CMSC 2014

DALLAS – Persons with multiple sclerosis who had been taking natalizumab for at least 2 years and then switched to fingolimod or injectables such as interferon-beta or glatiramer acetate faced more disability than did their counterparts who continued on the drug, according to results from a retrospective study of patient-reported data.

"If people stopped natalizumab after 2 years, regardless of their risk of progressive multifocal leukoencephalopathy [PML], we wanted to know if their disease worsened," Stacey S. Cofield, Ph.D., said in an interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis. "What we have seen in a short follow-up time is that, yes, it does."

Dr. Cofield is the deputy director of the North American Research Committee on Multiple Sclerosis (NARCOMS) in Birmingham, Ala., and is a faculty member in the biostatistics department at the University of Alabama, Birmingham.

To help close the gap of knowledge on clinical outcomes for patients who stop natalizumab (Tysabri) treatment, often due to an elevated risk for PML, Dr. Cofield and her associates reviewed outcomes as measured by the Patient-Determined Disease Steps (PDDS) scale. The PDDS is a validated, patient-reported scale of disease progression that runs from normal with a score of 0 to bedridden with a score of 8.

The investigators created three groups from a total of 547 patients who had undergone at least 2 years of continuous natalizumab treatment between 2005 and 2013 and had completed at least one follow-up survey that included a PDDS assessment: 406 whose only disease-modifying treatment during the time reviewed was natalizumab; 50 who switched to fingolimod (Gilenya) after at least 2 years of natalizumab; and 71 who switched to injectables after at least 2 years of natalizumab. A total of 10 patients who’d switched to other treatments, including exclusively symptomatic treatments, were not included in the study. The investigators also excluded another 10 patients who lacked PDDS assessments in the first survey during natalizumab treatment.

Patient characteristics across all three study groups at the start of their natalizumab treatment trended similarly: They tended to be white, female, have a median age of 50 years (P greater than .05 for all), and have similar baseline PDDS scores of between 3 and 4 (P = .1334). Roughly a third of each group reported having employment outside the home (P = .7104).

The median months of total follow-up were significantly different across the arms. For the natalizumab-only arm, the median range for follow-up was about 48 months; for fingolimod, it was 54 months; and for injectables, it was 60 months (P less than .0001).

Once patients had transitioned, Dr. Cofield reported, "the fingolimod switch had about 12 months of follow-up time. Patients stayed on natalizumab about 4 years before switching, on average." This was due, in part, to fingolimod not being available until 2010, leaving very little "capture time" for the window of data the investigators were reviewing, she said.

For the injectables group, the median follow-up time was 12 months.

Older age, male gender, and a lower baseline PDDS score were predictors of lower PDDS scores at follow-up (P less than .03 for all), but the total follow-up time was not (P = .69).

The adjusted mean PDDS score did not differ between the groups after 2 years of natalizumab therapy (P = .11); however, at the end of follow-up, the mean PDDS increase in the fingolimod group (0.58 points) and the injectables group (0.71) was significantly different from that of the natalizumab group (0.31; P = .007).

There was also a significant difference across the groups in the number of patients who had an increase in their PDDS score of at least 1 point: 31% for the natalizumab group, 46% for the fingolimod group, and 42.3% for the injectables group (P = .03).

"The mean change in the fingolimod group was slightly lower, but their group had a higher proportion with a 1 point increase," Dr. Cofield said. "So, the ones who switched to fingolimod either weren’t changing [their PDDS score] or were changing by one whole point."

"The take-away is that patients should be aware of the discussion they should be having with their physician after 2 years of treatment" with natalizumab, Dr. Cofield said in the interview. "Physicians can use this information to discuss the balance between the side effects and the risks of natalizumab, with the changes patients may see if they leave the treatment."

Dr. Cofield reported that she has received consulting fees from Teva Neuroscience and GlaxoSmithKline, among others. Biogen Idec funded the analysis of data for this study.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

DALLAS – Persons with multiple sclerosis who had been taking natalizumab for at least 2 years and then switched to fingolimod or injectables such as interferon-beta or glatiramer acetate faced more disability than did their counterparts who continued on the drug, according to results from a retrospective study of patient-reported data.

"If people stopped natalizumab after 2 years, regardless of their risk of progressive multifocal leukoencephalopathy [PML], we wanted to know if their disease worsened," Stacey S. Cofield, Ph.D., said in an interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis. "What we have seen in a short follow-up time is that, yes, it does."

Dr. Cofield is the deputy director of the North American Research Committee on Multiple Sclerosis (NARCOMS) in Birmingham, Ala., and is a faculty member in the biostatistics department at the University of Alabama, Birmingham.

To help close the gap of knowledge on clinical outcomes for patients who stop natalizumab (Tysabri) treatment, often due to an elevated risk for PML, Dr. Cofield and her associates reviewed outcomes as measured by the Patient-Determined Disease Steps (PDDS) scale. The PDDS is a validated, patient-reported scale of disease progression that runs from normal with a score of 0 to bedridden with a score of 8.

The investigators created three groups from a total of 547 patients who had undergone at least 2 years of continuous natalizumab treatment between 2005 and 2013 and had completed at least one follow-up survey that included a PDDS assessment: 406 whose only disease-modifying treatment during the time reviewed was natalizumab; 50 who switched to fingolimod (Gilenya) after at least 2 years of natalizumab; and 71 who switched to injectables after at least 2 years of natalizumab. A total of 10 patients who’d switched to other treatments, including exclusively symptomatic treatments, were not included in the study. The investigators also excluded another 10 patients who lacked PDDS assessments in the first survey during natalizumab treatment.

Patient characteristics across all three study groups at the start of their natalizumab treatment trended similarly: They tended to be white, female, have a median age of 50 years (P greater than .05 for all), and have similar baseline PDDS scores of between 3 and 4 (P = .1334). Roughly a third of each group reported having employment outside the home (P = .7104).

The median months of total follow-up were significantly different across the arms. For the natalizumab-only arm, the median range for follow-up was about 48 months; for fingolimod, it was 54 months; and for injectables, it was 60 months (P less than .0001).

Once patients had transitioned, Dr. Cofield reported, "the fingolimod switch had about 12 months of follow-up time. Patients stayed on natalizumab about 4 years before switching, on average." This was due, in part, to fingolimod not being available until 2010, leaving very little "capture time" for the window of data the investigators were reviewing, she said.

For the injectables group, the median follow-up time was 12 months.

Older age, male gender, and a lower baseline PDDS score were predictors of lower PDDS scores at follow-up (P less than .03 for all), but the total follow-up time was not (P = .69).

The adjusted mean PDDS score did not differ between the groups after 2 years of natalizumab therapy (P = .11); however, at the end of follow-up, the mean PDDS increase in the fingolimod group (0.58 points) and the injectables group (0.71) was significantly different from that of the natalizumab group (0.31; P = .007).

