Multiple Sclerosis Hub

SEATTLE – Researchers are working on new tools to objectively measure several domains affected by multiple sclerosis (MS) in hope of improving patient care, according to Jared Srinivasan.

Mr. Srinivasan, a research coordinator at South Shore Neurologic Associates in Patchogue, N.Y., sat down at the annual meeting of the Consortium of Multiple Sclerosis Centers for a video interview summarizing his work on new measurement tools for assessing disease status in MS patients with Mark Gudesblatt, MD, and other colleagues at South Shore Neurologic Associates.

“We are trying to find better ways of measuring disease status, rather than the EDSS [Expanded Disability Status Scale] ... It is not as sensitive as some other measures can be,” Mr. Srinivasan said. “We are trying to shed light on some new tools regarding objectively measuring cognition, manual dexterity, gait, and ocular coherence tomography.”

The overall goal, he said, “is to use a combination of these granular outcome measures to create a bigger picture of a patient’s disease so we can better treat them.”

One of the tools is called Neurotrax, which measures cognition in multiple dimensions (e.g., attention, information processing, motor skills, verbal functioning). With this and other new tools for manual dexterity and its cognitive aspects, as well as other dimensions of MS, the researchers are trying capture a fuller picture of MS in individual patients.

“The end goal of this is that if we can show that MS is such a complex disease that the current tools we are using do not quite capture the full nuances and granularity in it, then we can move toward using better measures that will capture that, which will move patient care forward.”

Mr. Srinivasan had nothing to disclose.

gwilliams@mdedge.com

SEATTLE – Researchers are working on new tools to objectively measure several domains affected by multiple sclerosis (MS) in hope of improving patient care, according to Jared Srinivasan.

Mr. Srinivasan, a research coordinator at South Shore Neurologic Associates in Patchogue, N.Y., sat down at the annual meeting of the Consortium of Multiple Sclerosis Centers for a video interview summarizing his work on new measurement tools for assessing disease status in MS patients with Mark Gudesblatt, MD, and other colleagues at South Shore Neurologic Associates.

“We are trying to find better ways of measuring disease status, rather than the EDSS [Expanded Disability Status Scale] ... It is not as sensitive as some other measures can be,” Mr. Srinivasan said. “We are trying to shed light on some new tools regarding objectively measuring cognition, manual dexterity, gait, and ocular coherence tomography.”

The overall goal, he said, “is to use a combination of these granular outcome measures to create a bigger picture of a patient’s disease so we can better treat them.”

One of the tools is called Neurotrax, which measures cognition in multiple dimensions (e.g., attention, information processing, motor skills, verbal functioning). With this and other new tools for manual dexterity and its cognitive aspects, as well as other dimensions of MS, the researchers are trying capture a fuller picture of MS in individual patients.

“The end goal of this is that if we can show that MS is such a complex disease that the current tools we are using do not quite capture the full nuances and granularity in it, then we can move toward using better measures that will capture that, which will move patient care forward.”

Mr. Srinivasan had nothing to disclose.

gwilliams@mdedge.com

SEATTLE – Researchers are working on new tools to objectively measure several domains affected by multiple sclerosis (MS) in hope of improving patient care, according to Jared Srinivasan.

Mr. Srinivasan, a research coordinator at South Shore Neurologic Associates in Patchogue, N.Y., sat down at the annual meeting of the Consortium of Multiple Sclerosis Centers for a video interview summarizing his work on new measurement tools for assessing disease status in MS patients with Mark Gudesblatt, MD, and other colleagues at South Shore Neurologic Associates.

“We are trying to find better ways of measuring disease status, rather than the EDSS [Expanded Disability Status Scale] ... It is not as sensitive as some other measures can be,” Mr. Srinivasan said. “We are trying to shed light on some new tools regarding objectively measuring cognition, manual dexterity, gait, and ocular coherence tomography.”

The overall goal, he said, “is to use a combination of these granular outcome measures to create a bigger picture of a patient’s disease so we can better treat them.”

One of the tools is called Neurotrax, which measures cognition in multiple dimensions (e.g., attention, information processing, motor skills, verbal functioning). With this and other new tools for manual dexterity and its cognitive aspects, as well as other dimensions of MS, the researchers are trying capture a fuller picture of MS in individual patients.

“The end goal of this is that if we can show that MS is such a complex disease that the current tools we are using do not quite capture the full nuances and granularity in it, then we can move toward using better measures that will capture that, which will move patient care forward.”

Mr. Srinivasan had nothing to disclose.

gwilliams@mdedge.com

SEATTLE – Patients with multiple sclerosis (MS) may be able to improve cognitive function through a brief course in mindfulness meditation, a new report suggests.

“The present study demonstrated significant improvement in processing speed, a core area of impairment in individuals with MS, following 4 weeks of mindfulness meditation,” said lead author Heena R. Manglani, a graduate student at the Ohio State University, Columbus. She spoke in an interview and in a presentation about the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

An estimated 43%-70% of people with MS experience cognitive decline. This decline “has a sophisticated neuroanatomic and pathophysiologic background and disturbs such vital cognitive domains as speed of information processing, memory, attention, executive functions, and visual perceptual function,” reported the authors of a 2017 review (Rev Neurosci. 2017 Nov 27;28[8]:845-860).

For the new study, researchers tested two strategies for cognitive enhancement in patients with MS. All study participants were aged 31-59 years and relapse free within the previous 30 days; most had relapsing remitting MS, and most did not show signs of cognitive decline.

The researchers assigned 20 patients to a 4-week adaptive computerized cognitive training program and 20 patients to a 4-week mindfulness meditation training program. Another 21 patients were assigned to a control group.

The adaptive training program relied on computerized games designed to boost processing speed, attention, and working memory. The mindfulness training focused on components such as awareness of breathing and of bodily sensations.

Researchers found that “the magnitude of cognitive gain from pre- to post training was greatest in participants in the mindfulness group, who did better than participants in either of the other two groups,” Ms. Manglani said.

Compared with the adaptive cognitive training and the control group, she said, the mindfulness meditation group showed statistically significant improvement in processing speed per scores on the Symbol Digit Modalities Test, which rose from 52.2 before training to 58.4 post training.

The interventions did not appear to have any effect on Paced Auditory Serial Addition scores, which measure working memory.

The findings suggest that “less than 20 hours of mindfulness may be effective in significantly improving processing speed in MS,” Ms. Manglani said. “It is much shorter than a typically delivered program. We hypothesize that you are training attention with mindfulness training. Attention has a lot of overlap with processing speed.”

Ms. Manglani noted that this was a pilot study, and she acknowledged that fairly few participants – only five or six in each group – showed signs of cognitive decline. The study also did not explore whether cognitive improvements translated to real-life changes in cognition.

“This effect needs to be replicated in a larger sample,” Ms. Manglani said, “and future studies are needed to establish the lasting effects of such training and how improvements in cognitive function may generalize to greater engagement in vocational and leisure activities and higher quality of life.”

The study was funded by the National Multiple Sclerosis Society and the National Institutes of Health. The authors reported no relevant disclosures except for one coauthor who received honoraria from Sanofi Genzyme and funding from the National Multiple Sclerosis Society and the NIH.
 

SEATTLE – Patients with multiple sclerosis (MS) may be able to improve cognitive function through a brief course in mindfulness meditation, a new report suggests.

“The present study demonstrated significant improvement in processing speed, a core area of impairment in individuals with MS, following 4 weeks of mindfulness meditation,” said lead author Heena R. Manglani, a graduate student at the Ohio State University, Columbus. She spoke in an interview and in a presentation about the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

An estimated 43%-70% of people with MS experience cognitive decline. This decline “has a sophisticated neuroanatomic and pathophysiologic background and disturbs such vital cognitive domains as speed of information processing, memory, attention, executive functions, and visual perceptual function,” reported the authors of a 2017 review (Rev Neurosci. 2017 Nov 27;28[8]:845-860).

For the new study, researchers tested two strategies for cognitive enhancement in patients with MS. All study participants were aged 31-59 years and relapse free within the previous 30 days; most had relapsing remitting MS, and most did not show signs of cognitive decline.

The researchers assigned 20 patients to a 4-week adaptive computerized cognitive training program and 20 patients to a 4-week mindfulness meditation training program. Another 21 patients were assigned to a control group.

