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Adherence to oral treatments for MS is poor
Seattle – , 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.
SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.
Seattle – , 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.
SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.
Seattle – , 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.
SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.
REPORTING FROM CMSC 2019
Extended-release arbaclofen reduces MS-related spasticity
SEATTLE – (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 GABAB 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.
SEATTLE – (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 GABAB 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.
SEATTLE – (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 GABAB 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.
REPORTING FROM CMSC 2019
Changes in Brain Networks May Predict MS Worsening
Key clinical point: Structural and functional network MRI measures predict long-term worsening in multiple sclerosis.
Major finding: The odds ratio of worsening for patients with abnormally high baseline resting state functional connectivity is 1.67.
Study details: A prospective imaging study of 233 patients with multiple sclerosis and 77 healthy controls.
Disclosures: Dr. Filippi has received research support from Biogen, Merck Serono, Novartis, Teva, and Roche.
Citation: Filippi M et al. AAN 2019, Abstract S49.004.
Key clinical point: Structural and functional network MRI measures predict long-term worsening in multiple sclerosis.
Major finding: The odds ratio of worsening for patients with abnormally high baseline resting state functional connectivity is 1.67.
Study details: A prospective imaging study of 233 patients with multiple sclerosis and 77 healthy controls.
Disclosures: Dr. Filippi has received research support from Biogen, Merck Serono, Novartis, Teva, and Roche.
Citation: Filippi M et al. AAN 2019, Abstract S49.004.
Key clinical point: Structural and functional network MRI measures predict long-term worsening in multiple sclerosis.
Major finding: The odds ratio of worsening for patients with abnormally high baseline resting state functional connectivity is 1.67.
Study details: A prospective imaging study of 233 patients with multiple sclerosis and 77 healthy controls.
Disclosures: Dr. Filippi has received research support from Biogen, Merck Serono, Novartis, Teva, and Roche.
Citation: Filippi M et al. AAN 2019, Abstract S49.004.
Sugary Drink Intake May be Associated with MS Severity
Key clinical point: Among patients with multiple sclerosis, consumption of sugar-sweetened beverages may be associated with more severe disability.
Major finding: Patients in the top quartile of sugar-sweetened beverage intake had an average EDSS of 4.1 and patients in the bottom quartile had an average EDSS of 3.4.
Study details: Cross-sectional study of 135 patients with MS.
Disclosures: Dr. Meier-Gerdingh had no disclosures. Coauthors reported research support and personal compensation from pharmaceutical companies.
Citation: Meier-Gerdingh E et al. AAN 2019, Abstract P4.2-063.
Key clinical point: Among patients with multiple sclerosis, consumption of sugar-sweetened beverages may be associated with more severe disability.
Major finding: Patients in the top quartile of sugar-sweetened beverage intake had an average EDSS of 4.1 and patients in the bottom quartile had an average EDSS of 3.4.
Study details: Cross-sectional study of 135 patients with MS.
Disclosures: Dr. Meier-Gerdingh had no disclosures. Coauthors reported research support and personal compensation from pharmaceutical companies.
Citation: Meier-Gerdingh E et al. AAN 2019, Abstract P4.2-063.
Key clinical point: Among patients with multiple sclerosis, consumption of sugar-sweetened beverages may be associated with more severe disability.
Major finding: Patients in the top quartile of sugar-sweetened beverage intake had an average EDSS of 4.1 and patients in the bottom quartile had an average EDSS of 3.4.
Study details: Cross-sectional study of 135 patients with MS.
Disclosures: Dr. Meier-Gerdingh had no disclosures. Coauthors reported research support and personal compensation from pharmaceutical companies.
Citation: Meier-Gerdingh E et al. AAN 2019, Abstract P4.2-063.
Researchers Examine Vitamin D, Skin Pigmentation, and Outcomes of Pediatric MS
Key clinical point: The relationship between vitamin D status and MS outcome in children relates to skin pigmentation.
Major finding: About 46% of children with MS were HLA-DRB1*15 positive.
Study details: A multisite, prospective study of 259 children with MS.
Disclosures: Ms. Dunn had no disclosures, but various coauthors have received compensation from companies such as Novartis, Merck, Teva, Celgene, and Genentech.
Citation: Dunn C et al. AAN 2019, Abstract S19.007.
Key clinical point: The relationship between vitamin D status and MS outcome in children relates to skin pigmentation.
Major finding: About 46% of children with MS were HLA-DRB1*15 positive.
Study details: A multisite, prospective study of 259 children with MS.
Disclosures: Ms. Dunn had no disclosures, but various coauthors have received compensation from companies such as Novartis, Merck, Teva, Celgene, and Genentech.
Citation: Dunn C et al. AAN 2019, Abstract S19.007.
Key clinical point: The relationship between vitamin D status and MS outcome in children relates to skin pigmentation.
Major finding: About 46% of children with MS were HLA-DRB1*15 positive.
Study details: A multisite, prospective study of 259 children with MS.
Disclosures: Ms. Dunn had no disclosures, but various coauthors have received compensation from companies such as Novartis, Merck, Teva, Celgene, and Genentech.
Citation: Dunn C et al. AAN 2019, Abstract S19.007.