There was also a significant difference across the groups in the number of patients who had an increase in their PDDS score of at least 1 point: 31% for the natalizumab group, 46% for the fingolimod group, and 42.3% for the injectables group (P = .03).

"The mean change in the fingolimod group was slightly lower, but their group had a higher proportion with a 1 point increase," Dr. Cofield said. "So, the ones who switched to fingolimod either weren’t changing [their PDDS score] or were changing by one whole point."

"The take-away is that patients should be aware of the discussion they should be having with their physician after 2 years of treatment" with natalizumab, Dr. Cofield said in the interview. "Physicians can use this information to discuss the balance between the side effects and the risks of natalizumab, with the changes patients may see if they leave the treatment."

Dr. Cofield reported that she has received consulting fees from Teva Neuroscience and GlaxoSmithKline, among others. Biogen Idec funded the analysis of data for this study.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

DALLAS – Persons with multiple sclerosis who had been taking natalizumab for at least 2 years and then switched to fingolimod or injectables such as interferon-beta or glatiramer acetate faced more disability than did their counterparts who continued on the drug, according to results from a retrospective study of patient-reported data.

"If people stopped natalizumab after 2 years, regardless of their risk of progressive multifocal leukoencephalopathy [PML], we wanted to know if their disease worsened," Stacey S. Cofield, Ph.D., said in an interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis. "What we have seen in a short follow-up time is that, yes, it does."

Dr. Cofield is the deputy director of the North American Research Committee on Multiple Sclerosis (NARCOMS) in Birmingham, Ala., and is a faculty member in the biostatistics department at the University of Alabama, Birmingham.

To help close the gap of knowledge on clinical outcomes for patients who stop natalizumab (Tysabri) treatment, often due to an elevated risk for PML, Dr. Cofield and her associates reviewed outcomes as measured by the Patient-Determined Disease Steps (PDDS) scale. The PDDS is a validated, patient-reported scale of disease progression that runs from normal with a score of 0 to bedridden with a score of 8.

The investigators created three groups from a total of 547 patients who had undergone at least 2 years of continuous natalizumab treatment between 2005 and 2013 and had completed at least one follow-up survey that included a PDDS assessment: 406 whose only disease-modifying treatment during the time reviewed was natalizumab; 50 who switched to fingolimod (Gilenya) after at least 2 years of natalizumab; and 71 who switched to injectables after at least 2 years of natalizumab. A total of 10 patients who’d switched to other treatments, including exclusively symptomatic treatments, were not included in the study. The investigators also excluded another 10 patients who lacked PDDS assessments in the first survey during natalizumab treatment.

Patient characteristics across all three study groups at the start of their natalizumab treatment trended similarly: They tended to be white, female, have a median age of 50 years (P greater than .05 for all), and have similar baseline PDDS scores of between 3 and 4 (P = .1334). Roughly a third of each group reported having employment outside the home (P = .7104).

The median months of total follow-up were significantly different across the arms. For the natalizumab-only arm, the median range for follow-up was about 48 months; for fingolimod, it was 54 months; and for injectables, it was 60 months (P less than .0001).

Once patients had transitioned, Dr. Cofield reported, "the fingolimod switch had about 12 months of follow-up time. Patients stayed on natalizumab about 4 years before switching, on average." This was due, in part, to fingolimod not being available until 2010, leaving very little "capture time" for the window of data the investigators were reviewing, she said.

For the injectables group, the median follow-up time was 12 months.

Older age, male gender, and a lower baseline PDDS score were predictors of lower PDDS scores at follow-up (P less than .03 for all), but the total follow-up time was not (P = .69).

The adjusted mean PDDS score did not differ between the groups after 2 years of natalizumab therapy (P = .11); however, at the end of follow-up, the mean PDDS increase in the fingolimod group (0.58 points) and the injectables group (0.71) was significantly different from that of the natalizumab group (0.31; P = .007).

There was also a significant difference across the groups in the number of patients who had an increase in their PDDS score of at least 1 point: 31% for the natalizumab group, 46% for the fingolimod group, and 42.3% for the injectables group (P = .03).

"The mean change in the fingolimod group was slightly lower, but their group had a higher proportion with a 1 point increase," Dr. Cofield said. "So, the ones who switched to fingolimod either weren’t changing [their PDDS score] or were changing by one whole point."

"The take-away is that patients should be aware of the discussion they should be having with their physician after 2 years of treatment" with natalizumab, Dr. Cofield said in the interview. "Physicians can use this information to discuss the balance between the side effects and the risks of natalizumab, with the changes patients may see if they leave the treatment."

Dr. Cofield reported that she has received consulting fees from Teva Neuroscience and GlaxoSmithKline, among others. Biogen Idec funded the analysis of data for this study.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

DALLAS – Patients with multiple sclerosis have likely already heard the worst about their treatment options from the Internet; they need help balancing risks and benefits.

The key is offering them options, knowing what problems need to be discussed, and monitoring treatment beyond what’s usually recommended on product labeling, said Dr. Donna Graves, an MS specialist at the University of Texas Southwestern Medical Center, Dallas. She shared her tips – and also a heads-up about alemtuzumab, which might be approved for MS as soon as this fall – at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

aotto@frontlinemedcom.com

DALLAS – Patients with multiple sclerosis have likely already heard the worst about their treatment options from the Internet; they need help balancing risks and benefits.

The key is offering them options, knowing what problems need to be discussed, and monitoring treatment beyond what’s usually recommended on product labeling, said Dr. Donna Graves, an MS specialist at the University of Texas Southwestern Medical Center, Dallas. She shared her tips – and also a heads-up about alemtuzumab, which might be approved for MS as soon as this fall – at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

aotto@frontlinemedcom.com

DALLAS – Patients with multiple sclerosis have likely already heard the worst about their treatment options from the Internet; they need help balancing risks and benefits.

The key is offering them options, knowing what problems need to be discussed, and monitoring treatment beyond what’s usually recommended on product labeling, said Dr. Donna Graves, an MS specialist at the University of Texas Southwestern Medical Center, Dallas. She shared her tips – and also a heads-up about alemtuzumab, which might be approved for MS as soon as this fall – at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

aotto@frontlinemedcom.com

DALLAS – Vaccinations are beneficial for individuals with multiple sclerosis because they help avoid infections, which in turn lower the risk of relapse.

But while inactive vaccines are considered safe for MS patients, the use of live vaccines such as Varivax, Zostavax, or yellow fever vaccine is more nuanced, especially as more disease-modifying therapies (DMT) become available. There are limited data available about the effect of live vaccines on patients who are on DMTs, and the final decision comes down to the risk-benefit ratio, said, Dr. Patricia K. Coyle, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University Medical Center.