The adaptive training program relied on computerized games designed to boost processing speed, attention, and working memory. The mindfulness training focused on components such as awareness of breathing and of bodily sensations.

Researchers found that “the magnitude of cognitive gain from pre- to post training was greatest in participants in the mindfulness group, who did better than participants in either of the other two groups,” Ms. Manglani said.

Compared with the adaptive cognitive training and the control group, she said, the mindfulness meditation group showed statistically significant improvement in processing speed per scores on the Symbol Digit Modalities Test, which rose from 52.2 before training to 58.4 post training.

The interventions did not appear to have any effect on Paced Auditory Serial Addition scores, which measure working memory.

The findings suggest that “less than 20 hours of mindfulness may be effective in significantly improving processing speed in MS,” Ms. Manglani said. “It is much shorter than a typically delivered program. We hypothesize that you are training attention with mindfulness training. Attention has a lot of overlap with processing speed.”

Ms. Manglani noted that this was a pilot study, and she acknowledged that fairly few participants – only five or six in each group – showed signs of cognitive decline. The study also did not explore whether cognitive improvements translated to real-life changes in cognition.

“This effect needs to be replicated in a larger sample,” Ms. Manglani said, “and future studies are needed to establish the lasting effects of such training and how improvements in cognitive function may generalize to greater engagement in vocational and leisure activities and higher quality of life.”

The study was funded by the National Multiple Sclerosis Society and the National Institutes of Health. The authors reported no relevant disclosures except for one coauthor who received honoraria from Sanofi Genzyme and funding from the National Multiple Sclerosis Society and the NIH.
 

SEATTLE – Patients with multiple sclerosis (MS) may be able to improve cognitive function through a brief course in mindfulness meditation, a new report suggests.

“The present study demonstrated significant improvement in processing speed, a core area of impairment in individuals with MS, following 4 weeks of mindfulness meditation,” said lead author Heena R. Manglani, a graduate student at the Ohio State University, Columbus. She spoke in an interview and in a presentation about the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

An estimated 43%-70% of people with MS experience cognitive decline. This decline “has a sophisticated neuroanatomic and pathophysiologic background and disturbs such vital cognitive domains as speed of information processing, memory, attention, executive functions, and visual perceptual function,” reported the authors of a 2017 review (Rev Neurosci. 2017 Nov 27;28[8]:845-860).

For the new study, researchers tested two strategies for cognitive enhancement in patients with MS. All study participants were aged 31-59 years and relapse free within the previous 30 days; most had relapsing remitting MS, and most did not show signs of cognitive decline.

The researchers assigned 20 patients to a 4-week adaptive computerized cognitive training program and 20 patients to a 4-week mindfulness meditation training program. Another 21 patients were assigned to a control group.

The adaptive training program relied on computerized games designed to boost processing speed, attention, and working memory. The mindfulness training focused on components such as awareness of breathing and of bodily sensations.

Researchers found that “the magnitude of cognitive gain from pre- to post training was greatest in participants in the mindfulness group, who did better than participants in either of the other two groups,” Ms. Manglani said.

Compared with the adaptive cognitive training and the control group, she said, the mindfulness meditation group showed statistically significant improvement in processing speed per scores on the Symbol Digit Modalities Test, which rose from 52.2 before training to 58.4 post training.

The interventions did not appear to have any effect on Paced Auditory Serial Addition scores, which measure working memory.

The findings suggest that “less than 20 hours of mindfulness may be effective in significantly improving processing speed in MS,” Ms. Manglani said. “It is much shorter than a typically delivered program. We hypothesize that you are training attention with mindfulness training. Attention has a lot of overlap with processing speed.”

Ms. Manglani noted that this was a pilot study, and she acknowledged that fairly few participants – only five or six in each group – showed signs of cognitive decline. The study also did not explore whether cognitive improvements translated to real-life changes in cognition.

“This effect needs to be replicated in a larger sample,” Ms. Manglani said, “and future studies are needed to establish the lasting effects of such training and how improvements in cognitive function may generalize to greater engagement in vocational and leisure activities and higher quality of life.”

The study was funded by the National Multiple Sclerosis Society and the National Institutes of Health. The authors reported no relevant disclosures except for one coauthor who received honoraria from Sanofi Genzyme and funding from the National Multiple Sclerosis Society and the NIH.
 

SEATTLE – Among patients with active relapsing-remitting multiple sclerosis (MS) who have been treated with interferon beta-1a, switching to alemtuzumab improves clinical and MRI outcomes, according to an analysis presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These outcomes may be maintained for 6 years without continuous treatment, said the investigators.

The CARE-MS II study demonstrated alemtuzumab’s superior efficacy, compared with subcutaneous interferon beta-1a, over 2 years in patients with active relapsing-remitting MS who had had an inadequate response to previous therapy. The trial was followed by a 4-year extension, during which patients who had received interferon beta-1a were given the option of discontinuing that therapy and initiating alemtuzumab. The alemtuzumab regimen for these patients was 12 mg/day for 5 consecutive days at baseline, and the same dose for 3 consecutive days at 1 year. Additional annual alemtuzumab as needed for disease activity was allowed. At investigators’ discretion, patients could receive other disease-modifying therapy (DMT) at any time. After the 4-year extension, patients could continue in the 5-year TOPAZ extension.

Carolina Ionete, MD, a neurologist at University of Massachusetts Memorial Medical Center in Worcester, and colleagues examined data from the TOPAZ extension study to evaluate the efficacy and safety of alemtuzumab over 6 years in patients with relapsing-remitting MS from CARE-MS II who discontinued interferon beta-1a. In TOPAZ, patients can receive additional alemtuzumab (12 mg/day on 3 consecutive days at 12 or more months after the most recent course) or other DMTs at any time at investigators’ discretion.

In all, 143 patients started alemtuzumab in the extension study. Of this group 117 patients (82%) completed year 2 of TOPAZ (i.e., year 6 after initiating alemtuzumab). The annualized relapse rate at year 6 was 0.19, and the annual rate of freedom from relapse ranged from 83% to 90% during years 1 through 6. At year 6, Expanded Disability Status Scale (EDSS) scores were stable (51%) or improved (17%) in 68% of patients, compared with the baseline of the main study. At year 6, the mean EDSS score change was 0.43. Over 6 years, 69% of patients were free from 6-month confirmed disability worsening, and 23% achieved 6-month confirmed disability improvement.

In addition, 69% of patients were free of MRI disease activity in year 6. The median percent cumulative brain volume loss from alemtuzumab initiation through year 6 was 0.53%, compared with 0.81% over 2 years with interferon beta-1a. Brain volume loss was 0.32% or less annually during years 2 through 6 after initiating alemtuzumab (0.04% at year 2, 0.15% at year 3, 0.14% at year 4, 0.07% at year 5, and 0.32% at year 6). These efficacy outcomes were observed as 57% of patients received neither additional alemtuzumab nor another DMT through year 6. Safety results were consistent with those for the alemtuzumab-treated patients in the core and extension studies.

Sanofi and Bayer HealthCare Pharmaceuticals supported this study. Dr. Ionete received research support from Biogen, Roche, and Sanofi. She reported receiving compensation for advisory board participation from Sanofi.

egreb@mdedge.com

SEATTLE – Among patients with active relapsing-remitting multiple sclerosis (MS) who have been treated with interferon beta-1a, switching to alemtuzumab improves clinical and MRI outcomes, according to an analysis presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These outcomes may be maintained for 6 years without continuous treatment, said the investigators.

The CARE-MS II study demonstrated alemtuzumab’s superior efficacy, compared with subcutaneous interferon beta-1a, over 2 years in patients with active relapsing-remitting MS who had had an inadequate response to previous therapy. The trial was followed by a 4-year extension, during which patients who had received interferon beta-1a were given the option of discontinuing that therapy and initiating alemtuzumab. The alemtuzumab regimen for these patients was 12 mg/day for 5 consecutive days at baseline, and the same dose for 3 consecutive days at 1 year. Additional annual alemtuzumab as needed for disease activity was allowed. At investigators’ discretion, patients could receive other disease-modifying therapy (DMT) at any time. After the 4-year extension, patients could continue in the 5-year TOPAZ extension.

