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Study identifies characteristics that may constitute the MS prodrome
SAN DIEGO – Compared with controls, patients who developed MS were more frequently admitted to the hospital or visited a physician for problems related to the nervous system, sensory organs, musculoskeletal system, and genitourinary system in the 5 years prior to MS onset, a multicenter matched cohort study found.
“People are seeking help for different conditions that are most likely related to their MS,” one of the study authors, Elaine Kingwell, PhD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “It suggests there could be opportunity to recognize and possibly diagnose and treat MS earlier.”
In a previously published study (Lancet Neurol. 2017;16[6]:445-51) led by Helen Tremlett, PhD, and first author Jose Wijnands, PhD, the team found increased health care utilization in people with MS across all health sectors – physician, hospital, and pharmacy (prescriptions filled).
For the current study, the team set out to identify early signs and symptoms that could define the MS prodrome. “We wanted to know why people went to the hospital, why people went to their physician, what kind of drugs they were prescribed, and what kind of specialists they saw,” explained Dr. Kingwell, an epidemiologist in the department of neurology at the University of British Columbia, Vancouver.
The researchers used health administrative and MS-specific data from four Canadian provinces to conduct a multicenter matched cohort study. Individuals were required to be in the province from 5 years pre-index date, measured as either the first demyelinating event in health administrative data or MS onset as determined by the treating neurologist, until the MS cases’ third demyelinating claim or diagnosis date. The potential for a prodromal period was examined in the 5 years pre-index date, and outcomes of interest were number of physician and hospital encounters per ICD-10 chapter, number of physician encounters per physician specialty, and percentage of people with one or more filled prescription per drug class.
The researchers used rate ratios and 95% confidence intervals to compare the rates of physician and hospital encounters between MS cases and controls and the proportion test to compare the percentage of people with one or more filled prescriptions between MS cases and controls. They used random-effects meta-analyses to pool results across Canadian provinces.
The population consisted of 13,951 MS patients and 66,940 controls derived from a health administration cohort and 3,202 MS patients and 16,006 controls derived from MS clinics. Compared with controls, in the 5 years before the first demyelinating claim or symptom onset, cases had more physician and hospital encounters for the nervous system (rate ratio = 1.70-4.75), sensory organs (RR = 1.40-2.28), musculoskeletal system (RR = 1.19-1.70), and genitourinary system (RR = 1.17-1.59), Dr. Kingwell and her associates reported.
Cases also had more encounters with psychiatrists (RR = 1.48-1.66) and urologists (RR = 1.49-1.80), and a higher proportion of filled prescriptions for hormonal preparations and drugs related to the musculoskeletal or genitourinary systems (ranging from 1.1 to 1.5 times higher; P less than .02 for all associations). “While we did not examine each individual drug, we did group drugs by their therapeutic class,” Dr. Wijnands noted in an interview after the meeting. “As for the increased number of visits to psychiatrists, it is intriguing. We don’t necessarily know all the reasons why. It opens up a lot of questions for people to follow up on.”
In contrast, MS cases had fewer pregnancy-related encounters, compared with controls (RR = 0.78-0.88).
Dr. Wijnands acknowledged certain limitations of the study, including its reliance on administrative data to measure the prodromal period. “When we described the prodrome itself, we relied on ICD codes from the physician and hospital data as well as prescriptions filled. Issues or problems for which individuals do not seek medical attention, for instance, would not be captured in our study,” she said.
The study was funded by the National MS Society. Dr. Wijnands receives salary support from the Michael Smith Foundation for Health Research /The Koehle Family Foundation, coauthor Ruth Ann Marrie, MD, PhD, holds the Waugh Family Chair in Multiple Sclerosis, and Dr. Tremlett is funded by the Canada Research Chair Program. Dr. Kingwell reported having no financial disclosures.
dbrunk@frontlinemedcom.com
SOURCE: Kingwell E et al. ACTRIMS Forum 2018, late-breaking poster 254.
SAN DIEGO – Compared with controls, patients who developed MS were more frequently admitted to the hospital or visited a physician for problems related to the nervous system, sensory organs, musculoskeletal system, and genitourinary system in the 5 years prior to MS onset, a multicenter matched cohort study found.
“People are seeking help for different conditions that are most likely related to their MS,” one of the study authors, Elaine Kingwell, PhD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “It suggests there could be opportunity to recognize and possibly diagnose and treat MS earlier.”
In a previously published study (Lancet Neurol. 2017;16[6]:445-51) led by Helen Tremlett, PhD, and first author Jose Wijnands, PhD, the team found increased health care utilization in people with MS across all health sectors – physician, hospital, and pharmacy (prescriptions filled).
For the current study, the team set out to identify early signs and symptoms that could define the MS prodrome. “We wanted to know why people went to the hospital, why people went to their physician, what kind of drugs they were prescribed, and what kind of specialists they saw,” explained Dr. Kingwell, an epidemiologist in the department of neurology at the University of British Columbia, Vancouver.
The researchers used health administrative and MS-specific data from four Canadian provinces to conduct a multicenter matched cohort study. Individuals were required to be in the province from 5 years pre-index date, measured as either the first demyelinating event in health administrative data or MS onset as determined by the treating neurologist, until the MS cases’ third demyelinating claim or diagnosis date. The potential for a prodromal period was examined in the 5 years pre-index date, and outcomes of interest were number of physician and hospital encounters per ICD-10 chapter, number of physician encounters per physician specialty, and percentage of people with one or more filled prescription per drug class.
The researchers used rate ratios and 95% confidence intervals to compare the rates of physician and hospital encounters between MS cases and controls and the proportion test to compare the percentage of people with one or more filled prescriptions between MS cases and controls. They used random-effects meta-analyses to pool results across Canadian provinces.
The population consisted of 13,951 MS patients and 66,940 controls derived from a health administration cohort and 3,202 MS patients and 16,006 controls derived from MS clinics. Compared with controls, in the 5 years before the first demyelinating claim or symptom onset, cases had more physician and hospital encounters for the nervous system (rate ratio = 1.70-4.75), sensory organs (RR = 1.40-2.28), musculoskeletal system (RR = 1.19-1.70), and genitourinary system (RR = 1.17-1.59), Dr. Kingwell and her associates reported.
Cases also had more encounters with psychiatrists (RR = 1.48-1.66) and urologists (RR = 1.49-1.80), and a higher proportion of filled prescriptions for hormonal preparations and drugs related to the musculoskeletal or genitourinary systems (ranging from 1.1 to 1.5 times higher; P less than .02 for all associations). “While we did not examine each individual drug, we did group drugs by their therapeutic class,” Dr. Wijnands noted in an interview after the meeting. “As for the increased number of visits to psychiatrists, it is intriguing. We don’t necessarily know all the reasons why. It opens up a lot of questions for people to follow up on.”
In contrast, MS cases had fewer pregnancy-related encounters, compared with controls (RR = 0.78-0.88).
Dr. Wijnands acknowledged certain limitations of the study, including its reliance on administrative data to measure the prodromal period. “When we described the prodrome itself, we relied on ICD codes from the physician and hospital data as well as prescriptions filled. Issues or problems for which individuals do not seek medical attention, for instance, would not be captured in our study,” she said.
The study was funded by the National MS Society. Dr. Wijnands receives salary support from the Michael Smith Foundation for Health Research /The Koehle Family Foundation, coauthor Ruth Ann Marrie, MD, PhD, holds the Waugh Family Chair in Multiple Sclerosis, and Dr. Tremlett is funded by the Canada Research Chair Program. Dr. Kingwell reported having no financial disclosures.
dbrunk@frontlinemedcom.com
SOURCE: Kingwell E et al. ACTRIMS Forum 2018, late-breaking poster 254.
SAN DIEGO – Compared with controls, patients who developed MS were more frequently admitted to the hospital or visited a physician for problems related to the nervous system, sensory organs, musculoskeletal system, and genitourinary system in the 5 years prior to MS onset, a multicenter matched cohort study found.
“People are seeking help for different conditions that are most likely related to their MS,” one of the study authors, Elaine Kingwell, PhD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “It suggests there could be opportunity to recognize and possibly diagnose and treat MS earlier.”
In a previously published study (Lancet Neurol. 2017;16[6]:445-51) led by Helen Tremlett, PhD, and first author Jose Wijnands, PhD, the team found increased health care utilization in people with MS across all health sectors – physician, hospital, and pharmacy (prescriptions filled).
For the current study, the team set out to identify early signs and symptoms that could define the MS prodrome. “We wanted to know why people went to the hospital, why people went to their physician, what kind of drugs they were prescribed, and what kind of specialists they saw,” explained Dr. Kingwell, an epidemiologist in the department of neurology at the University of British Columbia, Vancouver.
The researchers used health administrative and MS-specific data from four Canadian provinces to conduct a multicenter matched cohort study. Individuals were required to be in the province from 5 years pre-index date, measured as either the first demyelinating event in health administrative data or MS onset as determined by the treating neurologist, until the MS cases’ third demyelinating claim or diagnosis date. The potential for a prodromal period was examined in the 5 years pre-index date, and outcomes of interest were number of physician and hospital encounters per ICD-10 chapter, number of physician encounters per physician specialty, and percentage of people with one or more filled prescription per drug class.
The researchers used rate ratios and 95% confidence intervals to compare the rates of physician and hospital encounters between MS cases and controls and the proportion test to compare the percentage of people with one or more filled prescriptions between MS cases and controls. They used random-effects meta-analyses to pool results across Canadian provinces.
The population consisted of 13,951 MS patients and 66,940 controls derived from a health administration cohort and 3,202 MS patients and 16,006 controls derived from MS clinics. Compared with controls, in the 5 years before the first demyelinating claim or symptom onset, cases had more physician and hospital encounters for the nervous system (rate ratio = 1.70-4.75), sensory organs (RR = 1.40-2.28), musculoskeletal system (RR = 1.19-1.70), and genitourinary system (RR = 1.17-1.59), Dr. Kingwell and her associates reported.
Cases also had more encounters with psychiatrists (RR = 1.48-1.66) and urologists (RR = 1.49-1.80), and a higher proportion of filled prescriptions for hormonal preparations and drugs related to the musculoskeletal or genitourinary systems (ranging from 1.1 to 1.5 times higher; P less than .02 for all associations). “While we did not examine each individual drug, we did group drugs by their therapeutic class,” Dr. Wijnands noted in an interview after the meeting. “As for the increased number of visits to psychiatrists, it is intriguing. We don’t necessarily know all the reasons why. It opens up a lot of questions for people to follow up on.”