In a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Coyle summarizes what’s known so far about vaccines and MS, and provides tips to clinicians.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

DALLAS – Vaccinations are beneficial for individuals with multiple sclerosis because they help avoid infections, which in turn lower the risk of relapse.

But while inactive vaccines are considered safe for MS patients, the use of live vaccines such as Varivax, Zostavax, or yellow fever vaccine is more nuanced, especially as more disease-modifying therapies (DMT) become available. There are limited data available about the effect of live vaccines on patients who are on DMTs, and the final decision comes down to the risk-benefit ratio, said, Dr. Patricia K. Coyle, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University Medical Center.

In a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Coyle summarizes what’s known so far about vaccines and MS, and provides tips to clinicians.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

DALLAS – Vaccinations are beneficial for individuals with multiple sclerosis because they help avoid infections, which in turn lower the risk of relapse.

But while inactive vaccines are considered safe for MS patients, the use of live vaccines such as Varivax, Zostavax, or yellow fever vaccine is more nuanced, especially as more disease-modifying therapies (DMT) become available. There are limited data available about the effect of live vaccines on patients who are on DMTs, and the final decision comes down to the risk-benefit ratio, said, Dr. Patricia K. Coyle, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University Medical Center.

In a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Coyle summarizes what’s known so far about vaccines and MS, and provides tips to clinicians.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

DALLAS – Vaccinations are beneficial for individuals with multiple sclerosis because they help avoid infections, which in turn lower the risk of relapse.

But while inactive vaccines are considered safe for MS patients, the use of live vaccines such as Varivax, Zostavax, or yellow fever vaccine is more nuanced, especially as more disease-modifying therapies (DMT) become available. There are limited data available about the effect of live vaccines on patients who are on DMTs, and the final decision comes down to the risk-benefit ratio, said, Dr. Patricia K. Coyle, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University Medical Center.

In a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Coyle summarizes what’s known so far about vaccines and MS, and provides tips to clinicians.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

DALLAS – Vaccinations are beneficial for individuals with multiple sclerosis because they help avoid infections, which in turn lower the risk of relapse.

But while inactive vaccines are considered safe for MS patients, the use of live vaccines such as Varivax, Zostavax, or yellow fever vaccine is more nuanced, especially as more disease-modifying therapies (DMT) become available. There are limited data available about the effect of live vaccines on patients who are on DMTs, and the final decision comes down to the risk-benefit ratio, said, Dr. Patricia K. Coyle, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University Medical Center.

In a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Coyle summarizes what’s known so far about vaccines and MS, and provides tips to clinicians.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

DALLAS – Vaccinations are beneficial for individuals with multiple sclerosis because they help avoid infections, which in turn lower the risk of relapse.

But while inactive vaccines are considered safe for MS patients, the use of live vaccines such as Varivax, Zostavax, or yellow fever vaccine is more nuanced, especially as more disease-modifying therapies (DMT) become available. There are limited data available about the effect of live vaccines on patients who are on DMTs, and the final decision comes down to the risk-benefit ratio, said, Dr. Patricia K. Coyle, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University Medical Center.

In a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Coyle summarizes what’s known so far about vaccines and MS, and provides tips to clinicians.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

DALLAS – It might come as a surprise to learn how many good studies there are to support marijuana for multiple sclerosis, especially for subjective symptoms. The data are summarized in recent MS complementary and alternative medicine guidelines from the American Academy of Neurology.

But most of those studies were done using standardized products not available in the United States, which means that U.S. providers have to give advice in a country in which marijuana types and products vary considerably. It comes down to a case-by-case approach, Dr. Allen C. Bowling of the Colorado Neurological Institute, Englewood, explained in a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

aotto@frontlinemedcom.com

DALLAS – It might come as a surprise to learn how many good studies there are to support marijuana for multiple sclerosis, especially for subjective symptoms. The data are summarized in recent MS complementary and alternative medicine guidelines from the American Academy of Neurology.

But most of those studies were done using standardized products not available in the United States, which means that U.S. providers have to give advice in a country in which marijuana types and products vary considerably. It comes down to a case-by-case approach, Dr. Allen C. Bowling of the Colorado Neurological Institute, Englewood, explained in a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

aotto@frontlinemedcom.com

DALLAS – It might come as a surprise to learn how many good studies there are to support marijuana for multiple sclerosis, especially for subjective symptoms. The data are summarized in recent MS complementary and alternative medicine guidelines from the American Academy of Neurology.

But most of those studies were done using standardized products not available in the United States, which means that U.S. providers have to give advice in a country in which marijuana types and products vary considerably. It comes down to a case-by-case approach, Dr. Allen C. Bowling of the Colorado Neurological Institute, Englewood, explained in a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

aotto@frontlinemedcom.com

DALLAS – Exercise is generally safe for individuals with multiple sclerosis, according to a systematic review of randomized, controlled trials, supporting the promotion of exercise in this patient group.

The analysis showed that persons with MS who exercised had 27% lower risk of relapse, compared with patients who didn’t exercise. However, those who exercised had a 67% higher risk of adverse events, but the rate was no higher than adverse events (AEs) in healthy populations.

Frontline Medical News Image Library

"Patients with MS should not be deterred from exercise participation for concern of experiencing a relapse or adverse events, and such patients would further be expected to experience the many benefits of exercise training documented in the literature," wrote Mr. Matthew E. Platta and his colleagues in a study that was published in the Journal of the Neurological Sciences (2014 May 19 [doi:10.1016/j.jns.2014.05.016]).

Although reviews have shown the benefits of exercise for individuals with MS, none have looked at the risks of relapse and other AEs, Mr. Platta said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

Mr. Platta, a graduate student in the department of kinesiology and community health at the University of Illinois at Urbana-Champaign, and his colleagues analyzed 26 trials, including 1,295 participants. The trials were published up to November 2013 and examined the effect of exercise on MS relapses and adverse events. All trials included a nontreatment control arm.

The exercises included yoga, resistance training, aerobics, aquatics, and combined aerobics and resistance training.

Results showed that there were 26 relapses in the control groups, compared with 29 in the exercise group, corresponding with 6.3% and 4.6% of participants in the control and exercise groups, respectively.

The exercise group also had a 27% lower relative risk of relapse.

As for AEs, there were 5 in the control group, compared with 13 in the exercise group (or 1.2% and 2.0% in each group, respectively).

But the exercise group had a 67% higher relative risk of AEs, compared with the control group. However, the rate was not higher than the rates of AEs associated with exercise training in healthy populations, the researchers said.

The most common AEs in the control group were illness, ankle sprain, knee pain, and fall. The exercise group had additional AEs, including stroke, low back pain, trigeminal neuralgia, traffic accident, upper respiratory tract infection, rheumatoid arthritis flare up, and hernia. The most common types of AEs were musculoskeletal injuries (46%) and illnesses (23%).

