Multiple Sclerosis Hub

NATIONAL HARBOR, MD. – A pair of studies by the same research team has clarified how poor sleep worsens cognitive and physical function in people with multiple sclerosis (MS) and how poor sleep can be improved by exercise.

Whether the better sleep directly relates to the cognitive and physical improvements was not shown conclusively. However, a link between exercise and transient cognitive improvement has been demonstrated by others.

©Eraxion/ thinkstockphotos.com

“Exercise may be a nonpharmacological and an inexpensive method to address sleep symptoms,” said Catherine Siengsukon, Ph.D., of the University of Kansas Medical Center, Kansas City, at the annual meeting of the Consortium of Multiple Sclerosis Centers.

About half of all people with MS experience poor sleep that results from the disease itself, medications, anxiety/depression, or other causes. The fatigue and reduced physical and psychological function diminish the quality of life and can increase the risk of mortality. “But it is unknown if poor sleep quality may impact physical function in individuals with MS,” said Dr. Siengsukon.

In healthy individuals, cognitive aspects like attention, working and long-term memory, information processing, decision making, and problem solving can all be affected by poor sleep. “But which cognitive domains are associated with poor sleep quality in people with MS is unknown,” said Dr. Siengsukon.

In the first study, 40 people (36 females) with MS (mainly relapsing-remitting MS) were analyzed through a battery of established tests of sleep quality, cognitive function, physical function, depression, anxiety, and quality of life. The subjects had a disease duration of about 12 years. All were ambulatory without the need of assistance, and none had sleep apnea.

About 68% of the subjects were considered poor sleepers with the remainder being good sleepers. They were comparable in age, sex, type of MS, disease duration, and cognitive impairment.

Compared with good sleepers, poor sleepers were significantly impaired in visuospatial memory and questionnaire-assessed physical function, were more fatigued, were more prone to be anxious and depressed, and had a worse quality of life. Independent factors of poor sleep quality included state and trait anxiety (P = .003 and .02, respectively).

“Evidence demonstrates that sleep consolidates memory. Therefore, poor sleep may selectively impair memory while not impacting other cognitive domains,” said Dr. Siengsukon.

In the second study, the influence of supervised, moderate exercise and home exercise on sleep quality was assessed in 22 other MS patients. Most had relapsing-remitting MS. The inclusion and exclusion criteria were similar to those for the first study, with additional exclusion criteria concerning cardiovascular risk of exercise.

The supervised stretching and exercise program for 12 subjects was done at a social center and utilized recumbent exercise machines, with the home-based program for 10 subjects consisting of stretching and outdoor walking. Both exercise programs were done three times weekly for 12 weeks.

Both exercise programs were beneficial in improving sleep, with the moderate-intensity program being relatively more effective than home-based exercise in two measurement scales of sleep. The greater benefit of moderate exercise might reflect the mode of exercise, with subjects feeling safer and more relaxed using a recumbent exerciser, Dr. Siengsukon said. Offering the exercise in a social setting might have been another plus.

“The results suggest that moderate-intensity exercise may improve cardiovascular fitness in people with MS. While both groups experienced moderate to large effects on sleep quality, the mechanism for improvement in sleep quality remains to be determined, as the improvement was not related to change in cardiorespiratory fitness,” said Dr. Siengsukon.

A link between treadmill exercise and transient cognitive improvement has been reported.

The studies were supported by the National Institutes of Health and the National Multiple Sclerosis Society. Dr. Siengsukon disclosed grant support from the National Multiple Sclerosis Society.

NATIONAL HARBOR, MD. – A pair of studies by the same research team has clarified how poor sleep worsens cognitive and physical function in people with multiple sclerosis (MS) and how poor sleep can be improved by exercise.

Whether the better sleep directly relates to the cognitive and physical improvements was not shown conclusively. However, a link between exercise and transient cognitive improvement has been demonstrated by others.

©Eraxion/ thinkstockphotos.com

“Exercise may be a nonpharmacological and an inexpensive method to address sleep symptoms,” said Catherine Siengsukon, Ph.D., of the University of Kansas Medical Center, Kansas City, at the annual meeting of the Consortium of Multiple Sclerosis Centers.

About half of all people with MS experience poor sleep that results from the disease itself, medications, anxiety/depression, or other causes. The fatigue and reduced physical and psychological function diminish the quality of life and can increase the risk of mortality. “But it is unknown if poor sleep quality may impact physical function in individuals with MS,” said Dr. Siengsukon.

In healthy individuals, cognitive aspects like attention, working and long-term memory, information processing, decision making, and problem solving can all be affected by poor sleep. “But which cognitive domains are associated with poor sleep quality in people with MS is unknown,” said Dr. Siengsukon.

In the first study, 40 people (36 females) with MS (mainly relapsing-remitting MS) were analyzed through a battery of established tests of sleep quality, cognitive function, physical function, depression, anxiety, and quality of life. The subjects had a disease duration of about 12 years. All were ambulatory without the need of assistance, and none had sleep apnea.

About 68% of the subjects were considered poor sleepers with the remainder being good sleepers. They were comparable in age, sex, type of MS, disease duration, and cognitive impairment.

Compared with good sleepers, poor sleepers were significantly impaired in visuospatial memory and questionnaire-assessed physical function, were more fatigued, were more prone to be anxious and depressed, and had a worse quality of life. Independent factors of poor sleep quality included state and trait anxiety (P = .003 and .02, respectively).

“Evidence demonstrates that sleep consolidates memory. Therefore, poor sleep may selectively impair memory while not impacting other cognitive domains,” said Dr. Siengsukon.

In the second study, the influence of supervised, moderate exercise and home exercise on sleep quality was assessed in 22 other MS patients. Most had relapsing-remitting MS. The inclusion and exclusion criteria were similar to those for the first study, with additional exclusion criteria concerning cardiovascular risk of exercise.

The supervised stretching and exercise program for 12 subjects was done at a social center and utilized recumbent exercise machines, with the home-based program for 10 subjects consisting of stretching and outdoor walking. Both exercise programs were done three times weekly for 12 weeks.

Both exercise programs were beneficial in improving sleep, with the moderate-intensity program being relatively more effective than home-based exercise in two measurement scales of sleep. The greater benefit of moderate exercise might reflect the mode of exercise, with subjects feeling safer and more relaxed using a recumbent exerciser, Dr. Siengsukon said. Offering the exercise in a social setting might have been another plus.

“The results suggest that moderate-intensity exercise may improve cardiovascular fitness in people with MS. While both groups experienced moderate to large effects on sleep quality, the mechanism for improvement in sleep quality remains to be determined, as the improvement was not related to change in cardiorespiratory fitness,” said Dr. Siengsukon.

A link between treadmill exercise and transient cognitive improvement has been reported.

The studies were supported by the National Institutes of Health and the National Multiple Sclerosis Society. Dr. Siengsukon disclosed grant support from the National Multiple Sclerosis Society.

NATIONAL HARBOR, MD. – A pair of studies by the same research team has clarified how poor sleep worsens cognitive and physical function in people with multiple sclerosis (MS) and how poor sleep can be improved by exercise.

Whether the better sleep directly relates to the cognitive and physical improvements was not shown conclusively. However, a link between exercise and transient cognitive improvement has been demonstrated by others.

©Eraxion/ thinkstockphotos.com

“Exercise may be a nonpharmacological and an inexpensive method to address sleep symptoms,” said Catherine Siengsukon, Ph.D., of the University of Kansas Medical Center, Kansas City, at the annual meeting of the Consortium of Multiple Sclerosis Centers.

About half of all people with MS experience poor sleep that results from the disease itself, medications, anxiety/depression, or other causes. The fatigue and reduced physical and psychological function diminish the quality of life and can increase the risk of mortality. “But it is unknown if poor sleep quality may impact physical function in individuals with MS,” said Dr. Siengsukon.

In healthy individuals, cognitive aspects like attention, working and long-term memory, information processing, decision making, and problem solving can all be affected by poor sleep. “But which cognitive domains are associated with poor sleep quality in people with MS is unknown,” said Dr. Siengsukon.

In the first study, 40 people (36 females) with MS (mainly relapsing-remitting MS) were analyzed through a battery of established tests of sleep quality, cognitive function, physical function, depression, anxiety, and quality of life. The subjects had a disease duration of about 12 years. All were ambulatory without the need of assistance, and none had sleep apnea.

About 68% of the subjects were considered poor sleepers with the remainder being good sleepers. They were comparable in age, sex, type of MS, disease duration, and cognitive impairment.

Compared with good sleepers, poor sleepers were significantly impaired in visuospatial memory and questionnaire-assessed physical function, were more fatigued, were more prone to be anxious and depressed, and had a worse quality of life. Independent factors of poor sleep quality included state and trait anxiety (P = .003 and .02, respectively).

“Evidence demonstrates that sleep consolidates memory. Therefore, poor sleep may selectively impair memory while not impacting other cognitive domains,” said Dr. Siengsukon.

In the second study, the influence of supervised, moderate exercise and home exercise on sleep quality was assessed in 22 other MS patients. Most had relapsing-remitting MS. The inclusion and exclusion criteria were similar to those for the first study, with additional exclusion criteria concerning cardiovascular risk of exercise.

The supervised stretching and exercise program for 12 subjects was done at a social center and utilized recumbent exercise machines, with the home-based program for 10 subjects consisting of stretching and outdoor walking. Both exercise programs were done three times weekly for 12 weeks.

Both exercise programs were beneficial in improving sleep, with the moderate-intensity program being relatively more effective than home-based exercise in two measurement scales of sleep. The greater benefit of moderate exercise might reflect the mode of exercise, with subjects feeling safer and more relaxed using a recumbent exerciser, Dr. Siengsukon said. Offering the exercise in a social setting might have been another plus.

“The results suggest that moderate-intensity exercise may improve cardiovascular fitness in people with MS. While both groups experienced moderate to large effects on sleep quality, the mechanism for improvement in sleep quality remains to be determined, as the improvement was not related to change in cardiorespiratory fitness,” said Dr. Siengsukon.

A link between treadmill exercise and transient cognitive improvement has been reported.

The studies were supported by the National Institutes of Health and the National Multiple Sclerosis Society. Dr. Siengsukon disclosed grant support from the National Multiple Sclerosis Society.

VANCOUVER – Dimethyl fumarate and fingolimod appear to have an edge over other disease-modifying therapies for multiple sclerosis (MS) in real-world practice, according to a comparative effectiveness study reported at the annual meeting of the American Academy of Neurology.

Dr. Jacqueline A. Nicholas, a neuroimmunologist and MS specialist with the OhioHealth Multiple Sclerosis Center, Riverside Methodist Hospital, Columbus, and her colleagues analyzed claims data from 5,004 commercially insured adults with MS in the United States who started treatment with any of five oral and injectable disease-modifying therapies.

Susan London/Frontline Medical News

Findings reported at the meeting showed that dimethyl fumarate netted the greatest reduction in annualized relapse rate, at one-third, followed by fingolimod, at about one-fourth. The adjusted risk of relapse in the year after drug initiation was significantly higher for interferon-beta, glatiramer acetate, and teriflunomide, compared with dimethyl fumarate.