In contrast, MS cases had fewer pregnancy-related encounters, compared with controls (RR = 0.78-0.88).
Dr. Wijnands acknowledged certain limitations of the study, including its reliance on administrative data to measure the prodromal period. “When we described the prodrome itself, we relied on ICD codes from the physician and hospital data as well as prescriptions filled. Issues or problems for which individuals do not seek medical attention, for instance, would not be captured in our study,” she said.
The study was funded by the National MS Society. Dr. Wijnands receives salary support from the Michael Smith Foundation for Health Research /The Koehle Family Foundation, coauthor Ruth Ann Marrie, MD, PhD, holds the Waugh Family Chair in Multiple Sclerosis, and Dr. Tremlett is funded by the Canada Research Chair Program. Dr. Kingwell reported having no financial disclosures.
dbrunk@frontlinemedcom.com
SOURCE: Kingwell E et al. ACTRIMS Forum 2018, late-breaking poster 254.
REPORTING FROM ACTRIMS FORUM 2018
Key clinical point: Several phenotypic characteristics may constitute the MS prodrome.
Major finding: Compared with controls, in the 5 years before the first demyelinating claim or symptom onset, MS cases had more physician and hospital encounters for the nervous system (rate ratio = 1.70-4.75), sensory organs (RR = 1.40-2.28), and musculoskeletal system (RR = 1.19-1.70).
Study details: A multicenter matched cohort study of 13,951 MS patients and 66,940 controls derived from a health administration cohort and 3,202 MS patients and 16,006 controls derived from MS clinics.
Disclosures: The study was funded by the National MS Society. Dr. Wijnands receives salary support from the Michael Smith Foundation for Health Research /The Koehle Family Foundation, coauthor Ruth Ann Marrie, MD, PhD, holds the Waugh Family Chair in Multiple Sclerosis, and Dr. Tremlett is funded by the Canada Research Chair Program. Dr. Kingwell reported having no financial disclosures.
Source: Kingwell E et al. ACTRIMS Forum 2018, late-breaking poster 254.
Physicians often bypass cognition, depression screening in MS
SAN DIEGO – A new study finds that physicians at two . Physicians who did perform screening hardly ever used validated tools and often didn’t refer appropriate patients for higher-level care.
In addition, researchers interviewed 13 leading MS specialists from coast to coast and “found that about half reported not using formal screening tools to assess cognitive impairment and depression,” said study coauthor Tamar Sapir, PhD, chief scientific officer with Prime Education, a firm based in Fort Lauderdale, Fla., that provides a variety of health-related services such as training and research.
The study findings were presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. Three of the study authors spoke in interviews.
The researchers sought to understand how frequently MS patients are screened for cognitive problems and depression.
“Cognitive impairment is experienced by approximately half of patients with multiple sclerosis, yet many are never screened or treated, which can impact their daily activities, their ability to work, and overall quality of life,” Dr. Sapir said.
Depression, meanwhile, is believed to be much more common in patients with MS than in the general population, with one recent meta-analysis of 58 studies finding that the average prevalence was 31%. Other research suggests depression is underdiagnosed and undertreated in this population (J Neurol Sci. 2017 Jan 15;372:331-41; ISRN Neurology. 2012, Article ID 427102. doi: 10.5402/2012/427102).
For the current study, researchers tracked 300 patients at two unidentified MS clinics via their charts over a 2-year period from 2014 to 2016. Their median age was 52 years, 76% were women, and 15 had experienced at least one relapse within the previous 24 months.
“Screening for cognitive impairment and depression was documented for only 52% and 63% of MS patients, respectively, and only about a quarter of patients diagnosed with these conditions were referred to a higher level of care,” said lead author Guy J. Buckle, MD, MPH, of the Andrew C. Carlos MS Institute at Shepherd Center in Atlanta.
Among all 300 patients, just 2% and 4% were screened using a validated tool for cognitive impairment and depression, respectively.
The screening often turned up evidence of the conditions: Physicians saw signs of cognitive impairment in 69% and 78% of those screened aged under 65 years and aged 65 and older, respectively, and they detected depression in 71% and 54% of those screened in those two age groups, respectively.
Researchers also noted several disparities. “Cognitive screening was conducted more frequently in older, employed, or white patients, while the presence of cognitive impairment was documented more often in black, nonworking, and those on Medicare or Medicaid,” Dr. Buckle said. “Depression screening was performed most frequently in older or white patients, yet depression was more common in younger, nonworking patients and those on Medicare/Medicaid.”
In another part of their study, researchers surveyed 13 unidentified “national leaders” in MS research and treatment. Just seven said they used validated tools to screen for cognitive impairment and six said they used them to screen for depression.
“We hear from MS specialists that they want to be measuring for cognition but don’t know how to efficiently work it into their routine, how to approach the patient, and what tools to use,” said study coauthor Derrick S. Robertson, MD, of the University of South Florida, Tampa. “In addition, there is no one tool that is accepted in the MS treatment community.”
MS specialists who didn’t use the screening tests also pointed to factors like lack of reimbursement and lack of integration into electronic medical records. “Doubt very much that neurologists have time to use any of these tests,” one respondent said, referring to cognitive impairment screening.
What’s next? “There are several new exciting developments in clinical trials demonstrating efficacy of disease-modifying therapies in maintaining or improving cognition in patients with relapsing MS,” Dr. Robertson said. “This highlights the urgent need to overcome barriers to use of formal cognitive screening tools in clinical practice to identify patients who need a higher level of care, and perhaps even a change in treatment with the ultimate goal to improve quality of life and overall outcomes.”
Genentech funded the study through an educational grant. Dr. Sapir and three other study authors reported no relevant disclosures. Dr. Buckle and Dr. Robertson reported multiple disclosures, including principle investigator and advisory board/panel member work.
SOURCE: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.
SAN DIEGO – A new study finds that physicians at two . Physicians who did perform screening hardly ever used validated tools and often didn’t refer appropriate patients for higher-level care.
In addition, researchers interviewed 13 leading MS specialists from coast to coast and “found that about half reported not using formal screening tools to assess cognitive impairment and depression,” said study coauthor Tamar Sapir, PhD, chief scientific officer with Prime Education, a firm based in Fort Lauderdale, Fla., that provides a variety of health-related services such as training and research.
The study findings were presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. Three of the study authors spoke in interviews.
The researchers sought to understand how frequently MS patients are screened for cognitive problems and depression.
“Cognitive impairment is experienced by approximately half of patients with multiple sclerosis, yet many are never screened or treated, which can impact their daily activities, their ability to work, and overall quality of life,” Dr. Sapir said.
Depression, meanwhile, is believed to be much more common in patients with MS than in the general population, with one recent meta-analysis of 58 studies finding that the average prevalence was 31%. Other research suggests depression is underdiagnosed and undertreated in this population (J Neurol Sci. 2017 Jan 15;372:331-41; ISRN Neurology. 2012, Article ID 427102. doi: 10.5402/2012/427102).
For the current study, researchers tracked 300 patients at two unidentified MS clinics via their charts over a 2-year period from 2014 to 2016. Their median age was 52 years, 76% were women, and 15 had experienced at least one relapse within the previous 24 months.
“Screening for cognitive impairment and depression was documented for only 52% and 63% of MS patients, respectively, and only about a quarter of patients diagnosed with these conditions were referred to a higher level of care,” said lead author Guy J. Buckle, MD, MPH, of the Andrew C. Carlos MS Institute at Shepherd Center in Atlanta.
Among all 300 patients, just 2% and 4% were screened using a validated tool for cognitive impairment and depression, respectively.
The screening often turned up evidence of the conditions: Physicians saw signs of cognitive impairment in 69% and 78% of those screened aged under 65 years and aged 65 and older, respectively, and they detected depression in 71% and 54% of those screened in those two age groups, respectively.
Researchers also noted several disparities. “Cognitive screening was conducted more frequently in older, employed, or white patients, while the presence of cognitive impairment was documented more often in black, nonworking, and those on Medicare or Medicaid,” Dr. Buckle said. “Depression screening was performed most frequently in older or white patients, yet depression was more common in younger, nonworking patients and those on Medicare/Medicaid.”
In another part of their study, researchers surveyed 13 unidentified “national leaders” in MS research and treatment. Just seven said they used validated tools to screen for cognitive impairment and six said they used them to screen for depression.
“We hear from MS specialists that they want to be measuring for cognition but don’t know how to efficiently work it into their routine, how to approach the patient, and what tools to use,” said study coauthor Derrick S. Robertson, MD, of the University of South Florida, Tampa. “In addition, there is no one tool that is accepted in the MS treatment community.”
MS specialists who didn’t use the screening tests also pointed to factors like lack of reimbursement and lack of integration into electronic medical records. “Doubt very much that neurologists have time to use any of these tests,” one respondent said, referring to cognitive impairment screening.
What’s next? “There are several new exciting developments in clinical trials demonstrating efficacy of disease-modifying therapies in maintaining or improving cognition in patients with relapsing MS,” Dr. Robertson said. “This highlights the urgent need to overcome barriers to use of formal cognitive screening tools in clinical practice to identify patients who need a higher level of care, and perhaps even a change in treatment with the ultimate goal to improve quality of life and overall outcomes.”
Genentech funded the study through an educational grant. Dr. Sapir and three other study authors reported no relevant disclosures. Dr. Buckle and Dr. Robertson reported multiple disclosures, including principle investigator and advisory board/panel member work.
SOURCE: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.
SAN DIEGO – A new study finds that physicians at two . Physicians who did perform screening hardly ever used validated tools and often didn’t refer appropriate patients for higher-level care.
In addition, researchers interviewed 13 leading MS specialists from coast to coast and “found that about half reported not using formal screening tools to assess cognitive impairment and depression,” said study coauthor Tamar Sapir, PhD, chief scientific officer with Prime Education, a firm based in Fort Lauderdale, Fla., that provides a variety of health-related services such as training and research.
The study findings were presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. Three of the study authors spoke in interviews.
The researchers sought to understand how frequently MS patients are screened for cognitive problems and depression.