Why aren’t preferred DMTs prescribed for MS? Neurologists point to insurers, patients
SEATTLE –
Specifically, “it appears that patient reluctance to start moderate-efficacy DMTs is a major factor and may be impeding a significant uptake of the oral drugs in treatment-naive patients,” said study lead author Virginia Schobel, MSc, of the consulting firm Spherix Global Insights, who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
The third annual survey of neurologists was conducted in December 2018, and 218 neurologists took part. Participants answered questions via an online survey and provided cross-sectional retrospective chart reviews of 1,059 MS patients who started their first DMT over the previous 3 months. The survey participants managed the initial DMT selection in 935 of the cases.
For this survey, Ms. Schobel said, researchers focused on exploring reasons why data aren’t showing a major trend toward oral DMTs as first-line treatment. “A good proportion of neurologists agree that this is their preferred method, but we are not seeing the market move,” she said.
The survey asked neurologists if they agree with this statement: “When initiating a patient on DMT therapy, I prefer to use a DMT aggressive approach, using a high-efficacy agent as opposed to a therapy escalation approach whereby I start with a traditional first-line DMT and only progress to second line if/when the patient does not have an optimal response.” Nearly half (49%) of the neurologists agreed, while 16% disagreed and 36% were neutral.
Neurologists reported initiating their preferred DMT 77% of the time (standard efficacy DMTs), 81% of the time (moderate efficacy), and 75% (high efficacy).
When asked why they weren’t able to prescribe their top recommended DMT, neurologists offered these answers:
** In standard-efficacy cases (n = 96), insurance hitches – formulary limitations or denial – were responsible 67% of the time. Patient refusal or preference for another DMT were responsible 33% of the time, and other reasons accounted for 1%.
Why do patients face insurance hassles for standard-efficacy drugs? Ms. Schobel noted that generics are available for these drugs, and insurers may prefer them.
** In moderate-efficacy cases (n = 63), insurance hitches accounted for 40% of cases, while patient refusal made up 59% with other reasons at 3%.
** In high-efficacy cases (n = 46), insurance hitches accounted for 59% of cases, while patient refusal explained 41% of cases. Of the latter group, reasons included tolerability concerns (42%) and safety concerns other than progressive multifocal leukoencephalopathy (PML) risks (37%)
No study funding is reported, and the study authors report no relevant disclosures.
SEATTLE –
Specifically, “it appears that patient reluctance to start moderate-efficacy DMTs is a major factor and may be impeding a significant uptake of the oral drugs in treatment-naive patients,” said study lead author Virginia Schobel, MSc, of the consulting firm Spherix Global Insights, who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
The third annual survey of neurologists was conducted in December 2018, and 218 neurologists took part. Participants answered questions via an online survey and provided cross-sectional retrospective chart reviews of 1,059 MS patients who started their first DMT over the previous 3 months. The survey participants managed the initial DMT selection in 935 of the cases.
For this survey, Ms. Schobel said, researchers focused on exploring reasons why data aren’t showing a major trend toward oral DMTs as first-line treatment. “A good proportion of neurologists agree that this is their preferred method, but we are not seeing the market move,” she said.
The survey asked neurologists if they agree with this statement: “When initiating a patient on DMT therapy, I prefer to use a DMT aggressive approach, using a high-efficacy agent as opposed to a therapy escalation approach whereby I start with a traditional first-line DMT and only progress to second line if/when the patient does not have an optimal response.” Nearly half (49%) of the neurologists agreed, while 16% disagreed and 36% were neutral.
Neurologists reported initiating their preferred DMT 77% of the time (standard efficacy DMTs), 81% of the time (moderate efficacy), and 75% (high efficacy).
When asked why they weren’t able to prescribe their top recommended DMT, neurologists offered these answers:
** In standard-efficacy cases (n = 96), insurance hitches – formulary limitations or denial – were responsible 67% of the time. Patient refusal or preference for another DMT were responsible 33% of the time, and other reasons accounted for 1%.
Why do patients face insurance hassles for standard-efficacy drugs? Ms. Schobel noted that generics are available for these drugs, and insurers may prefer them.
** In moderate-efficacy cases (n = 63), insurance hitches accounted for 40% of cases, while patient refusal made up 59% with other reasons at 3%.
** In high-efficacy cases (n = 46), insurance hitches accounted for 59% of cases, while patient refusal explained 41% of cases. Of the latter group, reasons included tolerability concerns (42%) and safety concerns other than progressive multifocal leukoencephalopathy (PML) risks (37%)
No study funding is reported, and the study authors report no relevant disclosures.
SEATTLE –
Specifically, “it appears that patient reluctance to start moderate-efficacy DMTs is a major factor and may be impeding a significant uptake of the oral drugs in treatment-naive patients,” said study lead author Virginia Schobel, MSc, of the consulting firm Spherix Global Insights, who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
The third annual survey of neurologists was conducted in December 2018, and 218 neurologists took part. Participants answered questions via an online survey and provided cross-sectional retrospective chart reviews of 1,059 MS patients who started their first DMT over the previous 3 months. The survey participants managed the initial DMT selection in 935 of the cases.