“Right now, a lot of the data that we have to use in the clinic is based on clinical trials data. That’s often not what we see in the real world, the MS centers, and even the outpatient neurology setting,” Dr. Nicholas said in an interview. “This study is nice just because it points out that when you look at real-world data, it shows, yes, that these drugs work, and that some of the initial benefit for the oral disease-modifying therapies is what we thought. Obviously, we don’t have cross-trial comparisons to make from the clinical trials, so this is real data that we can actually use in our clinic setting.”

The findings are also helpful given changing health care models and ongoing issues with reimbursement and obtaining insurance approval to use various drugs, she added. “These are things that we can show to those payers as to why it’s important that we have these therapies and that we be able to decide as MS specialists what’s going to be best for the patient.

“Right now, the biggest challenge in the MS world is that obviously, as an MS specialist, you have a lot of experience and knowledge. And based on poor prognostic factors, when somebody comes in, you may not want to go with an escalation model [of treatment], where you are starting with something that a payer may think we should start with, an injectable,” Dr. Nicholas added. “Somebody may have more aggressive disease, and maybe you are going to want to start with an oral or an IV drug. But the payers are the ones right now who have the say. So it’s a lot of time and a lot of work [getting insurance approval], and while you are fighting to get what you know your patient needs, your patient’s suffering, accumulating disability, and possibly having more relapses.”

For the study, the investigators analyzed administrative data from the Truven MarketScan Commercial Claims Databases for 2012 through 2014.

Analyses were based on 2,564 patients treated with dimethyl fumarate (brand name Tecfidera), 735 with interferon-beta (Rebif, Avonex, Betaseron, and Extavia), 827 with glatiramer acetate (Copaxone), 417 with teriflunomide (Aubagio), and 461 with fingolimod (Gilenya).

Comparing the year before and the year after drug initiation, only dimethyl fumarate and fingolimod were associated with significant reductions in the annualized relapse rate, according to findings reported in a poster session. The reductions were 33% and 27%, respectively.

In the postinitiation year and with dimethyl fumarate as the comparator, the adjusted incidence rate ratio for relapse was similar for fingolimod but significantly higher for glatiramer acetate (1.28), interferon-beta (1.25), and teriflunomide (1.28).

“I don’t think that these findings are surprising,” Dr. Nicholas said. “I work in a large MS center and I would say this is generally what I see clinically in terms of the effectiveness. So it’s more reassuring to me than anything.”

She acknowledged that safety and tolerability will also come into play when selecting among disease-modifying therapies. “Those data are incredibly important, and we certainly balance that. With a health care claims database, that’s hard data to pull unless you are looking at one specific [adverse effect], but that’s something that needs to be very carefully weighed with the efficacy data for the patient,” she said.

In a companion study also reported in the poster session, the investigators compared the impact of starting the same five drugs on health care costs and utilization.

Results of that study showed that total health care costs rose in the postinitiation year for all five drugs, with the increase ranging from $38,801 for dimethyl fumarate to $52,352 for fingolimod.

However, total nonprescription medical costs decreased across the board, apparently driven by both less use of outpatient services and fewer inpatient hospital stays, with the greatest reduction seen for dimethyl fumarate.

Dr. Nicholas disclosed that she has received research funding from Genzyme, Novartis, Teva, Biogen, and Alexion, and has received consulting and speaking honoraria from Genzyme, Novartis, Teva, Biogen, and Medtronic. The study was supported by Biogen.

VANCOUVER – Dimethyl fumarate and fingolimod appear to have an edge over other disease-modifying therapies for multiple sclerosis (MS) in real-world practice, according to a comparative effectiveness study reported at the annual meeting of the American Academy of Neurology.

Dr. Jacqueline A. Nicholas, a neuroimmunologist and MS specialist with the OhioHealth Multiple Sclerosis Center, Riverside Methodist Hospital, Columbus, and her colleagues analyzed claims data from 5,004 commercially insured adults with MS in the United States who started treatment with any of five oral and injectable disease-modifying therapies.

Susan London/Frontline Medical News

Findings reported at the meeting showed that dimethyl fumarate netted the greatest reduction in annualized relapse rate, at one-third, followed by fingolimod, at about one-fourth. The adjusted risk of relapse in the year after drug initiation was significantly higher for interferon-beta, glatiramer acetate, and teriflunomide, compared with dimethyl fumarate.

“Right now, a lot of the data that we have to use in the clinic is based on clinical trials data. That’s often not what we see in the real world, the MS centers, and even the outpatient neurology setting,” Dr. Nicholas said in an interview. “This study is nice just because it points out that when you look at real-world data, it shows, yes, that these drugs work, and that some of the initial benefit for the oral disease-modifying therapies is what we thought. Obviously, we don’t have cross-trial comparisons to make from the clinical trials, so this is real data that we can actually use in our clinic setting.”

The findings are also helpful given changing health care models and ongoing issues with reimbursement and obtaining insurance approval to use various drugs, she added. “These are things that we can show to those payers as to why it’s important that we have these therapies and that we be able to decide as MS specialists what’s going to be best for the patient.

“Right now, the biggest challenge in the MS world is that obviously, as an MS specialist, you have a lot of experience and knowledge. And based on poor prognostic factors, when somebody comes in, you may not want to go with an escalation model [of treatment], where you are starting with something that a payer may think we should start with, an injectable,” Dr. Nicholas added. “Somebody may have more aggressive disease, and maybe you are going to want to start with an oral or an IV drug. But the payers are the ones right now who have the say. So it’s a lot of time and a lot of work [getting insurance approval], and while you are fighting to get what you know your patient needs, your patient’s suffering, accumulating disability, and possibly having more relapses.”

For the study, the investigators analyzed administrative data from the Truven MarketScan Commercial Claims Databases for 2012 through 2014.

Analyses were based on 2,564 patients treated with dimethyl fumarate (brand name Tecfidera), 735 with interferon-beta (Rebif, Avonex, Betaseron, and Extavia), 827 with glatiramer acetate (Copaxone), 417 with teriflunomide (Aubagio), and 461 with fingolimod (Gilenya).

Comparing the year before and the year after drug initiation, only dimethyl fumarate and fingolimod were associated with significant reductions in the annualized relapse rate, according to findings reported in a poster session. The reductions were 33% and 27%, respectively.

In the postinitiation year and with dimethyl fumarate as the comparator, the adjusted incidence rate ratio for relapse was similar for fingolimod but significantly higher for glatiramer acetate (1.28), interferon-beta (1.25), and teriflunomide (1.28).

“I don’t think that these findings are surprising,” Dr. Nicholas said. “I work in a large MS center and I would say this is generally what I see clinically in terms of the effectiveness. So it’s more reassuring to me than anything.”

She acknowledged that safety and tolerability will also come into play when selecting among disease-modifying therapies. “Those data are incredibly important, and we certainly balance that. With a health care claims database, that’s hard data to pull unless you are looking at one specific [adverse effect], but that’s something that needs to be very carefully weighed with the efficacy data for the patient,” she said.

In a companion study also reported in the poster session, the investigators compared the impact of starting the same five drugs on health care costs and utilization.

Results of that study showed that total health care costs rose in the postinitiation year for all five drugs, with the increase ranging from $38,801 for dimethyl fumarate to $52,352 for fingolimod.

However, total nonprescription medical costs decreased across the board, apparently driven by both less use of outpatient services and fewer inpatient hospital stays, with the greatest reduction seen for dimethyl fumarate.

Dr. Nicholas disclosed that she has received research funding from Genzyme, Novartis, Teva, Biogen, and Alexion, and has received consulting and speaking honoraria from Genzyme, Novartis, Teva, Biogen, and Medtronic. The study was supported by Biogen.

VANCOUVER – Dimethyl fumarate and fingolimod appear to have an edge over other disease-modifying therapies for multiple sclerosis (MS) in real-world practice, according to a comparative effectiveness study reported at the annual meeting of the American Academy of Neurology.

Dr. Jacqueline A. Nicholas, a neuroimmunologist and MS specialist with the OhioHealth Multiple Sclerosis Center, Riverside Methodist Hospital, Columbus, and her colleagues analyzed claims data from 5,004 commercially insured adults with MS in the United States who started treatment with any of five oral and injectable disease-modifying therapies.

Susan London/Frontline Medical News

Findings reported at the meeting showed that dimethyl fumarate netted the greatest reduction in annualized relapse rate, at one-third, followed by fingolimod, at about one-fourth. The adjusted risk of relapse in the year after drug initiation was significantly higher for interferon-beta, glatiramer acetate, and teriflunomide, compared with dimethyl fumarate.

“Right now, a lot of the data that we have to use in the clinic is based on clinical trials data. That’s often not what we see in the real world, the MS centers, and even the outpatient neurology setting,” Dr. Nicholas said in an interview. “This study is nice just because it points out that when you look at real-world data, it shows, yes, that these drugs work, and that some of the initial benefit for the oral disease-modifying therapies is what we thought. Obviously, we don’t have cross-trial comparisons to make from the clinical trials, so this is real data that we can actually use in our clinic setting.”

The findings are also helpful given changing health care models and ongoing issues with reimbursement and obtaining insurance approval to use various drugs, she added. “These are things that we can show to those payers as to why it’s important that we have these therapies and that we be able to decide as MS specialists what’s going to be best for the patient.

“Right now, the biggest challenge in the MS world is that obviously, as an MS specialist, you have a lot of experience and knowledge. And based on poor prognostic factors, when somebody comes in, you may not want to go with an escalation model [of treatment], where you are starting with something that a payer may think we should start with, an injectable,” Dr. Nicholas added. “Somebody may have more aggressive disease, and maybe you are going to want to start with an oral or an IV drug. But the payers are the ones right now who have the say. So it’s a lot of time and a lot of work [getting insurance approval], and while you are fighting to get what you know your patient needs, your patient’s suffering, accumulating disability, and possibly having more relapses.”

For the study, the investigators analyzed administrative data from the Truven MarketScan Commercial Claims Databases for 2012 through 2014.

Analyses were based on 2,564 patients treated with dimethyl fumarate (brand name Tecfidera), 735 with interferon-beta (Rebif, Avonex, Betaseron, and Extavia), 827 with glatiramer acetate (Copaxone), 417 with teriflunomide (Aubagio), and 461 with fingolimod (Gilenya).

Comparing the year before and the year after drug initiation, only dimethyl fumarate and fingolimod were associated with significant reductions in the annualized relapse rate, according to findings reported in a poster session. The reductions were 33% and 27%, respectively.

In the postinitiation year and with dimethyl fumarate as the comparator, the adjusted incidence rate ratio for relapse was similar for fingolimod but significantly higher for glatiramer acetate (1.28), interferon-beta (1.25), and teriflunomide (1.28).

“I don’t think that these findings are surprising,” Dr. Nicholas said. “I work in a large MS center and I would say this is generally what I see clinically in terms of the effectiveness. So it’s more reassuring to me than anything.”