Carolina Ionete, MD, a neurologist at University of Massachusetts Memorial Medical Center in Worcester, and colleagues examined data from the TOPAZ extension study to evaluate the efficacy and safety of alemtuzumab over 6 years in patients with relapsing-remitting MS from CARE-MS II who discontinued interferon beta-1a. In TOPAZ, patients can receive additional alemtuzumab (12 mg/day on 3 consecutive days at 12 or more months after the most recent course) or other DMTs at any time at investigators’ discretion.

In all, 143 patients started alemtuzumab in the extension study. Of this group 117 patients (82%) completed year 2 of TOPAZ (i.e., year 6 after initiating alemtuzumab). The annualized relapse rate at year 6 was 0.19, and the annual rate of freedom from relapse ranged from 83% to 90% during years 1 through 6. At year 6, Expanded Disability Status Scale (EDSS) scores were stable (51%) or improved (17%) in 68% of patients, compared with the baseline of the main study. At year 6, the mean EDSS score change was 0.43. Over 6 years, 69% of patients were free from 6-month confirmed disability worsening, and 23% achieved 6-month confirmed disability improvement.

In addition, 69% of patients were free of MRI disease activity in year 6. The median percent cumulative brain volume loss from alemtuzumab initiation through year 6 was 0.53%, compared with 0.81% over 2 years with interferon beta-1a. Brain volume loss was 0.32% or less annually during years 2 through 6 after initiating alemtuzumab (0.04% at year 2, 0.15% at year 3, 0.14% at year 4, 0.07% at year 5, and 0.32% at year 6). These efficacy outcomes were observed as 57% of patients received neither additional alemtuzumab nor another DMT through year 6. Safety results were consistent with those for the alemtuzumab-treated patients in the core and extension studies.

Sanofi and Bayer HealthCare Pharmaceuticals supported this study. Dr. Ionete received research support from Biogen, Roche, and Sanofi. She reported receiving compensation for advisory board participation from Sanofi.

egreb@mdedge.com

SEATTLE – Among patients with active relapsing-remitting multiple sclerosis (MS) who have been treated with interferon beta-1a, switching to alemtuzumab improves clinical and MRI outcomes, according to an analysis presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These outcomes may be maintained for 6 years without continuous treatment, said the investigators.

The CARE-MS II study demonstrated alemtuzumab’s superior efficacy, compared with subcutaneous interferon beta-1a, over 2 years in patients with active relapsing-remitting MS who had had an inadequate response to previous therapy. The trial was followed by a 4-year extension, during which patients who had received interferon beta-1a were given the option of discontinuing that therapy and initiating alemtuzumab. The alemtuzumab regimen for these patients was 12 mg/day for 5 consecutive days at baseline, and the same dose for 3 consecutive days at 1 year. Additional annual alemtuzumab as needed for disease activity was allowed. At investigators’ discretion, patients could receive other disease-modifying therapy (DMT) at any time. After the 4-year extension, patients could continue in the 5-year TOPAZ extension.

Carolina Ionete, MD, a neurologist at University of Massachusetts Memorial Medical Center in Worcester, and colleagues examined data from the TOPAZ extension study to evaluate the efficacy and safety of alemtuzumab over 6 years in patients with relapsing-remitting MS from CARE-MS II who discontinued interferon beta-1a. In TOPAZ, patients can receive additional alemtuzumab (12 mg/day on 3 consecutive days at 12 or more months after the most recent course) or other DMTs at any time at investigators’ discretion.

In all, 143 patients started alemtuzumab in the extension study. Of this group 117 patients (82%) completed year 2 of TOPAZ (i.e., year 6 after initiating alemtuzumab). The annualized relapse rate at year 6 was 0.19, and the annual rate of freedom from relapse ranged from 83% to 90% during years 1 through 6. At year 6, Expanded Disability Status Scale (EDSS) scores were stable (51%) or improved (17%) in 68% of patients, compared with the baseline of the main study. At year 6, the mean EDSS score change was 0.43. Over 6 years, 69% of patients were free from 6-month confirmed disability worsening, and 23% achieved 6-month confirmed disability improvement.

In addition, 69% of patients were free of MRI disease activity in year 6. The median percent cumulative brain volume loss from alemtuzumab initiation through year 6 was 0.53%, compared with 0.81% over 2 years with interferon beta-1a. Brain volume loss was 0.32% or less annually during years 2 through 6 after initiating alemtuzumab (0.04% at year 2, 0.15% at year 3, 0.14% at year 4, 0.07% at year 5, and 0.32% at year 6). These efficacy outcomes were observed as 57% of patients received neither additional alemtuzumab nor another DMT through year 6. Safety results were consistent with those for the alemtuzumab-treated patients in the core and extension studies.

Sanofi and Bayer HealthCare Pharmaceuticals supported this study. Dr. Ionete received research support from Biogen, Roche, and Sanofi. She reported receiving compensation for advisory board participation from Sanofi.

egreb@mdedge.com

SEATTLE – Patients with multiple sclerosis (MS) who stopped taking their disease-modifying therapy (DMT) for more than 60 days had significantly higher rates of relapse, hospitalization, emergency department visits and outpatient visits, a new study finds. Their nonmedication health care costs were higher, too.

“This information will help to inform patients about downstream economic risks of being off therapy. This may also help to inform payers of the importance of making DMTs easily and quickly available to patients with MS to prevent greater costs of health care resource utilization down the road,” study lead author Jacqueline A. Nicholas, MD, MPH, a clinical neuroimmunologist at OhioHealth Multiple Sclerosis Center, said in an interview. She spoke prior to the presentation of the findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Dr. Nicholas and her colleagues launched their study to better understand the economic and medical impacts of lapses in oral DMT.

The researchers used a claims database to track 8,779 patients with MS during 2011-2015 who had at least one claim for an oral DMT drug. The subjects were aged 18-63; 15% had a drug lapse of more than 60 days. After propensity matching, the subjects in both groups – 60-day lapse or not – had a mean age of 44 years.

An analysis found that “lapses in oral DMT use led to increased relapses, increased health care utilization, and higher costs incurred by individuals with MS,” Dr. Nicholas said.

Over an 18-month follow-up period, those with drug lapses of more than 60 days had 28% more relapses than did the other subjects (mean 1.2 vs. 0.8; P less than .0001).

Those with lapses greater than 60 days also had 40% more hospitalizations (0.2 vs. 0.1; P = .0003), 25% more emergency department visits (0.6 vs. 0.5; P = .0098), and 22% more outpatient visits (6.2 vs. 4.8; P less than .0001).

Nonmedication costs were 25% higher among patients with a greater than 60-day lapse ($16,012 vs. $12,092; P = .0006).

Moving forward, the researchers wrote, “more research is needed to better understand the reasons for lapses in therapy and the impact of lapse timing and lapse duration on outcomes in patients with MS receiving once- or twice-daily oral [disease-modifying drugs].”

The researchers noted that they don’t have information about the reasons why patients lapsed. They added that the information comes mainly from commercial insurers.

EMD Serono, a division of Merck KGaA, provided funding for the study. Dr. Nicholas disclosed grant support from EMD Serono, and two other study authors are employees of the company. Another two authors worked for a consulting firm that received funding from EMD Serono to conduct the study.

SEATTLE – Patients with multiple sclerosis (MS) who stopped taking their disease-modifying therapy (DMT) for more than 60 days had significantly higher rates of relapse, hospitalization, emergency department visits and outpatient visits, a new study finds. Their nonmedication health care costs were higher, too.

“This information will help to inform patients about downstream economic risks of being off therapy. This may also help to inform payers of the importance of making DMTs easily and quickly available to patients with MS to prevent greater costs of health care resource utilization down the road,” study lead author Jacqueline A. Nicholas, MD, MPH, a clinical neuroimmunologist at OhioHealth Multiple Sclerosis Center, said in an interview. She spoke prior to the presentation of the findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Dr. Nicholas and her colleagues launched their study to better understand the economic and medical impacts of lapses in oral DMT.

The researchers used a claims database to track 8,779 patients with MS during 2011-2015 who had at least one claim for an oral DMT drug. The subjects were aged 18-63; 15% had a drug lapse of more than 60 days. After propensity matching, the subjects in both groups – 60-day lapse or not – had a mean age of 44 years.

An analysis found that “lapses in oral DMT use led to increased relapses, increased health care utilization, and higher costs incurred by individuals with MS,” Dr. Nicholas said.