For this survey, Ms. Schobel said, researchers focused on exploring reasons why data aren’t showing a major trend toward oral DMTs as first-line treatment. “A good proportion of neurologists agree that this is their preferred method, but we are not seeing the market move,” she said.
The survey asked neurologists if they agree with this statement: “When initiating a patient on DMT therapy, I prefer to use a DMT aggressive approach, using a high-efficacy agent as opposed to a therapy escalation approach whereby I start with a traditional first-line DMT and only progress to second line if/when the patient does not have an optimal response.” Nearly half (49%) of the neurologists agreed, while 16% disagreed and 36% were neutral.
Neurologists reported initiating their preferred DMT 77% of the time (standard efficacy DMTs), 81% of the time (moderate efficacy), and 75% (high efficacy).
When asked why they weren’t able to prescribe their top recommended DMT, neurologists offered these answers:
** In standard-efficacy cases (n = 96), insurance hitches – formulary limitations or denial – were responsible 67% of the time. Patient refusal or preference for another DMT were responsible 33% of the time, and other reasons accounted for 1%.
Why do patients face insurance hassles for standard-efficacy drugs? Ms. Schobel noted that generics are available for these drugs, and insurers may prefer them.
** In moderate-efficacy cases (n = 63), insurance hitches accounted for 40% of cases, while patient refusal made up 59% with other reasons at 3%.
** In high-efficacy cases (n = 46), insurance hitches accounted for 59% of cases, while patient refusal explained 41% of cases. Of the latter group, reasons included tolerability concerns (42%) and safety concerns other than progressive multifocal leukoencephalopathy (PML) risks (37%)
No study funding is reported, and the study authors report no relevant disclosures.
REPORTING FROM CMSC 2019
Modest evidence for benefit in studies of cannabis in MS
SEATTLE – Reviewers found modest evidence of benefit and plenty of room for more research.
“Cannabis-based medicine may be useful for refractory MS symptoms, especially spasticity and pain, and side effects are usually well tolerated,” study lead author Natasha Breward, a graduate student at the College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, said in an interview. Ms. Breward spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
For the review, Ms. Breward and colleagues focused on 60 studies - 26 randomized controlled trials and 34 trials with other designs. Forty of the studies used nabiximols (Sativex), an oromucosal spray that is derived from the cannabis sativa plant and approved for use in multiple countries but not yet in the United States.
According to Ms. Breward, some of the other treatments included dried cannabis that is smoked or eaten and cannabidiol that’s typically delivered with tetrahydrocannabinol (THC) either oromucosally or as an oral capsule.
MS symptoms treated in the studies included spasticity (n = 29), pain (n = 8) and cognition (n = 6).
The researchers considered 22 studies to be poor quality, 14 to be fair quality, and 24 to be good/excellent quality.
As for results, the researchers found that the cannabis-based medicine “significantly reduced spasticity and pain in several individual good-quality studies,” Ms. Breward said. The drugs seem to work by inhibiting neurotransmitter release via cannabinoids, she said.
“However,” she added, “the variability in study quality – and in the products and regimens studied – make it hard to draw any conclusions about specific products and doses that may have the most potential benefit.”
As for adverse effects, dried cannabis was linked to decreased long-term cognitive function, which is distinct from being temporarily high, Ms. Breward said.
“Further research should focus on the use of different products and formulations of cannabis-based medicine such as cannabis oil and cannabidiol-prominent products, as no studies have focused on this area,” she said. “Research should also look at the potential of cannabis-based medicine for the treatment of disease progression, as cannabinoids are anti-inflammatory and immunomodulatory. Finally, more research regarding the potentially synergistic effects of cannabis-based medicine administered with current MS medications would also be useful.”
No study funding is reported and the authors report no relevant disclosures.
SEATTLE – Reviewers found modest evidence of benefit and plenty of room for more research.
“Cannabis-based medicine may be useful for refractory MS symptoms, especially spasticity and pain, and side effects are usually well tolerated,” study lead author Natasha Breward, a graduate student at the College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, said in an interview. Ms. Breward spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
For the review, Ms. Breward and colleagues focused on 60 studies - 26 randomized controlled trials and 34 trials with other designs. Forty of the studies used nabiximols (Sativex), an oromucosal spray that is derived from the cannabis sativa plant and approved for use in multiple countries but not yet in the United States.
According to Ms. Breward, some of the other treatments included dried cannabis that is smoked or eaten and cannabidiol that’s typically delivered with tetrahydrocannabinol (THC) either oromucosally or as an oral capsule.
MS symptoms treated in the studies included spasticity (n = 29), pain (n = 8) and cognition (n = 6).
The researchers considered 22 studies to be poor quality, 14 to be fair quality, and 24 to be good/excellent quality.
As for results, the researchers found that the cannabis-based medicine “significantly reduced spasticity and pain in several individual good-quality studies,” Ms. Breward said. The drugs seem to work by inhibiting neurotransmitter release via cannabinoids, she said.
“However,” she added, “the variability in study quality – and in the products and regimens studied – make it hard to draw any conclusions about specific products and doses that may have the most potential benefit.”
As for adverse effects, dried cannabis was linked to decreased long-term cognitive function, which is distinct from being temporarily high, Ms. Breward said.
