-1a,” said Douglas Arnold, MD, a neurologist at Montreal Neurological Institute and Hospital, and colleagues.

Compared with the general population, people with MS have more rapid brain volume loss that may lead to the accumulation of disability. Previous data suggest that intramuscular interferon beta-1a reduces brain volume loss at year 2.

To compare the effects of DAC HYP and intramuscular interferon beta-1a on brain volume change, Dr. Arnold and colleagues examined data from the DECIDE study, which compared these two drugs in people with relapsing-remitting MS. Participants in the randomized, double-blind trial received 150 mg of subcutaneous DAC HYP every four weeks or 30 mg of intramuscular interferon beta-1a once weekly for at least 96 weeks. Some participants continued in the study for as long as 144 weeks. Whole brain volume change was evaluated as the percentage brain volume change (PBVC) over the prespecified intervals of weeks 0 to 24, 24 to 96, and 0 to 96 using the structural image evaluation using normalization of atrophy (SIENA) method. The researchers performed subgroup analyses according to patients’ baseline demographics and clinical characteristics.

A total of 1,841 patients were enrolled in DECIDE. Patients’ mean age was 36, and 68% of participants were female. Mean duration of disease was approximately four years, the mean number of relapses in the previous year was approximately 1.5, and mean Expanded Disability Status Scale score was 2.5. Median brain volume was 1,498 cm³.

Annualized PBVC was significantly reduced in the DAC HYP group between baseline and Week 96, compared with the intramuscular interferon beta-1a group. The median annualized PBVC from baseline to Week 96 was -0.580 for interferon beta-1a and -0.553 for DAC HYP. Subgroup analyses indicated that annualized percentage brain volume loss between baseline and Week 96 was lower in the DAC HYP group than in the interferon beta-1a group across all subgroups, except in subgroups of patients who were male, had baseline T2 lesion volume equal to or above the median, and with MS diagnosis within three to 10 years.

Annualized percentage brain volume loss also was lower in the DAC HYP group, compared with the interferon beta-1a group in the period from baseline to Week 24 (-0.674 vs -0.745). Annualized PBVC also was reduced between weeks 24 and 96 for DAC HYP, compared with interferon beta-1a (-0.511 vs -0.549).

BARCELONA—Patients with relapsing-remitting multiple sclerosis (MS) who receive daclizumab high-yield process (DAC HYP) for two years have significantly less brain volume loss than patients who receive intramuscular interferon beta-1a for two years, according to research presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The effects of daclizumab, compared with those of interferon beta-1a, are not related to pseudoatrophy during the first 24 weeks of treatment, according to the investigators.

“These results are consistent with other MRI outcomes from DECIDE that showed significantly lower inflammatory and chronic brain MRI lesion activity for DAC HYP, compared with intramuscular interferon beta-1a,” said Douglas Arnold, MD, a neurologist at Montreal Neurological Institute and Hospital, and colleagues.

Compared with the general population, people with MS have more rapid brain volume loss that may lead to the accumulation of disability. Previous data suggest that intramuscular interferon beta-1a reduces brain volume loss at year 2.

To compare the effects of DAC HYP and intramuscular interferon beta-1a on brain volume change, Dr. Arnold and colleagues examined data from the DECIDE study, which compared these two drugs in people with relapsing-remitting MS. Participants in the randomized, double-blind trial received 150 mg of subcutaneous DAC HYP every four weeks or 30 mg of intramuscular interferon beta-1a once weekly for at least 96 weeks. Some participants continued in the study for as long as 144 weeks. Whole brain volume change was evaluated as the percentage brain volume change (PBVC) over the prespecified intervals of weeks 0 to 24, 24 to 96, and 0 to 96 using the structural image evaluation using normalization of atrophy (SIENA) method. The researchers performed subgroup analyses according to patients’ baseline demographics and clinical characteristics.

A total of 1,841 patients were enrolled in DECIDE. Patients’ mean age was 36, and 68% of participants were female. Mean duration of disease was approximately four years, the mean number of relapses in the previous year was approximately 1.5, and mean Expanded Disability Status Scale score was 2.5. Median brain volume was 1,498 cm³.

Annualized PBVC was significantly reduced in the DAC HYP group between baseline and Week 96, compared with the intramuscular interferon beta-1a group. The median annualized PBVC from baseline to Week 96 was -0.580 for interferon beta-1a and -0.553 for DAC HYP. Subgroup analyses indicated that annualized percentage brain volume loss between baseline and Week 96 was lower in the DAC HYP group than in the interferon beta-1a group across all subgroups, except in subgroups of patients who were male, had baseline T2 lesion volume equal to or above the median, and with MS diagnosis within three to 10 years.

Annualized percentage brain volume loss also was lower in the DAC HYP group, compared with the interferon beta-1a group in the period from baseline to Week 24 (-0.674 vs -0.745). Annualized PBVC also was reduced between weeks 24 and 96 for DAC HYP, compared with interferon beta-1a (-0.511 vs -0.549).

BARCELONA—Patients with relapsing-remitting multiple sclerosis (MS) who receive daclizumab high-yield process (DAC HYP) for two years have significantly less brain volume loss than patients who receive intramuscular interferon beta-1a for two years, according to research presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The effects of daclizumab, compared with those of interferon beta-1a, are not related to pseudoatrophy during the first 24 weeks of treatment, according to the investigators.

“These results are consistent with other MRI outcomes from DECIDE that showed significantly lower inflammatory and chronic brain MRI lesion activity for DAC HYP, compared with intramuscular interferon beta-1a,” said Douglas Arnold, MD, a neurologist at Montreal Neurological Institute and Hospital, and colleagues.

Compared with the general population, people with MS have more rapid brain volume loss that may lead to the accumulation of disability. Previous data suggest that intramuscular interferon beta-1a reduces brain volume loss at year 2.

To compare the effects of DAC HYP and intramuscular interferon beta-1a on brain volume change, Dr. Arnold and colleagues examined data from the DECIDE study, which compared these two drugs in people with relapsing-remitting MS. Participants in the randomized, double-blind trial received 150 mg of subcutaneous DAC HYP every four weeks or 30 mg of intramuscular interferon beta-1a once weekly for at least 96 weeks. Some participants continued in the study for as long as 144 weeks. Whole brain volume change was evaluated as the percentage brain volume change (PBVC) over the prespecified intervals of weeks 0 to 24, 24 to 96, and 0 to 96 using the structural image evaluation using normalization of atrophy (SIENA) method. The researchers performed subgroup analyses according to patients’ baseline demographics and clinical characteristics.

A total of 1,841 patients were enrolled in DECIDE. Patients’ mean age was 36, and 68% of participants were female. Mean duration of disease was approximately four years, the mean number of relapses in the previous year was approximately 1.5, and mean Expanded Disability Status Scale score was 2.5. Median brain volume was 1,498 cm³.

Annualized PBVC was significantly reduced in the DAC HYP group between baseline and Week 96, compared with the intramuscular interferon beta-1a group. The median annualized PBVC from baseline to Week 96 was -0.580 for interferon beta-1a and -0.553 for DAC HYP. Subgroup analyses indicated that annualized percentage brain volume loss between baseline and Week 96 was lower in the DAC HYP group than in the interferon beta-1a group across all subgroups, except in subgroups of patients who were male, had baseline T2 lesion volume equal to or above the median, and with MS diagnosis within three to 10 years.

Annualized percentage brain volume loss also was lower in the DAC HYP group, compared with the interferon beta-1a group in the period from baseline to Week 24 (-0.674 vs -0.745). Annualized PBVC also was reduced between weeks 24 and 96 for DAC HYP, compared with interferon beta-1a (-0.511 vs -0.549).

BARCELONA—The tetracycline antibiotic minocycline reduces the relative risk of multiple sclerosis (MS) in patients experiencing their first clinical demyelinating event by 44.6%, according to the results of a phase III double-blind placebo-controlled Canadian multicenter clinical trial reported at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

“Current proven therapies for patients experiencing their first clinical demyelinating event show benefit the earlier they are introduced. However, payment coverage varies throughout the world, often delaying treatment until patients have demonstrated a second clinical attack,” said Luanne M. Metz, MD, Professor and Head of the Division of Neurology and Director of the MS Program at the University of Calgary in Canada, and her research colleagues. “Current oral therapies may not be ideal options because of safety concerns. Minocycline is an inexpensive oral antibiotic with a recognized safety profile. It is widely available, often in generic formulation. Preclinical and preliminary clinical studies suggest it may be a therapeutic option in MS as both monotherapy and as an add-on treatment.”

Dr. Metz and colleagues enrolled subjects between ages 18 and 60, with onset of their first demyelinating symptoms within the previous 180 days and at least two T2 hyperintense lesions on brain MRI. The study subjects were randomized to oral minocycline 100 mg bid or identical placebo. Treatment continued for 24 months or until MS diagnosis by 2005 McDonald criteria was confirmed. Follow-up visits were scheduled at one, three, six, nine, 12, 15, 18, 21, and 24 months. MRI scans were scheduled at screen, months three, six, 12, and 24 and at early end of study. The primary outcome was the proportion of participants who developed MS by six months. Risk estimates, absolute risk reductions, and relative risk reductions were calculated from actuarial life table analysis.