"MS patients and clinicians can expect a low occurrence of AEs with exercise training, and, when AEs do occur, such events are commonly musculoskeletal in nature," Mr. Platta and his colleagues wrote.

There was no difference in the dropout rate between the two groups. The authors noted that "Future research might consider the inclusion of behavioral strategies for reducing dropout in RCTs of exercise training in MS."

They said that some of the analysis limitations include lack of complete reporting on the exercise training protocols, and potential for attention bias in the exercise group, compared with the control group.

Also, there was considerable variation in the type and prescription of exercises, they said. The sessions were between 1 and 5 days per week for 20-90 minutes per day. The duration of the programs was 4-24 weeks. Mr. Platta said there were too few trials to analyze the effect of different types of exercise separately.

The authors added that it is also important to record frequency and severity of temporary symptomatic changes in response to acute exercise bouts.

"Take-home message is that, taking into account that there are a lot of benefits to exercise, our findings show that the amount of relapses and adverse events are not too high to prevent physicians from recommending exercise [to individuals with MS]."

Mr. Platta and his coauthors had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

DALLAS – Exercise is generally safe for individuals with multiple sclerosis, according to a systematic review of randomized, controlled trials, supporting the promotion of exercise in this patient group.

The analysis showed that persons with MS who exercised had 27% lower risk of relapse, compared with patients who didn’t exercise. However, those who exercised had a 67% higher risk of adverse events, but the rate was no higher than adverse events (AEs) in healthy populations.

Frontline Medical News Image Library

"Patients with MS should not be deterred from exercise participation for concern of experiencing a relapse or adverse events, and such patients would further be expected to experience the many benefits of exercise training documented in the literature," wrote Mr. Matthew E. Platta and his colleagues in a study that was published in the Journal of the Neurological Sciences (2014 May 19 [doi:10.1016/j.jns.2014.05.016]).

Although reviews have shown the benefits of exercise for individuals with MS, none have looked at the risks of relapse and other AEs, Mr. Platta said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

Mr. Platta, a graduate student in the department of kinesiology and community health at the University of Illinois at Urbana-Champaign, and his colleagues analyzed 26 trials, including 1,295 participants. The trials were published up to November 2013 and examined the effect of exercise on MS relapses and adverse events. All trials included a nontreatment control arm.

The exercises included yoga, resistance training, aerobics, aquatics, and combined aerobics and resistance training.

Results showed that there were 26 relapses in the control groups, compared with 29 in the exercise group, corresponding with 6.3% and 4.6% of participants in the control and exercise groups, respectively.

The exercise group also had a 27% lower relative risk of relapse.

As for AEs, there were 5 in the control group, compared with 13 in the exercise group (or 1.2% and 2.0% in each group, respectively).

But the exercise group had a 67% higher relative risk of AEs, compared with the control group. However, the rate was not higher than the rates of AEs associated with exercise training in healthy populations, the researchers said.

The most common AEs in the control group were illness, ankle sprain, knee pain, and fall. The exercise group had additional AEs, including stroke, low back pain, trigeminal neuralgia, traffic accident, upper respiratory tract infection, rheumatoid arthritis flare up, and hernia. The most common types of AEs were musculoskeletal injuries (46%) and illnesses (23%).

"MS patients and clinicians can expect a low occurrence of AEs with exercise training, and, when AEs do occur, such events are commonly musculoskeletal in nature," Mr. Platta and his colleagues wrote.

There was no difference in the dropout rate between the two groups. The authors noted that "Future research might consider the inclusion of behavioral strategies for reducing dropout in RCTs of exercise training in MS."

They said that some of the analysis limitations include lack of complete reporting on the exercise training protocols, and potential for attention bias in the exercise group, compared with the control group.

Also, there was considerable variation in the type and prescription of exercises, they said. The sessions were between 1 and 5 days per week for 20-90 minutes per day. The duration of the programs was 4-24 weeks. Mr. Platta said there were too few trials to analyze the effect of different types of exercise separately.

The authors added that it is also important to record frequency and severity of temporary symptomatic changes in response to acute exercise bouts.

"Take-home message is that, taking into account that there are a lot of benefits to exercise, our findings show that the amount of relapses and adverse events are not too high to prevent physicians from recommending exercise [to individuals with MS]."

Mr. Platta and his coauthors had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

DALLAS – Exercise is generally safe for individuals with multiple sclerosis, according to a systematic review of randomized, controlled trials, supporting the promotion of exercise in this patient group.

The analysis showed that persons with MS who exercised had 27% lower risk of relapse, compared with patients who didn’t exercise. However, those who exercised had a 67% higher risk of adverse events, but the rate was no higher than adverse events (AEs) in healthy populations.

Frontline Medical News Image Library

"Patients with MS should not be deterred from exercise participation for concern of experiencing a relapse or adverse events, and such patients would further be expected to experience the many benefits of exercise training documented in the literature," wrote Mr. Matthew E. Platta and his colleagues in a study that was published in the Journal of the Neurological Sciences (2014 May 19 [doi:10.1016/j.jns.2014.05.016]).

Although reviews have shown the benefits of exercise for individuals with MS, none have looked at the risks of relapse and other AEs, Mr. Platta said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

Mr. Platta, a graduate student in the department of kinesiology and community health at the University of Illinois at Urbana-Champaign, and his colleagues analyzed 26 trials, including 1,295 participants. The trials were published up to November 2013 and examined the effect of exercise on MS relapses and adverse events. All trials included a nontreatment control arm.

The exercises included yoga, resistance training, aerobics, aquatics, and combined aerobics and resistance training.

Results showed that there were 26 relapses in the control groups, compared with 29 in the exercise group, corresponding with 6.3% and 4.6% of participants in the control and exercise groups, respectively.

The exercise group also had a 27% lower relative risk of relapse.

As for AEs, there were 5 in the control group, compared with 13 in the exercise group (or 1.2% and 2.0% in each group, respectively).

But the exercise group had a 67% higher relative risk of AEs, compared with the control group. However, the rate was not higher than the rates of AEs associated with exercise training in healthy populations, the researchers said.

The most common AEs in the control group were illness, ankle sprain, knee pain, and fall. The exercise group had additional AEs, including stroke, low back pain, trigeminal neuralgia, traffic accident, upper respiratory tract infection, rheumatoid arthritis flare up, and hernia. The most common types of AEs were musculoskeletal injuries (46%) and illnesses (23%).

"MS patients and clinicians can expect a low occurrence of AEs with exercise training, and, when AEs do occur, such events are commonly musculoskeletal in nature," Mr. Platta and his colleagues wrote.