“Further research should focus on the use of different products and formulations of cannabis-based medicine such as cannabis oil and cannabidiol-prominent products, as no studies have focused on this area,” she said. “Research should also look at the potential of cannabis-based medicine for the treatment of disease progression, as cannabinoids are anti-inflammatory and immunomodulatory. Finally, more research regarding the potentially synergistic effects of cannabis-based medicine administered with current MS medications would also be useful.”
No study funding is reported and the authors report no relevant disclosures.
SEATTLE – Reviewers found modest evidence of benefit and plenty of room for more research.
“Cannabis-based medicine may be useful for refractory MS symptoms, especially spasticity and pain, and side effects are usually well tolerated,” study lead author Natasha Breward, a graduate student at the College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, said in an interview. Ms. Breward spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
For the review, Ms. Breward and colleagues focused on 60 studies - 26 randomized controlled trials and 34 trials with other designs. Forty of the studies used nabiximols (Sativex), an oromucosal spray that is derived from the cannabis sativa plant and approved for use in multiple countries but not yet in the United States.
According to Ms. Breward, some of the other treatments included dried cannabis that is smoked or eaten and cannabidiol that’s typically delivered with tetrahydrocannabinol (THC) either oromucosally or as an oral capsule.
MS symptoms treated in the studies included spasticity (n = 29), pain (n = 8) and cognition (n = 6).
The researchers considered 22 studies to be poor quality, 14 to be fair quality, and 24 to be good/excellent quality.
As for results, the researchers found that the cannabis-based medicine “significantly reduced spasticity and pain in several individual good-quality studies,” Ms. Breward said. The drugs seem to work by inhibiting neurotransmitter release via cannabinoids, she said.
“However,” she added, “the variability in study quality – and in the products and regimens studied – make it hard to draw any conclusions about specific products and doses that may have the most potential benefit.”
As for adverse effects, dried cannabis was linked to decreased long-term cognitive function, which is distinct from being temporarily high, Ms. Breward said.
“Further research should focus on the use of different products and formulations of cannabis-based medicine such as cannabis oil and cannabidiol-prominent products, as no studies have focused on this area,” she said. “Research should also look at the potential of cannabis-based medicine for the treatment of disease progression, as cannabinoids are anti-inflammatory and immunomodulatory. Finally, more research regarding the potentially synergistic effects of cannabis-based medicine administered with current MS medications would also be useful.”
No study funding is reported and the authors report no relevant disclosures.
REPORTING FROM CMSC 2019
Alemtuzumab provides greater reductions in serum NfL than interferon beta-1a
Seattle – (MS), according to an analysis presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. This finding is consistent with the superior clinical efficacy of alemtuzumab, compared with interferon beta-1a, seen in clinical trials, said the researchers. The clinical implications of alemtuzumab’s reduction of NfL levels remain to be clarified.
The CARE-MS I trial indicated that alemtuzumab significantly improved clinical and MRI outcomes vs. subcutaneous interferon beta-1a over 2 years in treatment-naive patients with relapsing-remitting MS. Serum NfL level may indicate response to disease-modifying therapy.
Evis Havari, MSc, laboratory head of neuroimmunology immunomodulation at Sanofi in Framingham, Mass., and colleagues analyzed CARE-MS I data to determine the effect of alemtuzumab and subcutaneous interferon beta-1a on serum NfL over 2 years. The investigators also sought to compare participants’ serum NfL levels with the age-dependent median serum NfL levels in healthy controls, based on the approach described by Disanto et al. (Ann Neurol. 2017;81[6]:857-70).
In CARE-MS I, the investigators measured serum NfL with a single-molecule array. They used Generalized Additive Models of Location, Scale, and Shape to model serum NfL distribution in healthy controls and its association with age. They also derived age-dependent percentiles of serum NfL. CARE-MS I patients received 44 mcg of subcutaneous interferon beta-1a 3 times per week or 12 mg/day of alemtuzumab (a 5-day course at baseline and a 3-day course at 1 year). To obtain an age-independent measure of serum NfL, the researchers dichotomized samples into levels above or below the median. They used repeated logistic regression to estimate odds ratios (ORs).
The age range of participants in CARE-MS I was 18-53 years. Mean Expanded Disability Status Scale score was 2.0. In all, 354 participants received alemtuzumab, and 157 received interferon beta-1a.
Median serum NfL levels for healthy controls ranged from 12.0 pg/mL at 18 years of age to 27.1 pg/mL at 53 years. Median serum NfL levels were similar between the alemtuzumab and interferon beta-1a groups at baseline (31.7 pg/mL vs. 31.4 pg/mL). At 6 months after treatment, median serum NfL levels were significantly lower with alemtuzumab than with interferon beta-1a (17.2 pg/mL vs. 21.4 pg/mL). These levels remained significantly lower at month 24 in the alemtuzumab group (13.2 pg/mL vs. 18.7 pg/mL).
Significantly fewer patients in the alemtuzumab group had serum NfL levels higher than the age-dependent median in healthy controls at each post baseline time point, compared with the interferon beta-1a group (month 6: 46% vs. 65%; month 12: 38% vs. 53%; month 18: 31% vs. 44%; month 24: 28% vs. 53%). The odds for achieving serum NfL levels less than or equal to median levels for healthy controls were significantly greater for alemtuzumab than interferon beta-1a at month 6 (OR, 2.34), month 12 (OR, 1.81), month 18 (OR, 1.72), and month 24 (OR, 2.85).