Starting in December 2008, 236 patients were screened at 12 Canadian sites; 143 were randomized. Intention to treat analysis included 142 subjects, as one subject was randomized in error; 72 received minocycline. Mean age was 35.8; 68.3% were women. Onset was monofocal in 76.8%, median Expanded Disability Status Scale score was 1.5, mean duration since onset of demyelinating symptoms was 84.5 days, 69% had more than eight T2 lesions, and 34.5% had enhancing lesions at screen. The risk of conversion to MS by six months was 61.4% in the placebo group and 34.0% in the minocycline group. The absolute risk reduction was 27.4%, the relative risk reduction was 44.6%, and the number needed to treat (NNT) was four. At 12 months, the absolute risk reduction was 25.1%, the relative risk reduction was 37.6%, and the NNT was four.

Based on their findings, the researchers concluded that minocycline 100 mg bid reduces conversion of the first clinical demyelinating event to MS. “Given its known safety and low cost, minocycline should be considered for initial treatment as well as for combination therapy trials.”

BARCELONA—The tetracycline antibiotic minocycline reduces the relative risk of multiple sclerosis (MS) in patients experiencing their first clinical demyelinating event by 44.6%, according to the results of a phase III double-blind placebo-controlled Canadian multicenter clinical trial reported at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

“Current proven therapies for patients experiencing their first clinical demyelinating event show benefit the earlier they are introduced. However, payment coverage varies throughout the world, often delaying treatment until patients have demonstrated a second clinical attack,” said Luanne M. Metz, MD, Professor and Head of the Division of Neurology and Director of the MS Program at the University of Calgary in Canada, and her research colleagues. “Current oral therapies may not be ideal options because of safety concerns. Minocycline is an inexpensive oral antibiotic with a recognized safety profile. It is widely available, often in generic formulation. Preclinical and preliminary clinical studies suggest it may be a therapeutic option in MS as both monotherapy and as an add-on treatment.”

Dr. Metz and colleagues enrolled subjects between ages 18 and 60, with onset of their first demyelinating symptoms within the previous 180 days and at least two T2 hyperintense lesions on brain MRI. The study subjects were randomized to oral minocycline 100 mg bid or identical placebo. Treatment continued for 24 months or until MS diagnosis by 2005 McDonald criteria was confirmed. Follow-up visits were scheduled at one, three, six, nine, 12, 15, 18, 21, and 24 months. MRI scans were scheduled at screen, months three, six, 12, and 24 and at early end of study. The primary outcome was the proportion of participants who developed MS by six months. Risk estimates, absolute risk reductions, and relative risk reductions were calculated from actuarial life table analysis.

Starting in December 2008, 236 patients were screened at 12 Canadian sites; 143 were randomized. Intention to treat analysis included 142 subjects, as one subject was randomized in error; 72 received minocycline. Mean age was 35.8; 68.3% were women. Onset was monofocal in 76.8%, median Expanded Disability Status Scale score was 1.5, mean duration since onset of demyelinating symptoms was 84.5 days, 69% had more than eight T2 lesions, and 34.5% had enhancing lesions at screen. The risk of conversion to MS by six months was 61.4% in the placebo group and 34.0% in the minocycline group. The absolute risk reduction was 27.4%, the relative risk reduction was 44.6%, and the number needed to treat (NNT) was four. At 12 months, the absolute risk reduction was 25.1%, the relative risk reduction was 37.6%, and the NNT was four.

Based on their findings, the researchers concluded that minocycline 100 mg bid reduces conversion of the first clinical demyelinating event to MS. “Given its known safety and low cost, minocycline should be considered for initial treatment as well as for combination therapy trials.”

BARCELONA—The tetracycline antibiotic minocycline reduces the relative risk of multiple sclerosis (MS) in patients experiencing their first clinical demyelinating event by 44.6%, according to the results of a phase III double-blind placebo-controlled Canadian multicenter clinical trial reported at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

“Current proven therapies for patients experiencing their first clinical demyelinating event show benefit the earlier they are introduced. However, payment coverage varies throughout the world, often delaying treatment until patients have demonstrated a second clinical attack,” said Luanne M. Metz, MD, Professor and Head of the Division of Neurology and Director of the MS Program at the University of Calgary in Canada, and her research colleagues. “Current oral therapies may not be ideal options because of safety concerns. Minocycline is an inexpensive oral antibiotic with a recognized safety profile. It is widely available, often in generic formulation. Preclinical and preliminary clinical studies suggest it may be a therapeutic option in MS as both monotherapy and as an add-on treatment.”

Dr. Metz and colleagues enrolled subjects between ages 18 and 60, with onset of their first demyelinating symptoms within the previous 180 days and at least two T2 hyperintense lesions on brain MRI. The study subjects were randomized to oral minocycline 100 mg bid or identical placebo. Treatment continued for 24 months or until MS diagnosis by 2005 McDonald criteria was confirmed. Follow-up visits were scheduled at one, three, six, nine, 12, 15, 18, 21, and 24 months. MRI scans were scheduled at screen, months three, six, 12, and 24 and at early end of study. The primary outcome was the proportion of participants who developed MS by six months. Risk estimates, absolute risk reductions, and relative risk reductions were calculated from actuarial life table analysis.

Starting in December 2008, 236 patients were screened at 12 Canadian sites; 143 were randomized. Intention to treat analysis included 142 subjects, as one subject was randomized in error; 72 received minocycline. Mean age was 35.8; 68.3% were women. Onset was monofocal in 76.8%, median Expanded Disability Status Scale score was 1.5, mean duration since onset of demyelinating symptoms was 84.5 days, 69% had more than eight T2 lesions, and 34.5% had enhancing lesions at screen. The risk of conversion to MS by six months was 61.4% in the placebo group and 34.0% in the minocycline group. The absolute risk reduction was 27.4%, the relative risk reduction was 44.6%, and the number needed to treat (NNT) was four. At 12 months, the absolute risk reduction was 25.1%, the relative risk reduction was 37.6%, and the NNT was four.

Based on their findings, the researchers concluded that minocycline 100 mg bid reduces conversion of the first clinical demyelinating event to MS. “Given its known safety and low cost, minocycline should be considered for initial treatment as well as for combination therapy trials.”

BARCELONA—Data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) show that 31.2% to 44.8% of patients continuously treated with fingolimod in the FREEDOMS core and extension trials achieved NEDA-4 in each of the years three to seven. NEDA-4—no evidence of disease activity in the four areas of relapses, MRI lesions, brain atrophy, and disability progression—is a comprehensive measure of MS disease control. A separate analysis confirmed that NEDA-4 status in the first year is a better predictor of long-term outcomes than an assessment of three parameters (relapses, MRI lesions, and disability progression).

A follow-up analysis of pooled data from the FREEDOMS and FREEDOMS II core and extension trials was conducted to assess NEDA-4 each year for seven years in patients with relapsing-remitting multiple sclerosis (MS). Bruce Cree, PhD, MD, of the University of California San Francisco, and colleagues found that in the first year, 27.1% of patients on fingolimod achieved NEDA-4, compared with 9.1% on placebo. Switching from placebo to fingolimod after year two doubled the proportion of patients achieving NEDA-4 (12.7% to 27.4%) in year three. Of those patients on continuous fingolimod treatment, 31.2% to 44.8% reached NEDA-4 status in each of the years three to seven.

“Fingolimod showed sustained efficacy in achieving NEDA-3 and NEDA-4 over seven years,” Dr. Cree and colleagues reported. “Patients who were on placebo for the first two years demonstrated substantial improvements in NEDA-3 and NEDA-4 outcomes after switching to fingolimod. However, patients who received fingolimod from the start appeared to derive more benefit throughout the first five years.”

A separate follow-up analysis of data from the FREEDOMS and FREEDOMS II trials also confirmed for the first time that assessment of relapsing-remitting MS based on NEDA-4 allowed physicians to better predict long-term disability and brain shrinkage outcomes than just assessing relapses, MRI lesions, and disability progression. Ludwig Kappos, MD, of University Hospital in Basel, Switzerland, and colleagues found that NEDA-4 status over the first year was a significantly better predictor of disability and brain atrophy over the subsequent five years, as measured by patients reaching a stage of severe disability (EDSS of 6 or more) or having more than 0.4% mean annual brain volume loss. According to the researchers, these findings support the importance of assessing relapsing-remitting MS with NEDA-4 to enable a more reliable prediction of long-term disease outcomes.

“NEDA-3 status seems to correlate more with subsequent relapse and focal inflammatory MRI activity, while NEDA-4, which adds an imaging outcome that captures tissue destruction as a result of both focal and diffuse pathology, tended to be a better predictor of subsequent disability-related outcomes and brain volume loss,” Dr. Kappos and colleagues said. “These findings support use of NEDA-4 as a more comprehensive and balanced measure for relapsing-remitting MS.”

BARCELONA—Data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) show that 31.2% to 44.8% of patients continuously treated with fingolimod in the FREEDOMS core and extension trials achieved NEDA-4 in each of the years three to seven. NEDA-4—no evidence of disease activity in the four areas of relapses, MRI lesions, brain atrophy, and disability progression—is a comprehensive measure of MS disease control. A separate analysis confirmed that NEDA-4 status in the first year is a better predictor of long-term outcomes than an assessment of three parameters (relapses, MRI lesions, and disability progression).

A follow-up analysis of pooled data from the FREEDOMS and FREEDOMS II core and extension trials was conducted to assess NEDA-4 each year for seven years in patients with relapsing-remitting multiple sclerosis (MS). Bruce Cree, PhD, MD, of the University of California San Francisco, and colleagues found that in the first year, 27.1% of patients on fingolimod achieved NEDA-4, compared with 9.1% on placebo. Switching from placebo to fingolimod after year two doubled the proportion of patients achieving NEDA-4 (12.7% to 27.4%) in year three. Of those patients on continuous fingolimod treatment, 31.2% to 44.8% reached NEDA-4 status in each of the years three to seven.