There was no difference in the dropout rate between the two groups. The authors noted that "Future research might consider the inclusion of behavioral strategies for reducing dropout in RCTs of exercise training in MS."

They said that some of the analysis limitations include lack of complete reporting on the exercise training protocols, and potential for attention bias in the exercise group, compared with the control group.

Also, there was considerable variation in the type and prescription of exercises, they said. The sessions were between 1 and 5 days per week for 20-90 minutes per day. The duration of the programs was 4-24 weeks. Mr. Platta said there were too few trials to analyze the effect of different types of exercise separately.

The authors added that it is also important to record frequency and severity of temporary symptomatic changes in response to acute exercise bouts.

"Take-home message is that, taking into account that there are a lot of benefits to exercise, our findings show that the amount of relapses and adverse events are not too high to prevent physicians from recommending exercise [to individuals with MS]."

Mr. Platta and his coauthors had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

DALLAS – Identifying and correcting low 25-hydroxyvitamin D levels early in the course of multiple sclerosis was associated with improved outcomes, results of a randomized study showed.

"In people who have had MS for many years, a low vitamin D level may be a consequence of the disease rather than a cause," Dr. Alberto Ascherio, a professor of epidemiology and nutrition at Harvard Medical School, Boston, said in an interview during the poster session at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

Whitney McKnight/Frontline Medical News

"We looked at whether, at the first sign of a demyelinating attack, did the vitamin D level predict the long-term outcome of the disease?" Dr. Ascherio said.

Accordingly, in a randomized study, Dr. Ascherio and his colleagues found that patients with low vitamin D levels were found to have higher MS activity and more relapses with accelerated brain atrophy and neurodegeneration over a 5-year period, compared with patients whose vitamin D levels were higher.

In the study, 216 patients with clinically isolated syndrome (CIS) and two or fewer clinically silent brain lesions detected with imaging were randomly assigned to the early treatment arm. They received interferon beta-1b (Betaseron) 250 mcg subcutaneously every other day. The control arm of 118 patients, also with CIS and two or fewer clinically silent brain lesions received placebo treatment. The results of the study are published in JAMA Neurology (2014;71:306-14).

Serum levels of 25-hydroxyvitamin D [25(OH)D] were taken at baseline, and at 6, 12, and 24 months. The effects of 25(OH)D levels in patients assigned early treatment with interferon beta-1b were assessed by analyzing the vitamin’s serum concentration as a continuous variable at 20 ng/mL (50 nmol/L) increments, or as a dichotomous variable at levels less than 50 nmol/L vs. those of 50 nmol/L or greater.

Clinical and imaging follow-up was conducted on both treatment arms through 5 years.

Serum concentrations of 25(OH)D that increased by 20 ng/mL at 12 months resulted in a lower probability of conversion to MS (hazard ratio, 0.43; 95% confidence interval, 0.22-0.84; P = .01), and a lower trend toward conversion to clinically definite MS (HR, 0.48, 95% CI, 0.22-1.04; P = .06). The rate of newly active lesions was lower, with a rate ratio of 0.31 (95% CI, 0.15-0.61; P = .0008), and the rate ratio of relapse was 0.38 (95% CI, 0.14-0.99; P = .048).

With a 20 ng/mL change in [25(OH)D] in the first 12 months, the annual percentage change in T2 lesion volume was –26% (–39% to –12%; P = .0007), while the annual percent decline in brain volume was 0.64% (0.08% to 1.2%; P = .02).

The occurrence of flulike symptoms, commonly reported in interferon beta-1b treatment, was found not to differ according to 25(OH)D plasma levels in patients in the early treatment arm when tested at 6, 12, and 24 months.

Dr. Ascherio noted the findings were limited by the question of its generalizability, since nearly all patients were of white, of European descent, and had begun their treatment early. However, he concluded that the role of vitamin D in the course of the disease is now established and that, "it’s important to identify those patients with lower levels and correct their vitamin D deficiency early in the disease course."

This study was funded by Bayer. Dr. Ascherio said he has received honoraria from Almirall, Roche, Sanofi-Aventis, and Serono.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

DALLAS – Identifying and correcting low 25-hydroxyvitamin D levels early in the course of multiple sclerosis was associated with improved outcomes, results of a randomized study showed.

"In people who have had MS for many years, a low vitamin D level may be a consequence of the disease rather than a cause," Dr. Alberto Ascherio, a professor of epidemiology and nutrition at Harvard Medical School, Boston, said in an interview during the poster session at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

Whitney McKnight/Frontline Medical News

"We looked at whether, at the first sign of a demyelinating attack, did the vitamin D level predict the long-term outcome of the disease?" Dr. Ascherio said.

Accordingly, in a randomized study, Dr. Ascherio and his colleagues found that patients with low vitamin D levels were found to have higher MS activity and more relapses with accelerated brain atrophy and neurodegeneration over a 5-year period, compared with patients whose vitamin D levels were higher.

In the study, 216 patients with clinically isolated syndrome (CIS) and two or fewer clinically silent brain lesions detected with imaging were randomly assigned to the early treatment arm. They received interferon beta-1b (Betaseron) 250 mcg subcutaneously every other day. The control arm of 118 patients, also with CIS and two or fewer clinically silent brain lesions received placebo treatment. The results of the study are published in JAMA Neurology (2014;71:306-14).

Serum levels of 25-hydroxyvitamin D [25(OH)D] were taken at baseline, and at 6, 12, and 24 months. The effects of 25(OH)D levels in patients assigned early treatment with interferon beta-1b were assessed by analyzing the vitamin’s serum concentration as a continuous variable at 20 ng/mL (50 nmol/L) increments, or as a dichotomous variable at levels less than 50 nmol/L vs. those of 50 nmol/L or greater.

Clinical and imaging follow-up was conducted on both treatment arms through 5 years.

Serum concentrations of 25(OH)D that increased by 20 ng/mL at 12 months resulted in a lower probability of conversion to MS (hazard ratio, 0.43; 95% confidence interval, 0.22-0.84; P = .01), and a lower trend toward conversion to clinically definite MS (HR, 0.48, 95% CI, 0.22-1.04; P = .06). The rate of newly active lesions was lower, with a rate ratio of 0.31 (95% CI, 0.15-0.61; P = .0008), and the rate ratio of relapse was 0.38 (95% CI, 0.14-0.99; P = .048).

With a 20 ng/mL change in [25(OH)D] in the first 12 months, the annual percentage change in T2 lesion volume was –26% (–39% to –12%; P = .0007), while the annual percent decline in brain volume was 0.64% (0.08% to 1.2%; P = .02).

The occurrence of flulike symptoms, commonly reported in interferon beta-1b treatment, was found not to differ according to 25(OH)D plasma levels in patients in the early treatment arm when tested at 6, 12, and 24 months.