“Cognitive impairment is experienced by approximately half of patients with multiple sclerosis, yet many are never screened or treated, which can impact their daily activities, their ability to work, and overall quality of life,” Dr. Sapir said.
Depression, meanwhile, is believed to be much more common in patients with MS than in the general population, with one recent meta-analysis of 58 studies finding that the average prevalence was 31%. Other research suggests depression is underdiagnosed and undertreated in this population (J Neurol Sci. 2017 Jan 15;372:331-41; ISRN Neurology. 2012, Article ID 427102. doi: 10.5402/2012/427102).
For the current study, researchers tracked 300 patients at two unidentified MS clinics via their charts over a 2-year period from 2014 to 2016. Their median age was 52 years, 76% were women, and 15 had experienced at least one relapse within the previous 24 months.
“Screening for cognitive impairment and depression was documented for only 52% and 63% of MS patients, respectively, and only about a quarter of patients diagnosed with these conditions were referred to a higher level of care,” said lead author Guy J. Buckle, MD, MPH, of the Andrew C. Carlos MS Institute at Shepherd Center in Atlanta.
Among all 300 patients, just 2% and 4% were screened using a validated tool for cognitive impairment and depression, respectively.
The screening often turned up evidence of the conditions: Physicians saw signs of cognitive impairment in 69% and 78% of those screened aged under 65 years and aged 65 and older, respectively, and they detected depression in 71% and 54% of those screened in those two age groups, respectively.
Researchers also noted several disparities. “Cognitive screening was conducted more frequently in older, employed, or white patients, while the presence of cognitive impairment was documented more often in black, nonworking, and those on Medicare or Medicaid,” Dr. Buckle said. “Depression screening was performed most frequently in older or white patients, yet depression was more common in younger, nonworking patients and those on Medicare/Medicaid.”
In another part of their study, researchers surveyed 13 unidentified “national leaders” in MS research and treatment. Just seven said they used validated tools to screen for cognitive impairment and six said they used them to screen for depression.
“We hear from MS specialists that they want to be measuring for cognition but don’t know how to efficiently work it into their routine, how to approach the patient, and what tools to use,” said study coauthor Derrick S. Robertson, MD, of the University of South Florida, Tampa. “In addition, there is no one tool that is accepted in the MS treatment community.”
MS specialists who didn’t use the screening tests also pointed to factors like lack of reimbursement and lack of integration into electronic medical records. “Doubt very much that neurologists have time to use any of these tests,” one respondent said, referring to cognitive impairment screening.
What’s next? “There are several new exciting developments in clinical trials demonstrating efficacy of disease-modifying therapies in maintaining or improving cognition in patients with relapsing MS,” Dr. Robertson said. “This highlights the urgent need to overcome barriers to use of formal cognitive screening tools in clinical practice to identify patients who need a higher level of care, and perhaps even a change in treatment with the ultimate goal to improve quality of life and overall outcomes.”
Genentech funded the study through an educational grant. Dr. Sapir and three other study authors reported no relevant disclosures. Dr. Buckle and Dr. Robertson reported multiple disclosures, including principle investigator and advisory board/panel member work.
SOURCE: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.
REPORTING FROM ACTRIMS FORUM 2018
Key clinical point: Screening often turns up signs of trouble, but many MS patients are not screened annually for depression and cognitive impairment.
Major finding: 52% and 63% of patients with MS were screened for cognitive impairment and depression, respectively, over a 1-year period. Study details: 2-year analysis of medical records from two MS clinics in the Southeast.
Disclosures: Genentech funded the study through an educational grant. Some of the study authors reported various disclosures.
Source: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.
Nearly half of MS patients treated by primary docs miss out on meds
SAN DIEGO – than are those treated by neurologists, even though they have more symptoms.
Nearly 85% of those treated at MS centers by neurologists received the drugs, compared with just 51% of those treated at primary care offices, according to results of a study reported at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Dr. Halpern spoke in an interview at the ACTRIMS Forum.
The researchers analyzed data from the Sonya Slifka Longitudinal Multiple Sclerosis Study and focused on MS patients who received care at MS centers (376 patients, all treated by neurologists), neurology practices (552 patients), and primary care practices (55 patients).
In the three groups, most of the patients were female (77%-82%). To a statistically significant degree, those who were treated at primary care practices, compared with those at MS centers, were more likely to be white (98% vs. 82%), to have less than a college education (69% vs. 42%), and to have Medicaid/veteran coverage or be uninsured (22% vs. 11%).
In terms of rates of patients receiving disease-modifying therapies, there was a small difference between MS centers (84%) and neurology practices (79%); P less than .05.
However, the gap between these patients and those treated by primary care doctors was wide: Only 51% in the latter group received disease-modifying therapies, even though they reported more symptoms in areas such as vision, walking, bowel, speech, and numbness, compared with those in the other groups (P less than .05).
There was no statistically significant difference among the groups in reported symptoms of tremor, headache, pain, fatigue, cognition, swallowing, depression, mood, and anxiety.
The study doesn’t explain why the MS patients treated by primary care physicians are missing out on care, and it is not known whether the absence of treatment makes their conditions worse.
However, “it’s been well documented that the disease-modifying therapies can reduce the disease progression and the likelihood of experiencing relapses,” Dr. Halpern said. “Individuals with MS who are not being appropriately treated are more likely to experience symptoms, relapses, and faster disability.”
He speculated that primary care doctors may be falling behind on the treatment front because they lack the training and expertise to properly prescribe the MS medications, which are “difficult and complex drugs.”
Whatever the case, he said, there’s a clear need for more collaboration between MS subspecialists and primary care doctors.
The study was funded by the National MS Society. Dr. Halpern reported no relevant disclosures.
SOURCE: Halpern MT et al. ACTRIMS Forum 2018 Abstract P226.
SAN DIEGO – than are those treated by neurologists, even though they have more symptoms.
Nearly 85% of those treated at MS centers by neurologists received the drugs, compared with just 51% of those treated at primary care offices, according to results of a study reported at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Dr. Halpern spoke in an interview at the ACTRIMS Forum.
The researchers analyzed data from the Sonya Slifka Longitudinal Multiple Sclerosis Study and focused on MS patients who received care at MS centers (376 patients, all treated by neurologists), neurology practices (552 patients), and primary care practices (55 patients).
In the three groups, most of the patients were female (77%-82%). To a statistically significant degree, those who were treated at primary care practices, compared with those at MS centers, were more likely to be white (98% vs. 82%), to have less than a college education (69% vs. 42%), and to have Medicaid/veteran coverage or be uninsured (22% vs. 11%).
In terms of rates of patients receiving disease-modifying therapies, there was a small difference between MS centers (84%) and neurology practices (79%); P less than .05.
However, the gap between these patients and those treated by primary care doctors was wide: Only 51% in the latter group received disease-modifying therapies, even though they reported more symptoms in areas such as vision, walking, bowel, speech, and numbness, compared with those in the other groups (P less than .05).
There was no statistically significant difference among the groups in reported symptoms of tremor, headache, pain, fatigue, cognition, swallowing, depression, mood, and anxiety.
The study doesn’t explain why the MS patients treated by primary care physicians are missing out on care, and it is not known whether the absence of treatment makes their conditions worse.
However, “it’s been well documented that the disease-modifying therapies can reduce the disease progression and the likelihood of experiencing relapses,” Dr. Halpern said. “Individuals with MS who are not being appropriately treated are more likely to experience symptoms, relapses, and faster disability.”
He speculated that primary care doctors may be falling behind on the treatment front because they lack the training and expertise to properly prescribe the MS medications, which are “difficult and complex drugs.”
Whatever the case, he said, there’s a clear need for more collaboration between MS subspecialists and primary care doctors.
The study was funded by the National MS Society. Dr. Halpern reported no relevant disclosures.
SOURCE: Halpern MT et al. ACTRIMS Forum 2018 Abstract P226.
SAN DIEGO – than are those treated by neurologists, even though they have more symptoms.
Nearly 85% of those treated at MS centers by neurologists received the drugs, compared with just 51% of those treated at primary care offices, according to results of a study reported at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Dr. Halpern spoke in an interview at the ACTRIMS Forum.
The researchers analyzed data from the Sonya Slifka Longitudinal Multiple Sclerosis Study and focused on MS patients who received care at MS centers (376 patients, all treated by neurologists), neurology practices (552 patients), and primary care practices (55 patients).
In the three groups, most of the patients were female (77%-82%). To a statistically significant degree, those who were treated at primary care practices, compared with those at MS centers, were more likely to be white (98% vs. 82%), to have less than a college education (69% vs. 42%), and to have Medicaid/veteran coverage or be uninsured (22% vs. 11%).
In terms of rates of patients receiving disease-modifying therapies, there was a small difference between MS centers (84%) and neurology practices (79%); P less than .05.
However, the gap between these patients and those treated by primary care doctors was wide: Only 51% in the latter group received disease-modifying therapies, even though they reported more symptoms in areas such as vision, walking, bowel, speech, and numbness, compared with those in the other groups (P less than .05).
There was no statistically significant difference among the groups in reported symptoms of tremor, headache, pain, fatigue, cognition, swallowing, depression, mood, and anxiety.
The study doesn’t explain why the MS patients treated by primary care physicians are missing out on care, and it is not known whether the absence of treatment makes their conditions worse.
However, “it’s been well documented that the disease-modifying therapies can reduce the disease progression and the likelihood of experiencing relapses,” Dr. Halpern said. “Individuals with MS who are not being appropriately treated are more likely to experience symptoms, relapses, and faster disability.”
He speculated that primary care doctors may be falling behind on the treatment front because they lack the training and expertise to properly prescribe the MS medications, which are “difficult and complex drugs.”
Whatever the case, he said, there’s a clear need for more collaboration between MS subspecialists and primary care doctors.
The study was funded by the National MS Society. Dr. Halpern reported no relevant disclosures.
SOURCE: Halpern MT et al. ACTRIMS Forum 2018 Abstract P226.
REPORTING FROM ACTRIMS FORUM 2018
VIDEO: Teriflunomide and dimethyl fumarate are comparable in relapsing-remitting MS
SAN DIEGO – New industry-funded research finds that
“The fundamental conclusion is that there’s little to separate them. If you look at efficacy, safety, and MRI scanning, there were no differences between the two medications that matter. ... Both drugs can be used with equal confidence,” said Stanley Cohan, MD, PhD, medical director of Providence MS Center in Portland, Ore.