“Fingolimod showed sustained efficacy in achieving NEDA-3 and NEDA-4 over seven years,” Dr. Cree and colleagues reported. “Patients who were on placebo for the first two years demonstrated substantial improvements in NEDA-3 and NEDA-4 outcomes after switching to fingolimod. However, patients who received fingolimod from the start appeared to derive more benefit throughout the first five years.”

A separate follow-up analysis of data from the FREEDOMS and FREEDOMS II trials also confirmed for the first time that assessment of relapsing-remitting MS based on NEDA-4 allowed physicians to better predict long-term disability and brain shrinkage outcomes than just assessing relapses, MRI lesions, and disability progression. Ludwig Kappos, MD, of University Hospital in Basel, Switzerland, and colleagues found that NEDA-4 status over the first year was a significantly better predictor of disability and brain atrophy over the subsequent five years, as measured by patients reaching a stage of severe disability (EDSS of 6 or more) or having more than 0.4% mean annual brain volume loss. According to the researchers, these findings support the importance of assessing relapsing-remitting MS with NEDA-4 to enable a more reliable prediction of long-term disease outcomes.

“NEDA-3 status seems to correlate more with subsequent relapse and focal inflammatory MRI activity, while NEDA-4, which adds an imaging outcome that captures tissue destruction as a result of both focal and diffuse pathology, tended to be a better predictor of subsequent disability-related outcomes and brain volume loss,” Dr. Kappos and colleagues said. “These findings support use of NEDA-4 as a more comprehensive and balanced measure for relapsing-remitting MS.”

BARCELONA—Data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) show that 31.2% to 44.8% of patients continuously treated with fingolimod in the FREEDOMS core and extension trials achieved NEDA-4 in each of the years three to seven. NEDA-4—no evidence of disease activity in the four areas of relapses, MRI lesions, brain atrophy, and disability progression—is a comprehensive measure of MS disease control. A separate analysis confirmed that NEDA-4 status in the first year is a better predictor of long-term outcomes than an assessment of three parameters (relapses, MRI lesions, and disability progression).

A follow-up analysis of pooled data from the FREEDOMS and FREEDOMS II core and extension trials was conducted to assess NEDA-4 each year for seven years in patients with relapsing-remitting multiple sclerosis (MS). Bruce Cree, PhD, MD, of the University of California San Francisco, and colleagues found that in the first year, 27.1% of patients on fingolimod achieved NEDA-4, compared with 9.1% on placebo. Switching from placebo to fingolimod after year two doubled the proportion of patients achieving NEDA-4 (12.7% to 27.4%) in year three. Of those patients on continuous fingolimod treatment, 31.2% to 44.8% reached NEDA-4 status in each of the years three to seven.

“Fingolimod showed sustained efficacy in achieving NEDA-3 and NEDA-4 over seven years,” Dr. Cree and colleagues reported. “Patients who were on placebo for the first two years demonstrated substantial improvements in NEDA-3 and NEDA-4 outcomes after switching to fingolimod. However, patients who received fingolimod from the start appeared to derive more benefit throughout the first five years.”

A separate follow-up analysis of data from the FREEDOMS and FREEDOMS II trials also confirmed for the first time that assessment of relapsing-remitting MS based on NEDA-4 allowed physicians to better predict long-term disability and brain shrinkage outcomes than just assessing relapses, MRI lesions, and disability progression. Ludwig Kappos, MD, of University Hospital in Basel, Switzerland, and colleagues found that NEDA-4 status over the first year was a significantly better predictor of disability and brain atrophy over the subsequent five years, as measured by patients reaching a stage of severe disability (EDSS of 6 or more) or having more than 0.4% mean annual brain volume loss. According to the researchers, these findings support the importance of assessing relapsing-remitting MS with NEDA-4 to enable a more reliable prediction of long-term disease outcomes.

“NEDA-3 status seems to correlate more with subsequent relapse and focal inflammatory MRI activity, while NEDA-4, which adds an imaging outcome that captures tissue destruction as a result of both focal and diffuse pathology, tended to be a better predictor of subsequent disability-related outcomes and brain volume loss,” Dr. Kappos and colleagues said. “These findings support use of NEDA-4 as a more comprehensive and balanced measure for relapsing-remitting MS.”

BARCELONA—Among people with multiple sclerosis (MS), more men than women report current and past use of marijuana, according to the results of a survey presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

More men have spoken to their doctor about marijuana use than women, but fewer men thought that marijuana improves symptoms associated with MS.

“Gender differences in [marijuana] use and perceptions about use should be considered in discussions about use,” said Stacey Cofield, PhD, Associate Professor of Biostatistics at the University of Alabama at Birmingham and North American Research Committee on MS (NARCOMS) Coordinating Center Deputy Director. NARCOMS conducted the survey to investigate patients’ perceptions about the effectiveness of marijuana for treating MS symptoms.

NARCOMS is a participant-driven registry with semiannual, self-reported information about MS treatments and symptomatic therapies, financial status, insurance status, and MS disease status.

Participants in NARCOMS are invited to take part in additional research separate from the semiannual updates.

In August 2014, Dr. Cofield and colleagues invited 12,260 active participants in NARCOMS to complete an anonymous online questionnaire about current behaviors and attitudes toward marijuana use and legality. For the purpose of the survey, “marijuana” referred to smoked and ingested forms of the drug, as well as any controlled substance derived from marijuana or synthetic marijuana. Questions included whether participants had used marijuana before their MS diagnosis, whether they used or considered using marijuana to treat MS symptoms, and whether they had discussed marijuana with their doctor. In addition, participants were asked what symptoms they thought marijuana might improve in MS and whether they had any of those symptoms.

A total of 5,665 participants responded to the survey, and 78.3% of respondents were women. Men were older than women at the time of the survey, but the researchers found no difference in age at diagnosis between genders. A higher proportion of men than women described their MS status as progressive without a history of relapse.

More men than women reported having used marijuana before their MS diagnosis. When examining data for marijuana users, the researchers saw no difference between genders in the number of days of marijuana use in the previous 30 days. The median number of days of use was 20 for both genders. Similarly, the researchers found no gender difference in the proportion of respondents who thought that marijuana should be legal. Overall, 91.5% of respondents supported the drug’s legality.

A higher proportion of men than women reported having muscle spasms, cramps, and spasticity, but a lower proportion of men thought that marijuana was effective for treating these symptoms. Similarly, a higher proportion of men than women reported tremor, but the researchers found no difference between genders in the perceived improvement of tremor with marijuana treatment. Also, more men than women (9.5% vs 5.9%) thought that marijuana did not improve any symptoms.

A higher proportion of women than men reported having migraines or headaches, anxiety, and nausea or gastrointestinal issues and thought that marijuana improved these symptoms. Gender differences persisted when the investigators adjusted the data for type of MS, age, duration of disease, and current marijuana usage.

BARCELONA—Among people with multiple sclerosis (MS), more men than women report current and past use of marijuana, according to the results of a survey presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

More men have spoken to their doctor about marijuana use than women, but fewer men thought that marijuana improves symptoms associated with MS.

“Gender differences in [marijuana] use and perceptions about use should be considered in discussions about use,” said Stacey Cofield, PhD, Associate Professor of Biostatistics at the University of Alabama at Birmingham and North American Research Committee on MS (NARCOMS) Coordinating Center Deputy Director. NARCOMS conducted the survey to investigate patients’ perceptions about the effectiveness of marijuana for treating MS symptoms.

NARCOMS is a participant-driven registry with semiannual, self-reported information about MS treatments and symptomatic therapies, financial status, insurance status, and MS disease status.

Participants in NARCOMS are invited to take part in additional research separate from the semiannual updates.

In August 2014, Dr. Cofield and colleagues invited 12,260 active participants in NARCOMS to complete an anonymous online questionnaire about current behaviors and attitudes toward marijuana use and legality. For the purpose of the survey, “marijuana” referred to smoked and ingested forms of the drug, as well as any controlled substance derived from marijuana or synthetic marijuana. Questions included whether participants had used marijuana before their MS diagnosis, whether they used or considered using marijuana to treat MS symptoms, and whether they had discussed marijuana with their doctor. In addition, participants were asked what symptoms they thought marijuana might improve in MS and whether they had any of those symptoms.

A total of 5,665 participants responded to the survey, and 78.3% of respondents were women. Men were older than women at the time of the survey, but the researchers found no difference in age at diagnosis between genders. A higher proportion of men than women described their MS status as progressive without a history of relapse.

More men than women reported having used marijuana before their MS diagnosis. When examining data for marijuana users, the researchers saw no difference between genders in the number of days of marijuana use in the previous 30 days. The median number of days of use was 20 for both genders. Similarly, the researchers found no gender difference in the proportion of respondents who thought that marijuana should be legal. Overall, 91.5% of respondents supported the drug’s legality.

A higher proportion of men than women reported having muscle spasms, cramps, and spasticity, but a lower proportion of men thought that marijuana was effective for treating these symptoms. Similarly, a higher proportion of men than women reported tremor, but the researchers found no difference between genders in the perceived improvement of tremor with marijuana treatment. Also, more men than women (9.5% vs 5.9%) thought that marijuana did not improve any symptoms.

A higher proportion of women than men reported having migraines or headaches, anxiety, and nausea or gastrointestinal issues and thought that marijuana improved these symptoms. Gender differences persisted when the investigators adjusted the data for type of MS, age, duration of disease, and current marijuana usage.