Over an 18-month follow-up period, those with drug lapses of more than 60 days had 28% more relapses than did the other subjects (mean 1.2 vs. 0.8; P less than .0001).

Those with lapses greater than 60 days also had 40% more hospitalizations (0.2 vs. 0.1; P = .0003), 25% more emergency department visits (0.6 vs. 0.5; P = .0098), and 22% more outpatient visits (6.2 vs. 4.8; P less than .0001).

Nonmedication costs were 25% higher among patients with a greater than 60-day lapse ($16,012 vs. $12,092; P = .0006).

Moving forward, the researchers wrote, “more research is needed to better understand the reasons for lapses in therapy and the impact of lapse timing and lapse duration on outcomes in patients with MS receiving once- or twice-daily oral [disease-modifying drugs].”

The researchers noted that they don’t have information about the reasons why patients lapsed. They added that the information comes mainly from commercial insurers.

EMD Serono, a division of Merck KGaA, provided funding for the study. Dr. Nicholas disclosed grant support from EMD Serono, and two other study authors are employees of the company. Another two authors worked for a consulting firm that received funding from EMD Serono to conduct the study.

SEATTLE – Patients with multiple sclerosis (MS) who stopped taking their disease-modifying therapy (DMT) for more than 60 days had significantly higher rates of relapse, hospitalization, emergency department visits and outpatient visits, a new study finds. Their nonmedication health care costs were higher, too.

“This information will help to inform patients about downstream economic risks of being off therapy. This may also help to inform payers of the importance of making DMTs easily and quickly available to patients with MS to prevent greater costs of health care resource utilization down the road,” study lead author Jacqueline A. Nicholas, MD, MPH, a clinical neuroimmunologist at OhioHealth Multiple Sclerosis Center, said in an interview. She spoke prior to the presentation of the findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Dr. Nicholas and her colleagues launched their study to better understand the economic and medical impacts of lapses in oral DMT.

The researchers used a claims database to track 8,779 patients with MS during 2011-2015 who had at least one claim for an oral DMT drug. The subjects were aged 18-63; 15% had a drug lapse of more than 60 days. After propensity matching, the subjects in both groups – 60-day lapse or not – had a mean age of 44 years.

An analysis found that “lapses in oral DMT use led to increased relapses, increased health care utilization, and higher costs incurred by individuals with MS,” Dr. Nicholas said.

Over an 18-month follow-up period, those with drug lapses of more than 60 days had 28% more relapses than did the other subjects (mean 1.2 vs. 0.8; P less than .0001).

Those with lapses greater than 60 days also had 40% more hospitalizations (0.2 vs. 0.1; P = .0003), 25% more emergency department visits (0.6 vs. 0.5; P = .0098), and 22% more outpatient visits (6.2 vs. 4.8; P less than .0001).

Nonmedication costs were 25% higher among patients with a greater than 60-day lapse ($16,012 vs. $12,092; P = .0006).

Moving forward, the researchers wrote, “more research is needed to better understand the reasons for lapses in therapy and the impact of lapse timing and lapse duration on outcomes in patients with MS receiving once- or twice-daily oral [disease-modifying drugs].”

The researchers noted that they don’t have information about the reasons why patients lapsed. They added that the information comes mainly from commercial insurers.

EMD Serono, a division of Merck KGaA, provided funding for the study. Dr. Nicholas disclosed grant support from EMD Serono, and two other study authors are employees of the company. Another two authors worked for a consulting firm that received funding from EMD Serono to conduct the study.

SEATTLE – Among patients with multiple sclerosis who initiate treatment with fingolimod, a low baseline heart rate may not increase the risk of first-dose cardiac events, according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. In addition, the data “provide further evidence that first-dose cardiac events with fingolimod are rare,” regardless of whether the first dose is given in a clinic or a patient’s home, the study researchers said.

Transient heart rate decreases are an anticipated effect of starting fingolimod, and the U.S. prescribing information for the drug requires first-dose observation of heart rate and blood pressure for at least 6 hours. Heart rate and blood pressure may be monitored in a clinic or at home via the Gilenya@Home program.

To examine whether low baseline heart rate is associated with the likelihood of certain cardiac events during the first-dose observation period, John Osborne, MD, of State of the Heart Cardiology in Grapevine, Tex., and colleagues analyzed retrospective, first-dose observation data from Gilenya@Home between October 2014 and July 2017 and from Gilenya Assessment Network clinics between July 2010 and December 2016.

The investigators sought to determine whether baseline heart rate predicts the risk of documented bradycardia, new-onset second-degree atrioventricular block, or ED transfer for additional monitoring. In addition, they examined whether patients with heart rates above a certain threshold may be at risk of first-dose cardiac events.

Dr. Osborne and colleagues reviewed data from 5,572 in-home and 15,025 in-clinic first-dose observation procedures. They classified patients as having marked bradycardia (under 50 beats per minute), mild bradycardia (50-59 bpm), or a normal heart rate (at least 60 bpm) at baseline. During the 20,001 procedures with available data, 182 cardiac events occurred, including 28 instances of documented bradycardia, 13 instances of second-degree atrioventricular block, and 141 instances of ED transfer for extended monitoring; 40 events occurred during at-home monitoring, and 142 events occurred in clinic.

About 87.0% of the cardiac events occurred in patients with a normal baseline heart rate, 11.5% occurred in patients with mild bradycardia, and 1.1% occurred in patients with marked bradycardia. The two cardiac events in patients with marked bradycardia at baseline were ED transfers of patients whose first-dose observations occurred in clinics. “The threshold heart rate above which patients did not experience a cardiac event was 80 bpm, well within the normal range of 60-100 bpm,” the authors said.

“These data suggest that patients with a low baseline heart rate may be at no more risk of cardiac events than patients with a heart rate in the normal range, nor is there a baseline heart rate threshold below which a patient is at greater risk of cardiac events,” Dr. Osborne and colleagues concluded.

Dr. Osborne reporting receiving a consulting fee from Novartis, which markets Gilenya (fingolimod), and his coauthors are employees of Novartis.
 

jremaly@mdedge.com

SEATTLE – Among patients with multiple sclerosis who initiate treatment with fingolimod, a low baseline heart rate may not increase the risk of first-dose cardiac events, according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. In addition, the data “provide further evidence that first-dose cardiac events with fingolimod are rare,” regardless of whether the first dose is given in a clinic or a patient’s home, the study researchers said.

Transient heart rate decreases are an anticipated effect of starting fingolimod, and the U.S. prescribing information for the drug requires first-dose observation of heart rate and blood pressure for at least 6 hours. Heart rate and blood pressure may be monitored in a clinic or at home via the Gilenya@Home program.

To examine whether low baseline heart rate is associated with the likelihood of certain cardiac events during the first-dose observation period, John Osborne, MD, of State of the Heart Cardiology in Grapevine, Tex., and colleagues analyzed retrospective, first-dose observation data from Gilenya@Home between October 2014 and July 2017 and from Gilenya Assessment Network clinics between July 2010 and December 2016.

The investigators sought to determine whether baseline heart rate predicts the risk of documented bradycardia, new-onset second-degree atrioventricular block, or ED transfer for additional monitoring. In addition, they examined whether patients with heart rates above a certain threshold may be at risk of first-dose cardiac events.

Dr. Osborne and colleagues reviewed data from 5,572 in-home and 15,025 in-clinic first-dose observation procedures. They classified patients as having marked bradycardia (under 50 beats per minute), mild bradycardia (50-59 bpm), or a normal heart rate (at least 60 bpm) at baseline. During the 20,001 procedures with available data, 182 cardiac events occurred, including 28 instances of documented bradycardia, 13 instances of second-degree atrioventricular block, and 141 instances of ED transfer for extended monitoring; 40 events occurred during at-home monitoring, and 142 events occurred in clinic.

About 87.0% of the cardiac events occurred in patients with a normal baseline heart rate, 11.5% occurred in patients with mild bradycardia, and 1.1% occurred in patients with marked bradycardia. The two cardiac events in patients with marked bradycardia at baseline were ED transfers of patients whose first-dose observations occurred in clinics. “The threshold heart rate above which patients did not experience a cardiac event was 80 bpm, well within the normal range of 60-100 bpm,” the authors said.

“These data suggest that patients with a low baseline heart rate may be at no more risk of cardiac events than patients with a heart rate in the normal range, nor is there a baseline heart rate threshold below which a patient is at greater risk of cardiac events,” Dr. Osborne and colleagues concluded.