Sanofi and Bayer HealthCare Pharmaceuticals supported the study. Several of the investigators are employees of Sanofi.
SOURCE: Havari E et al. CMSC 2019. Abstract NIB01.
Seattle – (MS), according to an analysis presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. This finding is consistent with the superior clinical efficacy of alemtuzumab, compared with interferon beta-1a, seen in clinical trials, said the researchers. The clinical implications of alemtuzumab’s reduction of NfL levels remain to be clarified.
The CARE-MS I trial indicated that alemtuzumab significantly improved clinical and MRI outcomes vs. subcutaneous interferon beta-1a over 2 years in treatment-naive patients with relapsing-remitting MS. Serum NfL level may indicate response to disease-modifying therapy.
Evis Havari, MSc, laboratory head of neuroimmunology immunomodulation at Sanofi in Framingham, Mass., and colleagues analyzed CARE-MS I data to determine the effect of alemtuzumab and subcutaneous interferon beta-1a on serum NfL over 2 years. The investigators also sought to compare participants’ serum NfL levels with the age-dependent median serum NfL levels in healthy controls, based on the approach described by Disanto et al. (Ann Neurol. 2017;81[6]:857-70).
In CARE-MS I, the investigators measured serum NfL with a single-molecule array. They used Generalized Additive Models of Location, Scale, and Shape to model serum NfL distribution in healthy controls and its association with age. They also derived age-dependent percentiles of serum NfL. CARE-MS I patients received 44 mcg of subcutaneous interferon beta-1a 3 times per week or 12 mg/day of alemtuzumab (a 5-day course at baseline and a 3-day course at 1 year). To obtain an age-independent measure of serum NfL, the researchers dichotomized samples into levels above or below the median. They used repeated logistic regression to estimate odds ratios (ORs).
The age range of participants in CARE-MS I was 18-53 years. Mean Expanded Disability Status Scale score was 2.0. In all, 354 participants received alemtuzumab, and 157 received interferon beta-1a.
Median serum NfL levels for healthy controls ranged from 12.0 pg/mL at 18 years of age to 27.1 pg/mL at 53 years. Median serum NfL levels were similar between the alemtuzumab and interferon beta-1a groups at baseline (31.7 pg/mL vs. 31.4 pg/mL). At 6 months after treatment, median serum NfL levels were significantly lower with alemtuzumab than with interferon beta-1a (17.2 pg/mL vs. 21.4 pg/mL). These levels remained significantly lower at month 24 in the alemtuzumab group (13.2 pg/mL vs. 18.7 pg/mL).
Significantly fewer patients in the alemtuzumab group had serum NfL levels higher than the age-dependent median in healthy controls at each post baseline time point, compared with the interferon beta-1a group (month 6: 46% vs. 65%; month 12: 38% vs. 53%; month 18: 31% vs. 44%; month 24: 28% vs. 53%). The odds for achieving serum NfL levels less than or equal to median levels for healthy controls were significantly greater for alemtuzumab than interferon beta-1a at month 6 (OR, 2.34), month 12 (OR, 1.81), month 18 (OR, 1.72), and month 24 (OR, 2.85).
Sanofi and Bayer HealthCare Pharmaceuticals supported the study. Several of the investigators are employees of Sanofi.
SOURCE: Havari E et al. CMSC 2019. Abstract NIB01.
Seattle – (MS), according to an analysis presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. This finding is consistent with the superior clinical efficacy of alemtuzumab, compared with interferon beta-1a, seen in clinical trials, said the researchers. The clinical implications of alemtuzumab’s reduction of NfL levels remain to be clarified.
The CARE-MS I trial indicated that alemtuzumab significantly improved clinical and MRI outcomes vs. subcutaneous interferon beta-1a over 2 years in treatment-naive patients with relapsing-remitting MS. Serum NfL level may indicate response to disease-modifying therapy.
Evis Havari, MSc, laboratory head of neuroimmunology immunomodulation at Sanofi in Framingham, Mass., and colleagues analyzed CARE-MS I data to determine the effect of alemtuzumab and subcutaneous interferon beta-1a on serum NfL over 2 years. The investigators also sought to compare participants’ serum NfL levels with the age-dependent median serum NfL levels in healthy controls, based on the approach described by Disanto et al. (Ann Neurol. 2017;81[6]:857-70).
In CARE-MS I, the investigators measured serum NfL with a single-molecule array. They used Generalized Additive Models of Location, Scale, and Shape to model serum NfL distribution in healthy controls and its association with age. They also derived age-dependent percentiles of serum NfL. CARE-MS I patients received 44 mcg of subcutaneous interferon beta-1a 3 times per week or 12 mg/day of alemtuzumab (a 5-day course at baseline and a 3-day course at 1 year). To obtain an age-independent measure of serum NfL, the researchers dichotomized samples into levels above or below the median. They used repeated logistic regression to estimate odds ratios (ORs).
The age range of participants in CARE-MS I was 18-53 years. Mean Expanded Disability Status Scale score was 2.0. In all, 354 participants received alemtuzumab, and 157 received interferon beta-1a.