She acknowledged that safety and tolerability will also come into play when selecting among disease-modifying therapies. “Those data are incredibly important, and we certainly balance that. With a health care claims database, that’s hard data to pull unless you are looking at one specific [adverse effect], but that’s something that needs to be very carefully weighed with the efficacy data for the patient,” she said.

In a companion study also reported in the poster session, the investigators compared the impact of starting the same five drugs on health care costs and utilization.

Results of that study showed that total health care costs rose in the postinitiation year for all five drugs, with the increase ranging from $38,801 for dimethyl fumarate to $52,352 for fingolimod.

However, total nonprescription medical costs decreased across the board, apparently driven by both less use of outpatient services and fewer inpatient hospital stays, with the greatest reduction seen for dimethyl fumarate.

Dr. Nicholas disclosed that she has received research funding from Genzyme, Novartis, Teva, Biogen, and Alexion, and has received consulting and speaking honoraria from Genzyme, Novartis, Teva, Biogen, and Medtronic. The study was supported by Biogen.

NATIONAL HARBOR, MD. – The approved once-daily oral immunomodulator teriflunomide is effective in reducing relapse, and worsening of relapsing forms, of multiple sclerosis (RMS) in patients with faster-advancing disease.

The findings from a post hoc pooled subgroup analysis of patients in the TEMSO and TOWER randomized, double-blind, placebo-controlled phase III trials presented as a poster at the annual meeting of the Consortium of Multiple Sclerosis Centers expand the efficacy of teriflunomide to a broad spectrum of patients with RMS.

The pooled analysis examined the outcomes of treatment with two doses of teriflunomide in all patients (n = 2,257) and in a subgroup of patients with faster-advancing MS (n = 1,184) according to disease severity using a baseline Multiple Sclerosis Severity Score (MSSS) of 5 as a cutoff. The group with faster-advancing disease included 405 who received placebo, 396 treated with teriflunomide 7 mg, and 383 treated with teriflunomide 14 mg.

The 1,184 patients with faster-advancing MS were comparable to the other 1,073 patients in terms of age, sex, MS subtype, and number of relapses in the prior year. Baseline characteristics of the faster-advancing MS patients treated with placebo and both teriflunomide doses were comparable.

Relative to the placebo group, the annualized relapse rate in patients with faster-advancing MS was significantly reduced by both doses of teriflunomide, with a relative risk reduction of 30.3% for the 7-mg dose (P = .0002) and 37.5% for the 14-mg dose (P less than .0001). Time to first relapse was also reduced by teriflunomide 14 mg and 7 mg, with reductions in relapse risk of 43.2% (P less than .0001) and 28.8% (P = .0014), respectively, compared with placebo.

The higher dose of teriflunomide was effective in reducing the worsening of disability at greater than or equal to 12 weeks and 24 weeks, with reductions, compared with placebo, of 40.3% (P = .0076) and 46.1% (P = .0110), respectively.

The results were consistent with data reported in the individual TEMSO and TOWER trials, and prior analyses of the pooled data.

“These results indicate that teriflunomide is not only effective for MS patients with relatively mild disease, but also with rather more aggressive disease. Teriflunomide, a well-tolerated and convenient once-daily tablet, is a very reasonable option for this population,” said the presenter, Dr. Aaron E. Miller of the Icahn School of Medicine at Mount Sinai, New York.

Teriflunomide is approved for relapsing-remitting MS in many countries, including the United States and the European Union. The TEMSO and TOWER trials were pivotal in securing approval. The trials had a similar design, except for the absence of magnetic resonance imaging evaluation in TOWER.

The study was funded by Sanofi Genzyme. Dr. Miller disclosed consulting fees from Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, Mallinckrodt Paharmaceuticals/Questor, Novartis, Roche, and Teva, and grant/research support from Biogen, Genentech, Novartis, Questor, Roche, and Sanofi.

NATIONAL HARBOR, MD. – The approved once-daily oral immunomodulator teriflunomide is effective in reducing relapse, and worsening of relapsing forms, of multiple sclerosis (RMS) in patients with faster-advancing disease.

The findings from a post hoc pooled subgroup analysis of patients in the TEMSO and TOWER randomized, double-blind, placebo-controlled phase III trials presented as a poster at the annual meeting of the Consortium of Multiple Sclerosis Centers expand the efficacy of teriflunomide to a broad spectrum of patients with RMS.

The pooled analysis examined the outcomes of treatment with two doses of teriflunomide in all patients (n = 2,257) and in a subgroup of patients with faster-advancing MS (n = 1,184) according to disease severity using a baseline Multiple Sclerosis Severity Score (MSSS) of 5 as a cutoff. The group with faster-advancing disease included 405 who received placebo, 396 treated with teriflunomide 7 mg, and 383 treated with teriflunomide 14 mg.

The 1,184 patients with faster-advancing MS were comparable to the other 1,073 patients in terms of age, sex, MS subtype, and number of relapses in the prior year. Baseline characteristics of the faster-advancing MS patients treated with placebo and both teriflunomide doses were comparable.

Relative to the placebo group, the annualized relapse rate in patients with faster-advancing MS was significantly reduced by both doses of teriflunomide, with a relative risk reduction of 30.3% for the 7-mg dose (P = .0002) and 37.5% for the 14-mg dose (P less than .0001). Time to first relapse was also reduced by teriflunomide 14 mg and 7 mg, with reductions in relapse risk of 43.2% (P less than .0001) and 28.8% (P = .0014), respectively, compared with placebo.

The higher dose of teriflunomide was effective in reducing the worsening of disability at greater than or equal to 12 weeks and 24 weeks, with reductions, compared with placebo, of 40.3% (P = .0076) and 46.1% (P = .0110), respectively.

The results were consistent with data reported in the individual TEMSO and TOWER trials, and prior analyses of the pooled data.

“These results indicate that teriflunomide is not only effective for MS patients with relatively mild disease, but also with rather more aggressive disease. Teriflunomide, a well-tolerated and convenient once-daily tablet, is a very reasonable option for this population,” said the presenter, Dr. Aaron E. Miller of the Icahn School of Medicine at Mount Sinai, New York.

Teriflunomide is approved for relapsing-remitting MS in many countries, including the United States and the European Union. The TEMSO and TOWER trials were pivotal in securing approval. The trials had a similar design, except for the absence of magnetic resonance imaging evaluation in TOWER.

The study was funded by Sanofi Genzyme. Dr. Miller disclosed consulting fees from Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, Mallinckrodt Paharmaceuticals/Questor, Novartis, Roche, and Teva, and grant/research support from Biogen, Genentech, Novartis, Questor, Roche, and Sanofi.

NATIONAL HARBOR, MD. – The approved once-daily oral immunomodulator teriflunomide is effective in reducing relapse, and worsening of relapsing forms, of multiple sclerosis (RMS) in patients with faster-advancing disease.

The findings from a post hoc pooled subgroup analysis of patients in the TEMSO and TOWER randomized, double-blind, placebo-controlled phase III trials presented as a poster at the annual meeting of the Consortium of Multiple Sclerosis Centers expand the efficacy of teriflunomide to a broad spectrum of patients with RMS.

The pooled analysis examined the outcomes of treatment with two doses of teriflunomide in all patients (n = 2,257) and in a subgroup of patients with faster-advancing MS (n = 1,184) according to disease severity using a baseline Multiple Sclerosis Severity Score (MSSS) of 5 as a cutoff. The group with faster-advancing disease included 405 who received placebo, 396 treated with teriflunomide 7 mg, and 383 treated with teriflunomide 14 mg.

The 1,184 patients with faster-advancing MS were comparable to the other 1,073 patients in terms of age, sex, MS subtype, and number of relapses in the prior year. Baseline characteristics of the faster-advancing MS patients treated with placebo and both teriflunomide doses were comparable.

Relative to the placebo group, the annualized relapse rate in patients with faster-advancing MS was significantly reduced by both doses of teriflunomide, with a relative risk reduction of 30.3% for the 7-mg dose (P = .0002) and 37.5% for the 14-mg dose (P less than .0001). Time to first relapse was also reduced by teriflunomide 14 mg and 7 mg, with reductions in relapse risk of 43.2% (P less than .0001) and 28.8% (P = .0014), respectively, compared with placebo.

The higher dose of teriflunomide was effective in reducing the worsening of disability at greater than or equal to 12 weeks and 24 weeks, with reductions, compared with placebo, of 40.3% (P = .0076) and 46.1% (P = .0110), respectively.

The results were consistent with data reported in the individual TEMSO and TOWER trials, and prior analyses of the pooled data.

“These results indicate that teriflunomide is not only effective for MS patients with relatively mild disease, but also with rather more aggressive disease. Teriflunomide, a well-tolerated and convenient once-daily tablet, is a very reasonable option for this population,” said the presenter, Dr. Aaron E. Miller of the Icahn School of Medicine at Mount Sinai, New York.

Teriflunomide is approved for relapsing-remitting MS in many countries, including the United States and the European Union. The TEMSO and TOWER trials were pivotal in securing approval. The trials had a similar design, except for the absence of magnetic resonance imaging evaluation in TOWER.

The study was funded by Sanofi Genzyme. Dr. Miller disclosed consulting fees from Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, Mallinckrodt Paharmaceuticals/Questor, Novartis, Roche, and Teva, and grant/research support from Biogen, Genentech, Novartis, Questor, Roche, and Sanofi.

NATIONAL HARBOR, MD. – Follow-up of a cohort of patients in the United Kingdom has demonstrated associations between smoking and a higher risk of development of multiple sclerosis (MS), progression of MS-related disability, higher risk of premature death, and shortened life expectancy.

The findings highlight the need for clinical trials of the effects of quitting smoking and provide data that will be useful in the development of effective intervention strategies.

Dr. Cris S. Constantinescu of the University of Nottingham (England) discussed findings from the Nottingham University Hospitals MS Clinics database at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Although smokers had higher levels of comorbid conditions, it appeared that the influence of smoking is independent of the presence of comorbid conditions. Those who gave up smoking could do as well as nonsmokers,” said Dr. Constantinescu.

While ample epidemiologic evidence indicates that smoking is a driver of the development and progression of MS, there are few hard data. To gain insight, the researchers analyzed data on over 1,200 MS patients throughout England who were followed up beginning in the mid-1990s. About 60% of the patients had relapsing-remitting MS. The duration of MS and smoking were both about 20 years. About 60% of men and 50% of women were current smokers.

Regular smokers were 64% more likely to develop MS than were nonsmokers. Having ever smoked carried a 44% increased risk of MS (both P less than .001). MS patients who grew up in a household where one parent smoked were 50% more likely to become regular smokers. The risk climbed to 85% if both parents were smokers.

No association was evident between smoking and the development of primary progressive MS, but current smokers were almost 2.5 times more likely to develop secondary progressive MS. Smoking correlated with more severe MS disability, compared with nonsmokers. Ex-smokers had risks similar to those of nonsmokers of developing secondary MS and in the level of disease severity.

Every year a person refrained from smoking decreased the risk of severe disability by 5%. Current and ex-smokers displayed increased psychological and physical detriments of MS.