Dr. Ascherio noted the findings were limited by the question of its generalizability, since nearly all patients were of white, of European descent, and had begun their treatment early. However, he concluded that the role of vitamin D in the course of the disease is now established and that, "it’s important to identify those patients with lower levels and correct their vitamin D deficiency early in the disease course."

This study was funded by Bayer. Dr. Ascherio said he has received honoraria from Almirall, Roche, Sanofi-Aventis, and Serono.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

DALLAS – Identifying and correcting low 25-hydroxyvitamin D levels early in the course of multiple sclerosis was associated with improved outcomes, results of a randomized study showed.

"In people who have had MS for many years, a low vitamin D level may be a consequence of the disease rather than a cause," Dr. Alberto Ascherio, a professor of epidemiology and nutrition at Harvard Medical School, Boston, said in an interview during the poster session at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

Whitney McKnight/Frontline Medical News

"We looked at whether, at the first sign of a demyelinating attack, did the vitamin D level predict the long-term outcome of the disease?" Dr. Ascherio said.

Accordingly, in a randomized study, Dr. Ascherio and his colleagues found that patients with low vitamin D levels were found to have higher MS activity and more relapses with accelerated brain atrophy and neurodegeneration over a 5-year period, compared with patients whose vitamin D levels were higher.

In the study, 216 patients with clinically isolated syndrome (CIS) and two or fewer clinically silent brain lesions detected with imaging were randomly assigned to the early treatment arm. They received interferon beta-1b (Betaseron) 250 mcg subcutaneously every other day. The control arm of 118 patients, also with CIS and two or fewer clinically silent brain lesions received placebo treatment. The results of the study are published in JAMA Neurology (2014;71:306-14).

Serum levels of 25-hydroxyvitamin D [25(OH)D] were taken at baseline, and at 6, 12, and 24 months. The effects of 25(OH)D levels in patients assigned early treatment with interferon beta-1b were assessed by analyzing the vitamin’s serum concentration as a continuous variable at 20 ng/mL (50 nmol/L) increments, or as a dichotomous variable at levels less than 50 nmol/L vs. those of 50 nmol/L or greater.

Clinical and imaging follow-up was conducted on both treatment arms through 5 years.

Serum concentrations of 25(OH)D that increased by 20 ng/mL at 12 months resulted in a lower probability of conversion to MS (hazard ratio, 0.43; 95% confidence interval, 0.22-0.84; P = .01), and a lower trend toward conversion to clinically definite MS (HR, 0.48, 95% CI, 0.22-1.04; P = .06). The rate of newly active lesions was lower, with a rate ratio of 0.31 (95% CI, 0.15-0.61; P = .0008), and the rate ratio of relapse was 0.38 (95% CI, 0.14-0.99; P = .048).

With a 20 ng/mL change in [25(OH)D] in the first 12 months, the annual percentage change in T2 lesion volume was –26% (–39% to –12%; P = .0007), while the annual percent decline in brain volume was 0.64% (0.08% to 1.2%; P = .02).

The occurrence of flulike symptoms, commonly reported in interferon beta-1b treatment, was found not to differ according to 25(OH)D plasma levels in patients in the early treatment arm when tested at 6, 12, and 24 months.

Dr. Ascherio noted the findings were limited by the question of its generalizability, since nearly all patients were of white, of European descent, and had begun their treatment early. However, he concluded that the role of vitamin D in the course of the disease is now established and that, "it’s important to identify those patients with lower levels and correct their vitamin D deficiency early in the disease course."

This study was funded by Bayer. Dr. Ascherio said he has received honoraria from Almirall, Roche, Sanofi-Aventis, and Serono.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

DALLAS – The North American Registry for Care and Research in MS, a national database of multiple sclerosis patients, and the first of its kind, is expected to change multiple sclerosis care in the next decade.

The NARCRMS, which acts as both a database and a registry, will collect patient information from MS centers across the United States over time. It is modeled after the Alzheimer’s Disease Neuroimaging Initiative (ADNI), and it’s a collaboration between the industry and MS centers to create an open source database, "available in real time to patients, physicians, and industry," Dr. Kottil W. Rammohan, professor of clinical neurology and director of the MS center of excellence at the University of Miami, said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

The NARCRMS, not to be confused with NARCOMS (North American Research Committee on Multiple Sclerosis), hasn’t launched yet – it will be established later this year – but the leaders have great hopes for it, and say that it will help find answers to questions that exist because of a lack of data.

For instance, there are very few head-to-head trials comparing drugs with each other. The database could provide insight and the answer, said Dr. Rammohan.

More information and details will be available once the database is launched, but Dr. Rammohan provided an overview of the NARCRMS, and explained why a database hasn’t been established until now.

Dr. Rammohan said he had no relevant financial disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

DALLAS – The North American Registry for Care and Research in MS, a national database of multiple sclerosis patients, and the first of its kind, is expected to change multiple sclerosis care in the next decade.

The NARCRMS, which acts as both a database and a registry, will collect patient information from MS centers across the United States over time. It is modeled after the Alzheimer’s Disease Neuroimaging Initiative (ADNI), and it’s a collaboration between the industry and MS centers to create an open source database, "available in real time to patients, physicians, and industry," Dr. Kottil W. Rammohan, professor of clinical neurology and director of the MS center of excellence at the University of Miami, said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

The NARCRMS, not to be confused with NARCOMS (North American Research Committee on Multiple Sclerosis), hasn’t launched yet – it will be established later this year – but the leaders have great hopes for it, and say that it will help find answers to questions that exist because of a lack of data.

For instance, there are very few head-to-head trials comparing drugs with each other. The database could provide insight and the answer, said Dr. Rammohan.

More information and details will be available once the database is launched, but Dr. Rammohan provided an overview of the NARCRMS, and explained why a database hasn’t been established until now.

Dr. Rammohan said he had no relevant financial disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

DALLAS – The North American Registry for Care and Research in MS, a national database of multiple sclerosis patients, and the first of its kind, is expected to change multiple sclerosis care in the next decade.

The NARCRMS, which acts as both a database and a registry, will collect patient information from MS centers across the United States over time. It is modeled after the Alzheimer’s Disease Neuroimaging Initiative (ADNI), and it’s a collaboration between the industry and MS centers to create an open source database, "available in real time to patients, physicians, and industry," Dr. Kottil W. Rammohan, professor of clinical neurology and director of the MS center of excellence at the University of Miami, said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

The NARCRMS, not to be confused with NARCOMS (North American Research Committee on Multiple Sclerosis), hasn’t launched yet – it will be established later this year – but the leaders have great hopes for it, and say that it will help find answers to questions that exist because of a lack of data.

For instance, there are very few head-to-head trials comparing drugs with each other. The database could provide insight and the answer, said Dr. Rammohan.