BARCELONA—Among people with multiple sclerosis (MS), more men than women report current and past use of marijuana, according to the results of a survey presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

More men have spoken to their doctor about marijuana use than women, but fewer men thought that marijuana improves symptoms associated with MS.

“Gender differences in [marijuana] use and perceptions about use should be considered in discussions about use,” said Stacey Cofield, PhD, Associate Professor of Biostatistics at the University of Alabama at Birmingham and North American Research Committee on MS (NARCOMS) Coordinating Center Deputy Director. NARCOMS conducted the survey to investigate patients’ perceptions about the effectiveness of marijuana for treating MS symptoms.

NARCOMS is a participant-driven registry with semiannual, self-reported information about MS treatments and symptomatic therapies, financial status, insurance status, and MS disease status.

Participants in NARCOMS are invited to take part in additional research separate from the semiannual updates.

In August 2014, Dr. Cofield and colleagues invited 12,260 active participants in NARCOMS to complete an anonymous online questionnaire about current behaviors and attitudes toward marijuana use and legality. For the purpose of the survey, “marijuana” referred to smoked and ingested forms of the drug, as well as any controlled substance derived from marijuana or synthetic marijuana. Questions included whether participants had used marijuana before their MS diagnosis, whether they used or considered using marijuana to treat MS symptoms, and whether they had discussed marijuana with their doctor. In addition, participants were asked what symptoms they thought marijuana might improve in MS and whether they had any of those symptoms.

A total of 5,665 participants responded to the survey, and 78.3% of respondents were women. Men were older than women at the time of the survey, but the researchers found no difference in age at diagnosis between genders. A higher proportion of men than women described their MS status as progressive without a history of relapse.

More men than women reported having used marijuana before their MS diagnosis. When examining data for marijuana users, the researchers saw no difference between genders in the number of days of marijuana use in the previous 30 days. The median number of days of use was 20 for both genders. Similarly, the researchers found no gender difference in the proportion of respondents who thought that marijuana should be legal. Overall, 91.5% of respondents supported the drug’s legality.

A higher proportion of men than women reported having muscle spasms, cramps, and spasticity, but a lower proportion of men thought that marijuana was effective for treating these symptoms. Similarly, a higher proportion of men than women reported tremor, but the researchers found no difference between genders in the perceived improvement of tremor with marijuana treatment. Also, more men than women (9.5% vs 5.9%) thought that marijuana did not improve any symptoms.

A higher proportion of women than men reported having migraines or headaches, anxiety, and nausea or gastrointestinal issues and thought that marijuana improved these symptoms. Gender differences persisted when the investigators adjusted the data for type of MS, age, duration of disease, and current marijuana usage.

BARCELONA—Anti-LINGO-1 improved full-field visual evoked potential (FF-VEP) latency of the eye affected by acute optic neuritis relative to placebo, consistent with improved remyelination, according to a study reported at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). This latency recovery was greater in older subjects, subjects given the first dose earlier, and subjects with more severe pretreatment visual impairment.

In a primary efficacy analysis of the RENEW study, Orhan Aktas, MD, of Heinrich-Heine-Universität in Düsseldorf, Germany, and colleagues demonstrated an improvement versus placebo in optic nerve latency (-7.55 ms at week 24; -9.13 ms at week 32) consistent with remyelination in subjects with acute optic neuritis.

Research subjects ages 18 to 50 with a first unilateral acute optic neuritis episode were treated with high-dose steroids, then randomized to 100 mg/kg anti-LINGO-1 IV or placebo once every four weeks (ie, six doses) and followed to week 32. Optic nerve latency was measured using FF-VEP in the affected eye versus the baseline value for the unaffected eye. Between-treatment comparisons were evaluated by ANCOVA in the per-protocol population, defined as subjects who completed the study and did not miss more than one study dose or receive disease-modifying therapy for multiple sclerosis. Further analyses of latency recovery at week 24 (affected eye FF-VEP latency ≤10% worse than baseline of fellow eye) and efficacy stratified by prespecified baseline characteristics using the median as the cutoff were performed.

FF-VEP latency recovery in the affected eye versus baseline of the fellow eye was compared between 33 subjects who received anti-LINGO-1 and 36 treated with placebo. At week 24, 24 subjects had normal or mildly prolonged FF-VEP latency, 15 from the anti-LINGO-1 and nine from the placebo group. Assessment of subjects stratified by prespecified baseline characteristics showed that improvement in FF-VEP latency in the affected eye at week 24 with anti-LINGO-1 was greater in the following patient subgroups: age 33 or older (difference vs placebo, -14.17 ms compared with -0.89 ms in subjects younger than 33); those who received treatment less than 25 days from the onset of acute optic neuritis (-9.01 ms vs -6.68 ms for those receiving treatment more than 25 days after acute optic neuritis onset); and those who had a high-contrast visual acuity score less than 49 (-10.92 ms vs -4.14 ms for a score of 49 or more). None of the subgroup-by-treatment interactions reached statistical significance due to the small sample size.

BARCELONA—Anti-LINGO-1 improved full-field visual evoked potential (FF-VEP) latency of the eye affected by acute optic neuritis relative to placebo, consistent with improved remyelination, according to a study reported at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). This latency recovery was greater in older subjects, subjects given the first dose earlier, and subjects with more severe pretreatment visual impairment.

In a primary efficacy analysis of the RENEW study, Orhan Aktas, MD, of Heinrich-Heine-Universität in Düsseldorf, Germany, and colleagues demonstrated an improvement versus placebo in optic nerve latency (-7.55 ms at week 24; -9.13 ms at week 32) consistent with remyelination in subjects with acute optic neuritis.

Research subjects ages 18 to 50 with a first unilateral acute optic neuritis episode were treated with high-dose steroids, then randomized to 100 mg/kg anti-LINGO-1 IV or placebo once every four weeks (ie, six doses) and followed to week 32. Optic nerve latency was measured using FF-VEP in the affected eye versus the baseline value for the unaffected eye. Between-treatment comparisons were evaluated by ANCOVA in the per-protocol population, defined as subjects who completed the study and did not miss more than one study dose or receive disease-modifying therapy for multiple sclerosis. Further analyses of latency recovery at week 24 (affected eye FF-VEP latency ≤10% worse than baseline of fellow eye) and efficacy stratified by prespecified baseline characteristics using the median as the cutoff were performed.

FF-VEP latency recovery in the affected eye versus baseline of the fellow eye was compared between 33 subjects who received anti-LINGO-1 and 36 treated with placebo. At week 24, 24 subjects had normal or mildly prolonged FF-VEP latency, 15 from the anti-LINGO-1 and nine from the placebo group. Assessment of subjects stratified by prespecified baseline characteristics showed that improvement in FF-VEP latency in the affected eye at week 24 with anti-LINGO-1 was greater in the following patient subgroups: age 33 or older (difference vs placebo, -14.17 ms compared with -0.89 ms in subjects younger than 33); those who received treatment less than 25 days from the onset of acute optic neuritis (-9.01 ms vs -6.68 ms for those receiving treatment more than 25 days after acute optic neuritis onset); and those who had a high-contrast visual acuity score less than 49 (-10.92 ms vs -4.14 ms for a score of 49 or more). None of the subgroup-by-treatment interactions reached statistical significance due to the small sample size.

BARCELONA—Anti-LINGO-1 improved full-field visual evoked potential (FF-VEP) latency of the eye affected by acute optic neuritis relative to placebo, consistent with improved remyelination, according to a study reported at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). This latency recovery was greater in older subjects, subjects given the first dose earlier, and subjects with more severe pretreatment visual impairment.

In a primary efficacy analysis of the RENEW study, Orhan Aktas, MD, of Heinrich-Heine-Universität in Düsseldorf, Germany, and colleagues demonstrated an improvement versus placebo in optic nerve latency (-7.55 ms at week 24; -9.13 ms at week 32) consistent with remyelination in subjects with acute optic neuritis.

Research subjects ages 18 to 50 with a first unilateral acute optic neuritis episode were treated with high-dose steroids, then randomized to 100 mg/kg anti-LINGO-1 IV or placebo once every four weeks (ie, six doses) and followed to week 32. Optic nerve latency was measured using FF-VEP in the affected eye versus the baseline value for the unaffected eye. Between-treatment comparisons were evaluated by ANCOVA in the per-protocol population, defined as subjects who completed the study and did not miss more than one study dose or receive disease-modifying therapy for multiple sclerosis. Further analyses of latency recovery at week 24 (affected eye FF-VEP latency ≤10% worse than baseline of fellow eye) and efficacy stratified by prespecified baseline characteristics using the median as the cutoff were performed.

FF-VEP latency recovery in the affected eye versus baseline of the fellow eye was compared between 33 subjects who received anti-LINGO-1 and 36 treated with placebo. At week 24, 24 subjects had normal or mildly prolonged FF-VEP latency, 15 from the anti-LINGO-1 and nine from the placebo group. Assessment of subjects stratified by prespecified baseline characteristics showed that improvement in FF-VEP latency in the affected eye at week 24 with anti-LINGO-1 was greater in the following patient subgroups: age 33 or older (difference vs placebo, -14.17 ms compared with -0.89 ms in subjects younger than 33); those who received treatment less than 25 days from the onset of acute optic neuritis (-9.01 ms vs -6.68 ms for those receiving treatment more than 25 days after acute optic neuritis onset); and those who had a high-contrast visual acuity score less than 49 (-10.92 ms vs -4.14 ms for a score of 49 or more). None of the subgroup-by-treatment interactions reached statistical significance due to the small sample size.