In a subgroup of 923 patients, of whom 80 died, current smokers were almost 3 times and 1.5 times more likely to die, compared with never smokers and ex-smokers, respectively, and were twice as likely to die as were people without MS in the UK general population.

The findings have prompted studies into major aspects of smoking, such as the age when smoking begins, the success of various smoking cessation programs, and development of interventions. Some of the data discussed at the meeting were published in 2013 (Brain;136:2298-2304) and some are part of a manuscript in preparation.

NATIONAL HARBOR, MD. – Follow-up of a cohort of patients in the United Kingdom has demonstrated associations between smoking and a higher risk of development of multiple sclerosis (MS), progression of MS-related disability, higher risk of premature death, and shortened life expectancy.

The findings highlight the need for clinical trials of the effects of quitting smoking and provide data that will be useful in the development of effective intervention strategies.

Dr. Cris S. Constantinescu of the University of Nottingham (England) discussed findings from the Nottingham University Hospitals MS Clinics database at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Although smokers had higher levels of comorbid conditions, it appeared that the influence of smoking is independent of the presence of comorbid conditions. Those who gave up smoking could do as well as nonsmokers,” said Dr. Constantinescu.

While ample epidemiologic evidence indicates that smoking is a driver of the development and progression of MS, there are few hard data. To gain insight, the researchers analyzed data on over 1,200 MS patients throughout England who were followed up beginning in the mid-1990s. About 60% of the patients had relapsing-remitting MS. The duration of MS and smoking were both about 20 years. About 60% of men and 50% of women were current smokers.

Regular smokers were 64% more likely to develop MS than were nonsmokers. Having ever smoked carried a 44% increased risk of MS (both P less than .001). MS patients who grew up in a household where one parent smoked were 50% more likely to become regular smokers. The risk climbed to 85% if both parents were smokers.

No association was evident between smoking and the development of primary progressive MS, but current smokers were almost 2.5 times more likely to develop secondary progressive MS. Smoking correlated with more severe MS disability, compared with nonsmokers. Ex-smokers had risks similar to those of nonsmokers of developing secondary MS and in the level of disease severity.

Every year a person refrained from smoking decreased the risk of severe disability by 5%. Current and ex-smokers displayed increased psychological and physical detriments of MS.

In a subgroup of 923 patients, of whom 80 died, current smokers were almost 3 times and 1.5 times more likely to die, compared with never smokers and ex-smokers, respectively, and were twice as likely to die as were people without MS in the UK general population.

The findings have prompted studies into major aspects of smoking, such as the age when smoking begins, the success of various smoking cessation programs, and development of interventions. Some of the data discussed at the meeting were published in 2013 (Brain;136:2298-2304) and some are part of a manuscript in preparation.

NATIONAL HARBOR, MD. – Follow-up of a cohort of patients in the United Kingdom has demonstrated associations between smoking and a higher risk of development of multiple sclerosis (MS), progression of MS-related disability, higher risk of premature death, and shortened life expectancy.

The findings highlight the need for clinical trials of the effects of quitting smoking and provide data that will be useful in the development of effective intervention strategies.

Dr. Cris S. Constantinescu of the University of Nottingham (England) discussed findings from the Nottingham University Hospitals MS Clinics database at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Although smokers had higher levels of comorbid conditions, it appeared that the influence of smoking is independent of the presence of comorbid conditions. Those who gave up smoking could do as well as nonsmokers,” said Dr. Constantinescu.

While ample epidemiologic evidence indicates that smoking is a driver of the development and progression of MS, there are few hard data. To gain insight, the researchers analyzed data on over 1,200 MS patients throughout England who were followed up beginning in the mid-1990s. About 60% of the patients had relapsing-remitting MS. The duration of MS and smoking were both about 20 years. About 60% of men and 50% of women were current smokers.

Regular smokers were 64% more likely to develop MS than were nonsmokers. Having ever smoked carried a 44% increased risk of MS (both P less than .001). MS patients who grew up in a household where one parent smoked were 50% more likely to become regular smokers. The risk climbed to 85% if both parents were smokers.

No association was evident between smoking and the development of primary progressive MS, but current smokers were almost 2.5 times more likely to develop secondary progressive MS. Smoking correlated with more severe MS disability, compared with nonsmokers. Ex-smokers had risks similar to those of nonsmokers of developing secondary MS and in the level of disease severity.

Every year a person refrained from smoking decreased the risk of severe disability by 5%. Current and ex-smokers displayed increased psychological and physical detriments of MS.

In a subgroup of 923 patients, of whom 80 died, current smokers were almost 3 times and 1.5 times more likely to die, compared with never smokers and ex-smokers, respectively, and were twice as likely to die as were people without MS in the UK general population.

The findings have prompted studies into major aspects of smoking, such as the age when smoking begins, the success of various smoking cessation programs, and development of interventions. Some of the data discussed at the meeting were published in 2013 (Brain;136:2298-2304) and some are part of a manuscript in preparation.

NATIONAL HARBOR, MD—The Multiple Sclerosis @Point of Care clinician app, powered by IBM Watson, and the Multiple Sclerosis Association of America (MSAA) patient app My MS Manager facilitate the interface of clinicians and patients with multiple sclerosis (MS) and can lead to changes in MS management and improved patient outcomes, according to a presentation at the 2016 CMSC Annual Meeting. “A growing number of patients are using the My MS Manager app to enter their data, track their MS management, and share this data with their clinicians,” said lead author Elaine Rudell, PhD, CHCP, from @Point of Care in Livingston, New Jersey, and colleagues.

Multiple Sclerosis @Point of Care, powered by IBM Watson, and the patient app, the Multiple Sclerosis Association of America’s My MS Manager, use a HIPAA-compliant mobile platform to provide practice-based tools designed to enable shared decision-making. “These tools provide clinicians with access to evidence-based answers at the point of care while incorporating patient-reported outcomes,” said Dr. Rudell. The clinician platform contains up-to-date information about the etiology, epidemiology, pathophysiology, diagnosis, treatment, and management of MS. A cognitive learning tool answers specific questions clinicians pose to improve patient outcomes. The patient app provides patients with the ability to collect and track data (eg, activities of daily living, fatigue scale records, and medications) as well as utilize their personalized data for follow-up discussion with their health care provider.

In the present study, Dr. Rudell and colleagues sought to assess how clinicians utilize and value Multiple Sclerosis @Point of Care and the companion patient app. Data were collected and analyzed from clinicians caring for patients with MS and their participating patients. Data included demographic information, clinicians’ questions posed to the Ask Watson cognitive learning tool, clinicians’ self-reported impact of content on their patients’ health outcomes, number of registered patient app users, average active users/month, patient access frequency, patient record entries, and proprietary patient survey findings that further assess how patients use and value the app.

Currently, 10,627 clinicians use the platform. These providers spend an average of eight minutes per visit on the Multiple Sclerosis @Point of Care platform. Of these users, 77% are repeat users. Nearly 80% of learners posing questions on demand were neurologists, internists, general practitioners, or family practitioners treating patients with MS.

The patient app had 6,880 registered users at the time of the study, with an average of 1,022 active users per month. Active use of the app by patients with MS in this study resulted in 28,794 journal records for activities of daily living, 1,897 fatigue scale journal records, and 3,640 adherence journal records.

Patients accessed the patient app daily (31%), weekly (46%), and monthly (23%). Nearly 80% of patients reported that the app helps them better track how they are doing. Nearly 80% also agreed that regular use of the patient app improved their ability to discuss and manage their MS. Almost 90% of patient users agreed that the app motivated them to talk with clinicians about MS management. Nearly 75% of patient users shared their records with their clinicians. More than 70% of patients agreed that sharing records with their clinician has improved their MS management and sense of well-being.

Regarding the fatigue scale results, patients also agreed that clinicians are more aware of fatigue’s impact on their daily lives (80% of patient respondents), improved fatigue management (75%), and improved management of fatigue-related cognitive function (65%).

After reviewing patient records, clinicians changed medications (14%), changed other aspects of treatment plans (10%), suggested lifestyle changes (6%), requested more tests (1%), or concurred that treatment was on track (no changes, 69%).

This study was funded by @Point of Care.

—Glenn S. Williams

NATIONAL HARBOR, MD—The Multiple Sclerosis @Point of Care clinician app, powered by IBM Watson, and the Multiple Sclerosis Association of America (MSAA) patient app My MS Manager facilitate the interface of clinicians and patients with multiple sclerosis (MS) and can lead to changes in MS management and improved patient outcomes, according to a presentation at the 2016 CMSC Annual Meeting. “A growing number of patients are using the My MS Manager app to enter their data, track their MS management, and share this data with their clinicians,” said lead author Elaine Rudell, PhD, CHCP, from @Point of Care in Livingston, New Jersey, and colleagues.

Multiple Sclerosis @Point of Care, powered by IBM Watson, and the patient app, the Multiple Sclerosis Association of America’s My MS Manager, use a HIPAA-compliant mobile platform to provide practice-based tools designed to enable shared decision-making. “These tools provide clinicians with access to evidence-based answers at the point of care while incorporating patient-reported outcomes,” said Dr. Rudell. The clinician platform contains up-to-date information about the etiology, epidemiology, pathophysiology, diagnosis, treatment, and management of MS. A cognitive learning tool answers specific questions clinicians pose to improve patient outcomes. The patient app provides patients with the ability to collect and track data (eg, activities of daily living, fatigue scale records, and medications) as well as utilize their personalized data for follow-up discussion with their health care provider.

In the present study, Dr. Rudell and colleagues sought to assess how clinicians utilize and value Multiple Sclerosis @Point of Care and the companion patient app. Data were collected and analyzed from clinicians caring for patients with MS and their participating patients. Data included demographic information, clinicians’ questions posed to the Ask Watson cognitive learning tool, clinicians’ self-reported impact of content on their patients’ health outcomes, number of registered patient app users, average active users/month, patient access frequency, patient record entries, and proprietary patient survey findings that further assess how patients use and value the app.

Currently, 10,627 clinicians use the platform. These providers spend an average of eight minutes per visit on the Multiple Sclerosis @Point of Care platform. Of these users, 77% are repeat users. Nearly 80% of learners posing questions on demand were neurologists, internists, general practitioners, or family practitioners treating patients with MS.

The patient app had 6,880 registered users at the time of the study, with an average of 1,022 active users per month. Active use of the app by patients with MS in this study resulted in 28,794 journal records for activities of daily living, 1,897 fatigue scale journal records, and 3,640 adherence journal records.

Patients accessed the patient app daily (31%), weekly (46%), and monthly (23%). Nearly 80% of patients reported that the app helps them better track how they are doing. Nearly 80% also agreed that regular use of the patient app improved their ability to discuss and manage their MS. Almost 90% of patient users agreed that the app motivated them to talk with clinicians about MS management. Nearly 75% of patient users shared their records with their clinicians. More than 70% of patients agreed that sharing records with their clinician has improved their MS management and sense of well-being.

Regarding the fatigue scale results, patients also agreed that clinicians are more aware of fatigue’s impact on their daily lives (80% of patient respondents), improved fatigue management (75%), and improved management of fatigue-related cognitive function (65%).