Median serum NfL levels for healthy controls ranged from 12.0 pg/mL at 18 years of age to 27.1 pg/mL at 53 years. Median serum NfL levels were similar between the alemtuzumab and interferon beta-1a groups at baseline (31.7 pg/mL vs. 31.4 pg/mL). At 6 months after treatment, median serum NfL levels were significantly lower with alemtuzumab than with interferon beta-1a (17.2 pg/mL vs. 21.4 pg/mL). These levels remained significantly lower at month 24 in the alemtuzumab group (13.2 pg/mL vs. 18.7 pg/mL).
Significantly fewer patients in the alemtuzumab group had serum NfL levels higher than the age-dependent median in healthy controls at each post baseline time point, compared with the interferon beta-1a group (month 6: 46% vs. 65%; month 12: 38% vs. 53%; month 18: 31% vs. 44%; month 24: 28% vs. 53%). The odds for achieving serum NfL levels less than or equal to median levels for healthy controls were significantly greater for alemtuzumab than interferon beta-1a at month 6 (OR, 2.34), month 12 (OR, 1.81), month 18 (OR, 1.72), and month 24 (OR, 2.85).
Sanofi and Bayer HealthCare Pharmaceuticals supported the study. Several of the investigators are employees of Sanofi.
SOURCE: Havari E et al. CMSC 2019. Abstract NIB01.
REPORTING FROM CMSC 2019
Key clinical point: Compared with interferon beta-1a, alemtuzumab provides greater reduction of serum NfL level.
Major finding: At month 24, median serum NfL level was 13.2 pg/mL in the alemtuzumab group and 18.7 pg/mL in the interferon group.
Study details: A prospective, randomized study of 511 patients with relapsing-remitting MS.
Disclosures: Sanofi and Bayer HealthCare Pharmaceuticals supported the study. Several of the investigators are employees of Sanofi.
Source: Havari E et al. CMSC 2019. Abstract NIB01.
Association between cytomegalovirus and MS varies by region
SEATTLE – presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. In the United States, the association between CMV seropositivity and MS is not statistically significant, whereas combined data from all regions show a significant positive association, researchers said.
“To our knowledge, this is the largest meta-analysis evaluation of the association between CMV seropositivity and MS,” said Smathorn Thakolwiboon, MD, a neurology resident at Texas Tech University, Lubbock, and colleagues. Understanding the reasons for the geographic heterogeneity will require further research, they said.
Researchers have hypothesized that increased incidence of autoimmune conditions may be linked to the prevention or delay of common infections, but studies have been inconclusive (Neurology. 2017 Sep 26;89[13]:1330-7.).
To evaluate the association between CMV seropositivity and MS, Dr. Thakolwiboon and colleagues searched databases, including PubMed/MEDLINE, Embase, and Web of Science, from inception through Dec. 2018. They included in their analysis observational studies that evaluated the seroprevalence of CMV immunoglobulin G (IgG) in adults with MS and healthy controls. They estimated the odds ratio (OR) for CMV seropositivity and MS.
An initial search yielded 982 articles, 56 of which underwent full review. The researchers ultimately included 13 articles in their quantitative analysis. The studies included data from 3,049 patients with MS and 3,604 controls.
Overall, CMV seropositivity was significantly associated with MS (OR, 1.58; 95% confidence interval, 1.04-2.39; P = .031), but the relationship varied by region. In five U.S. studies, the association was not statistically significant (OR, 1.57; 95% CI, 0.83-2.99; P = .168). CMV seropositivity was negatively associated with MS in Europe (OR, 0.81; 95% CI, 0.68-0.96; P less than .001), but positively associated with MS in the Middle East (OR, 5.42; 95% CI, 1.06-27.89; P less than .001). “The meta-analysis showed a heterogeneity of the association between CMV seropositivity and MS,” the researchers concluded. “More genetic and environmental studies are needed for better understanding this geographic heterogeneity.”
Dr. Thakolwiboon had no disclosures. A coauthor disclosed speaking and advisory board roles with EMD Serono, Genzyme, Novartis, and Teva.
SOURCE: Thakolwiboon S et al. CMSC 2019. Abstract EPI01.
SEATTLE – presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. In the United States, the association between CMV seropositivity and MS is not statistically significant, whereas combined data from all regions show a significant positive association, researchers said.
“To our knowledge, this is the largest meta-analysis evaluation of the association between CMV seropositivity and MS,” said Smathorn Thakolwiboon, MD, a neurology resident at Texas Tech University, Lubbock, and colleagues. Understanding the reasons for the geographic heterogeneity will require further research, they said.
Researchers have hypothesized that increased incidence of autoimmune conditions may be linked to the prevention or delay of common infections, but studies have been inconclusive (Neurology. 2017 Sep 26;89[13]:1330-7.).
To evaluate the association between CMV seropositivity and MS, Dr. Thakolwiboon and colleagues searched databases, including PubMed/MEDLINE, Embase, and Web of Science, from inception through Dec. 2018. They included in their analysis observational studies that evaluated the seroprevalence of CMV immunoglobulin G (IgG) in adults with MS and healthy controls. They estimated the odds ratio (OR) for CMV seropositivity and MS.