Dr. Osborne reporting receiving a consulting fee from Novartis, which markets Gilenya (fingolimod), and his coauthors are employees of Novartis.
 

jremaly@mdedge.com

SEATTLE – Among patients with multiple sclerosis who initiate treatment with fingolimod, a low baseline heart rate may not increase the risk of first-dose cardiac events, according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. In addition, the data “provide further evidence that first-dose cardiac events with fingolimod are rare,” regardless of whether the first dose is given in a clinic or a patient’s home, the study researchers said.

Transient heart rate decreases are an anticipated effect of starting fingolimod, and the U.S. prescribing information for the drug requires first-dose observation of heart rate and blood pressure for at least 6 hours. Heart rate and blood pressure may be monitored in a clinic or at home via the Gilenya@Home program.

To examine whether low baseline heart rate is associated with the likelihood of certain cardiac events during the first-dose observation period, John Osborne, MD, of State of the Heart Cardiology in Grapevine, Tex., and colleagues analyzed retrospective, first-dose observation data from Gilenya@Home between October 2014 and July 2017 and from Gilenya Assessment Network clinics between July 2010 and December 2016.

The investigators sought to determine whether baseline heart rate predicts the risk of documented bradycardia, new-onset second-degree atrioventricular block, or ED transfer for additional monitoring. In addition, they examined whether patients with heart rates above a certain threshold may be at risk of first-dose cardiac events.

Dr. Osborne and colleagues reviewed data from 5,572 in-home and 15,025 in-clinic first-dose observation procedures. They classified patients as having marked bradycardia (under 50 beats per minute), mild bradycardia (50-59 bpm), or a normal heart rate (at least 60 bpm) at baseline. During the 20,001 procedures with available data, 182 cardiac events occurred, including 28 instances of documented bradycardia, 13 instances of second-degree atrioventricular block, and 141 instances of ED transfer for extended monitoring; 40 events occurred during at-home monitoring, and 142 events occurred in clinic.

About 87.0% of the cardiac events occurred in patients with a normal baseline heart rate, 11.5% occurred in patients with mild bradycardia, and 1.1% occurred in patients with marked bradycardia. The two cardiac events in patients with marked bradycardia at baseline were ED transfers of patients whose first-dose observations occurred in clinics. “The threshold heart rate above which patients did not experience a cardiac event was 80 bpm, well within the normal range of 60-100 bpm,” the authors said.

“These data suggest that patients with a low baseline heart rate may be at no more risk of cardiac events than patients with a heart rate in the normal range, nor is there a baseline heart rate threshold below which a patient is at greater risk of cardiac events,” Dr. Osborne and colleagues concluded.

Dr. Osborne reporting receiving a consulting fee from Novartis, which markets Gilenya (fingolimod), and his coauthors are employees of Novartis.
 

jremaly@mdedge.com

SEATTLE – Management of multiple sclerosis (MS) relapse consists of 3 main steps: timely and careful evaluation; treatment, if necessary; and assessment of treatment response, according to an algorithm presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Acute clinical relapses are a defining feature of MS with highly variable symptoms and potentially disabling effects,” said first author Amy Perrin Ross, APN, an MS certified nurse at Loyola University Chicago in Maywood, Ill., and coauthors. “Although clinicians have several management options for MS relapses, including several therapeutic interventions or observation, these options vary in terms of clinical evidence of efficacy, safety, cost, and tolerability. No consensus statements currently exist to help clinicians approach patients with acute MS relapse.”

To offer an algorithm for the management of MS relapses based on evidence and clinical experience, a work group of MS clinicians reviewed published literature on MS relapses and shared their clinical experiences managing relapses. They sought to develop a standardized and optimized approach to management.

The group reached consensus on an iterative management algorithm that consists of evaluation of symptoms to distinguish an MS relapse from a pseudorelapse; treatment, if necessary; and assessment of treatment response.

“Timely and careful evaluation of new symptoms in patients with MS is paramount, and distinguishing an MS relapse from a pseudorelapse is essential,” the authors said. “This evaluation is primarily clinical, and imaging findings may not be necessary for confirmation.”

Corticosteroid therapy is the mainstay of MS relapse management. For patients who cannot tolerate corticosteroids or in whom corticosteroids have been ineffective, clinicians may consider adrenocorticotropic hormone (ACTH). In patients with fulminant demyelination, plasma exchange therapy may be considered. In mild cases, observation may be reasonable, the authors said.

The group recommends that, between 3 and 5 weeks after the initial evaluation, a clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire should be undertaken.

If a patient’s response to treatment has been suboptimal – that is, symptoms have worsened despite treatment or there has been a lack of functional recovery – “reevaluation of the relapse and treatment with an alternative option should be considered,” they said.

The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
 

jremaly@mdedge.com

SEATTLE – Management of multiple sclerosis (MS) relapse consists of 3 main steps: timely and careful evaluation; treatment, if necessary; and assessment of treatment response, according to an algorithm presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Acute clinical relapses are a defining feature of MS with highly variable symptoms and potentially disabling effects,” said first author Amy Perrin Ross, APN, an MS certified nurse at Loyola University Chicago in Maywood, Ill., and coauthors. “Although clinicians have several management options for MS relapses, including several therapeutic interventions or observation, these options vary in terms of clinical evidence of efficacy, safety, cost, and tolerability. No consensus statements currently exist to help clinicians approach patients with acute MS relapse.”

To offer an algorithm for the management of MS relapses based on evidence and clinical experience, a work group of MS clinicians reviewed published literature on MS relapses and shared their clinical experiences managing relapses. They sought to develop a standardized and optimized approach to management.

The group reached consensus on an iterative management algorithm that consists of evaluation of symptoms to distinguish an MS relapse from a pseudorelapse; treatment, if necessary; and assessment of treatment response.

“Timely and careful evaluation of new symptoms in patients with MS is paramount, and distinguishing an MS relapse from a pseudorelapse is essential,” the authors said. “This evaluation is primarily clinical, and imaging findings may not be necessary for confirmation.”

Corticosteroid therapy is the mainstay of MS relapse management. For patients who cannot tolerate corticosteroids or in whom corticosteroids have been ineffective, clinicians may consider adrenocorticotropic hormone (ACTH). In patients with fulminant demyelination, plasma exchange therapy may be considered. In mild cases, observation may be reasonable, the authors said.

The group recommends that, between 3 and 5 weeks after the initial evaluation, a clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire should be undertaken.

If a patient’s response to treatment has been suboptimal – that is, symptoms have worsened despite treatment or there has been a lack of functional recovery – “reevaluation of the relapse and treatment with an alternative option should be considered,” they said.

The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
 

jremaly@mdedge.com

SEATTLE – Management of multiple sclerosis (MS) relapse consists of 3 main steps: timely and careful evaluation; treatment, if necessary; and assessment of treatment response, according to an algorithm presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Acute clinical relapses are a defining feature of MS with highly variable symptoms and potentially disabling effects,” said first author Amy Perrin Ross, APN, an MS certified nurse at Loyola University Chicago in Maywood, Ill., and coauthors. “Although clinicians have several management options for MS relapses, including several therapeutic interventions or observation, these options vary in terms of clinical evidence of efficacy, safety, cost, and tolerability. No consensus statements currently exist to help clinicians approach patients with acute MS relapse.”

To offer an algorithm for the management of MS relapses based on evidence and clinical experience, a work group of MS clinicians reviewed published literature on MS relapses and shared their clinical experiences managing relapses. They sought to develop a standardized and optimized approach to management.

The group reached consensus on an iterative management algorithm that consists of evaluation of symptoms to distinguish an MS relapse from a pseudorelapse; treatment, if necessary; and assessment of treatment response.

“Timely and careful evaluation of new symptoms in patients with MS is paramount, and distinguishing an MS relapse from a pseudorelapse is essential,” the authors said. “This evaluation is primarily clinical, and imaging findings may not be necessary for confirmation.”

Corticosteroid therapy is the mainstay of MS relapse management. For patients who cannot tolerate corticosteroids or in whom corticosteroids have been ineffective, clinicians may consider adrenocorticotropic hormone (ACTH). In patients with fulminant demyelination, plasma exchange therapy may be considered. In mild cases, observation may be reasonable, the authors said.