After reviewing patient records, clinicians changed medications (14%), changed other aspects of treatment plans (10%), suggested lifestyle changes (6%), requested more tests (1%), or concurred that treatment was on track (no changes, 69%).

This study was funded by @Point of Care.

—Glenn S. Williams

NATIONAL HARBOR, MD—The Multiple Sclerosis @Point of Care clinician app, powered by IBM Watson, and the Multiple Sclerosis Association of America (MSAA) patient app My MS Manager facilitate the interface of clinicians and patients with multiple sclerosis (MS) and can lead to changes in MS management and improved patient outcomes, according to a presentation at the 2016 CMSC Annual Meeting. “A growing number of patients are using the My MS Manager app to enter their data, track their MS management, and share this data with their clinicians,” said lead author Elaine Rudell, PhD, CHCP, from @Point of Care in Livingston, New Jersey, and colleagues.

Multiple Sclerosis @Point of Care, powered by IBM Watson, and the patient app, the Multiple Sclerosis Association of America’s My MS Manager, use a HIPAA-compliant mobile platform to provide practice-based tools designed to enable shared decision-making. “These tools provide clinicians with access to evidence-based answers at the point of care while incorporating patient-reported outcomes,” said Dr. Rudell. The clinician platform contains up-to-date information about the etiology, epidemiology, pathophysiology, diagnosis, treatment, and management of MS. A cognitive learning tool answers specific questions clinicians pose to improve patient outcomes. The patient app provides patients with the ability to collect and track data (eg, activities of daily living, fatigue scale records, and medications) as well as utilize their personalized data for follow-up discussion with their health care provider.

In the present study, Dr. Rudell and colleagues sought to assess how clinicians utilize and value Multiple Sclerosis @Point of Care and the companion patient app. Data were collected and analyzed from clinicians caring for patients with MS and their participating patients. Data included demographic information, clinicians’ questions posed to the Ask Watson cognitive learning tool, clinicians’ self-reported impact of content on their patients’ health outcomes, number of registered patient app users, average active users/month, patient access frequency, patient record entries, and proprietary patient survey findings that further assess how patients use and value the app.

Currently, 10,627 clinicians use the platform. These providers spend an average of eight minutes per visit on the Multiple Sclerosis @Point of Care platform. Of these users, 77% are repeat users. Nearly 80% of learners posing questions on demand were neurologists, internists, general practitioners, or family practitioners treating patients with MS.

The patient app had 6,880 registered users at the time of the study, with an average of 1,022 active users per month. Active use of the app by patients with MS in this study resulted in 28,794 journal records for activities of daily living, 1,897 fatigue scale journal records, and 3,640 adherence journal records.

Patients accessed the patient app daily (31%), weekly (46%), and monthly (23%). Nearly 80% of patients reported that the app helps them better track how they are doing. Nearly 80% also agreed that regular use of the patient app improved their ability to discuss and manage their MS. Almost 90% of patient users agreed that the app motivated them to talk with clinicians about MS management. Nearly 75% of patient users shared their records with their clinicians. More than 70% of patients agreed that sharing records with their clinician has improved their MS management and sense of well-being.

Regarding the fatigue scale results, patients also agreed that clinicians are more aware of fatigue’s impact on their daily lives (80% of patient respondents), improved fatigue management (75%), and improved management of fatigue-related cognitive function (65%).

After reviewing patient records, clinicians changed medications (14%), changed other aspects of treatment plans (10%), suggested lifestyle changes (6%), requested more tests (1%), or concurred that treatment was on track (no changes, 69%).

This study was funded by @Point of Care.

—Glenn S. Williams

NATIONAL HARBOR, MD—Total health care costs increase following initiation of a disease-modifying therapy for multiple sclerosis (MS), but a subsequent overall decrease in health care resource utilization may partially offset the increased costs, according to data presented at the 2016 CMSC Annual Meeting. Upon initiation of disease-modifying therapy, total health care costs increase by $38,561 for patients receiving dimethyl fumarate and by $53,626 for patients receiving fingolimod.

There are limited real-world data on comparative health care resource utilization and costs associated with disease-modifying therapy use in routine clinical practice. Researchers decided to further investigate the effect of the initiation of disease-modifying therapy (ie, dimethyl fumarate, interferon β, glatiramer acetate, teriflunomide, or fingolimod) on health care resource utilization. Jacqueline Nicholas, MD, MPH, a neuroimmunologist at OhioHealth in Columbus, and her colleagues conducted this study.

Researchers used data collected between January 2012 and December 2014 from the Truven MarketScan Commercial Claims Databases, which included administrative claims and eligibility records of 80 million commercially insured people from the United States. Demographic information included age at index date, sex, type of health plan, and region of residence. The mean patient age was 43.2 for patients who initiated glatiramer acetate and 48.6 for patients who initiated teriflunomide. Between 76.9% and 84.1% of patients were female.

Jacqueline Nicholas, MD, MPH

Patients with MS who initiated a disease-modifying therapy in 2013 were analyzed. The index date was defined as the first claim for the disease-modifying therapy. Only patients with no disease-modifying therapy exposure in the year before the index date were included in this study. Researchers evaluated baseline clinical characteristics based on claims dated within one year before the index date and included chronic disease burden (measured using Charlson Comorbidity Index and MS-related symptoms).

Health care resource utilization was defined as the proportion of patients who were hospitalized or who had visited the emergency room during one year before and one year after the index date. Total health care costs were estimated for one year before and one year after the index date. Costs of prescriptions were not included, and costs were adjusted to the 2014 values based on the Consumer Price Index Medical Component.

There was a significant increase in health care costs in the post-index period for all disease-modifying therapies. Patients receiving dimethyl fumarate had a lower increase in their health care costs, compared with patients receiving interferon β, glatiramer acetate, or fingolimod. Following the initiation of disease-modifying therapy, medical costs decreased significantly among patients receiving dimethyl fumarate or interferon β.

Medical cost reductions (excluding prescription medicine costs) were highly dependent on a decreased use of outpatient services and hospital stays, which suggests that the increased costs of disease-modifying therapies are partially offset by reduced health resource utilization and costs.

One limitation of this study was that it focused on health resource utilization and costs only one year before and one year after initiation of disease-modifying therapy. Researchers recommend that future studies assess outcomes over a longer period of time. In addition, the claims data were not collected specifically for clinical research and did not provide the clinical information needed to assess disease severity.

This study was supported by Biogen.

—Erica Robinson

NATIONAL HARBOR, MD—Total health care costs increase following initiation of a disease-modifying therapy for multiple sclerosis (MS), but a subsequent overall decrease in health care resource utilization may partially offset the increased costs, according to data presented at the 2016 CMSC Annual Meeting. Upon initiation of disease-modifying therapy, total health care costs increase by $38,561 for patients receiving dimethyl fumarate and by $53,626 for patients receiving fingolimod.

There are limited real-world data on comparative health care resource utilization and costs associated with disease-modifying therapy use in routine clinical practice. Researchers decided to further investigate the effect of the initiation of disease-modifying therapy (ie, dimethyl fumarate, interferon β, glatiramer acetate, teriflunomide, or fingolimod) on health care resource utilization. Jacqueline Nicholas, MD, MPH, a neuroimmunologist at OhioHealth in Columbus, and her colleagues conducted this study.

Researchers used data collected between January 2012 and December 2014 from the Truven MarketScan Commercial Claims Databases, which included administrative claims and eligibility records of 80 million commercially insured people from the United States. Demographic information included age at index date, sex, type of health plan, and region of residence. The mean patient age was 43.2 for patients who initiated glatiramer acetate and 48.6 for patients who initiated teriflunomide. Between 76.9% and 84.1% of patients were female.

Jacqueline Nicholas, MD, MPH

Patients with MS who initiated a disease-modifying therapy in 2013 were analyzed. The index date was defined as the first claim for the disease-modifying therapy. Only patients with no disease-modifying therapy exposure in the year before the index date were included in this study. Researchers evaluated baseline clinical characteristics based on claims dated within one year before the index date and included chronic disease burden (measured using Charlson Comorbidity Index and MS-related symptoms).

Health care resource utilization was defined as the proportion of patients who were hospitalized or who had visited the emergency room during one year before and one year after the index date. Total health care costs were estimated for one year before and one year after the index date. Costs of prescriptions were not included, and costs were adjusted to the 2014 values based on the Consumer Price Index Medical Component.

There was a significant increase in health care costs in the post-index period for all disease-modifying therapies. Patients receiving dimethyl fumarate had a lower increase in their health care costs, compared with patients receiving interferon β, glatiramer acetate, or fingolimod. Following the initiation of disease-modifying therapy, medical costs decreased significantly among patients receiving dimethyl fumarate or interferon β.

Medical cost reductions (excluding prescription medicine costs) were highly dependent on a decreased use of outpatient services and hospital stays, which suggests that the increased costs of disease-modifying therapies are partially offset by reduced health resource utilization and costs.

One limitation of this study was that it focused on health resource utilization and costs only one year before and one year after initiation of disease-modifying therapy. Researchers recommend that future studies assess outcomes over a longer period of time. In addition, the claims data were not collected specifically for clinical research and did not provide the clinical information needed to assess disease severity.

This study was supported by Biogen.

—Erica Robinson

NATIONAL HARBOR, MD—Total health care costs increase following initiation of a disease-modifying therapy for multiple sclerosis (MS), but a subsequent overall decrease in health care resource utilization may partially offset the increased costs, according to data presented at the 2016 CMSC Annual Meeting. Upon initiation of disease-modifying therapy, total health care costs increase by $38,561 for patients receiving dimethyl fumarate and by $53,626 for patients receiving fingolimod.

There are limited real-world data on comparative health care resource utilization and costs associated with disease-modifying therapy use in routine clinical practice. Researchers decided to further investigate the effect of the initiation of disease-modifying therapy (ie, dimethyl fumarate, interferon β, glatiramer acetate, teriflunomide, or fingolimod) on health care resource utilization. Jacqueline Nicholas, MD, MPH, a neuroimmunologist at OhioHealth in Columbus, and her colleagues conducted this study.

Researchers used data collected between January 2012 and December 2014 from the Truven MarketScan Commercial Claims Databases, which included administrative claims and eligibility records of 80 million commercially insured people from the United States. Demographic information included age at index date, sex, type of health plan, and region of residence. The mean patient age was 43.2 for patients who initiated glatiramer acetate and 48.6 for patients who initiated teriflunomide. Between 76.9% and 84.1% of patients were female.

Jacqueline Nicholas, MD, MPH

Patients with MS who initiated a disease-modifying therapy in 2013 were analyzed. The index date was defined as the first claim for the disease-modifying therapy. Only patients with no disease-modifying therapy exposure in the year before the index date were included in this study. Researchers evaluated baseline clinical characteristics based on claims dated within one year before the index date and included chronic disease burden (measured using Charlson Comorbidity Index and MS-related symptoms).