BARCELONA—Long-term treatment with delayed-release dimethyl fumarate demonstrated strong and sustained effects on relapses and disability progression among patients newly diagnosed with relapsing-remitting multiple sclerosis (MS), according to data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Delayed-release dimethyl fumarate demonstrated efficacy and safety in patients with relapsing-remitting MS in the phase III DEFINE and CONFIRM studies. ENDORSE is an eight-year extension of DEFINE and CONFIRM. In an integrated analysis of the DEFINE, CONFIRM, and ENDORSE trials, Jing Marantz, MD, PhD, and colleagues reported six-year outcomes with delayed-release dimethyl fumarate in newly diagnosed patients with relapsing-remitting MS.

Five-Year Data
In ENDORSE, patients randomized in DEFINE or CONFIRM to delayed-release dimethyl fumarate 240 mg bid or tid continued on the same dosage. Patients randomized to placebo or glatiramer acetate (CONFIRM only) were re-randomized 1:1 to delayed-release dimethyl fumarate bid or tid. Results for the 240 mg bid dose were reported in the integrated analysis, as this represents the approved dosage. The glatiramer acetate arm was excluded from the parent analysis of newly diagnosed patients in DEFINE or CONFIRM.

“Newly diagnosed” was defined as MS diagnosis within one year prior to parent study entry and patients were either treatment-naïve or previously treated with corticosteroids alone. Minimum follow-up (data as of May 14, 2014) was approximately five years; patients who received active treatment bid in previous studies (bid/bid) remaining on study received approximately five years or more of continuous delayed-release dimethyl fumarate treatment; patients receiving placebo bid remaining on study received two years of placebo in DEFINE or CONFIRM, followed by approximately three years of delayed-release dimethyl fumarate in the ENDORSE trial (delayed treatment).

The newly diagnosed population included 144 bid and 85 placebo bid patients. At five years (ENDORSE Year 3), the annualized relapse rate in the newly diagnosed population was 0.137 in the bid patient group and 0.169 in the placebo bid group. Although the annualized relapse rate at five years was lower in the bid patient group compared with those who received delayed treatment (placebo followed by delayed-release dimethyl fumarate bid), those patients who switched to active treatment demonstrated improvements after switching to delayed-release dimethyl fumarate in ENDORSE: annualized relapse rate was 0.244 from years zero to two (DEFINE and CONFIRM), and 0.102 from years three to five (ENDORSE). The Kaplan–Meier estimated proportion of patients with 24-week confirmed disability progression at five years was 8.1% in those who remained on bid dosing and 20.4% in those who switched from placebo to active treatment.

Six-Year Data
New long-term data from the six years of study—two years in DEFINE or CONFIRM followed by four years in the safety extension ENDORSE study—showed that the annualized relapse rate for the 144 newly diagnosed patients who started delayed-release dimethyl fumarate at the beginning of the study remained low (0.14). In those 85 patients who switched from placebo to active treatment, researchers saw that the annualized relapse rate was reduced from 0.26 during the placebo period to 0.1 in years three to six on delayed-release dimethyl fumarate treatment, which represents a 61% reduction. The proportion of patients with a 24-week confirmed disability after six years of treatment was 15.7%, compared with 24.3% in those who switched to active treatment in year three.

The overall risk/benefit profile of delayed-release dimethyl fumarate remained consistent across all patients treated up to six years. “Early initiation of delayed-release dimethyl fumarate therapy does confer a long-term benefit for patients,” the researchers concluded.

BARCELONA—Long-term treatment with delayed-release dimethyl fumarate demonstrated strong and sustained effects on relapses and disability progression among patients newly diagnosed with relapsing-remitting multiple sclerosis (MS), according to data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Delayed-release dimethyl fumarate demonstrated efficacy and safety in patients with relapsing-remitting MS in the phase III DEFINE and CONFIRM studies. ENDORSE is an eight-year extension of DEFINE and CONFIRM. In an integrated analysis of the DEFINE, CONFIRM, and ENDORSE trials, Jing Marantz, MD, PhD, and colleagues reported six-year outcomes with delayed-release dimethyl fumarate in newly diagnosed patients with relapsing-remitting MS.

Five-Year Data
In ENDORSE, patients randomized in DEFINE or CONFIRM to delayed-release dimethyl fumarate 240 mg bid or tid continued on the same dosage. Patients randomized to placebo or glatiramer acetate (CONFIRM only) were re-randomized 1:1 to delayed-release dimethyl fumarate bid or tid. Results for the 240 mg bid dose were reported in the integrated analysis, as this represents the approved dosage. The glatiramer acetate arm was excluded from the parent analysis of newly diagnosed patients in DEFINE or CONFIRM.

“Newly diagnosed” was defined as MS diagnosis within one year prior to parent study entry and patients were either treatment-naïve or previously treated with corticosteroids alone. Minimum follow-up (data as of May 14, 2014) was approximately five years; patients who received active treatment bid in previous studies (bid/bid) remaining on study received approximately five years or more of continuous delayed-release dimethyl fumarate treatment; patients receiving placebo bid remaining on study received two years of placebo in DEFINE or CONFIRM, followed by approximately three years of delayed-release dimethyl fumarate in the ENDORSE trial (delayed treatment).

The newly diagnosed population included 144 bid and 85 placebo bid patients. At five years (ENDORSE Year 3), the annualized relapse rate in the newly diagnosed population was 0.137 in the bid patient group and 0.169 in the placebo bid group. Although the annualized relapse rate at five years was lower in the bid patient group compared with those who received delayed treatment (placebo followed by delayed-release dimethyl fumarate bid), those patients who switched to active treatment demonstrated improvements after switching to delayed-release dimethyl fumarate in ENDORSE: annualized relapse rate was 0.244 from years zero to two (DEFINE and CONFIRM), and 0.102 from years three to five (ENDORSE). The Kaplan–Meier estimated proportion of patients with 24-week confirmed disability progression at five years was 8.1% in those who remained on bid dosing and 20.4% in those who switched from placebo to active treatment.

Six-Year Data
New long-term data from the six years of study—two years in DEFINE or CONFIRM followed by four years in the safety extension ENDORSE study—showed that the annualized relapse rate for the 144 newly diagnosed patients who started delayed-release dimethyl fumarate at the beginning of the study remained low (0.14). In those 85 patients who switched from placebo to active treatment, researchers saw that the annualized relapse rate was reduced from 0.26 during the placebo period to 0.1 in years three to six on delayed-release dimethyl fumarate treatment, which represents a 61% reduction. The proportion of patients with a 24-week confirmed disability after six years of treatment was 15.7%, compared with 24.3% in those who switched to active treatment in year three.

The overall risk/benefit profile of delayed-release dimethyl fumarate remained consistent across all patients treated up to six years. “Early initiation of delayed-release dimethyl fumarate therapy does confer a long-term benefit for patients,” the researchers concluded.

BARCELONA—Long-term treatment with delayed-release dimethyl fumarate demonstrated strong and sustained effects on relapses and disability progression among patients newly diagnosed with relapsing-remitting multiple sclerosis (MS), according to data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Delayed-release dimethyl fumarate demonstrated efficacy and safety in patients with relapsing-remitting MS in the phase III DEFINE and CONFIRM studies. ENDORSE is an eight-year extension of DEFINE and CONFIRM. In an integrated analysis of the DEFINE, CONFIRM, and ENDORSE trials, Jing Marantz, MD, PhD, and colleagues reported six-year outcomes with delayed-release dimethyl fumarate in newly diagnosed patients with relapsing-remitting MS.

Five-Year Data
In ENDORSE, patients randomized in DEFINE or CONFIRM to delayed-release dimethyl fumarate 240 mg bid or tid continued on the same dosage. Patients randomized to placebo or glatiramer acetate (CONFIRM only) were re-randomized 1:1 to delayed-release dimethyl fumarate bid or tid. Results for the 240 mg bid dose were reported in the integrated analysis, as this represents the approved dosage. The glatiramer acetate arm was excluded from the parent analysis of newly diagnosed patients in DEFINE or CONFIRM.

“Newly diagnosed” was defined as MS diagnosis within one year prior to parent study entry and patients were either treatment-naïve or previously treated with corticosteroids alone. Minimum follow-up (data as of May 14, 2014) was approximately five years; patients who received active treatment bid in previous studies (bid/bid) remaining on study received approximately five years or more of continuous delayed-release dimethyl fumarate treatment; patients receiving placebo bid remaining on study received two years of placebo in DEFINE or CONFIRM, followed by approximately three years of delayed-release dimethyl fumarate in the ENDORSE trial (delayed treatment).

The newly diagnosed population included 144 bid and 85 placebo bid patients. At five years (ENDORSE Year 3), the annualized relapse rate in the newly diagnosed population was 0.137 in the bid patient group and 0.169 in the placebo bid group. Although the annualized relapse rate at five years was lower in the bid patient group compared with those who received delayed treatment (placebo followed by delayed-release dimethyl fumarate bid), those patients who switched to active treatment demonstrated improvements after switching to delayed-release dimethyl fumarate in ENDORSE: annualized relapse rate was 0.244 from years zero to two (DEFINE and CONFIRM), and 0.102 from years three to five (ENDORSE). The Kaplan–Meier estimated proportion of patients with 24-week confirmed disability progression at five years was 8.1% in those who remained on bid dosing and 20.4% in those who switched from placebo to active treatment.