The group recommends that, between 3 and 5 weeks after the initial evaluation, a clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire should be undertaken.

If a patient’s response to treatment has been suboptimal – that is, symptoms have worsened despite treatment or there has been a lack of functional recovery – “reevaluation of the relapse and treatment with an alternative option should be considered,” they said.

The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
 

jremaly@mdedge.com

SEATTLE – A 0.5-mg/day dose of fingolimod reduces disease activity in multiple sclerosis to a greater extent than 20 mg/day of glatiramer acetate, according to a controlled, head-to-head study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Investigations that directly compare the efficacy and safety of disease-modifying therapies can provide valuable information that influences treatment decisions in clinical practice. Phase 3 clinical trials indicated that oral fingolimod (0.5 mg/day) is more effective than placebo and interferon beta-1a in patients with multiple sclerosis (MS). However, how fingolimod compares with glatiramer acetate is unclear.

Bruce A. C. Cree, MD, PhD, clinical research director of the Multiple Sclerosis Center at the University of California, San Francisco, and colleagues sought to compare the efficacy of once-daily 0.5 mg and 0.25 mg oral fingolimod with that of once-daily 20 mg subcutaneous injections of glatiramer acetate in reducing disease activity over 12 months in patients with relapsing remitting MS. They conducted the phase 3b, multicenter, rater- and dose-blinded ASSESS study. Dr. Cree and colleagues randomized 352 eligible patients to 0.5 mg/day of oral fingolimod, 370 patients to 0.25 mg/day of oral fingolimod, and 342 patients to 20 mg/day of subcutaneous glatiramer acetate. They examined the potential superiority of each fingolimod dose to glatiramer acetate separately, starting with the higher dose. The primary endpoint was the change in annualized relapse rate, and the secondary endpoints were MRI measures of disease activity at 12 months. Finally, the investigators evaluated safety and tolerability.

A total of 859 patients (80.7%) completed the study. Over 12 months, the annualized relapse rate was 0.153 for the 0.5 mg fingolimod group and 0.258 for the glatiramer acetate group (relative reduction, 40.7%). The 0.25-mg dose of fingolimod achieved a numerical RR of 14.6%, but this result was not statistically significant. Compared with glatiramer acetate, the 0.5-mg and 0.25-mg doses of fingolimod significantly reduced the mean number of new or newly enlarged T2 lesions (RR, 54.4% and 42.1%, respectively) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses).

The adverse events that participants reported for both doses of fingolimod were consistent with the treatment’s known safety profile. More discontinuations were reported with glatiramer acetate than with fingolimod. These events mainly resulted from injection-related adverse events, consent withdrawal, and unsatisfactory therapeutic effects. Dr. Cree and colleagues plan to report the results of additional cognitive and functional system evaluations, including the Symbol Digit Modalities Test and the MS Functional Composite, later this year.

The study was not supported by outside funding. Dr. Cree reported receiving consulting fees from AbbVie, Akili, Biogen, EMD Serono, and Novartis.

egreb@mdedge.com

SEATTLE – A 0.5-mg/day dose of fingolimod reduces disease activity in multiple sclerosis to a greater extent than 20 mg/day of glatiramer acetate, according to a controlled, head-to-head study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Investigations that directly compare the efficacy and safety of disease-modifying therapies can provide valuable information that influences treatment decisions in clinical practice. Phase 3 clinical trials indicated that oral fingolimod (0.5 mg/day) is more effective than placebo and interferon beta-1a in patients with multiple sclerosis (MS). However, how fingolimod compares with glatiramer acetate is unclear.

Bruce A. C. Cree, MD, PhD, clinical research director of the Multiple Sclerosis Center at the University of California, San Francisco, and colleagues sought to compare the efficacy of once-daily 0.5 mg and 0.25 mg oral fingolimod with that of once-daily 20 mg subcutaneous injections of glatiramer acetate in reducing disease activity over 12 months in patients with relapsing remitting MS. They conducted the phase 3b, multicenter, rater- and dose-blinded ASSESS study. Dr. Cree and colleagues randomized 352 eligible patients to 0.5 mg/day of oral fingolimod, 370 patients to 0.25 mg/day of oral fingolimod, and 342 patients to 20 mg/day of subcutaneous glatiramer acetate. They examined the potential superiority of each fingolimod dose to glatiramer acetate separately, starting with the higher dose. The primary endpoint was the change in annualized relapse rate, and the secondary endpoints were MRI measures of disease activity at 12 months. Finally, the investigators evaluated safety and tolerability.

A total of 859 patients (80.7%) completed the study. Over 12 months, the annualized relapse rate was 0.153 for the 0.5 mg fingolimod group and 0.258 for the glatiramer acetate group (relative reduction, 40.7%). The 0.25-mg dose of fingolimod achieved a numerical RR of 14.6%, but this result was not statistically significant. Compared with glatiramer acetate, the 0.5-mg and 0.25-mg doses of fingolimod significantly reduced the mean number of new or newly enlarged T2 lesions (RR, 54.4% and 42.1%, respectively) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses).

The adverse events that participants reported for both doses of fingolimod were consistent with the treatment’s known safety profile. More discontinuations were reported with glatiramer acetate than with fingolimod. These events mainly resulted from injection-related adverse events, consent withdrawal, and unsatisfactory therapeutic effects. Dr. Cree and colleagues plan to report the results of additional cognitive and functional system evaluations, including the Symbol Digit Modalities Test and the MS Functional Composite, later this year.

The study was not supported by outside funding. Dr. Cree reported receiving consulting fees from AbbVie, Akili, Biogen, EMD Serono, and Novartis.

egreb@mdedge.com

SEATTLE – A 0.5-mg/day dose of fingolimod reduces disease activity in multiple sclerosis to a greater extent than 20 mg/day of glatiramer acetate, according to a controlled, head-to-head study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Investigations that directly compare the efficacy and safety of disease-modifying therapies can provide valuable information that influences treatment decisions in clinical practice. Phase 3 clinical trials indicated that oral fingolimod (0.5 mg/day) is more effective than placebo and interferon beta-1a in patients with multiple sclerosis (MS). However, how fingolimod compares with glatiramer acetate is unclear.

Bruce A. C. Cree, MD, PhD, clinical research director of the Multiple Sclerosis Center at the University of California, San Francisco, and colleagues sought to compare the efficacy of once-daily 0.5 mg and 0.25 mg oral fingolimod with that of once-daily 20 mg subcutaneous injections of glatiramer acetate in reducing disease activity over 12 months in patients with relapsing remitting MS. They conducted the phase 3b, multicenter, rater- and dose-blinded ASSESS study. Dr. Cree and colleagues randomized 352 eligible patients to 0.5 mg/day of oral fingolimod, 370 patients to 0.25 mg/day of oral fingolimod, and 342 patients to 20 mg/day of subcutaneous glatiramer acetate. They examined the potential superiority of each fingolimod dose to glatiramer acetate separately, starting with the higher dose. The primary endpoint was the change in annualized relapse rate, and the secondary endpoints were MRI measures of disease activity at 12 months. Finally, the investigators evaluated safety and tolerability.

A total of 859 patients (80.7%) completed the study. Over 12 months, the annualized relapse rate was 0.153 for the 0.5 mg fingolimod group and 0.258 for the glatiramer acetate group (relative reduction, 40.7%). The 0.25-mg dose of fingolimod achieved a numerical RR of 14.6%, but this result was not statistically significant. Compared with glatiramer acetate, the 0.5-mg and 0.25-mg doses of fingolimod significantly reduced the mean number of new or newly enlarged T2 lesions (RR, 54.4% and 42.1%, respectively) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses).

The adverse events that participants reported for both doses of fingolimod were consistent with the treatment’s known safety profile. More discontinuations were reported with glatiramer acetate than with fingolimod. These events mainly resulted from injection-related adverse events, consent withdrawal, and unsatisfactory therapeutic effects. Dr. Cree and colleagues plan to report the results of additional cognitive and functional system evaluations, including the Symbol Digit Modalities Test and the MS Functional Composite, later this year.

The study was not supported by outside funding. Dr. Cree reported receiving consulting fees from AbbVie, Akili, Biogen, EMD Serono, and Novartis.

egreb@mdedge.com

SEATTLE – A small new study suggests that patients with multiple sclerosis (MS) who use cannabis in a hazardous way are more likely to suffer from symptoms of anxiety and depression, although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.