Health care resource utilization was defined as the proportion of patients who were hospitalized or who had visited the emergency room during one year before and one year after the index date. Total health care costs were estimated for one year before and one year after the index date. Costs of prescriptions were not included, and costs were adjusted to the 2014 values based on the Consumer Price Index Medical Component.

There was a significant increase in health care costs in the post-index period for all disease-modifying therapies. Patients receiving dimethyl fumarate had a lower increase in their health care costs, compared with patients receiving interferon β, glatiramer acetate, or fingolimod. Following the initiation of disease-modifying therapy, medical costs decreased significantly among patients receiving dimethyl fumarate or interferon β.

Medical cost reductions (excluding prescription medicine costs) were highly dependent on a decreased use of outpatient services and hospital stays, which suggests that the increased costs of disease-modifying therapies are partially offset by reduced health resource utilization and costs.

One limitation of this study was that it focused on health resource utilization and costs only one year before and one year after initiation of disease-modifying therapy. Researchers recommend that future studies assess outcomes over a longer period of time. In addition, the claims data were not collected specifically for clinical research and did not provide the clinical information needed to assess disease severity.

This study was supported by Biogen.

—Erica Robinson

NATIONAL HARBOR, MD—After eight years of fingolimod treatment, disability improves or remains stable for a majority of patients with relapsing-remitting multiple sclerosis (MS), according to data presented at the 2016 CMSC Annual Meeting.

The two-year phase III FREEDOMS and FREEDOMS II trial data revealed that fingolimod reduced confirmed disability progression in patients with MS, but evaluating disability over a longer time span may help to determine the full impact of treatment. Shannon Ritter, MD, an employee of Novartis Pharmaceuticals, and her colleagues examined trends in changes in Expanded Disability Status Scale (EDSS) scores over a maximum of eight years. Their objective was to investigate patients’ evolving disability patterns and the impact of fingolimod treatment on long-term disability.

The investigators conducted post hoc analyses that included data collected for as long as 96 months from baseline from patients randomized to fingolimod 0.5 mg or placebo in both two- year FREEDOMS trials. In addition, patients who switched or continued 0.5 mg fingolimod in the extension trials, and those who continuously received 0.5 mg fingolimod in the LONGTERMS trial, were also included in the analysis.

Disability progression was considered minimal if there was an increase or decrease of 0.5 points from a baseline EDSS score of 5.5 or lower, or if there was no change in a baseline score greater than 5.5. Disability was considered to have improved if the baseline EDSS score decreased by 1.0 or more points, either confirmed at six months only, or confirmed at six months and sustained until month 24, 48, or 96. Worsening was defined as an increase of 1.0 point or more from the baseline EDSS score, either confirmed at six months only or confirmed at six months and sustained until month 24, 48, and 96. Stable/improving was defined as the minimal and improving categories combined, and fluctuating was identified as changes in the EDSS score that were different from those defined in other categories.

Results showed that significant improvements were more likely to be noted after longer periods of continuous fingolimod treatment. Disability fluctuated or changed minimally at 24 months, and the proportion of patients in these categories decreased by almost 50% at 96 months. Researchers noted that 22.6% of patients in the continuous fingolimod group were improving, 22.6% were worsening, and 54.7% of patients had minimal change or were fluctuating at 96 months. However, 20% of patients in the switch group were improving, 28% were worsening, and 52% had changed minimally or were fluctuating at 96 months. Overall, the proportion of patients improving or worsening was larger at 96 months than at 24 months.

Researchers also investigated the impact of delaying fingolimod treatment on long-term disability and concluded that patients with worsening disability over 96 months benefited from early fingolimod treatment. Fewer patients in the continuous fingolimod group had worsening disability, compared with the switch group, at 24 months. By 96 months, the continuous fingolimod group maintained proportionally fewer patients with worsening disability, compared with the switch group. The data indicate that the majority of patients receiving continuous fingolimod treatment were either stable or improving at 96 months. Proportionally more patients had improving disability at 96 months, compared to 24 months. These results support the practice of longer follow-up periods to properly detect the impact of treatment.

This study was supported by Oxford PharmaGenesis in Oxford UK, and funded by Novartis Pharmaceuticals.

—Erica Robinson

NATIONAL HARBOR, MD—After eight years of fingolimod treatment, disability improves or remains stable for a majority of patients with relapsing-remitting multiple sclerosis (MS), according to data presented at the 2016 CMSC Annual Meeting.

The two-year phase III FREEDOMS and FREEDOMS II trial data revealed that fingolimod reduced confirmed disability progression in patients with MS, but evaluating disability over a longer time span may help to determine the full impact of treatment. Shannon Ritter, MD, an employee of Novartis Pharmaceuticals, and her colleagues examined trends in changes in Expanded Disability Status Scale (EDSS) scores over a maximum of eight years. Their objective was to investigate patients’ evolving disability patterns and the impact of fingolimod treatment on long-term disability.

The investigators conducted post hoc analyses that included data collected for as long as 96 months from baseline from patients randomized to fingolimod 0.5 mg or placebo in both two- year FREEDOMS trials. In addition, patients who switched or continued 0.5 mg fingolimod in the extension trials, and those who continuously received 0.5 mg fingolimod in the LONGTERMS trial, were also included in the analysis.

Disability progression was considered minimal if there was an increase or decrease of 0.5 points from a baseline EDSS score of 5.5 or lower, or if there was no change in a baseline score greater than 5.5. Disability was considered to have improved if the baseline EDSS score decreased by 1.0 or more points, either confirmed at six months only, or confirmed at six months and sustained until month 24, 48, or 96. Worsening was defined as an increase of 1.0 point or more from the baseline EDSS score, either confirmed at six months only or confirmed at six months and sustained until month 24, 48, and 96. Stable/improving was defined as the minimal and improving categories combined, and fluctuating was identified as changes in the EDSS score that were different from those defined in other categories.

Results showed that significant improvements were more likely to be noted after longer periods of continuous fingolimod treatment. Disability fluctuated or changed minimally at 24 months, and the proportion of patients in these categories decreased by almost 50% at 96 months. Researchers noted that 22.6% of patients in the continuous fingolimod group were improving, 22.6% were worsening, and 54.7% of patients had minimal change or were fluctuating at 96 months. However, 20% of patients in the switch group were improving, 28% were worsening, and 52% had changed minimally or were fluctuating at 96 months. Overall, the proportion of patients improving or worsening was larger at 96 months than at 24 months.

Researchers also investigated the impact of delaying fingolimod treatment on long-term disability and concluded that patients with worsening disability over 96 months benefited from early fingolimod treatment. Fewer patients in the continuous fingolimod group had worsening disability, compared with the switch group, at 24 months. By 96 months, the continuous fingolimod group maintained proportionally fewer patients with worsening disability, compared with the switch group. The data indicate that the majority of patients receiving continuous fingolimod treatment were either stable or improving at 96 months. Proportionally more patients had improving disability at 96 months, compared to 24 months. These results support the practice of longer follow-up periods to properly detect the impact of treatment.

This study was supported by Oxford PharmaGenesis in Oxford UK, and funded by Novartis Pharmaceuticals.

—Erica Robinson

NATIONAL HARBOR, MD—After eight years of fingolimod treatment, disability improves or remains stable for a majority of patients with relapsing-remitting multiple sclerosis (MS), according to data presented at the 2016 CMSC Annual Meeting.

The two-year phase III FREEDOMS and FREEDOMS II trial data revealed that fingolimod reduced confirmed disability progression in patients with MS, but evaluating disability over a longer time span may help to determine the full impact of treatment. Shannon Ritter, MD, an employee of Novartis Pharmaceuticals, and her colleagues examined trends in changes in Expanded Disability Status Scale (EDSS) scores over a maximum of eight years. Their objective was to investigate patients’ evolving disability patterns and the impact of fingolimod treatment on long-term disability.

The investigators conducted post hoc analyses that included data collected for as long as 96 months from baseline from patients randomized to fingolimod 0.5 mg or placebo in both two- year FREEDOMS trials. In addition, patients who switched or continued 0.5 mg fingolimod in the extension trials, and those who continuously received 0.5 mg fingolimod in the LONGTERMS trial, were also included in the analysis.

Disability progression was considered minimal if there was an increase or decrease of 0.5 points from a baseline EDSS score of 5.5 or lower, or if there was no change in a baseline score greater than 5.5. Disability was considered to have improved if the baseline EDSS score decreased by 1.0 or more points, either confirmed at six months only, or confirmed at six months and sustained until month 24, 48, or 96. Worsening was defined as an increase of 1.0 point or more from the baseline EDSS score, either confirmed at six months only or confirmed at six months and sustained until month 24, 48, and 96. Stable/improving was defined as the minimal and improving categories combined, and fluctuating was identified as changes in the EDSS score that were different from those defined in other categories.

Results showed that significant improvements were more likely to be noted after longer periods of continuous fingolimod treatment. Disability fluctuated or changed minimally at 24 months, and the proportion of patients in these categories decreased by almost 50% at 96 months. Researchers noted that 22.6% of patients in the continuous fingolimod group were improving, 22.6% were worsening, and 54.7% of patients had minimal change or were fluctuating at 96 months. However, 20% of patients in the switch group were improving, 28% were worsening, and 52% had changed minimally or were fluctuating at 96 months. Overall, the proportion of patients improving or worsening was larger at 96 months than at 24 months.

Researchers also investigated the impact of delaying fingolimod treatment on long-term disability and concluded that patients with worsening disability over 96 months benefited from early fingolimod treatment. Fewer patients in the continuous fingolimod group had worsening disability, compared with the switch group, at 24 months. By 96 months, the continuous fingolimod group maintained proportionally fewer patients with worsening disability, compared with the switch group. The data indicate that the majority of patients receiving continuous fingolimod treatment were either stable or improving at 96 months. Proportionally more patients had improving disability at 96 months, compared to 24 months. These results support the practice of longer follow-up periods to properly detect the impact of treatment.

This study was supported by Oxford PharmaGenesis in Oxford UK, and funded by Novartis Pharmaceuticals.

—Erica Robinson

NATIONAL HARBOR, MD—Risk of new or additional flu-like symptoms in patients with multiple sclerosis (MS) transitioning from nonpegylated interferon beta-1a to pegylated interferon beta-1a is low, according to a report at the 2016 CMSC Annual Meeting. Scheduled naproxen therapy may be a beneficial prophylactic strategy, according to researchers. “Ninety percent of patients did not experience new or worsening flu-like symptoms,” said Robert T. Naismith, MD, Associate Professor, Washington University School of Medicine, St. Louis, Missouri, and colleagues.

Robert T. Naismith, MD

Dr. Naismith and coinvestigators conducted the ALLOW study, a one-year, phase IIIb open-label, randomized trial to characterize flu-like symptoms in patients with relapsing MS who transitioned from nonpegylated interferon beta-1a to pegylated interferon beta-1a. The study included patients age 18 to 65 with relapsing MS who had been treated with a stable dose of nonpegylated interferon for four months or more prior to screening. Their drug regimen was continued throughout a four-week run-in period for evaluation of flu-like symptoms including influenza-like illness, myalgia, pyrexia, or asthenia on that regimen. All patients were then switched to pegylated interferon beta-1a titrated to 125 μg every two weeks. Patients were randomized one-to-one to continue their current flu-like symptom management or to commence a regimen of naproxen 500 mg twice daily, starting 24 hours before each dose of pegylated interferon beta-1a and continuing for 48 hours after, for the first eight weeks of treatment.