Six-Year Data
New long-term data from the six years of study—two years in DEFINE or CONFIRM followed by four years in the safety extension ENDORSE study—showed that the annualized relapse rate for the 144 newly diagnosed patients who started delayed-release dimethyl fumarate at the beginning of the study remained low (0.14). In those 85 patients who switched from placebo to active treatment, researchers saw that the annualized relapse rate was reduced from 0.26 during the placebo period to 0.1 in years three to six on delayed-release dimethyl fumarate treatment, which represents a 61% reduction. The proportion of patients with a 24-week confirmed disability after six years of treatment was 15.7%, compared with 24.3% in those who switched to active treatment in year three.

The overall risk/benefit profile of delayed-release dimethyl fumarate remained consistent across all patients treated up to six years. “Early initiation of delayed-release dimethyl fumarate therapy does confer a long-term benefit for patients,” the researchers concluded.

BARCELONA—Prolonged-release fampridine improves objective and subjective measures of walking in patients with multiple sclerosis (MS), according to research presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The drug also may improve patients’ quality of life.

Rachel Farrell, PhD, a consultant at the National Hospital for Neurology and Neurosurgery in London, and colleagues enrolled 133 patients (93 females) with MS and severe walking impairment into a study to examine the long-term efficacy of prolonged-release fampridine on walking, quality of life, and functional ability when used in routine clinical practice. Participants were examined by neurologists and specialist physiotherapists in a specialist ambulation clinic. Study outcomes included Timed 25-Foot Walk (T25FW), MS Walking Scale (MSWS-12), the EuroQol 5-dimension instrument (EQ-5D-5L), functional goals of treatment, and walking aid use. Patients whose T25FW speed increased by 20% or more from baseline and whose MSWS-12 scores also improved were considered responders.

Participants’ mean Expanded Disability Status Scale score at baseline was 6.41. In all, 105 patients achieved responder status at two weeks. Mean baseline T25FW speed was 0.822 ft/s for responders and 0.934 ft/s for nonresponders.

At two weeks, mean T25FW speed improved by 83.3% from baseline in the responder group, compared with a deterioration of 2.73% among nonresponders. Responders continued to walk faster at 22 months (0.920 ft/s) than at baseline. The researchers also observed significant improvements in the MSWS-12 among responders (-21.7), but not among nonresponders (+5.7).

In addition, the EQ-5D-5L index improved significantly among responders (+0.114), compared with nonresponders (-0.046). Responders reported more anxiety or depression on EQ-5L-5D at baseline than nonresponders, but scored better on the other four domains of the index. After four months, 79% of patients had achieved their goals (eg, walking to the corner shop, reducing falls, increasing social activities, or doing housework). After 10 months, 55% of patients had maintained their goals, and a further 38% had achieved their goals.

The majority of patients required the same walking aids at the end of the study period. A total of 17 patients required fewer aids, and three patients required more assistance. “This [result] suggests that prolonged-release fampridine responders perform better functionally for up to 22 months of treatment,” said Dr. Farrell.

Side effects reported in the study were the same as those described in phase III and IV trials of fampridine. They included insomnia, urinary tract infections, gastrointestinal side effects, dizziness, and headaches.

“This cohort has a higher responder rate than that of pivotal trials. This [result] may be due to the severity of their walking impairment and the open-label nature of this study,” said Dr. Farrell. “This [finding] brings into question the current practice of using a 20% improvement as the threshold for clinical significance.” Overall, “the results of this study validate the utility of prolonged-release fampridine in improving walking of people with MS in routine clinical practice,” she concluded.

BARCELONA—Prolonged-release fampridine improves objective and subjective measures of walking in patients with multiple sclerosis (MS), according to research presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The drug also may improve patients’ quality of life.

Rachel Farrell, PhD, a consultant at the National Hospital for Neurology and Neurosurgery in London, and colleagues enrolled 133 patients (93 females) with MS and severe walking impairment into a study to examine the long-term efficacy of prolonged-release fampridine on walking, quality of life, and functional ability when used in routine clinical practice. Participants were examined by neurologists and specialist physiotherapists in a specialist ambulation clinic. Study outcomes included Timed 25-Foot Walk (T25FW), MS Walking Scale (MSWS-12), the EuroQol 5-dimension instrument (EQ-5D-5L), functional goals of treatment, and walking aid use. Patients whose T25FW speed increased by 20% or more from baseline and whose MSWS-12 scores also improved were considered responders.

Participants’ mean Expanded Disability Status Scale score at baseline was 6.41. In all, 105 patients achieved responder status at two weeks. Mean baseline T25FW speed was 0.822 ft/s for responders and 0.934 ft/s for nonresponders.

At two weeks, mean T25FW speed improved by 83.3% from baseline in the responder group, compared with a deterioration of 2.73% among nonresponders. Responders continued to walk faster at 22 months (0.920 ft/s) than at baseline. The researchers also observed significant improvements in the MSWS-12 among responders (-21.7), but not among nonresponders (+5.7).

In addition, the EQ-5D-5L index improved significantly among responders (+0.114), compared with nonresponders (-0.046). Responders reported more anxiety or depression on EQ-5L-5D at baseline than nonresponders, but scored better on the other four domains of the index. After four months, 79% of patients had achieved their goals (eg, walking to the corner shop, reducing falls, increasing social activities, or doing housework). After 10 months, 55% of patients had maintained their goals, and a further 38% had achieved their goals.

The majority of patients required the same walking aids at the end of the study period. A total of 17 patients required fewer aids, and three patients required more assistance. “This [result] suggests that prolonged-release fampridine responders perform better functionally for up to 22 months of treatment,” said Dr. Farrell.

Side effects reported in the study were the same as those described in phase III and IV trials of fampridine. They included insomnia, urinary tract infections, gastrointestinal side effects, dizziness, and headaches.

“This cohort has a higher responder rate than that of pivotal trials. This [result] may be due to the severity of their walking impairment and the open-label nature of this study,” said Dr. Farrell. “This [finding] brings into question the current practice of using a 20% improvement as the threshold for clinical significance.” Overall, “the results of this study validate the utility of prolonged-release fampridine in improving walking of people with MS in routine clinical practice,” she concluded.

BARCELONA—Prolonged-release fampridine improves objective and subjective measures of walking in patients with multiple sclerosis (MS), according to research presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The drug also may improve patients’ quality of life.

Rachel Farrell, PhD, a consultant at the National Hospital for Neurology and Neurosurgery in London, and colleagues enrolled 133 patients (93 females) with MS and severe walking impairment into a study to examine the long-term efficacy of prolonged-release fampridine on walking, quality of life, and functional ability when used in routine clinical practice. Participants were examined by neurologists and specialist physiotherapists in a specialist ambulation clinic. Study outcomes included Timed 25-Foot Walk (T25FW), MS Walking Scale (MSWS-12), the EuroQol 5-dimension instrument (EQ-5D-5L), functional goals of treatment, and walking aid use. Patients whose T25FW speed increased by 20% or more from baseline and whose MSWS-12 scores also improved were considered responders.

Participants’ mean Expanded Disability Status Scale score at baseline was 6.41. In all, 105 patients achieved responder status at two weeks. Mean baseline T25FW speed was 0.822 ft/s for responders and 0.934 ft/s for nonresponders.

At two weeks, mean T25FW speed improved by 83.3% from baseline in the responder group, compared with a deterioration of 2.73% among nonresponders. Responders continued to walk faster at 22 months (0.920 ft/s) than at baseline. The researchers also observed significant improvements in the MSWS-12 among responders (-21.7), but not among nonresponders (+5.7).

In addition, the EQ-5D-5L index improved significantly among responders (+0.114), compared with nonresponders (-0.046). Responders reported more anxiety or depression on EQ-5L-5D at baseline than nonresponders, but scored better on the other four domains of the index. After four months, 79% of patients had achieved their goals (eg, walking to the corner shop, reducing falls, increasing social activities, or doing housework). After 10 months, 55% of patients had maintained their goals, and a further 38% had achieved their goals.

The majority of patients required the same walking aids at the end of the study period. A total of 17 patients required fewer aids, and three patients required more assistance. “This [result] suggests that prolonged-release fampridine responders perform better functionally for up to 22 months of treatment,” said Dr. Farrell.

Side effects reported in the study were the same as those described in phase III and IV trials of fampridine. They included insomnia, urinary tract infections, gastrointestinal side effects, dizziness, and headaches.

“This cohort has a higher responder rate than that of pivotal trials. This [result] may be due to the severity of their walking impairment and the open-label nature of this study,” said Dr. Farrell. “This [finding] brings into question the current practice of using a 20% improvement as the threshold for clinical significance.” Overall, “the results of this study validate the utility of prolonged-release fampridine in improving walking of people with MS in routine clinical practice,” she concluded.

BARCELONA—Alemtuzumab’s benefits for patients with relapsing-remitting multiple sclerosis (MS) may persist for five years, according to data from an extension study presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Participants who received alemtuzumab in the phase III pivotal studies CARE-MS I and CARE-MS II had positive outcomes throughout the course of the two-year trials. These benefits were maintained through three additional years in the extension study. In the pivotal studies, courses of treatment were administered at month zero and at month 12. After the initial two courses of treatment, 68% of treated patients from CARE-MS I and 60% of treated patients from CARE-MS II did not receive additional alemtuzumab during the following four years (ie, through month 60).