An initial search yielded 982 articles, 56 of which underwent full review. The researchers ultimately included 13 articles in their quantitative analysis. The studies included data from 3,049 patients with MS and 3,604 controls.
Overall, CMV seropositivity was significantly associated with MS (OR, 1.58; 95% confidence interval, 1.04-2.39; P = .031), but the relationship varied by region. In five U.S. studies, the association was not statistically significant (OR, 1.57; 95% CI, 0.83-2.99; P = .168). CMV seropositivity was negatively associated with MS in Europe (OR, 0.81; 95% CI, 0.68-0.96; P less than .001), but positively associated with MS in the Middle East (OR, 5.42; 95% CI, 1.06-27.89; P less than .001). “The meta-analysis showed a heterogeneity of the association between CMV seropositivity and MS,” the researchers concluded. “More genetic and environmental studies are needed for better understanding this geographic heterogeneity.”
Dr. Thakolwiboon had no disclosures. A coauthor disclosed speaking and advisory board roles with EMD Serono, Genzyme, Novartis, and Teva.
SOURCE: Thakolwiboon S et al. CMSC 2019. Abstract EPI01.
SEATTLE – presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. In the United States, the association between CMV seropositivity and MS is not statistically significant, whereas combined data from all regions show a significant positive association, researchers said.
“To our knowledge, this is the largest meta-analysis evaluation of the association between CMV seropositivity and MS,” said Smathorn Thakolwiboon, MD, a neurology resident at Texas Tech University, Lubbock, and colleagues. Understanding the reasons for the geographic heterogeneity will require further research, they said.
Researchers have hypothesized that increased incidence of autoimmune conditions may be linked to the prevention or delay of common infections, but studies have been inconclusive (Neurology. 2017 Sep 26;89[13]:1330-7.).
To evaluate the association between CMV seropositivity and MS, Dr. Thakolwiboon and colleagues searched databases, including PubMed/MEDLINE, Embase, and Web of Science, from inception through Dec. 2018. They included in their analysis observational studies that evaluated the seroprevalence of CMV immunoglobulin G (IgG) in adults with MS and healthy controls. They estimated the odds ratio (OR) for CMV seropositivity and MS.
An initial search yielded 982 articles, 56 of which underwent full review. The researchers ultimately included 13 articles in their quantitative analysis. The studies included data from 3,049 patients with MS and 3,604 controls.
Overall, CMV seropositivity was significantly associated with MS (OR, 1.58; 95% confidence interval, 1.04-2.39; P = .031), but the relationship varied by region. In five U.S. studies, the association was not statistically significant (OR, 1.57; 95% CI, 0.83-2.99; P = .168). CMV seropositivity was negatively associated with MS in Europe (OR, 0.81; 95% CI, 0.68-0.96; P less than .001), but positively associated with MS in the Middle East (OR, 5.42; 95% CI, 1.06-27.89; P less than .001). “The meta-analysis showed a heterogeneity of the association between CMV seropositivity and MS,” the researchers concluded. “More genetic and environmental studies are needed for better understanding this geographic heterogeneity.”
Dr. Thakolwiboon had no disclosures. A coauthor disclosed speaking and advisory board roles with EMD Serono, Genzyme, Novartis, and Teva.
SOURCE: Thakolwiboon S et al. CMSC 2019. Abstract EPI01.
REPORTING FROM CMSC 2019
Key clinical point: Cytomegalovirus seropositivity may be associated with increased likelihood of multiple sclerosis in the Middle East and decreased likelihood in Europe.
Major finding: Overall, cytomegalovirus seropositivity was significantly associated with multiple sclerosis (OR, 1.58), but the relationship varied by region.
Study details: A meta-analysis of 13 studies that included data from 3,049 patients with MS and 3,604 controls.
Disclosures: Dr. Thakolwiboon had no disclosures. A coauthor disclosed speaking and advisory board roles with EMD Serono, Genzyme, Novartis, and Teva.
Source: Thakolwiboon S et al. CMSC 2019. Abstract EPI01.
Periodic limb movements during sleep are common in patients with MS and fatigue
Seattle – , according to a retrospective analysis described at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“PLMS may contribute to daytime sleepiness and should be recognized and potentially treated. The etiology of fatigue related to sleep problems in people with MS is multifactorial and not just due to obstructive sleep apnea,” said lead author Jared Srinivasan, clinical research coordinator at South Shore Neurologic Associates in East Northport, New York, and colleagues.
Fatigue is common in patients with MS and can be disabling. For many patients with MS, sleep apnea is the underlying cause of fatigue. PLMS – leg movements that usually occur at 20- to 40-second intervals during sleep – are not commonly reported in MS. These movements cause sleep fragmentation, increase the energy cost of sleep, and contribute to daytime somnolence. Patients with PLMS often are unaware that they have them and do not report related symptoms unless they are specifically questioned about them. Polysomnography (PSG) is an effective, objective method of evaluating a patient for PLMS, but previous studies of PLMS in patients with MS have been small.
Mr. Srinivasan and colleagues performed a retrospective analysis to investigate the incidence and degree of PLMS in people with MS who had reported fatigue, had not previously been diagnosed as having sleep apnea or PLMS, and agreed to undergo overnight PSG.