The primary end point was the proportion of patients experiencing new or worsening flu-like symptoms, which was defined as a 2 or more point increase in flu-like symptom score. Secondary end points were flu-like symptom severity over 48 weeks and impact of naproxen, the onset and duration of flu-like symptoms following pegylated interferon beta-1a injection, the incidence of adverse events, and walking as measured by the Patient Determined Disease Steps (PDDS), a self-assessment walking scale that ranges from normal (0) to bedridden (8).

Of 201 patients who were randomized, 81.6% within each arm completed the study. Baseline characteristics were balanced between the two arms. A majority (89.6%) of patients did not experience new or worsening flu-like symptoms during the first eight weeks of following treatment switch. Flu-like symptom severity remained low across all study populations through week 48, with a majority of the symptoms being mild to moderate. Naproxen did not reduce flu-like symptom severity compared with current flu-like symptom management regimen. Following injection, overall flu-like symptom onset occurred between a mean of 12.0 and 12.8 hours and lasted for a mean duration of 13.8 to 17.0 hours. The most common adverse events were injection-site erythema, injection-site reaction, and influenza-like illness. No significant increase in walking disability was reported by patients who completed the study.

This study was sponsored by Biogen.

—Glenn S. Williams

NATIONAL HARBOR, MD—Risk of new or additional flu-like symptoms in patients with multiple sclerosis (MS) transitioning from nonpegylated interferon beta-1a to pegylated interferon beta-1a is low, according to a report at the 2016 CMSC Annual Meeting. Scheduled naproxen therapy may be a beneficial prophylactic strategy, according to researchers. “Ninety percent of patients did not experience new or worsening flu-like symptoms,” said Robert T. Naismith, MD, Associate Professor, Washington University School of Medicine, St. Louis, Missouri, and colleagues.

Robert T. Naismith, MD

Dr. Naismith and coinvestigators conducted the ALLOW study, a one-year, phase IIIb open-label, randomized trial to characterize flu-like symptoms in patients with relapsing MS who transitioned from nonpegylated interferon beta-1a to pegylated interferon beta-1a. The study included patients age 18 to 65 with relapsing MS who had been treated with a stable dose of nonpegylated interferon for four months or more prior to screening. Their drug regimen was continued throughout a four-week run-in period for evaluation of flu-like symptoms including influenza-like illness, myalgia, pyrexia, or asthenia on that regimen. All patients were then switched to pegylated interferon beta-1a titrated to 125 μg every two weeks. Patients were randomized one-to-one to continue their current flu-like symptom management or to commence a regimen of naproxen 500 mg twice daily, starting 24 hours before each dose of pegylated interferon beta-1a and continuing for 48 hours after, for the first eight weeks of treatment.

The primary end point was the proportion of patients experiencing new or worsening flu-like symptoms, which was defined as a 2 or more point increase in flu-like symptom score. Secondary end points were flu-like symptom severity over 48 weeks and impact of naproxen, the onset and duration of flu-like symptoms following pegylated interferon beta-1a injection, the incidence of adverse events, and walking as measured by the Patient Determined Disease Steps (PDDS), a self-assessment walking scale that ranges from normal (0) to bedridden (8).

Of 201 patients who were randomized, 81.6% within each arm completed the study. Baseline characteristics were balanced between the two arms. A majority (89.6%) of patients did not experience new or worsening flu-like symptoms during the first eight weeks of following treatment switch. Flu-like symptom severity remained low across all study populations through week 48, with a majority of the symptoms being mild to moderate. Naproxen did not reduce flu-like symptom severity compared with current flu-like symptom management regimen. Following injection, overall flu-like symptom onset occurred between a mean of 12.0 and 12.8 hours and lasted for a mean duration of 13.8 to 17.0 hours. The most common adverse events were injection-site erythema, injection-site reaction, and influenza-like illness. No significant increase in walking disability was reported by patients who completed the study.

This study was sponsored by Biogen.

—Glenn S. Williams

NATIONAL HARBOR, MD—Risk of new or additional flu-like symptoms in patients with multiple sclerosis (MS) transitioning from nonpegylated interferon beta-1a to pegylated interferon beta-1a is low, according to a report at the 2016 CMSC Annual Meeting. Scheduled naproxen therapy may be a beneficial prophylactic strategy, according to researchers. “Ninety percent of patients did not experience new or worsening flu-like symptoms,” said Robert T. Naismith, MD, Associate Professor, Washington University School of Medicine, St. Louis, Missouri, and colleagues.

Robert T. Naismith, MD

Dr. Naismith and coinvestigators conducted the ALLOW study, a one-year, phase IIIb open-label, randomized trial to characterize flu-like symptoms in patients with relapsing MS who transitioned from nonpegylated interferon beta-1a to pegylated interferon beta-1a. The study included patients age 18 to 65 with relapsing MS who had been treated with a stable dose of nonpegylated interferon for four months or more prior to screening. Their drug regimen was continued throughout a four-week run-in period for evaluation of flu-like symptoms including influenza-like illness, myalgia, pyrexia, or asthenia on that regimen. All patients were then switched to pegylated interferon beta-1a titrated to 125 μg every two weeks. Patients were randomized one-to-one to continue their current flu-like symptom management or to commence a regimen of naproxen 500 mg twice daily, starting 24 hours before each dose of pegylated interferon beta-1a and continuing for 48 hours after, for the first eight weeks of treatment.

The primary end point was the proportion of patients experiencing new or worsening flu-like symptoms, which was defined as a 2 or more point increase in flu-like symptom score. Secondary end points were flu-like symptom severity over 48 weeks and impact of naproxen, the onset and duration of flu-like symptoms following pegylated interferon beta-1a injection, the incidence of adverse events, and walking as measured by the Patient Determined Disease Steps (PDDS), a self-assessment walking scale that ranges from normal (0) to bedridden (8).

Of 201 patients who were randomized, 81.6% within each arm completed the study. Baseline characteristics were balanced between the two arms. A majority (89.6%) of patients did not experience new or worsening flu-like symptoms during the first eight weeks of following treatment switch. Flu-like symptom severity remained low across all study populations through week 48, with a majority of the symptoms being mild to moderate. Naproxen did not reduce flu-like symptom severity compared with current flu-like symptom management regimen. Following injection, overall flu-like symptom onset occurred between a mean of 12.0 and 12.8 hours and lasted for a mean duration of 13.8 to 17.0 hours. The most common adverse events were injection-site erythema, injection-site reaction, and influenza-like illness. No significant increase in walking disability was reported by patients who completed the study.

This study was sponsored by Biogen.

—Glenn S. Williams

NATIONAL HARBOR, MD. – Updated imaging protocols for patients with multiple sclerosis from a panel of North American neurology and radiology experts promise to improve the accuracy of diagnosis and monitoring.

The guidelines emphasize the use of three-dimensional MRI to provide complete coverage of the brain, monitoring for progressive multifocal leukoencephalopathy (PML), and optical orbit MRI for severe optic neuritis.

Key clinical guideline changes include more specific timing of brain MRI when monitoring patients receiving disease modifying therapy, timing of brain MRI to monitor for PML, updated evidence of the value of MRI changes in determining the effectiveness of treatment, and the inclusion of radiologic isolated syndrome.

Dr. Anthony Traboulsee of the University of British Columbia, Vancouver, discussed the latest MRI guidelines at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“MS is a life-long disorder and MRI is one of the best ways to monitor for new lesions that can be occurring in the absence of new symptoms (clinically silent disease activity). These lesions accumulate and lead to future disability. In order to accurately determine if changes are occurring, we need MRIs that are similar in quality over time regardless of where the patient had an MRI performed. A standardized MRI protocol provides this quality of data,” Dr. Traboulsee said.

The guidelines, published in the American Journal of Neuroradiology (Am J Neuroradiol. 2015 Nov 12. doi: 10.3174/ajnr.A4539), recommend a first MRI as soon as a physician suspects MS in a patient, with subsequent MRIs typically done annually to determine whether the disease is stable or progressive, which could prompt a change in treatment. “Breakthrough activity on MRI that is occurring while on treatment can lead to future disability and is an opportunity to consider switching therapy,” Dr. Traboulsee said.

More frequent scans could be appropriate for patients with a more aggressive and active disease course, and when treatment has been changed. More frequent monitoring and diffusion-weighted imaging is also recommended for patients taking natalizumab (Tysabri), since they are at high risk for PML.

Another goal of the guidelines is to describe how best to use MRI to support an early diagnosis of MS and to help avoid misdiagnosis. Early treatment depends on an early diagnosis. “We find the biggest impact of our disease-modifying therapy is in the first decade. The goal is to prevent new injury and optimize brain health through treatment and lifestyle,” said Dr. Traboulsee.

MRI scans alone should not be diagnostic. Clinical information is also needed, such as numbness or problems with balance. Abnormal brain MRIs occur in about 5% of people without MS and white spots in the brain that are unrelated to MS can naturally develop as people age.

If clinically isolated syndrome is suspected, a cervical cord MRI should be done along with a brain MRI. Use of a gadolinium contrast agent is recommended to better determine disease activity and speed diagnosis.

Dr. Traboulsee received grant support from Biogen, Chugai, Hoffman la Roche, and Sanofi Genzyme. He reported being a steering committee member for Hoffman la Roche and has been a consultant to Biogen, Chugai, EMD Serono, Hoffman la Roche, MedImmune, Sanofi Genzyme, and Teva Neuroscience.

NATIONAL HARBOR, MD. – Updated imaging protocols for patients with multiple sclerosis from a panel of North American neurology and radiology experts promise to improve the accuracy of diagnosis and monitoring.

The guidelines emphasize the use of three-dimensional MRI to provide complete coverage of the brain, monitoring for progressive multifocal leukoencephalopathy (PML), and optical orbit MRI for severe optic neuritis.

Key clinical guideline changes include more specific timing of brain MRI when monitoring patients receiving disease modifying therapy, timing of brain MRI to monitor for PML, updated evidence of the value of MRI changes in determining the effectiveness of treatment, and the inclusion of radiologic isolated syndrome.

Dr. Anthony Traboulsee of the University of British Columbia, Vancouver, discussed the latest MRI guidelines at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“MS is a life-long disorder and MRI is one of the best ways to monitor for new lesions that can be occurring in the absence of new symptoms (clinically silent disease activity). These lesions accumulate and lead to future disability. In order to accurately determine if changes are occurring, we need MRIs that are similar in quality over time regardless of where the patient had an MRI performed. A standardized MRI protocol provides this quality of data,” Dr. Traboulsee said.