The low annualized relapse rates observed in patients who received alemtuzumab in CARE-MS I (0.18) and CARE-MS II (0.27) were maintained from year three (0.19 and 0.22, respectively) to year five (0.15 and 0.18, respectively). Through year five, 80% and 76% of patients who received alemtuzumab in CARE-MS I and CARE-MS II, respectively, did not have worsening of disability progression confirmed over six months, as measured by the Expanded Disability Status Scale (EDSS). Through year five, 33% and 43% of patients who had disability before receiving alemtuzumab in CARE-MS I and CARE-MS II, respectively, had improvement in EDSS score confirmed over at least six months, as compared with pretreatment baseline.

Furthermore, through year five, patients who received alemtuzumab in CARE-MS I and II had a slowing of brain atrophy, as measured by brain parenchymal fraction on MRI. In years three, four, and five, the median yearly brain volume loss was 0.20% or less, which was lower than the rate observed during the two-year pivotal studies. In each of years three, four, and five, most patients had no evidence of MRI disease activity (70–72% in CARE-MS I and 68–70% in CARE-MS II).

Through year five, the incidence of most adverse events during the extension study was comparable to or lower than that of the pivotal studies. The frequency of thyroid adverse events was highest in year three and declined in the subsequent years.

The phase III trials of alemtuzumab were randomized, rater-blinded, two-year pivotal studies comparing alemtuzumab with high-dose subcutaneous interferon beta-1a in patients with relapsing-remitting MS who had active disease and were either new to treatment (ie, in CARE-MS I) or who had had an inadequate response to another therapy (ie, in CARE-MS II).

More than 90% of the patients who received alemtuzumab in the CARE-MS phase III trials enrolled in the extension study. These patients were eligible to receive additional treatment with alemtuzumab in the extension study if they had at least one relapse or at least two new or enlarging brain or spinal cord lesions.

“These data illustrate that most alemtuzumab patients experienced sustained effects of treatment, despite the absence of additional treatment courses,” said Eva Havrdová, MD, PhD, Professor of Neurology at Charles University in Prague. “It is encouraging to see consistent effects maintained across multiple meaningful outcomes through five years.”

Serious side effects associated with alemtuzumab included infusion-associated reactions, autoimmune disorders (eg, thyroid disease, autoimmune cytopenias, and nephropathies), infections, and pneumonitis. The most common side effects of alemtuzumab are rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in an extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting.

BARCELONA—Alemtuzumab’s benefits for patients with relapsing-remitting multiple sclerosis (MS) may persist for five years, according to data from an extension study presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Participants who received alemtuzumab in the phase III pivotal studies CARE-MS I and CARE-MS II had positive outcomes throughout the course of the two-year trials. These benefits were maintained through three additional years in the extension study. In the pivotal studies, courses of treatment were administered at month zero and at month 12. After the initial two courses of treatment, 68% of treated patients from CARE-MS I and 60% of treated patients from CARE-MS II did not receive additional alemtuzumab during the following four years (ie, through month 60).

The low annualized relapse rates observed in patients who received alemtuzumab in CARE-MS I (0.18) and CARE-MS II (0.27) were maintained from year three (0.19 and 0.22, respectively) to year five (0.15 and 0.18, respectively). Through year five, 80% and 76% of patients who received alemtuzumab in CARE-MS I and CARE-MS II, respectively, did not have worsening of disability progression confirmed over six months, as measured by the Expanded Disability Status Scale (EDSS). Through year five, 33% and 43% of patients who had disability before receiving alemtuzumab in CARE-MS I and CARE-MS II, respectively, had improvement in EDSS score confirmed over at least six months, as compared with pretreatment baseline.

Furthermore, through year five, patients who received alemtuzumab in CARE-MS I and II had a slowing of brain atrophy, as measured by brain parenchymal fraction on MRI. In years three, four, and five, the median yearly brain volume loss was 0.20% or less, which was lower than the rate observed during the two-year pivotal studies. In each of years three, four, and five, most patients had no evidence of MRI disease activity (70–72% in CARE-MS I and 68–70% in CARE-MS II).

Through year five, the incidence of most adverse events during the extension study was comparable to or lower than that of the pivotal studies. The frequency of thyroid adverse events was highest in year three and declined in the subsequent years.

The phase III trials of alemtuzumab were randomized, rater-blinded, two-year pivotal studies comparing alemtuzumab with high-dose subcutaneous interferon beta-1a in patients with relapsing-remitting MS who had active disease and were either new to treatment (ie, in CARE-MS I) or who had had an inadequate response to another therapy (ie, in CARE-MS II).

More than 90% of the patients who received alemtuzumab in the CARE-MS phase III trials enrolled in the extension study. These patients were eligible to receive additional treatment with alemtuzumab in the extension study if they had at least one relapse or at least two new or enlarging brain or spinal cord lesions.

“These data illustrate that most alemtuzumab patients experienced sustained effects of treatment, despite the absence of additional treatment courses,” said Eva Havrdová, MD, PhD, Professor of Neurology at Charles University in Prague. “It is encouraging to see consistent effects maintained across multiple meaningful outcomes through five years.”

Serious side effects associated with alemtuzumab included infusion-associated reactions, autoimmune disorders (eg, thyroid disease, autoimmune cytopenias, and nephropathies), infections, and pneumonitis. The most common side effects of alemtuzumab are rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in an extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting.

BARCELONA—Alemtuzumab’s benefits for patients with relapsing-remitting multiple sclerosis (MS) may persist for five years, according to data from an extension study presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Participants who received alemtuzumab in the phase III pivotal studies CARE-MS I and CARE-MS II had positive outcomes throughout the course of the two-year trials. These benefits were maintained through three additional years in the extension study. In the pivotal studies, courses of treatment were administered at month zero and at month 12. After the initial two courses of treatment, 68% of treated patients from CARE-MS I and 60% of treated patients from CARE-MS II did not receive additional alemtuzumab during the following four years (ie, through month 60).

The low annualized relapse rates observed in patients who received alemtuzumab in CARE-MS I (0.18) and CARE-MS II (0.27) were maintained from year three (0.19 and 0.22, respectively) to year five (0.15 and 0.18, respectively). Through year five, 80% and 76% of patients who received alemtuzumab in CARE-MS I and CARE-MS II, respectively, did not have worsening of disability progression confirmed over six months, as measured by the Expanded Disability Status Scale (EDSS). Through year five, 33% and 43% of patients who had disability before receiving alemtuzumab in CARE-MS I and CARE-MS II, respectively, had improvement in EDSS score confirmed over at least six months, as compared with pretreatment baseline.

Furthermore, through year five, patients who received alemtuzumab in CARE-MS I and II had a slowing of brain atrophy, as measured by brain parenchymal fraction on MRI. In years three, four, and five, the median yearly brain volume loss was 0.20% or less, which was lower than the rate observed during the two-year pivotal studies. In each of years three, four, and five, most patients had no evidence of MRI disease activity (70–72% in CARE-MS I and 68–70% in CARE-MS II).

Through year five, the incidence of most adverse events during the extension study was comparable to or lower than that of the pivotal studies. The frequency of thyroid adverse events was highest in year three and declined in the subsequent years.

The phase III trials of alemtuzumab were randomized, rater-blinded, two-year pivotal studies comparing alemtuzumab with high-dose subcutaneous interferon beta-1a in patients with relapsing-remitting MS who had active disease and were either new to treatment (ie, in CARE-MS I) or who had had an inadequate response to another therapy (ie, in CARE-MS II).

More than 90% of the patients who received alemtuzumab in the CARE-MS phase III trials enrolled in the extension study. These patients were eligible to receive additional treatment with alemtuzumab in the extension study if they had at least one relapse or at least two new or enlarging brain or spinal cord lesions.

“These data illustrate that most alemtuzumab patients experienced sustained effects of treatment, despite the absence of additional treatment courses,” said Eva Havrdová, MD, PhD, Professor of Neurology at Charles University in Prague. “It is encouraging to see consistent effects maintained across multiple meaningful outcomes through five years.”

Serious side effects associated with alemtuzumab included infusion-associated reactions, autoimmune disorders (eg, thyroid disease, autoimmune cytopenias, and nephropathies), infections, and pneumonitis. The most common side effects of alemtuzumab are rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in an extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting.

BARCELONA—Initial findings from a global initiative called vs.MS were presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Sponsored by Genzyme and aimed at fostering better informed care, the survey aimed at uncovering the often unspoken emotional and physical challenges faced by patients living with relapsing-remitting multiple sclerosis (MS) and their caregivers.

The vs.MS survey was developed with input and guidance from a steering committee of leading global neurologists specializing in MS. The online survey addressed topics such as progression and disability, cognitive challenges, relationship and intimacy issues, emotional burden, fatigue and sensitivity, bladder and bowel challenges, and the impact of MS on careers.

The vs.MS survey was fielded among more than 1,500 people in seven countries, including patients with relapsing-remitting MS and their caregivers.

An initial set of data from the vs.MS global survey elucidate the impact that the disease may have on various aspects of day-to-day life for people living with relapsing-remitting MS. For example, half of respondents feel their ability to progress in their career has changed for the worse since they were diagnosed with relapsing-remitting MS, and 40% are concerned about being able to keep their job.

The vs.MS survey also revealed the effect of MS on the emotional well-being of those living with the disease and their caregivers. For example, more than half of respondents living with relapsing-remitting MS feel lonely or isolated because of their MS, while more than half of caregivers do not discuss their fear of MS progressing to avoid upsetting the person they care for.

“The results of this global survey offer a unique look into the realities of relapsing MS, including the challenges that people living with MS and their care partners deal with on a daily basis,” said Barry Singer, MD, Director of the MS Center for Innovations in Care at Missouri Baptist Medical Center in St. Louis, and a vs.MS steering committee member. “We are hopeful that insight into the daily struggles of those living with MS will result in better disease management.”