Dr. Cohan spoke in a video interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
The researchers analyzed retrospective data collected in the phase 4 Teri-RADAR study, which tracked two groups of 50 patients each at MS centers in the United States as they took 14 mg of teriflunomide (Aubagio) daily or 240 mg of delayed-release dimethyl fumarate (Tecfidera) twice daily.
In both groups, participants had an average age of about 49 years, about three-quarters were women, and about 93% were white. Twenty-two percent of those in the teriflunomide group had relapses in the 18 months before the index date, compared with 10% of the dimethyl fumarate group.
The study – funded by Sanofi, maker of teriflunomide – followed up with patients at a mean of 15-16 months.
Mean annualized percentage of brain volume change (PBVC) was lower in teriflunomide-treated patients, compared with those treated with dimethyl fumarate (–0.2% vs. –0.5%; P = .02). Also, fewer teriflunomide-treated patients showed signs of annualized PBVC above a mean annualized brain volume loss rate threshold of 0.4% (25.9% vs. 58.6%; P = .01).
As for adverse effects, rashes affected none of the teriflunomide group but 28% of the dimethyl fumarate group. The teriflunomide group experienced skin reactions (12%) and diarrhea (16%), while these adverse events were not reported in the dimethyl fumarate group.
The study authors reported a variety of disclosures, and several are employees of Sanofi. Dr. Cohan reported a variety of disclosures, including multiple relationships with Sanofi.
SAN DIEGO – New industry-funded research finds that
“The fundamental conclusion is that there’s little to separate them. If you look at efficacy, safety, and MRI scanning, there were no differences between the two medications that matter. ... Both drugs can be used with equal confidence,” said Stanley Cohan, MD, PhD, medical director of Providence MS Center in Portland, Ore.
Dr. Cohan spoke in a video interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
The researchers analyzed retrospective data collected in the phase 4 Teri-RADAR study, which tracked two groups of 50 patients each at MS centers in the United States as they took 14 mg of teriflunomide (Aubagio) daily or 240 mg of delayed-release dimethyl fumarate (Tecfidera) twice daily.
In both groups, participants had an average age of about 49 years, about three-quarters were women, and about 93% were white. Twenty-two percent of those in the teriflunomide group had relapses in the 18 months before the index date, compared with 10% of the dimethyl fumarate group.
The study – funded by Sanofi, maker of teriflunomide – followed up with patients at a mean of 15-16 months.
Mean annualized percentage of brain volume change (PBVC) was lower in teriflunomide-treated patients, compared with those treated with dimethyl fumarate (–0.2% vs. –0.5%; P = .02). Also, fewer teriflunomide-treated patients showed signs of annualized PBVC above a mean annualized brain volume loss rate threshold of 0.4% (25.9% vs. 58.6%; P = .01).
As for adverse effects, rashes affected none of the teriflunomide group but 28% of the dimethyl fumarate group. The teriflunomide group experienced skin reactions (12%) and diarrhea (16%), while these adverse events were not reported in the dimethyl fumarate group.
The study authors reported a variety of disclosures, and several are employees of Sanofi. Dr. Cohan reported a variety of disclosures, including multiple relationships with Sanofi.
SAN DIEGO – New industry-funded research finds that
“The fundamental conclusion is that there’s little to separate them. If you look at efficacy, safety, and MRI scanning, there were no differences between the two medications that matter. ... Both drugs can be used with equal confidence,” said Stanley Cohan, MD, PhD, medical director of Providence MS Center in Portland, Ore.
Dr. Cohan spoke in a video interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
The researchers analyzed retrospective data collected in the phase 4 Teri-RADAR study, which tracked two groups of 50 patients each at MS centers in the United States as they took 14 mg of teriflunomide (Aubagio) daily or 240 mg of delayed-release dimethyl fumarate (Tecfidera) twice daily.
In both groups, participants had an average age of about 49 years, about three-quarters were women, and about 93% were white. Twenty-two percent of those in the teriflunomide group had relapses in the 18 months before the index date, compared with 10% of the dimethyl fumarate group.
The study – funded by Sanofi, maker of teriflunomide – followed up with patients at a mean of 15-16 months.
Mean annualized percentage of brain volume change (PBVC) was lower in teriflunomide-treated patients, compared with those treated with dimethyl fumarate (–0.2% vs. –0.5%; P = .02). Also, fewer teriflunomide-treated patients showed signs of annualized PBVC above a mean annualized brain volume loss rate threshold of 0.4% (25.9% vs. 58.6%; P = .01).
As for adverse effects, rashes affected none of the teriflunomide group but 28% of the dimethyl fumarate group. The teriflunomide group experienced skin reactions (12%) and diarrhea (16%), while these adverse events were not reported in the dimethyl fumarate group.
The study authors reported a variety of disclosures, and several are employees of Sanofi. Dr. Cohan reported a variety of disclosures, including multiple relationships with Sanofi.
REPORTING FROM ACTRIMS Forum 2018
Adil Harroud, MD
VIDEO: Advanced practice providers take on many roles in MS care
SAN DIEGO – A new survey suggests that advanced practice providers who care for multiple sclerosis patients are highly satisfied with their jobs, which encompass a wide range of responsibilities.
Researchers received survey responses from 215 nurse practitioners and 395 physician assistants who answered Web questionnaires in 2016 and 2017. Of those who care for multiple sclerosis (MS) patients, 92.5% and 77.8% respectively said they provide at least 9 of 11 services, such as direct care, supportive services, and care coordination.
“Nurse practitioners in particular are providing lots of different services from diagnosis to education to symptom management,” said Michael T. Halpern, MD, PhD, MPH, of Temple University, Philadelphia. “Physician assistants are also providing a diverse range of MS services, but not as frequently as nurse practitioners.”
Dr. Halpern was the presenting author of the study reporting the survey results. He spoke in a video interview at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis, where the study findings were presented.
Advanced practice providers also reported high levels of job satisfaction. About 80% in both groups reported being very or extremely satisfied with their careers and with their colleagues; 90% of nurse practitioners reported being very or extremely satisfied by their relationships with patients, as did 86% of physician assistants.
The providers “appear to really enjoy working with individuals with MS,” Dr. Halpern said. But he cautioned that there’s a need for additional training for these providers; some respondents said their lack of knowledge was a hindrance to care.
The study was funded by the National Multiple Sclerosis Society. Dr. Halpern reported no relevant disclosures.
SAN DIEGO – A new survey suggests that advanced practice providers who care for multiple sclerosis patients are highly satisfied with their jobs, which encompass a wide range of responsibilities.
Researchers received survey responses from 215 nurse practitioners and 395 physician assistants who answered Web questionnaires in 2016 and 2017. Of those who care for multiple sclerosis (MS) patients, 92.5% and 77.8% respectively said they provide at least 9 of 11 services, such as direct care, supportive services, and care coordination.
“Nurse practitioners in particular are providing lots of different services from diagnosis to education to symptom management,” said Michael T. Halpern, MD, PhD, MPH, of Temple University, Philadelphia. “Physician assistants are also providing a diverse range of MS services, but not as frequently as nurse practitioners.”
Dr. Halpern was the presenting author of the study reporting the survey results. He spoke in a video interview at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis, where the study findings were presented.
Advanced practice providers also reported high levels of job satisfaction. About 80% in both groups reported being very or extremely satisfied with their careers and with their colleagues; 90% of nurse practitioners reported being very or extremely satisfied by their relationships with patients, as did 86% of physician assistants.
The providers “appear to really enjoy working with individuals with MS,” Dr. Halpern said. But he cautioned that there’s a need for additional training for these providers; some respondents said their lack of knowledge was a hindrance to care.
The study was funded by the National Multiple Sclerosis Society. Dr. Halpern reported no relevant disclosures.
SAN DIEGO – A new survey suggests that advanced practice providers who care for multiple sclerosis patients are highly satisfied with their jobs, which encompass a wide range of responsibilities.
Researchers received survey responses from 215 nurse practitioners and 395 physician assistants who answered Web questionnaires in 2016 and 2017. Of those who care for multiple sclerosis (MS) patients, 92.5% and 77.8% respectively said they provide at least 9 of 11 services, such as direct care, supportive services, and care coordination.
“Nurse practitioners in particular are providing lots of different services from diagnosis to education to symptom management,” said Michael T. Halpern, MD, PhD, MPH, of Temple University, Philadelphia. “Physician assistants are also providing a diverse range of MS services, but not as frequently as nurse practitioners.”
Dr. Halpern was the presenting author of the study reporting the survey results. He spoke in a video interview at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis, where the study findings were presented.
Advanced practice providers also reported high levels of job satisfaction. About 80% in both groups reported being very or extremely satisfied with their careers and with their colleagues; 90% of nurse practitioners reported being very or extremely satisfied by their relationships with patients, as did 86% of physician assistants.
The providers “appear to really enjoy working with individuals with MS,” Dr. Halpern said. But he cautioned that there’s a need for additional training for these providers; some respondents said their lack of knowledge was a hindrance to care.
The study was funded by the National Multiple Sclerosis Society. Dr. Halpern reported no relevant disclosures.
REPORTING FROM ACTRIMS FORUM 2018
‘Real-world evidence’ used to compare agents for relapsing-remitting MS
SAN DIEGO – Delayed-release dimethyl fumarate did not show any differences versus fingolimod in relapse rate over a 1-year, “real-world” study of patients with relapsing-remitting multiple sclerosis, but a significantly greater proportion of patients taking delayed-release dimethyl fumarate achieved relapse-free status and a lower annualized relapsed rate, compared with patients on glatiramer acetate
“There is a need for real-world data that compares the effectiveness of the growing number of MS [multiple sclerosis] treatment options,” Christophe Hotermans, MD, vice president of Global Medical Therapeutic Areas at Boston-based Biogen, said in an interview during ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “These results were consistent with previous analyses of efficacy of these treatments in people with relapsing-remitting MS, which showed no significant differences in efficacy between delayed-release dimethyl fumarate [DMF, Tecfidera] versus fingolimod [FTY, Gilenya] and greater efficacy with dimethyl fumarate, compared with glatiramer acetate [GA].”
The findings come from EFFECT (Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis), a multicenter, international, retrospective, single-time-point medical record review study comparing the effectiveness of DMF vs. other disease-modifying therapies, including FTY and GA in patients with relapsing-remitting MS.
Endpoints included the Kaplan-Meier estimated proportion of patients who relapsed at 12 months and annualized relapse rate. Baseline covariates were used in estimating propensity scores. The data were divided into four strata using quartiles of propensity scores. After assessing for balance in baseline covariates between the treatment groups, Kaplan-Meier estimates of relapse and estimates of treatment effects were pooled across the four strata.
At the meeting, Jinny Min, PharmD, a medical postdoctoral research fellow at Biogen, reported results from 816 DMF patients, 781 FTY patients, and 1,042 GA patients. In the trimmed analysis set, the estimated proportion of DMF and FTY patients who relapsed at 12 months after treatment initiation was 12% vs. 13%, respectively (hazard ratio, 1.07, P = .693; the adjusted rate ratio for annualized relapse was 1.09, P = .617). In the analysis of DMF vs. GA patients, the estimated proportion of DMF patients that relapsed at 12 months was 12% vs. 21%, respectively (HR, 0.71), which represented a significant decrease of 29% (P less than .02). The adjusted rate ratio for annualized relapse was 0.69, representing a significant decrease of 31% (P less than .01).
“We hope that these data help health care providers and people living with MS as they consider their treatment options,” Dr. Hotermans said. “The limitations of this study are similar to those that would be present in other retrospective studies that utilize real-world data. However, we worked to mitigate many of those limitations through a propensity-score estimation approach to adjust for confounders. An additional limitation that is inherent to the study design (retrospective chart review) is that patients’ medical history, MS disease, treatment history, and relapse history were limited to the information available in the medical records.”
The study was supported by Biogen, which markets DMF. Dr. Hotermans and Dr. Min are employees of the company.
SOURCE: Min J et al. ACTRIMS Forum 2018, Abstract P016.
SAN DIEGO – Delayed-release dimethyl fumarate did not show any differences versus fingolimod in relapse rate over a 1-year, “real-world” study of patients with relapsing-remitting multiple sclerosis, but a significantly greater proportion of patients taking delayed-release dimethyl fumarate achieved relapse-free status and a lower annualized relapsed rate, compared with patients on glatiramer acetate
“There is a need for real-world data that compares the effectiveness of the growing number of MS [multiple sclerosis] treatment options,” Christophe Hotermans, MD, vice president of Global Medical Therapeutic Areas at Boston-based Biogen, said in an interview during ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “These results were consistent with previous analyses of efficacy of these treatments in people with relapsing-remitting MS, which showed no significant differences in efficacy between delayed-release dimethyl fumarate [DMF, Tecfidera] versus fingolimod [FTY, Gilenya] and greater efficacy with dimethyl fumarate, compared with glatiramer acetate [GA].”
The findings come from EFFECT (Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis), a multicenter, international, retrospective, single-time-point medical record review study comparing the effectiveness of DMF vs. other disease-modifying therapies, including FTY and GA in patients with relapsing-remitting MS.
Endpoints included the Kaplan-Meier estimated proportion of patients who relapsed at 12 months and annualized relapse rate. Baseline covariates were used in estimating propensity scores. The data were divided into four strata using quartiles of propensity scores. After assessing for balance in baseline covariates between the treatment groups, Kaplan-Meier estimates of relapse and estimates of treatment effects were pooled across the four strata.
At the meeting, Jinny Min, PharmD, a medical postdoctoral research fellow at Biogen, reported results from 816 DMF patients, 781 FTY patients, and 1,042 GA patients. In the trimmed analysis set, the estimated proportion of DMF and FTY patients who relapsed at 12 months after treatment initiation was 12% vs. 13%, respectively (hazard ratio, 1.07, P = .693; the adjusted rate ratio for annualized relapse was 1.09, P = .617). In the analysis of DMF vs. GA patients, the estimated proportion of DMF patients that relapsed at 12 months was 12% vs. 21%, respectively (HR, 0.71), which represented a significant decrease of 29% (P less than .02). The adjusted rate ratio for annualized relapse was 0.69, representing a significant decrease of 31% (P less than .01).
“We hope that these data help health care providers and people living with MS as they consider their treatment options,” Dr. Hotermans said. “The limitations of this study are similar to those that would be present in other retrospective studies that utilize real-world data. However, we worked to mitigate many of those limitations through a propensity-score estimation approach to adjust for confounders. An additional limitation that is inherent to the study design (retrospective chart review) is that patients’ medical history, MS disease, treatment history, and relapse history were limited to the information available in the medical records.”
The study was supported by Biogen, which markets DMF. Dr. Hotermans and Dr. Min are employees of the company.
SOURCE: Min J et al. ACTRIMS Forum 2018, Abstract P016.
SAN DIEGO – Delayed-release dimethyl fumarate did not show any differences versus fingolimod in relapse rate over a 1-year, “real-world” study of patients with relapsing-remitting multiple sclerosis, but a significantly greater proportion of patients taking delayed-release dimethyl fumarate achieved relapse-free status and a lower annualized relapsed rate, compared with patients on glatiramer acetate
“There is a need for real-world data that compares the effectiveness of the growing number of MS [multiple sclerosis] treatment options,” Christophe Hotermans, MD, vice president of Global Medical Therapeutic Areas at Boston-based Biogen, said in an interview during ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “These results were consistent with previous analyses of efficacy of these treatments in people with relapsing-remitting MS, which showed no significant differences in efficacy between delayed-release dimethyl fumarate [DMF, Tecfidera] versus fingolimod [FTY, Gilenya] and greater efficacy with dimethyl fumarate, compared with glatiramer acetate [GA].”
The findings come from EFFECT (Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis), a multicenter, international, retrospective, single-time-point medical record review study comparing the effectiveness of DMF vs. other disease-modifying therapies, including FTY and GA in patients with relapsing-remitting MS.
Endpoints included the Kaplan-Meier estimated proportion of patients who relapsed at 12 months and annualized relapse rate. Baseline covariates were used in estimating propensity scores. The data were divided into four strata using quartiles of propensity scores. After assessing for balance in baseline covariates between the treatment groups, Kaplan-Meier estimates of relapse and estimates of treatment effects were pooled across the four strata.
At the meeting, Jinny Min, PharmD, a medical postdoctoral research fellow at Biogen, reported results from 816 DMF patients, 781 FTY patients, and 1,042 GA patients. In the trimmed analysis set, the estimated proportion of DMF and FTY patients who relapsed at 12 months after treatment initiation was 12% vs. 13%, respectively (hazard ratio, 1.07, P = .693; the adjusted rate ratio for annualized relapse was 1.09, P = .617). In the analysis of DMF vs. GA patients, the estimated proportion of DMF patients that relapsed at 12 months was 12% vs. 21%, respectively (HR, 0.71), which represented a significant decrease of 29% (P less than .02). The adjusted rate ratio for annualized relapse was 0.69, representing a significant decrease of 31% (P less than .01).
“We hope that these data help health care providers and people living with MS as they consider their treatment options,” Dr. Hotermans said. “The limitations of this study are similar to those that would be present in other retrospective studies that utilize real-world data. However, we worked to mitigate many of those limitations through a propensity-score estimation approach to adjust for confounders. An additional limitation that is inherent to the study design (retrospective chart review) is that patients’ medical history, MS disease, treatment history, and relapse history were limited to the information available in the medical records.”
The study was supported by Biogen, which markets DMF. Dr. Hotermans and Dr. Min are employees of the company.
SOURCE: Min J et al. ACTRIMS Forum 2018, Abstract P016.
REPORTING FROM ACTRIMS FORUM 2018
Key clinical point:
Major finding: Delayed-release dimethyl fumarate had a 29% lower risk of relapse during the 12-month period vs. glatiramer acetate.
Study details: Results from a multicenter study of 816 delayed-release dimethyl fumarate patients, 781 fingolimod patients, and 1,042 glatiramer acetate patients with relapsing-remitting MS.
Disclosures: The study was supported by Biogen, which markets delayed-release dimethyl fumarate. Dr. Hotermans and Dr. Min are employees of the company.
Source: Min J et al. ACTRIMS Forum 2018, Abstract P016.
Trial of clozapine, risperidone halted in MS
SAN DIEGO – New Zealand researchers halted a small trial that was testing the use of the antipsychotics clozapine and risperidone to treat progressive multiple sclerosis because significant side effects caused participants to withdraw.
The adverse events appeared even though the doses were much smaller than those routinely given to patients with psychiatric illnesses. “The neurologists realized it was in the participants’ best interest to stop,” said study lead author Anne Camille La Flamme, PhD, of Victoria University of Wellington (New Zealand). “Adverse events included dizziness, muscle weakness, and falls.”
The researchers launched the study – a blinded, randomized, placebo-controlled trial – to learn whether the two antipsychotic drugs, also known by the brand names Clozaril and Risperdal, have potential as treatments for progressive multiple sclerosis.
Previous in-vitro research had linked the drugs to anti-inflammatory effects in the central nervous system, Dr. La Flamme said, and researchers believed that the progressive form of MS might be especially vulnerable to their effects because of high immune system involvement.
The researchers planned to randomly assign three groups of 12 patients per arm to placebo, clozapine, and risperidone.
For clozapine, “the doses were very low, much lower than you’d expect for psychiatric use,” Dr. La Flamme said. A typical dose for psychiatric disorders is about 350 mg/day, she said, and the trial aimed to use 100-150 mg/day with an eye toward preventing dose-dependent side effects.
As for risperidone, a typical dose is about 4 mg/day, and the trial began at 2 mg/day and would increase to 3.5 mg/day, she said.
Three subjects in the clozapine group had to withdraw within 2 weeks when their doses had only reached an average of 35 mg/day. Two of three in the risperidone group withdrew within 4 months.
In light of the adverse effects, “it was deemed not wise to continue,” Dr. La Flamme said.
The placebo group, meanwhile, completed the trial at 178 days and had adverse effects that were more indicative of MS, she said.
What happened? One possibility is that disability from MS made the adverse events more evident, Dr. La Flamme said. Another possible explanation is that the underlying MS physiology changed the targets of the medications, she said.
“We have no conclusive evidence that would suggest one over the other,” she said. “But a lot of the evidence supports the idea that it’s a change in the physiology, that something about those pathways has been altered.”
It’s clear, she said, that the doses of the drugs in the trial were not appropriate. However, a big question remains: “We do not know whether these medicines are effective at reducing neuroinflammation.”
It’s possible, she said, that a “whisper of a dose” could still be effective. “It may get back to how these agents metabolize and become an active form.”
The study was funded by New Zealand’s Ministry of Business, Innovation and Employment. Dr. La Flamme disclosed that the study team has a patent for repurposing of clozapine and risperidone to treat MS.
SOURCE: La Flamme A et al. ACTRIMS Forum 2018, abstract P031.
SAN DIEGO – New Zealand researchers halted a small trial that was testing the use of the antipsychotics clozapine and risperidone to treat progressive multiple sclerosis because significant side effects caused participants to withdraw.
The adverse events appeared even though the doses were much smaller than those routinely given to patients with psychiatric illnesses. “The neurologists realized it was in the participants’ best interest to stop,” said study lead author Anne Camille La Flamme, PhD, of Victoria University of Wellington (New Zealand). “Adverse events included dizziness, muscle weakness, and falls.”
The researchers launched the study – a blinded, randomized, placebo-controlled trial – to learn whether the two antipsychotic drugs, also known by the brand names Clozaril and Risperdal, have potential as treatments for progressive multiple sclerosis.
Previous in-vitro research had linked the drugs to anti-inflammatory effects in the central nervous system, Dr. La Flamme said, and researchers believed that the progressive form of MS might be especially vulnerable to their effects because of high immune system involvement.
The researchers planned to randomly assign three groups of 12 patients per arm to placebo, clozapine, and risperidone.
For clozapine, “the doses were very low, much lower than you’d expect for psychiatric use,” Dr. La Flamme said. A typical dose for psychiatric disorders is about 350 mg/day, she said, and the trial aimed to use 100-150 mg/day with an eye toward preventing dose-dependent side effects.
As for risperidone, a typical dose is about 4 mg/day, and the trial began at 2 mg/day and would increase to 3.5 mg/day, she said.
Three subjects in the clozapine group had to withdraw within 2 weeks when their doses had only reached an average of 35 mg/day. Two of three in the risperidone group withdrew within 4 months.
In light of the adverse effects, “it was deemed not wise to continue,” Dr. La Flamme said.
The placebo group, meanwhile, completed the trial at 178 days and had adverse effects that were more indicative of MS, she said.
What happened? One possibility is that disability from MS made the adverse events more evident, Dr. La Flamme said. Another possible explanation is that the underlying MS physiology changed the targets of the medications, she said.
“We have no conclusive evidence that would suggest one over the other,” she said. “But a lot of the evidence supports the idea that it’s a change in the physiology, that something about those pathways has been altered.”
It’s clear, she said, that the doses of the drugs in the trial were not appropriate. However, a big question remains: “We do not know whether these medicines are effective at reducing neuroinflammation.”
It’s possible, she said, that a “whisper of a dose” could still be effective. “It may get back to how these agents metabolize and become an active form.”
The study was funded by New Zealand’s Ministry of Business, Innovation and Employment. Dr. La Flamme disclosed that the study team has a patent for repurposing of clozapine and risperidone to treat MS.
SOURCE: La Flamme A et al. ACTRIMS Forum 2018, abstract P031.
SAN DIEGO – New Zealand researchers halted a small trial that was testing the use of the antipsychotics clozapine and risperidone to treat progressive multiple sclerosis because significant side effects caused participants to withdraw.
The adverse events appeared even though the doses were much smaller than those routinely given to patients with psychiatric illnesses. “The neurologists realized it was in the participants’ best interest to stop,” said study lead author Anne Camille La Flamme, PhD, of Victoria University of Wellington (New Zealand). “Adverse events included dizziness, muscle weakness, and falls.”
The researchers launched the study – a blinded, randomized, placebo-controlled trial – to learn whether the two antipsychotic drugs, also known by the brand names Clozaril and Risperdal, have potential as treatments for progressive multiple sclerosis.
Previous in-vitro research had linked the drugs to anti-inflammatory effects in the central nervous system, Dr. La Flamme said, and researchers believed that the progressive form of MS might be especially vulnerable to their effects because of high immune system involvement.
The researchers planned to randomly assign three groups of 12 patients per arm to placebo, clozapine, and risperidone.
For clozapine, “the doses were very low, much lower than you’d expect for psychiatric use,” Dr. La Flamme said. A typical dose for psychiatric disorders is about 350 mg/day, she said, and the trial aimed to use 100-150 mg/day with an eye toward preventing dose-dependent side effects.
As for risperidone, a typical dose is about 4 mg/day, and the trial began at 2 mg/day and would increase to 3.5 mg/day, she said.
Three subjects in the clozapine group had to withdraw within 2 weeks when their doses had only reached an average of 35 mg/day. Two of three in the risperidone group withdrew within 4 months.
In light of the adverse effects, “it was deemed not wise to continue,” Dr. La Flamme said.
The placebo group, meanwhile, completed the trial at 178 days and had adverse effects that were more indicative of MS, she said.
What happened? One possibility is that disability from MS made the adverse events more evident, Dr. La Flamme said. Another possible explanation is that the underlying MS physiology changed the targets of the medications, she said.
“We have no conclusive evidence that would suggest one over the other,” she said. “But a lot of the evidence supports the idea that it’s a change in the physiology, that something about those pathways has been altered.”
It’s clear, she said, that the doses of the drugs in the trial were not appropriate. However, a big question remains: “We do not know whether these medicines are effective at reducing neuroinflammation.”
It’s possible, she said, that a “whisper of a dose” could still be effective. “It may get back to how these agents metabolize and become an active form.”
The study was funded by New Zealand’s Ministry of Business, Innovation and Employment. Dr. La Flamme disclosed that the study team has a patent for repurposing of clozapine and risperidone to treat MS.
SOURCE: La Flamme A et al. ACTRIMS Forum 2018, abstract P031.
REPORTING FROM ACTRIMS Forum 2018
MAGNIMS and McDonald Criteria Have Similar Accuracy
The 2016 Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) criteria have accuracy similar to that of the 2010 McDonald criteria in predicting the development of clinically definite multiple sclerosis (MS), according to a retrospective study.
“Among the different modifications proposed, our results support removal of the distinction between symptomatic and asymptomatic lesions, which simplifies the clinical use of MRI criteria, and suggest that further consideration be given to increasing the number of lesions needed to define periventricular involvement from one to three, because this might slightly increase specificity,” said Massimo Filippi, MD, of the neuroimaging research unit in the division of neuroscience at San Raffaele Scientific Institute at Vita-Salute San Raffaele University in Milan, and colleagues. The report was published online ahead of print December 21, 2017, in Lancet Neurology. “Further effort is still needed to improve cortical lesion assessment, and more studies should be done to evaluate the effect of including optic nerve assessment as an additional dissemination in space [DIS] criterion.”
An Effort to Draft Revisions
In an effort to guide revisions of MS diagnostic criteria, Dr. Filippi and other members of the MAGNIMS network compared the performance of the 2010 McDonald and 2016 MAGNIMS criteria for MS in a cohort of 368 patients with clinically isolated syndrome (CIS) who were screened between June 16, 1995, and January 27, 2017. They used a time-dependent receiver operating characteristic curve analysis to evaluate MRI criteria performance for DIS, dissemination in time (DIT), and DIS plus DIT. Changes to the DIS definition contained in the 2016 MAGNIMS criteria included removal of the distinction between symptomatic and asymptomatic lesions, increasing the number of lesions needed to define periventricular involvement to three, combining cortical and juxtacortical lesions, and inclusion of optic nerve evaluation. For DIT, removal of the distinction between symptomatic and asymptomatic lesions was suggested.
Dr. Filippi and his coauthors at eight centers reported that 189 (51%) of the 368 patients had developed clinically definite MS by the last evaluation, which occurred at a median of 50 months from baseline. At 36 months, DIS alone showed high sensitivity in the 2010 McDonald and 2016 MAGNIMS criteria (91% vs 93%, respectively), similar specificity (33% vs 32%), and similar area under the curve values (AUC, 0.62 vs 0.63). Inclusion of symptomatic lesions did not alter performance. The researchers also found that requiring three periventricular lesions reduced sensitivity to 85% and increased specificity to 40%, but did not affect AUC values (AUC, 0.63). When optic nerve evaluation was included, sensitivity was similar (92%), while specificity decreased to 26%, and AUC declined to 0.59.
The 2016 MAGNIMS and 2010 McDonald criteria achieved similar sensitivity, specificity, and AUC values when compared on the performance of DIT criteria and DIS plus DIT criteria.
“For both sets of criteria, specificity was lower than that of previous studies that evaluated the diagnostic performance of the 2010 McDonald criteria,” the authors wrote. “Several factors could help explain our findings, including the different follow-up durations, the statistical methods (eg, using a time-to-event analysis in our study), and the effect of treatment, which might have delayed or prevented the occurrence of the second attack during the study period.” They acknowledged certain limitations of the study, including its retrospective design and the fact that patients were recruited in highly specialized centers, which may have resulted in the selection of patients at higher risk of conversion to clinically definite MS.
MRI Abnormalities May Not Indicate MS
As MS diagnosis evolves, revisions to existing diagnostic criteria have increased sensitivity, thus helping clinicians establish earlier diagnoses. Although the study by Dr. Filippi et al showed that for both sets of MRI criteria, sensitivity was greater than specificity for predicting clinically definite MS, the modest specificity is cause for concern, said Anne H. Cross, MD, Head of the Neuroimmunology (MS) Section, and Robert N. Naismith, MD, Associate Professor of Neurology, both at Washington University in St. Louis, in an accompanying editorial. They cited one study that emphasized the importance of not misdiagnosing other CNS diseases as MS. “In that study at four academic medical centers, 110 people seen over a period of less than 1.5 years were found to have been misdiagnosed,” said Drs. Cross and Naismith. “[Seventy percent] of the 110 individuals had received disease-modifying therapy, and 31% had unnecessary morbidity. Leading factors contributing to erroneous diagnosis in the study included overreliance on MRI abnormalities in patients with nonspecific neurologic symptoms.”
Vascular and other diseases can cause MRI abnormalities that could meet the 2016 MAGNIMS recommendations or the 2010 and 2017 McDonald MRI criteria, the authors continued. For example, patients with monophasic inflammatory and infectious diseases might have gadolinium-enhancing lesions that meet the 2017 McDonald criteria for DIT, which require only the simultaneous presence of gadolinium-enhancing and gadolinium-negative lesions in the proper locations. For patients with an atypical presentation who meet the 2010 and 2017 McDonald or 2016 MAGNIMS recommendations, clinicians should weigh all of the observed imaging features (including the number of periventricular lesions, along with lesion size, shape, and location) to improve diagnostic specificity and help to limit misdiagnoses, they concluded.
—Doug Brunk
Suggested Reading
Cross AH, Naismith RT. Refining the use of MRI to predict multiple sclerosis. Lancet Neurol. 2017 Dec 21 [Epub ahead of print].
Filippi M, Preziosa P, Meani A, et al. Prediction of a multiple sclerosis diagnosis in patients with clinically isolated syndrome using the 2016 MAGNIMS and 2010 McDonald criteria: a retrospective study. Lancet Neurol. 2017 Dec 21 [Epub ahead of print].
The 2016 Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) criteria have accuracy similar to that of the 2010 McDonald criteria in predicting the development of clinically definite multiple sclerosis (MS), according to a retrospective study.
“Among the different modifications proposed, our results support removal of the distinction between symptomatic and asymptomatic lesions, which simplifies the clinical use of MRI criteria, and suggest that further consideration be given to increasing the number of lesions needed to define periventricular involvement from one to three, because this might slightly increase specificity,” said Massimo Filippi, MD, of the neuroimaging research unit in the division of neuroscience at San Raffaele Scientific Institute at Vita-Salute San Raffaele University in Milan, and colleagues. The report was published online ahead of print December 21, 2017, in Lancet Neurology. “Further effort is still needed to improve cortical lesion assessment, and more studies should be done to evaluate the effect of including optic nerve assessment as an additional dissemination in space [DIS] criterion.”
An Effort to Draft Revisions
In an effort to guide revisions of MS diagnostic criteria, Dr. Filippi and other members of the MAGNIMS network compared the performance of the 2010 McDonald and 2016 MAGNIMS criteria for MS in a cohort of 368 patients with clinically isolated syndrome (CIS) who were screened between June 16, 1995, and January 27, 2017. They used a time-dependent receiver operating characteristic curve analysis to evaluate MRI criteria performance for DIS, dissemination in time (DIT), and DIS plus DIT. Changes to the DIS definition contained in the 2016 MAGNIMS criteria included removal of the distinction between symptomatic and asymptomatic lesions, increasing the number of lesions needed to define periventricular involvement to three, combining cortical and juxtacortical lesions, and inclusion of optic nerve evaluation. For DIT, removal of the distinction between symptomatic and asymptomatic lesions was suggested.
Dr. Filippi and his coauthors at eight centers reported that 189 (51%) of the 368 patients had developed clinically definite MS by the last evaluation, which occurred at a median of 50 months from baseline. At 36 months, DIS alone showed high sensitivity in the 2010 McDonald and 2016 MAGNIMS criteria (91% vs 93%, respectively), similar specificity (33% vs 32%), and similar area under the curve values (AUC, 0.62 vs 0.63). Inclusion of symptomatic lesions did not alter performance. The researchers also found that requiring three periventricular lesions reduced sensitivity to 85% and increased specificity to 40%, but did not affect AUC values (AUC, 0.63). When optic nerve evaluation was included, sensitivity was similar (92%), while specificity decreased to 26%, and AUC declined to 0.59.
The 2016 MAGNIMS and 2010 McDonald criteria achieved similar sensitivity, specificity, and AUC values when compared on the performance of DIT criteria and DIS plus DIT criteria.
“For both sets of criteria, specificity was lower than that of previous studies that evaluated the diagnostic performance of the 2010 McDonald criteria,” the authors wrote. “Several factors could help explain our findings, including the different follow-up durations, the statistical methods (eg, using a time-to-event analysis in our study), and the effect of treatment, which might have delayed or prevented the occurrence of the second attack during the study period.” They acknowledged certain limitations of the study, including its retrospective design and the fact that patients were recruited in highly specialized centers, which may have resulted in the selection of patients at higher risk of conversion to clinically definite MS.
MRI Abnormalities May Not Indicate MS
As MS diagnosis evolves, revisions to existing diagnostic criteria have increased sensitivity, thus helping clinicians establish earlier diagnoses. Although the study by Dr. Filippi et al showed that for both sets of MRI criteria, sensitivity was greater than specificity for predicting clinically definite MS, the modest specificity is cause for concern, said Anne H. Cross, MD, Head of the Neuroimmunology (MS) Section, and Robert N. Naismith, MD, Associate Professor of Neurology, both at Washington University in St. Louis, in an accompanying editorial. They cited one study that emphasized the importance of not misdiagnosing other CNS diseases as MS. “In that study at four academic medical centers, 110 people seen over a period of less than 1.5 years were found to have been misdiagnosed,” said Drs. Cross and Naismith. “[Seventy percent] of the 110 individuals had received disease-modifying therapy, and 31% had unnecessary morbidity. Leading factors contributing to erroneous diagnosis in the study included overreliance on MRI abnormalities in patients with nonspecific neurologic symptoms.”
Vascular and other diseases can cause MRI abnormalities that could meet the 2016 MAGNIMS recommendations or the 2010 and 2017 McDonald MRI criteria, the authors continued. For example, patients with monophasic inflammatory and infectious diseases might have gadolinium-enhancing lesions that meet the 2017 McDonald criteria for DIT, which require only the simultaneous presence of gadolinium-enhancing and gadolinium-negative lesions in the proper locations. For patients with an atypical presentation who meet the 2010 and 2017 McDonald or 2016 MAGNIMS recommendations, clinicians should weigh all of the observed imaging features (including the number of periventricular lesions, along with lesion size, shape, and location) to improve diagnostic specificity and help to limit misdiagnoses, they concluded.
—Doug Brunk
Suggested Reading
Cross AH, Naismith RT. Refining the use of MRI to predict multiple sclerosis. Lancet Neurol. 2017 Dec 21 [Epub ahead of print].
Filippi M, Preziosa P, Meani A, et al. Prediction of a multiple sclerosis diagnosis in patients with clinically isolated syndrome using the 2016 MAGNIMS and 2010 McDonald criteria: a retrospective study. Lancet Neurol. 2017 Dec 21 [Epub ahead of print].
The 2016 Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) criteria have accuracy similar to that of the 2010 McDonald criteria in predicting the development of clinically definite multiple sclerosis (MS), according to a retrospective study.
“Among the different modifications proposed, our results support removal of the distinction between symptomatic and asymptomatic lesions, which simplifies the clinical use of MRI criteria, and suggest that further consideration be given to increasing the number of lesions needed to define periventricular involvement from one to three, because this might slightly increase specificity,” said Massimo Filippi, MD, of the neuroimaging research unit in the division of neuroscience at San Raffaele Scientific Institute at Vita-Salute San Raffaele University in Milan, and colleagues. The report was published online ahead of print December 21, 2017, in Lancet Neurology. “Further effort is still needed to improve cortical lesion assessment, and more studies should be done to evaluate the effect of including optic nerve assessment as an additional dissemination in space [DIS] criterion.”
An Effort to Draft Revisions
In an effort to guide revisions of MS diagnostic criteria, Dr. Filippi and other members of the MAGNIMS network compared the performance of the 2010 McDonald and 2016 MAGNIMS criteria for MS in a cohort of 368 patients with clinically isolated syndrome (CIS) who were screened between June 16, 1995, and January 27, 2017. They used a time-dependent receiver operating characteristic curve analysis to evaluate MRI criteria performance for DIS, dissemination in time (DIT), and DIS plus DIT. Changes to the DIS definition contained in the 2016 MAGNIMS criteria included removal of the distinction between symptomatic and asymptomatic lesions, increasing the number of lesions needed to define periventricular involvement to three, combining cortical and juxtacortical lesions, and inclusion of optic nerve evaluation. For DIT, removal of the distinction between symptomatic and asymptomatic lesions was suggested.
Dr. Filippi and his coauthors at eight centers reported that 189 (51%) of the 368 patients had developed clinically definite MS by the last evaluation, which occurred at a median of 50 months from baseline. At 36 months, DIS alone showed high sensitivity in the 2010 McDonald and 2016 MAGNIMS criteria (91% vs 93%, respectively), similar specificity (33% vs 32%), and similar area under the curve values (AUC, 0.62 vs 0.63). Inclusion of symptomatic lesions did not alter performance. The researchers also found that requiring three periventricular lesions reduced sensitivity to 85% and increased specificity to 40%, but did not affect AUC values (AUC, 0.63). When optic nerve evaluation was included, sensitivity was similar (92%), while specificity decreased to 26%, and AUC declined to 0.59.
The 2016 MAGNIMS and 2010 McDonald criteria achieved similar sensitivity, specificity, and AUC values when compared on the performance of DIT criteria and DIS plus DIT criteria.
“For both sets of criteria, specificity was lower than that of previous studies that evaluated the diagnostic performance of the 2010 McDonald criteria,” the authors wrote. “Several factors could help explain our findings, including the different follow-up durations, the statistical methods (eg, using a time-to-event analysis in our study), and the effect of treatment, which might have delayed or prevented the occurrence of the second attack during the study period.” They acknowledged certain limitations of the study, including its retrospective design and the fact that patients were recruited in highly specialized centers, which may have resulted in the selection of patients at higher risk of conversion to clinically definite MS.
MRI Abnormalities May Not Indicate MS
As MS diagnosis evolves, revisions to existing diagnostic criteria have increased sensitivity, thus helping clinicians establish earlier diagnoses. Although the study by Dr. Filippi et al showed that for both sets of MRI criteria, sensitivity was greater than specificity for predicting clinically definite MS, the modest specificity is cause for concern, said Anne H. Cross, MD, Head of the Neuroimmunology (MS) Section, and Robert N. Naismith, MD, Associate Professor of Neurology, both at Washington University in St. Louis, in an accompanying editorial. They cited one study that emphasized the importance of not misdiagnosing other CNS diseases as MS. “In that study at four academic medical centers, 110 people seen over a period of less than 1.5 years were found to have been misdiagnosed,” said Drs. Cross and Naismith. “[Seventy percent] of the 110 individuals had received disease-modifying therapy, and 31% had unnecessary morbidity. Leading factors contributing to erroneous diagnosis in the study included overreliance on MRI abnormalities in patients with nonspecific neurologic symptoms.”
Vascular and other diseases can cause MRI abnormalities that could meet the 2016 MAGNIMS recommendations or the 2010 and 2017 McDonald MRI criteria, the authors continued. For example, patients with monophasic inflammatory and infectious diseases might have gadolinium-enhancing lesions that meet the 2017 McDonald criteria for DIT, which require only the simultaneous presence of gadolinium-enhancing and gadolinium-negative lesions in the proper locations. For patients with an atypical presentation who meet the 2010 and 2017 McDonald or 2016 MAGNIMS recommendations, clinicians should weigh all of the observed imaging features (including the number of periventricular lesions, along with lesion size, shape, and location) to improve diagnostic specificity and help to limit misdiagnoses, they concluded.
—Doug Brunk
Suggested Reading
Cross AH, Naismith RT. Refining the use of MRI to predict multiple sclerosis. Lancet Neurol. 2017 Dec 21 [Epub ahead of print].
Filippi M, Preziosa P, Meani A, et al. Prediction of a multiple sclerosis diagnosis in patients with clinically isolated syndrome using the 2016 MAGNIMS and 2010 McDonald criteria: a retrospective study. Lancet Neurol. 2017 Dec 21 [Epub ahead of print].
Rituximab May Provide Greater Benefits Than Other First-Line MS Therapies
Rituximab is associated with a lower drug discontinuation rate than all other commonly prescribed disease-modifying treatments (DMTs) used as initial therapy for relapsing-remitting multiple sclerosis (MS), according to a retrospective study of patient data from a Swedish MS registry.
In addition, relapse rates were lower with rituximab (Rituxan) than they were with injectable DMTs and dimethyl fumarate (Tecfidera), according to the study, which was published online ahead of print January 8 in JAMA Neurology.
The results suggest that rituximab “can be considered an option” for treatment-naive patients with relapsing-remitting MS, according to Mathias Granqvist, MD, a graduate student in the Department of Clinical Neuroscience at the Karolinska Institute in Stockholm, and his coauthors.
Anti-CD20 agents such as rituximab are “likely to become an additional treatment option” for relapsing-remitting MS, and off-label use of rituximab for this indication has “increased considerably” in Sweden in recent years, the investigators said. Relapsing-remitting MS is not an approved indication for rituximab in the United States, but in Sweden “there is no difference in reimbursement policy ... because all DMTs are covered by the national health insurance, including off-label medications.”
The emergence of new DMTs for relapsing-remitting MS has changed the treatment landscape recently, although in real-world practice, there is a lack of “detailed knowledge about how to tailor therapy,” the authors said. They noted that the majority of patients discontinue traditional first-line treatment with injectable DMTs (ie, interferon beta and glatiramer acetate) within two years, suggesting a need for better treatment options.
To evaluate the real-world effectiveness of rituximab in this setting, Dr. Granqvist and his colleagues selected patient registry data for two Swedish counties that included 494 participants who received a diagnosis of relapsing-remitting MS between January 1, 2012, and October 31, 2015.
The largest subset of patients (215) received injectable DMTs, while 120 received rituximab, 86 received dimethyl fumarate, 50 received natalizumab (Tysabri), 17 received fingolimod (Gilenya), and six received other treatments, according to the authors.
The proportion of patients who stayed on treatment was significantly higher for rituximab versus all other DMTs. Compared with rituximab, the hazard ratios for drug discontinuation, after adjusting for covariates and propensity score, were 11.4 for injectable DMTs, 15.1 for dimethyl fumarate, 5.9 for fingolimod, and 11.3 for natalizumab.
Rituximab-treated patients also had lower rates of clinical relapse, neuroradiologic disease activity, and adverse events, compared with patients who received injectable DMTs or dimethyl fumarate, according to the investigators.
In comparison with fingolimod and natalizumab, rituximab was associated with lower relapse rates and fewer gadolinium-enhancing lesions, but those differences did not reach statistical significance in all analyses.
The study was funded by the Swedish Medical Research Council, among other sources. Study authors reported conflicts of interest related to Biogen, Novartis, and Genzyme.
—Andrew D. Bowser
Suggested Reading
Granqvist M, Boremalm M, Poorghobad A, et al. Comparative effectiveness of rituximab and other initial treatment choices for multiple sclerosis. JAMA Neurol. 2018 Jan 8 [Epub ahead of print].
Rituximab is associated with a lower drug discontinuation rate than all other commonly prescribed disease-modifying treatments (DMTs) used as initial therapy for relapsing-remitting multiple sclerosis (MS), according to a retrospective study of patient data from a Swedish MS registry.
In addition, relapse rates were lower with rituximab (Rituxan) than they were with injectable DMTs and dimethyl fumarate (Tecfidera), according to the study, which was published online ahead of print January 8 in JAMA Neurology.
The results suggest that rituximab “can be considered an option” for treatment-naive patients with relapsing-remitting MS, according to Mathias Granqvist, MD, a graduate student in the Department of Clinical Neuroscience at the Karolinska Institute in Stockholm, and his coauthors.
Anti-CD20 agents such as rituximab are “likely to become an additional treatment option” for relapsing-remitting MS, and off-label use of rituximab for this indication has “increased considerably” in Sweden in recent years, the investigators said. Relapsing-remitting MS is not an approved indication for rituximab in the United States, but in Sweden “there is no difference in reimbursement policy ... because all DMTs are covered by the national health insurance, including off-label medications.”
The emergence of new DMTs for relapsing-remitting MS has changed the treatment landscape recently, although in real-world practice, there is a lack of “detailed knowledge about how to tailor therapy,” the authors said. They noted that the majority of patients discontinue traditional first-line treatment with injectable DMTs (ie, interferon beta and glatiramer acetate) within two years, suggesting a need for better treatment options.
To evaluate the real-world effectiveness of rituximab in this setting, Dr. Granqvist and his colleagues selected patient registry data for two Swedish counties that included 494 participants who received a diagnosis of relapsing-remitting MS between January 1, 2012, and October 31, 2015.
The largest subset of patients (215) received injectable DMTs, while 120 received rituximab, 86 received dimethyl fumarate, 50 received natalizumab (Tysabri), 17 received fingolimod (Gilenya), and six received other treatments, according to the authors.
The proportion of patients who stayed on treatment was significantly higher for rituximab versus all other DMTs. Compared with rituximab, the hazard ratios for drug discontinuation, after adjusting for covariates and propensity score, were 11.4 for injectable DMTs, 15.1 for dimethyl fumarate, 5.9 for fingolimod, and 11.3 for natalizumab.
Rituximab-treated patients also had lower rates of clinical relapse, neuroradiologic disease activity, and adverse events, compared with patients who received injectable DMTs or dimethyl fumarate, according to the investigators.
In comparison with fingolimod and natalizumab, rituximab was associated with lower relapse rates and fewer gadolinium-enhancing lesions, but those differences did not reach statistical significance in all analyses.
The study was funded by the Swedish Medical Research Council, among other sources. Study authors reported conflicts of interest related to Biogen, Novartis, and Genzyme.
—Andrew D. Bowser
Suggested Reading
Granqvist M, Boremalm M, Poorghobad A, et al. Comparative effectiveness of rituximab and other initial treatment choices for multiple sclerosis. JAMA Neurol. 2018 Jan 8 [Epub ahead of print].
Rituximab is associated with a lower drug discontinuation rate than all other commonly prescribed disease-modifying treatments (DMTs) used as initial therapy for relapsing-remitting multiple sclerosis (MS), according to a retrospective study of patient data from a Swedish MS registry.
In addition, relapse rates were lower with rituximab (Rituxan) than they were with injectable DMTs and dimethyl fumarate (Tecfidera), according to the study, which was published online ahead of print January 8 in JAMA Neurology.
The results suggest that rituximab “can be considered an option” for treatment-naive patients with relapsing-remitting MS, according to Mathias Granqvist, MD, a graduate student in the Department of Clinical Neuroscience at the Karolinska Institute in Stockholm, and his coauthors.
Anti-CD20 agents such as rituximab are “likely to become an additional treatment option” for relapsing-remitting MS, and off-label use of rituximab for this indication has “increased considerably” in Sweden in recent years, the investigators said. Relapsing-remitting MS is not an approved indication for rituximab in the United States, but in Sweden “there is no difference in reimbursement policy ... because all DMTs are covered by the national health insurance, including off-label medications.”
The emergence of new DMTs for relapsing-remitting MS has changed the treatment landscape recently, although in real-world practice, there is a lack of “detailed knowledge about how to tailor therapy,” the authors said. They noted that the majority of patients discontinue traditional first-line treatment with injectable DMTs (ie, interferon beta and glatiramer acetate) within two years, suggesting a need for better treatment options.
To evaluate the real-world effectiveness of rituximab in this setting, Dr. Granqvist and his colleagues selected patient registry data for two Swedish counties that included 494 participants who received a diagnosis of relapsing-remitting MS between January 1, 2012, and October 31, 2015.
The largest subset of patients (215) received injectable DMTs, while 120 received rituximab, 86 received dimethyl fumarate, 50 received natalizumab (Tysabri), 17 received fingolimod (Gilenya), and six received other treatments, according to the authors.
The proportion of patients who stayed on treatment was significantly higher for rituximab versus all other DMTs. Compared with rituximab, the hazard ratios for drug discontinuation, after adjusting for covariates and propensity score, were 11.4 for injectable DMTs, 15.1 for dimethyl fumarate, 5.9 for fingolimod, and 11.3 for natalizumab.
Rituximab-treated patients also had lower rates of clinical relapse, neuroradiologic disease activity, and adverse events, compared with patients who received injectable DMTs or dimethyl fumarate, according to the investigators.
In comparison with fingolimod and natalizumab, rituximab was associated with lower relapse rates and fewer gadolinium-enhancing lesions, but those differences did not reach statistical significance in all analyses.
The study was funded by the Swedish Medical Research Council, among other sources. Study authors reported conflicts of interest related to Biogen, Novartis, and Genzyme.
—Andrew D. Bowser
Suggested Reading
Granqvist M, Boremalm M, Poorghobad A, et al. Comparative effectiveness of rituximab and other initial treatment choices for multiple sclerosis. JAMA Neurol. 2018 Jan 8 [Epub ahead of print].