The guidelines, published in the American Journal of Neuroradiology (Am J Neuroradiol. 2015 Nov 12. doi: 10.3174/ajnr.A4539), recommend a first MRI as soon as a physician suspects MS in a patient, with subsequent MRIs typically done annually to determine whether the disease is stable or progressive, which could prompt a change in treatment. “Breakthrough activity on MRI that is occurring while on treatment can lead to future disability and is an opportunity to consider switching therapy,” Dr. Traboulsee said.

More frequent scans could be appropriate for patients with a more aggressive and active disease course, and when treatment has been changed. More frequent monitoring and diffusion-weighted imaging is also recommended for patients taking natalizumab (Tysabri), since they are at high risk for PML.

Another goal of the guidelines is to describe how best to use MRI to support an early diagnosis of MS and to help avoid misdiagnosis. Early treatment depends on an early diagnosis. “We find the biggest impact of our disease-modifying therapy is in the first decade. The goal is to prevent new injury and optimize brain health through treatment and lifestyle,” said Dr. Traboulsee.

MRI scans alone should not be diagnostic. Clinical information is also needed, such as numbness or problems with balance. Abnormal brain MRIs occur in about 5% of people without MS and white spots in the brain that are unrelated to MS can naturally develop as people age.

If clinically isolated syndrome is suspected, a cervical cord MRI should be done along with a brain MRI. Use of a gadolinium contrast agent is recommended to better determine disease activity and speed diagnosis.

Dr. Traboulsee received grant support from Biogen, Chugai, Hoffman la Roche, and Sanofi Genzyme. He reported being a steering committee member for Hoffman la Roche and has been a consultant to Biogen, Chugai, EMD Serono, Hoffman la Roche, MedImmune, Sanofi Genzyme, and Teva Neuroscience.

NATIONAL HARBOR, MD. – Updated imaging protocols for patients with multiple sclerosis from a panel of North American neurology and radiology experts promise to improve the accuracy of diagnosis and monitoring.

The guidelines emphasize the use of three-dimensional MRI to provide complete coverage of the brain, monitoring for progressive multifocal leukoencephalopathy (PML), and optical orbit MRI for severe optic neuritis.

Key clinical guideline changes include more specific timing of brain MRI when monitoring patients receiving disease modifying therapy, timing of brain MRI to monitor for PML, updated evidence of the value of MRI changes in determining the effectiveness of treatment, and the inclusion of radiologic isolated syndrome.

Dr. Anthony Traboulsee of the University of British Columbia, Vancouver, discussed the latest MRI guidelines at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“MS is a life-long disorder and MRI is one of the best ways to monitor for new lesions that can be occurring in the absence of new symptoms (clinically silent disease activity). These lesions accumulate and lead to future disability. In order to accurately determine if changes are occurring, we need MRIs that are similar in quality over time regardless of where the patient had an MRI performed. A standardized MRI protocol provides this quality of data,” Dr. Traboulsee said.

The guidelines, published in the American Journal of Neuroradiology (Am J Neuroradiol. 2015 Nov 12. doi: 10.3174/ajnr.A4539), recommend a first MRI as soon as a physician suspects MS in a patient, with subsequent MRIs typically done annually to determine whether the disease is stable or progressive, which could prompt a change in treatment. “Breakthrough activity on MRI that is occurring while on treatment can lead to future disability and is an opportunity to consider switching therapy,” Dr. Traboulsee said.

More frequent scans could be appropriate for patients with a more aggressive and active disease course, and when treatment has been changed. More frequent monitoring and diffusion-weighted imaging is also recommended for patients taking natalizumab (Tysabri), since they are at high risk for PML.

Another goal of the guidelines is to describe how best to use MRI to support an early diagnosis of MS and to help avoid misdiagnosis. Early treatment depends on an early diagnosis. “We find the biggest impact of our disease-modifying therapy is in the first decade. The goal is to prevent new injury and optimize brain health through treatment and lifestyle,” said Dr. Traboulsee.

MRI scans alone should not be diagnostic. Clinical information is also needed, such as numbness or problems with balance. Abnormal brain MRIs occur in about 5% of people without MS and white spots in the brain that are unrelated to MS can naturally develop as people age.

If clinically isolated syndrome is suspected, a cervical cord MRI should be done along with a brain MRI. Use of a gadolinium contrast agent is recommended to better determine disease activity and speed diagnosis.

Dr. Traboulsee received grant support from Biogen, Chugai, Hoffman la Roche, and Sanofi Genzyme. He reported being a steering committee member for Hoffman la Roche and has been a consultant to Biogen, Chugai, EMD Serono, Hoffman la Roche, MedImmune, Sanofi Genzyme, and Teva Neuroscience.

NATIONAL HARBOR, MD—In a real-world comparison in patients with multiple sclerosis (MS), dimethyl fumarate and fingolimod were associated with the largest reduction in unadjusted relapse rates after initiation of disease-modifying therapy (DMT), according to data presented at the 2016 CMSC Annual Meeting. In addition, dimethyl fumarate was associated with significantly fewer arrhythmias, compared with glatiramer acetate, interferon beta, and teriflunomide after initiation of DMT.

Real-world data on the comparative effectiveness of DMTs for MS management are limited. The goal of this study, led by Aaron Boster, MD, Systems Medical Chief of Neuroimmunology for OhioHealth in Columbus, Ohio, and his colleagues was to compare the annual relapse rate in patients initiating delayed-release dimethyl fumarate, glatiramer acetate, interferon beta, fingolimod, or teriflunomide.

For this investigation, researchers used data from the Truven MarketScan Claim database, which includes information from 80 million commercially insured people in the United States. Patients with MS between ages 18 and 64 who initiated a DMT of choice in 2013 were included in the study.

Aaron Boster, MD

Dr. Boster and his colleagues calculated arrhythmias based on the number of MS-related relapses within one year after DMT initiation and examined chronic disease burden and MS-related symptoms. Composite scores depended on the presence of 22 chronic conditions, including diabetes, peptic ulcer, liver disease, and cancer. The Poisson regression model was used to estimate adjusted incidence rate ratios of relapse rate. The researchers adjusted the data for demographic and clinical characteristics such as age, sex, region, and place of residence.

The most significant decreases in unadjusted relapse rate were among patients receiving dimethyl fumarate or fingolimod. Dimethyl fumarate was associated with a lower number of arrhythmias, compared with other DMTs. Overall, patients initiating dimethyl fumarate or fingolimod were more adherent to treatment than patients receiving teriflunomide, glatiramer acetate, or interferon beta in the first year after DMT initiation. “Insights provided by real-world data, and the implications for differences in real-world comparative effectiveness of available DMTs, should be taken into account when making decisions on appropriate therapy for the management of MS,” said Dr. Boster and colleagues.

Some limitations of the study were that the data were not collected specifically for clinical research and that the results that did not provide certain clinical information required to assess disease severity properly.

—Erica Robinson

NATIONAL HARBOR, MD—In a real-world comparison in patients with multiple sclerosis (MS), dimethyl fumarate and fingolimod were associated with the largest reduction in unadjusted relapse rates after initiation of disease-modifying therapy (DMT), according to data presented at the 2016 CMSC Annual Meeting. In addition, dimethyl fumarate was associated with significantly fewer arrhythmias, compared with glatiramer acetate, interferon beta, and teriflunomide after initiation of DMT.

Real-world data on the comparative effectiveness of DMTs for MS management are limited. The goal of this study, led by Aaron Boster, MD, Systems Medical Chief of Neuroimmunology for OhioHealth in Columbus, Ohio, and his colleagues was to compare the annual relapse rate in patients initiating delayed-release dimethyl fumarate, glatiramer acetate, interferon beta, fingolimod, or teriflunomide.

For this investigation, researchers used data from the Truven MarketScan Claim database, which includes information from 80 million commercially insured people in the United States. Patients with MS between ages 18 and 64 who initiated a DMT of choice in 2013 were included in the study.

Aaron Boster, MD

Dr. Boster and his colleagues calculated arrhythmias based on the number of MS-related relapses within one year after DMT initiation and examined chronic disease burden and MS-related symptoms. Composite scores depended on the presence of 22 chronic conditions, including diabetes, peptic ulcer, liver disease, and cancer. The Poisson regression model was used to estimate adjusted incidence rate ratios of relapse rate. The researchers adjusted the data for demographic and clinical characteristics such as age, sex, region, and place of residence.

The most significant decreases in unadjusted relapse rate were among patients receiving dimethyl fumarate or fingolimod. Dimethyl fumarate was associated with a lower number of arrhythmias, compared with other DMTs. Overall, patients initiating dimethyl fumarate or fingolimod were more adherent to treatment than patients receiving teriflunomide, glatiramer acetate, or interferon beta in the first year after DMT initiation. “Insights provided by real-world data, and the implications for differences in real-world comparative effectiveness of available DMTs, should be taken into account when making decisions on appropriate therapy for the management of MS,” said Dr. Boster and colleagues.

Some limitations of the study were that the data were not collected specifically for clinical research and that the results that did not provide certain clinical information required to assess disease severity properly.

—Erica Robinson

NATIONAL HARBOR, MD—In a real-world comparison in patients with multiple sclerosis (MS), dimethyl fumarate and fingolimod were associated with the largest reduction in unadjusted relapse rates after initiation of disease-modifying therapy (DMT), according to data presented at the 2016 CMSC Annual Meeting. In addition, dimethyl fumarate was associated with significantly fewer arrhythmias, compared with glatiramer acetate, interferon beta, and teriflunomide after initiation of DMT.

Real-world data on the comparative effectiveness of DMTs for MS management are limited. The goal of this study, led by Aaron Boster, MD, Systems Medical Chief of Neuroimmunology for OhioHealth in Columbus, Ohio, and his colleagues was to compare the annual relapse rate in patients initiating delayed-release dimethyl fumarate, glatiramer acetate, interferon beta, fingolimod, or teriflunomide.

For this investigation, researchers used data from the Truven MarketScan Claim database, which includes information from 80 million commercially insured people in the United States. Patients with MS between ages 18 and 64 who initiated a DMT of choice in 2013 were included in the study.

Aaron Boster, MD

Dr. Boster and his colleagues calculated arrhythmias based on the number of MS-related relapses within one year after DMT initiation and examined chronic disease burden and MS-related symptoms. Composite scores depended on the presence of 22 chronic conditions, including diabetes, peptic ulcer, liver disease, and cancer. The Poisson regression model was used to estimate adjusted incidence rate ratios of relapse rate. The researchers adjusted the data for demographic and clinical characteristics such as age, sex, region, and place of residence.

The most significant decreases in unadjusted relapse rate were among patients receiving dimethyl fumarate or fingolimod. Dimethyl fumarate was associated with a lower number of arrhythmias, compared with other DMTs. Overall, patients initiating dimethyl fumarate or fingolimod were more adherent to treatment than patients receiving teriflunomide, glatiramer acetate, or interferon beta in the first year after DMT initiation. “Insights provided by real-world data, and the implications for differences in real-world comparative effectiveness of available DMTs, should be taken into account when making decisions on appropriate therapy for the management of MS,” said Dr. Boster and colleagues.

Some limitations of the study were that the data were not collected specifically for clinical research and that the results that did not provide certain clinical information required to assess disease severity properly.

—Erica Robinson