More information and details will be available once the database is launched, but Dr. Rammohan provided an overview of the NARCRMS, and explained why a database hasn’t been established until now.

Dr. Rammohan said he had no relevant financial disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

DALLAS – The superior performance of an iPad-based app for the self-administration of the multiple sclerosis performance test, when compared with a technician-administered one, could mean big changes in how data are collected and interpreted for the purposes of clinical trials and disease management, according to an expert.

"There are some important implications of this," said Dr. Richard Rudick, who was director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic until recently accepting a position with Biogen Idec as vice president, development sciences, Value-Based Medicine Group.

Among the considerations implicated by the findings is that unfiltered, accurate patient data could be transferred in real time to the "cloud" where it would be available for immediate viewing, as well as kept for future study. This would give clinicians new ways to "collect, display, aggregate, and analyze neurological performance," Dr. Rudick said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

iPad app bested technician performance

The app-based multiple sclerosis performance test (MSPT) was developed by Dr. Rudick and his colleagues to simulate the technician-based one in all aspects and comprises the walking speed test, the manual dexterity test, the low-contrast visual acuity test, and the processing speed test. These approximate the MSPT’s timed 25-foot walk test, the 9-hole peg test, the Sloan low-contrast visual acuity test, and the Symbol Digit Modalities Test.

The industry-sponsored, cross-sectional validation study matched 49 healthy controls with 51 patients according to age, sex, and education. Roughly three-quarters of the study arm had relapsing MS, and a quarter had the progressive form of the disease.

Participants were tested at a single site via each modality, once in the morning and then again in the afternoon. The test/retest results were consistent and correlative, according to Dr. Rudick. "They were highly reliable, whether the technician did it, or the iPad," he said.

The question was whether the two tests were measuring the same thing. Because data for all aspects of each test were comparable, Dr. Rudick concluded that the tests were comparable.

The most important measure was how well the app version separated the two study groups, when compared with the ability of the technician-based test, according to Dr. Rudick. "In virtually every case, except for the visual, the iPad actually does a little bit better than the technician in distinguishing the MS patients from the healthy controls," he said.

For example, in the timed 25-foot walk test administered by the technician, the mean score in the MS group was 7 (P less than .001; standard deviation, 4.28), while the mean score for the walking speed test in the MS group was 7.26 (P less than .001; SD, 4.25). In the healthy controls group, the mean score for the technician-given test was 4.24 (P less than .001). That group’s mean score for the self-given walking speed test was 4.27 (P less than .001; SD, 4.27).

Still need humans

Patient-reported outcomes were also correlative to both forms of the tests. However, in an interview after the presentation, Dr. Rudick said that patient-reported cognitive impairment doesn’t usually correlate with the actual measurements used in neurocognitive testing. "What does seem to correlate with patients reporting cognitive impairment is if they are depressed. Then the depression score matches the patient-reported cognitive impairment better than the actual cognitive test score does," he said.

When Dr. Rudick asked the audience, which included many physician assistants and registered nurses in addition to physicians, whether they would embrace the use of this technology, the majority assented. However, during the discussion following the presentation, Neil Jouvenant, a physician assistant at the University of Nebraska Medical Center in Omaha, said there are some patients for whom this technology would not be appropriate, such as those who walk with difficulty.

In an interview, Mr. Jouvenant said that in addition, "you still need a technician to instruct and encourage patients. If the iPad were to instruct a patient to ‘get up now, strap this to your back, and walk 25 feet,’ they won’t because they don’t really think they can. There is a fine line between someone who can walk a certain distance and someone who can’t." The technician can help in those situations, he said.

More inclusive and comprehensive

Although Dr. Rudick agreed that at least for now, this technology is not appropriate for all patients, the technology does hold promise for those who would have been excluded in the past, such as patients who live in rural areas but would like to participate in clinical trials.

The collection of normative data from healthy adults will also mean that clinical interpretations of MSPT scores will have broader utility in MS patients and groups, and the technology can be adapted to yield additional data such as specific measurements for balance and speed.

Dr. Patricia Coyle, professor of psychiatry and neurology at the State University of New York at Stony Brook, and director of the MS comprehensive care center there, said in an interview that technology such as this has the power to "revolutionize" disease management, particularly if it is collected into a central database accessible to any clinician or researcher.

"There are only so many MS patients, and we don’t have a good idea of their disease activity. They’re not tracked. No one’s trying to pull that data together," she said. But having these data "potentially would mean revolutionizing" the field.

Novartis funded the study on the MSPT app. Dr. Rudick said that he has received consulting fees from Genzyme and Novartis. Dr. Coyle reported she has financial relationships with Biogen Idec, Genentech, and Genzyme, among others.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

DALLAS – The superior performance of an iPad-based app for the self-administration of the multiple sclerosis performance test, when compared with a technician-administered one, could mean big changes in how data are collected and interpreted for the purposes of clinical trials and disease management, according to an expert.

"There are some important implications of this," said Dr. Richard Rudick, who was director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic until recently accepting a position with Biogen Idec as vice president, development sciences, Value-Based Medicine Group.

Among the considerations implicated by the findings is that unfiltered, accurate patient data could be transferred in real time to the "cloud" where it would be available for immediate viewing, as well as kept for future study. This would give clinicians new ways to "collect, display, aggregate, and analyze neurological performance," Dr. Rudick said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

iPad app bested technician performance

The app-based multiple sclerosis performance test (MSPT) was developed by Dr. Rudick and his colleagues to simulate the technician-based one in all aspects and comprises the walking speed test, the manual dexterity test, the low-contrast visual acuity test, and the processing speed test. These approximate the MSPT’s timed 25-foot walk test, the 9-hole peg test, the Sloan low-contrast visual acuity test, and the Symbol Digit Modalities Test.

The industry-sponsored, cross-sectional validation study matched 49 healthy controls with 51 patients according to age, sex, and education. Roughly three-quarters of the study arm had relapsing MS, and a quarter had the progressive form of the disease.

Participants were tested at a single site via each modality, once in the morning and then again in the afternoon. The test/retest results were consistent and correlative, according to Dr. Rudick. "They were highly reliable, whether the technician did it, or the iPad," he said.

The question was whether the two tests were measuring the same thing. Because data for all aspects of each test were comparable, Dr. Rudick concluded that the tests were comparable.

The most important measure was how well the app version separated the two study groups, when compared with the ability of the technician-based test, according to Dr. Rudick. "In virtually every case, except for the visual, the iPad actually does a little bit better than the technician in distinguishing the MS patients from the healthy controls," he said.

For example, in the timed 25-foot walk test administered by the technician, the mean score in the MS group was 7 (P less than .001; standard deviation, 4.28), while the mean score for the walking speed test in the MS group was 7.26 (P less than .001; SD, 4.25). In the healthy controls group, the mean score for the technician-given test was 4.24 (P less than .001). That group’s mean score for the self-given walking speed test was 4.27 (P less than .001; SD, 4.27).