For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.

The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.

Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.

They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).

The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.

The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.

No study funding was reported and the authors report no relevant disclosures.

SEATTLE – A small new study suggests that patients with multiple sclerosis (MS) who use cannabis in a hazardous way are more likely to suffer from symptoms of anxiety and depression, although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.

For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.

The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.

Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.

They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).

The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.

The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.

No study funding was reported and the authors report no relevant disclosures.

SEATTLE – A small new study suggests that patients with multiple sclerosis (MS) who use cannabis in a hazardous way are more likely to suffer from symptoms of anxiety and depression, although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.

For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.

The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.

Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.

They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).

The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.

The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.

No study funding was reported and the authors report no relevant disclosures.

Seattle – Over 2 years of follow-up, approximately one-third of patients with multiple sclerosis (MS) have a lapse in oral therapy of 30 days or longer, and approximately half discontinue their index oral therapy, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These results indicate “poor adherence to currently available oral medications” and “may imply a need for treatments with dosing regimens that facilitate adherence,” said Jacqueline Nicholas, MD, MPH, a clinical neuroimmunologist at the Ohio MS Center in Columbus, and colleagues.

Research has found that lapses in MS treatment regimens and discontinuation of disease-modifying therapy are associated with an increased likelihood of relapse. Few studies, however, have examined lapses in oral therapy and discontinuation of oral treatments in patients with MS. To address this gap, Dr. Nicholas and colleagues conducted a retrospective administrative claims study using data from the IQVIA RWD Adjudicated Claims – USA database.

The researchers examined claims filed between July 1, 2012, and June 30, 2017. Eligible participants were aged 18-63 years and had two or more MS diagnosis claims (i.e., ICD-9-CM code: 340.xx and ICD-10-CM code: G35) between July 1, 2013, and June 30, 2015. Participants also had one or more once- or twice-daily oral disease-modifying drug (DMD) claims between July 1, 2013, and June 30, 2015; continuous eligibility with commercial insurance for 1 year before (i.e., baseline) and 2 years after (i.e., follow-up) oral DMD initiation; and no oral DMD use during baseline.

The investigators defined the longest lapse in therapy as the number of days between the lapsing of the supply of the prior prescription and the fulfillment of a new prescription (i.e., the period during which no DMD was available, based on medical or pharmacy claims). Discontinuation was defined as cessation of the oral DMD for a minimum of 60 days without reinitiation (i.e., discontinuing treatment or switching therapy).

In all, 4,193 patients met the eligibility criteria. The population’s mean age was 45.4 years, and 76.3% of the patients were female. The mean duration of the longest lapse was 35.6 days. The longest lapse was 0 to fewer than 15 days for 44.6% of patients, 15 to fewer than 30 days for 25.6% of patients, 30 to fewer than 45 days for 11.0% of patients, 45 to fewer than 60 days for 5.2% of patients, 60 to fewer than 75 days for 3.5% of patients, 75 to fewer than 90 days for 1.7% of patients, and 90 or more days for 8.3% of patients. In addition, 45.2% of patients discontinued oral DMD treatment, and the mean time to discontinuation was 249.0 days.

The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.

egreb@mdedge.com

SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.

Seattle – Over 2 years of follow-up, approximately one-third of patients with multiple sclerosis (MS) have a lapse in oral therapy of 30 days or longer, and approximately half discontinue their index oral therapy, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These results indicate “poor adherence to currently available oral medications” and “may imply a need for treatments with dosing regimens that facilitate adherence,” said Jacqueline Nicholas, MD, MPH, a clinical neuroimmunologist at the Ohio MS Center in Columbus, and colleagues.

Research has found that lapses in MS treatment regimens and discontinuation of disease-modifying therapy are associated with an increased likelihood of relapse. Few studies, however, have examined lapses in oral therapy and discontinuation of oral treatments in patients with MS. To address this gap, Dr. Nicholas and colleagues conducted a retrospective administrative claims study using data from the IQVIA RWD Adjudicated Claims – USA database.

The researchers examined claims filed between July 1, 2012, and June 30, 2017. Eligible participants were aged 18-63 years and had two or more MS diagnosis claims (i.e., ICD-9-CM code: 340.xx and ICD-10-CM code: G35) between July 1, 2013, and June 30, 2015. Participants also had one or more once- or twice-daily oral disease-modifying drug (DMD) claims between July 1, 2013, and June 30, 2015; continuous eligibility with commercial insurance for 1 year before (i.e., baseline) and 2 years after (i.e., follow-up) oral DMD initiation; and no oral DMD use during baseline.

The investigators defined the longest lapse in therapy as the number of days between the lapsing of the supply of the prior prescription and the fulfillment of a new prescription (i.e., the period during which no DMD was available, based on medical or pharmacy claims). Discontinuation was defined as cessation of the oral DMD for a minimum of 60 days without reinitiation (i.e., discontinuing treatment or switching therapy).

In all, 4,193 patients met the eligibility criteria. The population’s mean age was 45.4 years, and 76.3% of the patients were female. The mean duration of the longest lapse was 35.6 days. The longest lapse was 0 to fewer than 15 days for 44.6% of patients, 15 to fewer than 30 days for 25.6% of patients, 30 to fewer than 45 days for 11.0% of patients, 45 to fewer than 60 days for 5.2% of patients, 60 to fewer than 75 days for 3.5% of patients, 75 to fewer than 90 days for 1.7% of patients, and 90 or more days for 8.3% of patients. In addition, 45.2% of patients discontinued oral DMD treatment, and the mean time to discontinuation was 249.0 days.

The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.

egreb@mdedge.com

SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.

Seattle – Over 2 years of follow-up, approximately one-third of patients with multiple sclerosis (MS) have a lapse in oral therapy of 30 days or longer, and approximately half discontinue their index oral therapy, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These results indicate “poor adherence to currently available oral medications” and “may imply a need for treatments with dosing regimens that facilitate adherence,” said Jacqueline Nicholas, MD, MPH, a clinical neuroimmunologist at the Ohio MS Center in Columbus, and colleagues.

Research has found that lapses in MS treatment regimens and discontinuation of disease-modifying therapy are associated with an increased likelihood of relapse. Few studies, however, have examined lapses in oral therapy and discontinuation of oral treatments in patients with MS. To address this gap, Dr. Nicholas and colleagues conducted a retrospective administrative claims study using data from the IQVIA RWD Adjudicated Claims – USA database.

The researchers examined claims filed between July 1, 2012, and June 30, 2017. Eligible participants were aged 18-63 years and had two or more MS diagnosis claims (i.e., ICD-9-CM code: 340.xx and ICD-10-CM code: G35) between July 1, 2013, and June 30, 2015. Participants also had one or more once- or twice-daily oral disease-modifying drug (DMD) claims between July 1, 2013, and June 30, 2015; continuous eligibility with commercial insurance for 1 year before (i.e., baseline) and 2 years after (i.e., follow-up) oral DMD initiation; and no oral DMD use during baseline.

The investigators defined the longest lapse in therapy as the number of days between the lapsing of the supply of the prior prescription and the fulfillment of a new prescription (i.e., the period during which no DMD was available, based on medical or pharmacy claims). Discontinuation was defined as cessation of the oral DMD for a minimum of 60 days without reinitiation (i.e., discontinuing treatment or switching therapy).

In all, 4,193 patients met the eligibility criteria. The population’s mean age was 45.4 years, and 76.3% of the patients were female. The mean duration of the longest lapse was 35.6 days. The longest lapse was 0 to fewer than 15 days for 44.6% of patients, 15 to fewer than 30 days for 25.6% of patients, 30 to fewer than 45 days for 11.0% of patients, 45 to fewer than 60 days for 5.2% of patients, 60 to fewer than 75 days for 3.5% of patients, 75 to fewer than 90 days for 1.7% of patients, and 90 or more days for 8.3% of patients. In addition, 45.2% of patients discontinued oral DMD treatment, and the mean time to discontinuation was 249.0 days.

The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.

egreb@mdedge.com

SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.

SEATTLE – A regimen of twice-daily doses of extended-release arbaclofen appears to reduce spasticity effectively in patients with multiple sclerosis (MS), according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. The regimen is well tolerated.