While at ECTRIMS, Genzyme brought together people from across the MS community—people living with MS, health care providers specializing in the disease, and advocacy groups—to review the full vs.MS survey findings and begin developing a program that will be introduced to the community.

In the coming months, Genzyme will reveal the full vs.MS data set and partner with the MS community to encourage behavior and attitude shifts in an effort to yield better outcomes for those affected by the disease.

BARCELONA—Initial findings from a global initiative called vs.MS were presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Sponsored by Genzyme and aimed at fostering better informed care, the survey aimed at uncovering the often unspoken emotional and physical challenges faced by patients living with relapsing-remitting multiple sclerosis (MS) and their caregivers.

The vs.MS survey was developed with input and guidance from a steering committee of leading global neurologists specializing in MS. The online survey addressed topics such as progression and disability, cognitive challenges, relationship and intimacy issues, emotional burden, fatigue and sensitivity, bladder and bowel challenges, and the impact of MS on careers.

The vs.MS survey was fielded among more than 1,500 people in seven countries, including patients with relapsing-remitting MS and their caregivers.

An initial set of data from the vs.MS global survey elucidate the impact that the disease may have on various aspects of day-to-day life for people living with relapsing-remitting MS. For example, half of respondents feel their ability to progress in their career has changed for the worse since they were diagnosed with relapsing-remitting MS, and 40% are concerned about being able to keep their job.

The vs.MS survey also revealed the effect of MS on the emotional well-being of those living with the disease and their caregivers. For example, more than half of respondents living with relapsing-remitting MS feel lonely or isolated because of their MS, while more than half of caregivers do not discuss their fear of MS progressing to avoid upsetting the person they care for.

“The results of this global survey offer a unique look into the realities of relapsing MS, including the challenges that people living with MS and their care partners deal with on a daily basis,” said Barry Singer, MD, Director of the MS Center for Innovations in Care at Missouri Baptist Medical Center in St. Louis, and a vs.MS steering committee member. “We are hopeful that insight into the daily struggles of those living with MS will result in better disease management.”

While at ECTRIMS, Genzyme brought together people from across the MS community—people living with MS, health care providers specializing in the disease, and advocacy groups—to review the full vs.MS survey findings and begin developing a program that will be introduced to the community.

In the coming months, Genzyme will reveal the full vs.MS data set and partner with the MS community to encourage behavior and attitude shifts in an effort to yield better outcomes for those affected by the disease.

BARCELONA—Initial findings from a global initiative called vs.MS were presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Sponsored by Genzyme and aimed at fostering better informed care, the survey aimed at uncovering the often unspoken emotional and physical challenges faced by patients living with relapsing-remitting multiple sclerosis (MS) and their caregivers.

The vs.MS survey was developed with input and guidance from a steering committee of leading global neurologists specializing in MS. The online survey addressed topics such as progression and disability, cognitive challenges, relationship and intimacy issues, emotional burden, fatigue and sensitivity, bladder and bowel challenges, and the impact of MS on careers.

The vs.MS survey was fielded among more than 1,500 people in seven countries, including patients with relapsing-remitting MS and their caregivers.

An initial set of data from the vs.MS global survey elucidate the impact that the disease may have on various aspects of day-to-day life for people living with relapsing-remitting MS. For example, half of respondents feel their ability to progress in their career has changed for the worse since they were diagnosed with relapsing-remitting MS, and 40% are concerned about being able to keep their job.

The vs.MS survey also revealed the effect of MS on the emotional well-being of those living with the disease and their caregivers. For example, more than half of respondents living with relapsing-remitting MS feel lonely or isolated because of their MS, while more than half of caregivers do not discuss their fear of MS progressing to avoid upsetting the person they care for.

“The results of this global survey offer a unique look into the realities of relapsing MS, including the challenges that people living with MS and their care partners deal with on a daily basis,” said Barry Singer, MD, Director of the MS Center for Innovations in Care at Missouri Baptist Medical Center in St. Louis, and a vs.MS steering committee member. “We are hopeful that insight into the daily struggles of those living with MS will result in better disease management.”

While at ECTRIMS, Genzyme brought together people from across the MS community—people living with MS, health care providers specializing in the disease, and advocacy groups—to review the full vs.MS survey findings and begin developing a program that will be introduced to the community.

In the coming months, Genzyme will reveal the full vs.MS data set and partner with the MS community to encourage behavior and attitude shifts in an effort to yield better outcomes for those affected by the disease.

BARCELONA—Teriflunomide significantly slows brain-volume loss, compared with placebo, over two years in people with relapsing-remitting multiple sclerosis (MS), according to new data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In this analysis, researchers examined MRI data from the TEMSO study using Structural Image Evaluation Using Normalization of Atrophy (SIENA).

In the phase III TEMSO study, 1,088 participants with relapsing-remitting MS between ages 18 and 55 were randomly assigned to daily oral doses of placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide for 108 weeks. The treatment arms were approximately equal in size, and randomization was stratified according to the baseline Expanded Disability Status Scale score and according to trial site, with a block size of six. Researchers regularly assessed the patients’ change in brain volume from baseline. The study’s primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks. A total of 796 patients completed the study, with similar proportions of patients in the three study groups.

By month 12, median reduction from baseline in brain volume was 0.39%, 0.40%, and 0.61% for patients receiving 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups, compared with placebo. For patients receiving 14 mg of teriflunomide, the change in volume was 36.9% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change in volume was 34.4% lower than that for placebo.

The significant difference in reduction of brain atrophy for teriflunomide versus placebo was maintained at month 24. Median reduction in brain volume from baseline was 0.90%, 0.94%, and 1.29% for 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups versus placebo. For patients receiving 14 mg of teriflunomide, the change was 30.6% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change was 27.6% lower than that for placebo. In the MS clinical studies of teriflunomide, including TEMSO, the incidence of serious adverse events was similar between patients who received teriflunomide and those treated with placebo.

“Control or prevention of brain atrophy is an important target for MS treatment,” said Ludwig Kappos, MD, Chair of Neurology at University Hospital Basel in Switzerland. “These data help provide further insight into teriflunomide’s potential effects.”

BARCELONA—Teriflunomide significantly slows brain-volume loss, compared with placebo, over two years in people with relapsing-remitting multiple sclerosis (MS), according to new data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In this analysis, researchers examined MRI data from the TEMSO study using Structural Image Evaluation Using Normalization of Atrophy (SIENA).

In the phase III TEMSO study, 1,088 participants with relapsing-remitting MS between ages 18 and 55 were randomly assigned to daily oral doses of placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide for 108 weeks. The treatment arms were approximately equal in size, and randomization was stratified according to the baseline Expanded Disability Status Scale score and according to trial site, with a block size of six. Researchers regularly assessed the patients’ change in brain volume from baseline. The study’s primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks. A total of 796 patients completed the study, with similar proportions of patients in the three study groups.

By month 12, median reduction from baseline in brain volume was 0.39%, 0.40%, and 0.61% for patients receiving 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups, compared with placebo. For patients receiving 14 mg of teriflunomide, the change in volume was 36.9% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change in volume was 34.4% lower than that for placebo.

The significant difference in reduction of brain atrophy for teriflunomide versus placebo was maintained at month 24. Median reduction in brain volume from baseline was 0.90%, 0.94%, and 1.29% for 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups versus placebo. For patients receiving 14 mg of teriflunomide, the change was 30.6% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change was 27.6% lower than that for placebo. In the MS clinical studies of teriflunomide, including TEMSO, the incidence of serious adverse events was similar between patients who received teriflunomide and those treated with placebo.

“Control or prevention of brain atrophy is an important target for MS treatment,” said Ludwig Kappos, MD, Chair of Neurology at University Hospital Basel in Switzerland. “These data help provide further insight into teriflunomide’s potential effects.”

BARCELONA—Teriflunomide significantly slows brain-volume loss, compared with placebo, over two years in people with relapsing-remitting multiple sclerosis (MS), according to new data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In this analysis, researchers examined MRI data from the TEMSO study using Structural Image Evaluation Using Normalization of Atrophy (SIENA).

In the phase III TEMSO study, 1,088 participants with relapsing-remitting MS between ages 18 and 55 were randomly assigned to daily oral doses of placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide for 108 weeks. The treatment arms were approximately equal in size, and randomization was stratified according to the baseline Expanded Disability Status Scale score and according to trial site, with a block size of six. Researchers regularly assessed the patients’ change in brain volume from baseline. The study’s primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks. A total of 796 patients completed the study, with similar proportions of patients in the three study groups.

By month 12, median reduction from baseline in brain volume was 0.39%, 0.40%, and 0.61% for patients receiving 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups, compared with placebo. For patients receiving 14 mg of teriflunomide, the change in volume was 36.9% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change in volume was 34.4% lower than that for placebo.

The significant difference in reduction of brain atrophy for teriflunomide versus placebo was maintained at month 24. Median reduction in brain volume from baseline was 0.90%, 0.94%, and 1.29% for 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups versus placebo. For patients receiving 14 mg of teriflunomide, the change was 30.6% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change was 27.6% lower than that for placebo. In the MS clinical studies of teriflunomide, including TEMSO, the incidence of serious adverse events was similar between patients who received teriflunomide and those treated with placebo.

“Control or prevention of brain atrophy is an important target for MS treatment,” said Ludwig Kappos, MD, Chair of Neurology at University Hospital Basel in Switzerland. “These data help provide further insight into teriflunomide’s potential effects.”