The investigators included 292 participants in their study. The population’s average age was 47.3 years. Approximately 81% of patients were female. About 41% of the population had a PLMS index (PLMS per hour) greater than 0. Of participants with PSG-identified PLMS, 10% had a PLMS index of 5-10, 5% had a PLMS index of 11-21, and 12% had a PLMS index greater than 21. About 38% of the population experienced arousal because of PLMS. Of patients with arousal, 34% had a PLMS arousal index (number of arousals per hour) between 0 and 5, 31% had PLMS arousal index of 5-20, 14% had a PLMS arousal index of 20-50, and 21% had a PLMS arousal index greater than 50.
The investigators did not receive financial support for this study and did not report disclosures.
SOURCE: Srinivasan J et al. CMSC 2019. Abstract QOL29.
Seattle – , according to a retrospective analysis described at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“PLMS may contribute to daytime sleepiness and should be recognized and potentially treated. The etiology of fatigue related to sleep problems in people with MS is multifactorial and not just due to obstructive sleep apnea,” said lead author Jared Srinivasan, clinical research coordinator at South Shore Neurologic Associates in East Northport, New York, and colleagues.
Fatigue is common in patients with MS and can be disabling. For many patients with MS, sleep apnea is the underlying cause of fatigue. PLMS – leg movements that usually occur at 20- to 40-second intervals during sleep – are not commonly reported in MS. These movements cause sleep fragmentation, increase the energy cost of sleep, and contribute to daytime somnolence. Patients with PLMS often are unaware that they have them and do not report related symptoms unless they are specifically questioned about them. Polysomnography (PSG) is an effective, objective method of evaluating a patient for PLMS, but previous studies of PLMS in patients with MS have been small.
Mr. Srinivasan and colleagues performed a retrospective analysis to investigate the incidence and degree of PLMS in people with MS who had reported fatigue, had not previously been diagnosed as having sleep apnea or PLMS, and agreed to undergo overnight PSG.
The investigators included 292 participants in their study. The population’s average age was 47.3 years. Approximately 81% of patients were female. About 41% of the population had a PLMS index (PLMS per hour) greater than 0. Of participants with PSG-identified PLMS, 10% had a PLMS index of 5-10, 5% had a PLMS index of 11-21, and 12% had a PLMS index greater than 21. About 38% of the population experienced arousal because of PLMS. Of patients with arousal, 34% had a PLMS arousal index (number of arousals per hour) between 0 and 5, 31% had PLMS arousal index of 5-20, 14% had a PLMS arousal index of 20-50, and 21% had a PLMS arousal index greater than 50.
The investigators did not receive financial support for this study and did not report disclosures.
SOURCE: Srinivasan J et al. CMSC 2019. Abstract QOL29.
Seattle – , according to a retrospective analysis described at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“PLMS may contribute to daytime sleepiness and should be recognized and potentially treated. The etiology of fatigue related to sleep problems in people with MS is multifactorial and not just due to obstructive sleep apnea,” said lead author Jared Srinivasan, clinical research coordinator at South Shore Neurologic Associates in East Northport, New York, and colleagues.
Fatigue is common in patients with MS and can be disabling. For many patients with MS, sleep apnea is the underlying cause of fatigue. PLMS – leg movements that usually occur at 20- to 40-second intervals during sleep – are not commonly reported in MS. These movements cause sleep fragmentation, increase the energy cost of sleep, and contribute to daytime somnolence. Patients with PLMS often are unaware that they have them and do not report related symptoms unless they are specifically questioned about them. Polysomnography (PSG) is an effective, objective method of evaluating a patient for PLMS, but previous studies of PLMS in patients with MS have been small.
Mr. Srinivasan and colleagues performed a retrospective analysis to investigate the incidence and degree of PLMS in people with MS who had reported fatigue, had not previously been diagnosed as having sleep apnea or PLMS, and agreed to undergo overnight PSG.
The investigators included 292 participants in their study. The population’s average age was 47.3 years. Approximately 81% of patients were female. About 41% of the population had a PLMS index (PLMS per hour) greater than 0. Of participants with PSG-identified PLMS, 10% had a PLMS index of 5-10, 5% had a PLMS index of 11-21, and 12% had a PLMS index greater than 21. About 38% of the population experienced arousal because of PLMS. Of patients with arousal, 34% had a PLMS arousal index (number of arousals per hour) between 0 and 5, 31% had PLMS arousal index of 5-20, 14% had a PLMS arousal index of 20-50, and 21% had a PLMS arousal index greater than 50.
The investigators did not receive financial support for this study and did not report disclosures.
SOURCE: Srinivasan J et al. CMSC 2019. Abstract QOL29.
REPORTING FROM CMSC 2019
Key clinical point: Periodic limb movements during sleep are common in patients with multiple sclerosis who report fatigue.
Major finding: Approximately 41% of patients with multiple sclerosis and fatigue had periodic limb movements during sleep.
Study details: A retrospective study of 292 patients with MS and fatigue who underwent polysomnography.
Disclosures: The investigators did not receive financial support for this study and did not report disclosures.
Source: Srinivasan J et al. CMSC 2019. Abstract QOL29.