Spasticity is common in MS, and the traditional treatment is oral baclofen, a GABA_B receptor agonist. Therapeutic doses of baclofen may cause side effects that decrease adherence, however. Arbaclofen is a more active R-enantiomer of baclofen, which is a racemic mixture. Arbaclofen extended-release (ER) tablets enable twice-daily administration, which reduces dosing frequency and may decrease the rate of adverse events.

Daniel Kantor, MD, a faculty member at Florida Atlantic University in Boca Raton, and colleagues conducted a multicenter, double-blind, parallel-group study to compare the efficacy and safety of arbaclofen ER with those of placebo and baclofen in patients with MS-related spasticity. They randomized adults in North America and Eastern Europe in equal groups to arbaclofen ER (20 mg b.i.d.), baclofen (20 mg q.i.d.), or placebo. The dose was titrated over 2 weeks, and participants subsequently entered a 12-week maintenance phase. The study’s two primary endpoints were the mean change in Total Numeric-Transformed Modified Ashworth Scale for the most affected limb (TNmAS-MAL) and Clinician Global Impression of Change (CGIC) from baseline through the maintenance period.

Dr. Kantor and colleagues randomized 341 patients in their study. Of this population, 57.5% had relapsing-remitting MS, 38.4% had secondary progressive MS, 2.6% had primary progressive MS, and 0.9% had progressive relapsing MS. Thirteen patients from one site were excluded from analysis after study completion when an audit found irregularities. The mean baseline TNmAS-MAL score was 7.93 in the arbaclofen ER group, 7.75 in the baclofen group, and 7.55 in the placebo group. At the end of the maintenance period, the mean decrease in TNmAS-MAL score was larger with arbaclofen ER than with placebo (least-squares mean [LSMean] −2.90 vs. −1.95). In addition, CGIC was significantly improved for arbaclofen ER, compared with placebo (LSMean 1.00 vs. 0.52).

Furthermore, the change in MS Spasticity Scale (MSSS-88) was greater in the arbaclofen ER group than in the placebo group (−30.1 vs. −16.7). Results on the TNmAS, CGIC, and MSSS-88 did not significantly differ between arbaclofen ER and baclofen. Drowsiness and dizziness were less common in the arbaclofen ER group than in the baclofen group. A total of 63 (57.3%) patients receiving arbaclofen ER, 82 (72.6%) receiving baclofen, and 59 (50.0%) receiving placebo reported treatment-emergent adverse events. The most common adverse events were somnolence, asthenia, and muscle weakness.

The study did not have funding support. Dr. Kantor reported having received consulting fees from AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech/Roche, Mylan, Novartis, Osmotica, and Sanofi Genzyme.

egreb@mdedge.com

SEATTLE – A regimen of twice-daily doses of extended-release arbaclofen appears to reduce spasticity effectively in patients with multiple sclerosis (MS), according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. The regimen is well tolerated.

Spasticity is common in MS, and the traditional treatment is oral baclofen, a GABA_B receptor agonist. Therapeutic doses of baclofen may cause side effects that decrease adherence, however. Arbaclofen is a more active R-enantiomer of baclofen, which is a racemic mixture. Arbaclofen extended-release (ER) tablets enable twice-daily administration, which reduces dosing frequency and may decrease the rate of adverse events.

Daniel Kantor, MD, a faculty member at Florida Atlantic University in Boca Raton, and colleagues conducted a multicenter, double-blind, parallel-group study to compare the efficacy and safety of arbaclofen ER with those of placebo and baclofen in patients with MS-related spasticity. They randomized adults in North America and Eastern Europe in equal groups to arbaclofen ER (20 mg b.i.d.), baclofen (20 mg q.i.d.), or placebo. The dose was titrated over 2 weeks, and participants subsequently entered a 12-week maintenance phase. The study’s two primary endpoints were the mean change in Total Numeric-Transformed Modified Ashworth Scale for the most affected limb (TNmAS-MAL) and Clinician Global Impression of Change (CGIC) from baseline through the maintenance period.

Dr. Kantor and colleagues randomized 341 patients in their study. Of this population, 57.5% had relapsing-remitting MS, 38.4% had secondary progressive MS, 2.6% had primary progressive MS, and 0.9% had progressive relapsing MS. Thirteen patients from one site were excluded from analysis after study completion when an audit found irregularities. The mean baseline TNmAS-MAL score was 7.93 in the arbaclofen ER group, 7.75 in the baclofen group, and 7.55 in the placebo group. At the end of the maintenance period, the mean decrease in TNmAS-MAL score was larger with arbaclofen ER than with placebo (least-squares mean [LSMean] −2.90 vs. −1.95). In addition, CGIC was significantly improved for arbaclofen ER, compared with placebo (LSMean 1.00 vs. 0.52).

Furthermore, the change in MS Spasticity Scale (MSSS-88) was greater in the arbaclofen ER group than in the placebo group (−30.1 vs. −16.7). Results on the TNmAS, CGIC, and MSSS-88 did not significantly differ between arbaclofen ER and baclofen. Drowsiness and dizziness were less common in the arbaclofen ER group than in the baclofen group. A total of 63 (57.3%) patients receiving arbaclofen ER, 82 (72.6%) receiving baclofen, and 59 (50.0%) receiving placebo reported treatment-emergent adverse events. The most common adverse events were somnolence, asthenia, and muscle weakness.

The study did not have funding support. Dr. Kantor reported having received consulting fees from AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech/Roche, Mylan, Novartis, Osmotica, and Sanofi Genzyme.

egreb@mdedge.com

SEATTLE – A regimen of twice-daily doses of extended-release arbaclofen appears to reduce spasticity effectively in patients with multiple sclerosis (MS), according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. The regimen is well tolerated.

Spasticity is common in MS, and the traditional treatment is oral baclofen, a GABA_B receptor agonist. Therapeutic doses of baclofen may cause side effects that decrease adherence, however. Arbaclofen is a more active R-enantiomer of baclofen, which is a racemic mixture. Arbaclofen extended-release (ER) tablets enable twice-daily administration, which reduces dosing frequency and may decrease the rate of adverse events.

Daniel Kantor, MD, a faculty member at Florida Atlantic University in Boca Raton, and colleagues conducted a multicenter, double-blind, parallel-group study to compare the efficacy and safety of arbaclofen ER with those of placebo and baclofen in patients with MS-related spasticity. They randomized adults in North America and Eastern Europe in equal groups to arbaclofen ER (20 mg b.i.d.), baclofen (20 mg q.i.d.), or placebo. The dose was titrated over 2 weeks, and participants subsequently entered a 12-week maintenance phase. The study’s two primary endpoints were the mean change in Total Numeric-Transformed Modified Ashworth Scale for the most affected limb (TNmAS-MAL) and Clinician Global Impression of Change (CGIC) from baseline through the maintenance period.

Dr. Kantor and colleagues randomized 341 patients in their study. Of this population, 57.5% had relapsing-remitting MS, 38.4% had secondary progressive MS, 2.6% had primary progressive MS, and 0.9% had progressive relapsing MS. Thirteen patients from one site were excluded from analysis after study completion when an audit found irregularities. The mean baseline TNmAS-MAL score was 7.93 in the arbaclofen ER group, 7.75 in the baclofen group, and 7.55 in the placebo group. At the end of the maintenance period, the mean decrease in TNmAS-MAL score was larger with arbaclofen ER than with placebo (least-squares mean [LSMean] −2.90 vs. −1.95). In addition, CGIC was significantly improved for arbaclofen ER, compared with placebo (LSMean 1.00 vs. 0.52).

Furthermore, the change in MS Spasticity Scale (MSSS-88) was greater in the arbaclofen ER group than in the placebo group (−30.1 vs. −16.7). Results on the TNmAS, CGIC, and MSSS-88 did not significantly differ between arbaclofen ER and baclofen. Drowsiness and dizziness were less common in the arbaclofen ER group than in the baclofen group. A total of 63 (57.3%) patients receiving arbaclofen ER, 82 (72.6%) receiving baclofen, and 59 (50.0%) receiving placebo reported treatment-emergent adverse events. The most common adverse events were somnolence, asthenia, and muscle weakness.

The study did not have funding support. Dr. Kantor reported having received consulting fees from AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech/Roche, Mylan, Novartis, Osmotica, and Sanofi Genzyme.

egreb@mdedge.com