Still need humans

Patient-reported outcomes were also correlative to both forms of the tests. However, in an interview after the presentation, Dr. Rudick said that patient-reported cognitive impairment doesn’t usually correlate with the actual measurements used in neurocognitive testing. "What does seem to correlate with patients reporting cognitive impairment is if they are depressed. Then the depression score matches the patient-reported cognitive impairment better than the actual cognitive test score does," he said.

When Dr. Rudick asked the audience, which included many physician assistants and registered nurses in addition to physicians, whether they would embrace the use of this technology, the majority assented. However, during the discussion following the presentation, Neil Jouvenant, a physician assistant at the University of Nebraska Medical Center in Omaha, said there are some patients for whom this technology would not be appropriate, such as those who walk with difficulty.

In an interview, Mr. Jouvenant said that in addition, "you still need a technician to instruct and encourage patients. If the iPad were to instruct a patient to ‘get up now, strap this to your back, and walk 25 feet,’ they won’t because they don’t really think they can. There is a fine line between someone who can walk a certain distance and someone who can’t." The technician can help in those situations, he said.

More inclusive and comprehensive

Although Dr. Rudick agreed that at least for now, this technology is not appropriate for all patients, the technology does hold promise for those who would have been excluded in the past, such as patients who live in rural areas but would like to participate in clinical trials.

The collection of normative data from healthy adults will also mean that clinical interpretations of MSPT scores will have broader utility in MS patients and groups, and the technology can be adapted to yield additional data such as specific measurements for balance and speed.

Dr. Patricia Coyle, professor of psychiatry and neurology at the State University of New York at Stony Brook, and director of the MS comprehensive care center there, said in an interview that technology such as this has the power to "revolutionize" disease management, particularly if it is collected into a central database accessible to any clinician or researcher.

"There are only so many MS patients, and we don’t have a good idea of their disease activity. They’re not tracked. No one’s trying to pull that data together," she said. But having these data "potentially would mean revolutionizing" the field.

Novartis funded the study on the MSPT app. Dr. Rudick said that he has received consulting fees from Genzyme and Novartis. Dr. Coyle reported she has financial relationships with Biogen Idec, Genentech, and Genzyme, among others.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

DALLAS – The superior performance of an iPad-based app for the self-administration of the multiple sclerosis performance test, when compared with a technician-administered one, could mean big changes in how data are collected and interpreted for the purposes of clinical trials and disease management, according to an expert.

"There are some important implications of this," said Dr. Richard Rudick, who was director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic until recently accepting a position with Biogen Idec as vice president, development sciences, Value-Based Medicine Group.

Among the considerations implicated by the findings is that unfiltered, accurate patient data could be transferred in real time to the "cloud" where it would be available for immediate viewing, as well as kept for future study. This would give clinicians new ways to "collect, display, aggregate, and analyze neurological performance," Dr. Rudick said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

iPad app bested technician performance

The app-based multiple sclerosis performance test (MSPT) was developed by Dr. Rudick and his colleagues to simulate the technician-based one in all aspects and comprises the walking speed test, the manual dexterity test, the low-contrast visual acuity test, and the processing speed test. These approximate the MSPT’s timed 25-foot walk test, the 9-hole peg test, the Sloan low-contrast visual acuity test, and the Symbol Digit Modalities Test.

The industry-sponsored, cross-sectional validation study matched 49 healthy controls with 51 patients according to age, sex, and education. Roughly three-quarters of the study arm had relapsing MS, and a quarter had the progressive form of the disease.

Participants were tested at a single site via each modality, once in the morning and then again in the afternoon. The test/retest results were consistent and correlative, according to Dr. Rudick. "They were highly reliable, whether the technician did it, or the iPad," he said.

The question was whether the two tests were measuring the same thing. Because data for all aspects of each test were comparable, Dr. Rudick concluded that the tests were comparable.

The most important measure was how well the app version separated the two study groups, when compared with the ability of the technician-based test, according to Dr. Rudick. "In virtually every case, except for the visual, the iPad actually does a little bit better than the technician in distinguishing the MS patients from the healthy controls," he said.

For example, in the timed 25-foot walk test administered by the technician, the mean score in the MS group was 7 (P less than .001; standard deviation, 4.28), while the mean score for the walking speed test in the MS group was 7.26 (P less than .001; SD, 4.25). In the healthy controls group, the mean score for the technician-given test was 4.24 (P less than .001). That group’s mean score for the self-given walking speed test was 4.27 (P less than .001; SD, 4.27).

Still need humans

Patient-reported outcomes were also correlative to both forms of the tests. However, in an interview after the presentation, Dr. Rudick said that patient-reported cognitive impairment doesn’t usually correlate with the actual measurements used in neurocognitive testing. "What does seem to correlate with patients reporting cognitive impairment is if they are depressed. Then the depression score matches the patient-reported cognitive impairment better than the actual cognitive test score does," he said.

When Dr. Rudick asked the audience, which included many physician assistants and registered nurses in addition to physicians, whether they would embrace the use of this technology, the majority assented. However, during the discussion following the presentation, Neil Jouvenant, a physician assistant at the University of Nebraska Medical Center in Omaha, said there are some patients for whom this technology would not be appropriate, such as those who walk with difficulty.

In an interview, Mr. Jouvenant said that in addition, "you still need a technician to instruct and encourage patients. If the iPad were to instruct a patient to ‘get up now, strap this to your back, and walk 25 feet,’ they won’t because they don’t really think they can. There is a fine line between someone who can walk a certain distance and someone who can’t." The technician can help in those situations, he said.

More inclusive and comprehensive

Although Dr. Rudick agreed that at least for now, this technology is not appropriate for all patients, the technology does hold promise for those who would have been excluded in the past, such as patients who live in rural areas but would like to participate in clinical trials.

The collection of normative data from healthy adults will also mean that clinical interpretations of MSPT scores will have broader utility in MS patients and groups, and the technology can be adapted to yield additional data such as specific measurements for balance and speed.

Dr. Patricia Coyle, professor of psychiatry and neurology at the State University of New York at Stony Brook, and director of the MS comprehensive care center there, said in an interview that technology such as this has the power to "revolutionize" disease management, particularly if it is collected into a central database accessible to any clinician or researcher.

"There are only so many MS patients, and we don’t have a good idea of their disease activity. They’re not tracked. No one’s trying to pull that data together," she said. But having these data "potentially would mean revolutionizing" the field.

Novartis funded the study on the MSPT app. Dr. Rudick said that he has received consulting fees from Genzyme and Novartis. Dr. Coyle reported she has financial relationships with Biogen Idec, Genentech, and Genzyme, among others.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight