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Anxiety and fatigue impair processing speed in MS
SEATTLE – (MS), according to data described at the annual meeting of the Consortium of Multiple Sclerosis Centers. Increased anxiety is associated with slower processing speed in the context of increasing cognitive fatigue. “This [finding] has implications on development of cognitive remediation strategies, which may aim to target patient fatigue or anxiety to improve processing speed,” said Caroline Altaras, a doctoral candidate at Yeshiva University in New York, and colleagues.
Approximately 90% of patients with MS have fatigue, which can be a highly debilitating symptom. Fatigue often is understood to include motor fatigue (difficulty maintaining physical stamina) and cognitive fatigue (difficulty maintaining mental stamina). MS-related fatigue decreases patients’ quality of life, including cognitive functioning.
Anxiety is a psychiatric comorbidity that is highly prevalent in MS and that has a bidirectional association with fatigue. Anxiety and fatigue independently impair cognitive function.
Impaired processing speed is the most common cognitive impairment among patients with MS. Ms. Altaras and colleagues conducted a study to analyze how anxiety and fatigue interact to affect processing speed in MS. They evaluated total fatigue, cognitive fatigue, and motor fatigue separately. The investigators collected data from 183 patients with MS who had been referred by physicians for neuropsychological testing at the MS Center at Holy Name Medical Center in Teaneck, New Jersey. Researchers measured patients’ anxiety and fatigue using the Hospital Anxiety and Depression Scale (HADS, a self-reported measure) and the Fatigue Scale for Motor and Cognitive Functions (FSMC), which measures cognitive fatigue and motor fatigue. Patients also took the Symbol Digit Modalities Test (SDMT), a neuropsychological measure of processing speed. Ms. Altaras and colleagues created three multivariate general linear models using SPSS 25.0 to test the hypothesized relationships, using fatigue types (cognitive, motor, and total) as separate outcomes. The investigators controlled their analyses for gender, age, and education.
The researchers found a significant interaction effect of cognitive fatigue and anxiety on SDMT score. Specifically, patients with MS and minimal anxiety and cognitive fatigue had similar SDMT performance; as anxiety increased, patients who had increased cognitive fatigue demonstrated worse performance on the SDMT. Ms. Altaras and colleagues observed that SDMT performance improved slightly with worsening anxiety when cognitive fatigue was minimal. Although total fatigue interacted significantly with anxiety to affect SDMT performance, motor fatigue did not, which suggests that the effects of total fatigue largely resulted from cognitive fatigue.
The study had no outside financial support, and the authors reported no disclosures.
SEATTLE – (MS), according to data described at the annual meeting of the Consortium of Multiple Sclerosis Centers. Increased anxiety is associated with slower processing speed in the context of increasing cognitive fatigue. “This [finding] has implications on development of cognitive remediation strategies, which may aim to target patient fatigue or anxiety to improve processing speed,” said Caroline Altaras, a doctoral candidate at Yeshiva University in New York, and colleagues.
Approximately 90% of patients with MS have fatigue, which can be a highly debilitating symptom. Fatigue often is understood to include motor fatigue (difficulty maintaining physical stamina) and cognitive fatigue (difficulty maintaining mental stamina). MS-related fatigue decreases patients’ quality of life, including cognitive functioning.
Anxiety is a psychiatric comorbidity that is highly prevalent in MS and that has a bidirectional association with fatigue. Anxiety and fatigue independently impair cognitive function.
Impaired processing speed is the most common cognitive impairment among patients with MS. Ms. Altaras and colleagues conducted a study to analyze how anxiety and fatigue interact to affect processing speed in MS. They evaluated total fatigue, cognitive fatigue, and motor fatigue separately. The investigators collected data from 183 patients with MS who had been referred by physicians for neuropsychological testing at the MS Center at Holy Name Medical Center in Teaneck, New Jersey. Researchers measured patients’ anxiety and fatigue using the Hospital Anxiety and Depression Scale (HADS, a self-reported measure) and the Fatigue Scale for Motor and Cognitive Functions (FSMC), which measures cognitive fatigue and motor fatigue. Patients also took the Symbol Digit Modalities Test (SDMT), a neuropsychological measure of processing speed. Ms. Altaras and colleagues created three multivariate general linear models using SPSS 25.0 to test the hypothesized relationships, using fatigue types (cognitive, motor, and total) as separate outcomes. The investigators controlled their analyses for gender, age, and education.
The researchers found a significant interaction effect of cognitive fatigue and anxiety on SDMT score. Specifically, patients with MS and minimal anxiety and cognitive fatigue had similar SDMT performance; as anxiety increased, patients who had increased cognitive fatigue demonstrated worse performance on the SDMT. Ms. Altaras and colleagues observed that SDMT performance improved slightly with worsening anxiety when cognitive fatigue was minimal. Although total fatigue interacted significantly with anxiety to affect SDMT performance, motor fatigue did not, which suggests that the effects of total fatigue largely resulted from cognitive fatigue.
The study had no outside financial support, and the authors reported no disclosures.
SEATTLE – (MS), according to data described at the annual meeting of the Consortium of Multiple Sclerosis Centers. Increased anxiety is associated with slower processing speed in the context of increasing cognitive fatigue. “This [finding] has implications on development of cognitive remediation strategies, which may aim to target patient fatigue or anxiety to improve processing speed,” said Caroline Altaras, a doctoral candidate at Yeshiva University in New York, and colleagues.
Approximately 90% of patients with MS have fatigue, which can be a highly debilitating symptom. Fatigue often is understood to include motor fatigue (difficulty maintaining physical stamina) and cognitive fatigue (difficulty maintaining mental stamina). MS-related fatigue decreases patients’ quality of life, including cognitive functioning.
Anxiety is a psychiatric comorbidity that is highly prevalent in MS and that has a bidirectional association with fatigue. Anxiety and fatigue independently impair cognitive function.
Impaired processing speed is the most common cognitive impairment among patients with MS. Ms. Altaras and colleagues conducted a study to analyze how anxiety and fatigue interact to affect processing speed in MS. They evaluated total fatigue, cognitive fatigue, and motor fatigue separately. The investigators collected data from 183 patients with MS who had been referred by physicians for neuropsychological testing at the MS Center at Holy Name Medical Center in Teaneck, New Jersey. Researchers measured patients’ anxiety and fatigue using the Hospital Anxiety and Depression Scale (HADS, a self-reported measure) and the Fatigue Scale for Motor and Cognitive Functions (FSMC), which measures cognitive fatigue and motor fatigue. Patients also took the Symbol Digit Modalities Test (SDMT), a neuropsychological measure of processing speed. Ms. Altaras and colleagues created three multivariate general linear models using SPSS 25.0 to test the hypothesized relationships, using fatigue types (cognitive, motor, and total) as separate outcomes. The investigators controlled their analyses for gender, age, and education.
The researchers found a significant interaction effect of cognitive fatigue and anxiety on SDMT score. Specifically, patients with MS and minimal anxiety and cognitive fatigue had similar SDMT performance; as anxiety increased, patients who had increased cognitive fatigue demonstrated worse performance on the SDMT. Ms. Altaras and colleagues observed that SDMT performance improved slightly with worsening anxiety when cognitive fatigue was minimal. Although total fatigue interacted significantly with anxiety to affect SDMT performance, motor fatigue did not, which suggests that the effects of total fatigue largely resulted from cognitive fatigue.
The study had no outside financial support, and the authors reported no disclosures.
REPORTING FROM CMSC 2019
Key clinical point: Anxiety and fatigue interact to affect processing speed in MS.
Major finding: Cognitive fatigue and anxiety interact to affect performance on the Symbol Digit Modalities Test.
Study details: A prospective study of 183 patients with MS referred for neuropsychological testing.
Disclosures: The study had no outside funding, and the investigators had no disclosures.
MS significantly affects employment and home activities
SEATTLE – according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. The disease appears to prevent people from achieving their full potential at work and at home, largely because of its associated fatigue, said the researchers. “The economic impact of identifying an effective treatment for this symptom of MS cannot be overstated,” said Terrie Livingston, PharmD, head of patient outcomes and solutions at EMD Serono in Wayland, Massachusetts, and colleagues.
The research results from an initiative by the North American Registry for Care and Research in MS (NARCRMS). Since December 2016, NARCRMS has prospectively collected clinical and imaging data, information about patients’ health care economics, and data about the effects of MS on daily life. To examine the economic impact of MS and to help implement health economics outcomes research (HEOR) in decision-making processes, NARCRMS established the HEOR Advisory Group in 2017. The registry created a Health-Related Productivity Questionnaire and Health Resource Utilization Questionnaire, both of which were incorporated into the existing case report forms. Patients complete these questionnaires at enrollment and at annual and exacerbation visits.
As of January 2, 2019, NARCRMS had enrolled 378 people with MS into the registry, and 368 had completed the HEOR case report forms. Among the respondents, 270 (73%) are employed either full or part time. During the week before reporting, 39 respondents (11%) reported that MS kept them from work, 93 (25%) reported that MS affected their work, 105 (29%) reported that MS stopped them from finishing household chores, and 140 (38%) reported that MS affected their household chores. Fatigue was the symptom most commonly reported to affect work and household chores. In the 3 months before reporting, 13 patients (4%) had inpatient hospital stays, 24 patients (7%) visited the ED, 71 patients (19%) visited a general practitioner, and 296 (80%) patients visited a neurologist.
The study had no sponsor. Several of the study authors reported receiving compensation from companies such as Biogen, Celgene, Genentech, Novartis, Sanofi Genzyme, and Teva.
SEATTLE – according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. The disease appears to prevent people from achieving their full potential at work and at home, largely because of its associated fatigue, said the researchers. “The economic impact of identifying an effective treatment for this symptom of MS cannot be overstated,” said Terrie Livingston, PharmD, head of patient outcomes and solutions at EMD Serono in Wayland, Massachusetts, and colleagues.
The research results from an initiative by the North American Registry for Care and Research in MS (NARCRMS). Since December 2016, NARCRMS has prospectively collected clinical and imaging data, information about patients’ health care economics, and data about the effects of MS on daily life. To examine the economic impact of MS and to help implement health economics outcomes research (HEOR) in decision-making processes, NARCRMS established the HEOR Advisory Group in 2017. The registry created a Health-Related Productivity Questionnaire and Health Resource Utilization Questionnaire, both of which were incorporated into the existing case report forms. Patients complete these questionnaires at enrollment and at annual and exacerbation visits.
As of January 2, 2019, NARCRMS had enrolled 378 people with MS into the registry, and 368 had completed the HEOR case report forms. Among the respondents, 270 (73%) are employed either full or part time. During the week before reporting, 39 respondents (11%) reported that MS kept them from work, 93 (25%) reported that MS affected their work, 105 (29%) reported that MS stopped them from finishing household chores, and 140 (38%) reported that MS affected their household chores. Fatigue was the symptom most commonly reported to affect work and household chores. In the 3 months before reporting, 13 patients (4%) had inpatient hospital stays, 24 patients (7%) visited the ED, 71 patients (19%) visited a general practitioner, and 296 (80%) patients visited a neurologist.
The study had no sponsor. Several of the study authors reported receiving compensation from companies such as Biogen, Celgene, Genentech, Novartis, Sanofi Genzyme, and Teva.
SEATTLE – according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. The disease appears to prevent people from achieving their full potential at work and at home, largely because of its associated fatigue, said the researchers. “The economic impact of identifying an effective treatment for this symptom of MS cannot be overstated,” said Terrie Livingston, PharmD, head of patient outcomes and solutions at EMD Serono in Wayland, Massachusetts, and colleagues.
The research results from an initiative by the North American Registry for Care and Research in MS (NARCRMS). Since December 2016, NARCRMS has prospectively collected clinical and imaging data, information about patients’ health care economics, and data about the effects of MS on daily life. To examine the economic impact of MS and to help implement health economics outcomes research (HEOR) in decision-making processes, NARCRMS established the HEOR Advisory Group in 2017. The registry created a Health-Related Productivity Questionnaire and Health Resource Utilization Questionnaire, both of which were incorporated into the existing case report forms. Patients complete these questionnaires at enrollment and at annual and exacerbation visits.
As of January 2, 2019, NARCRMS had enrolled 378 people with MS into the registry, and 368 had completed the HEOR case report forms. Among the respondents, 270 (73%) are employed either full or part time. During the week before reporting, 39 respondents (11%) reported that MS kept them from work, 93 (25%) reported that MS affected their work, 105 (29%) reported that MS stopped them from finishing household chores, and 140 (38%) reported that MS affected their household chores. Fatigue was the symptom most commonly reported to affect work and household chores. In the 3 months before reporting, 13 patients (4%) had inpatient hospital stays, 24 patients (7%) visited the ED, 71 patients (19%) visited a general practitioner, and 296 (80%) patients visited a neurologist.
The study had no sponsor. Several of the study authors reported receiving compensation from companies such as Biogen, Celgene, Genentech, Novartis, Sanofi Genzyme, and Teva.
REPORTING FROM CMSC 2019
Key clinical point: Fatigue is the most common symptom preventing people with MS from completing work or chores.
Major finding: Approximately 28% of people with MS may be underemployed or unemployed.
Study details: An analysis of registry data, including questionnaires for 368 patients with MS.
Disclosures: The study had no sponsor. Dr. Livingston is an employee of EMD Serono.
Alemtuzumab increases the likelihood of disability improvement in MS
Seattle – , according to a pooled analysis presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Patients who achieved this outcome had improvement in several functional systems, regardless of their baseline EDSS scores. “These results suggest a broad and prolonged effect of alemtuzumab on disability improvement and a potential for changing the MS disease course,” said Samuel F. Hunter, MD, a neurologist and psychiatrist at the Advanced Neurosciences Institute in Franklin, Tenn., and colleagues.
The researchers’ findings come from their analysis of pooled data from the CARE-MS I and CARE-MS II trials. Those studies indicated that alemtuzumab improved clinical and MRI outcomes over 2 years in relapsing-remitting MS, compared with interferon beta-1a. In a 4-year extension, alemtuzumab’s efficacy was maintained, and 81% of participants continued in the study until year 6. In addition, 34% of alemtuzumab-treated patients in CARE-MS I and 43% of alemtuzumab-treated patients in CARE-MS II achieved 6-month confirmed disability improvement. The relationship between baseline disability levels and the achievement of disability improvement is not well understood, however.
Dr. Hunter and colleagues conducted a pooled analysis of CARE-MS I and CARE-MS II data to evaluate how baseline disability affects improvements in each functional system in patients treated with alemtuzumab over 6 years. In those studies, patients received two 12-mg/day courses of alemtuzumab: a 5-day course at baseline and a 3-day course 12 months later. Additional treatment with alemtuzumab or other disease-modifying therapies was provided as needed during the extension study.
The investigators defined confirmed disability improvement as a decrease of 1 or more points in EDSS score confirmed over 6 months among patients with a baseline EDSS score of 2 or higher. Improvement (i.e., a decrease of 1 or more points) or stability (i.e., no change) in each of the functional system scores was assessed in patients with confirmed disability improvement, stratified by baseline EDSS scores. Patients were grouped according to whether their baseline EDSS scores were 2.0-2.5, 3.0-3.5, 4.0-4.5, 5.0-5.5, or 6.0-6.5.
A total of 208 of 565 patients (37%) achieved 6-month confirmed disability improvement through year 6. This outcome was achieved by the highest percentages of patients with baseline EDSS scores of 4.0-4.5 (57%) and 3.0-3.5 (44%), followed by those with baseline EDSS scores of 5.0-5.5 (28%) and 2.0-2.5 (27%). No patients with baseline EDSS scores of 6.0-6.5 achieved confirmed disability improvement.
At 6 months after onset of confirmed disability improvement, patients within each baseline EDSS group showed stability or improvement in each individual functional system. The proportion of stable or improved patients was 94% or greater in the 2.0-2.5 group, 92% or greater in the 3.0-3.5 group, 88% or greater in the 4.0-4.5 group, and 75% or greater in the 5.0-5.5 group. Between 67% and 76% of patients achieved improvements in two or more functional systems. Improvements were most frequent in the pyramidal (13% to 50%), sensory (42% to 50%), and cerebellar (13% to 55%) functional systems.
Sanofi, Bayer HealthCare Pharmaceuticals supported the study. Dr. Hunter received grants and financial support from AbbVie, Actelion, Acorda, Adamas, Alkermes, Avanir, Bayer HealthCare, Biogen, Novartis, Osmotica, Questcor, Roche, Sanofi, Synthon, and Teva.
SOURCE: Hunter SF et al. CMSC 2019. Abstract DXT08.
Seattle – , according to a pooled analysis presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Patients who achieved this outcome had improvement in several functional systems, regardless of their baseline EDSS scores. “These results suggest a broad and prolonged effect of alemtuzumab on disability improvement and a potential for changing the MS disease course,” said Samuel F. Hunter, MD, a neurologist and psychiatrist at the Advanced Neurosciences Institute in Franklin, Tenn., and colleagues.
The researchers’ findings come from their analysis of pooled data from the CARE-MS I and CARE-MS II trials. Those studies indicated that alemtuzumab improved clinical and MRI outcomes over 2 years in relapsing-remitting MS, compared with interferon beta-1a. In a 4-year extension, alemtuzumab’s efficacy was maintained, and 81% of participants continued in the study until year 6. In addition, 34% of alemtuzumab-treated patients in CARE-MS I and 43% of alemtuzumab-treated patients in CARE-MS II achieved 6-month confirmed disability improvement. The relationship between baseline disability levels and the achievement of disability improvement is not well understood, however.
Dr. Hunter and colleagues conducted a pooled analysis of CARE-MS I and CARE-MS II data to evaluate how baseline disability affects improvements in each functional system in patients treated with alemtuzumab over 6 years. In those studies, patients received two 12-mg/day courses of alemtuzumab: a 5-day course at baseline and a 3-day course 12 months later. Additional treatment with alemtuzumab or other disease-modifying therapies was provided as needed during the extension study.
The investigators defined confirmed disability improvement as a decrease of 1 or more points in EDSS score confirmed over 6 months among patients with a baseline EDSS score of 2 or higher. Improvement (i.e., a decrease of 1 or more points) or stability (i.e., no change) in each of the functional system scores was assessed in patients with confirmed disability improvement, stratified by baseline EDSS scores. Patients were grouped according to whether their baseline EDSS scores were 2.0-2.5, 3.0-3.5, 4.0-4.5, 5.0-5.5, or 6.0-6.5.
A total of 208 of 565 patients (37%) achieved 6-month confirmed disability improvement through year 6. This outcome was achieved by the highest percentages of patients with baseline EDSS scores of 4.0-4.5 (57%) and 3.0-3.5 (44%), followed by those with baseline EDSS scores of 5.0-5.5 (28%) and 2.0-2.5 (27%). No patients with baseline EDSS scores of 6.0-6.5 achieved confirmed disability improvement.
At 6 months after onset of confirmed disability improvement, patients within each baseline EDSS group showed stability or improvement in each individual functional system. The proportion of stable or improved patients was 94% or greater in the 2.0-2.5 group, 92% or greater in the 3.0-3.5 group, 88% or greater in the 4.0-4.5 group, and 75% or greater in the 5.0-5.5 group. Between 67% and 76% of patients achieved improvements in two or more functional systems. Improvements were most frequent in the pyramidal (13% to 50%), sensory (42% to 50%), and cerebellar (13% to 55%) functional systems.
Sanofi, Bayer HealthCare Pharmaceuticals supported the study. Dr. Hunter received grants and financial support from AbbVie, Actelion, Acorda, Adamas, Alkermes, Avanir, Bayer HealthCare, Biogen, Novartis, Osmotica, Questcor, Roche, Sanofi, Synthon, and Teva.
SOURCE: Hunter SF et al. CMSC 2019. Abstract DXT08.
Seattle – , according to a pooled analysis presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Patients who achieved this outcome had improvement in several functional systems, regardless of their baseline EDSS scores. “These results suggest a broad and prolonged effect of alemtuzumab on disability improvement and a potential for changing the MS disease course,” said Samuel F. Hunter, MD, a neurologist and psychiatrist at the Advanced Neurosciences Institute in Franklin, Tenn., and colleagues.
The researchers’ findings come from their analysis of pooled data from the CARE-MS I and CARE-MS II trials. Those studies indicated that alemtuzumab improved clinical and MRI outcomes over 2 years in relapsing-remitting MS, compared with interferon beta-1a. In a 4-year extension, alemtuzumab’s efficacy was maintained, and 81% of participants continued in the study until year 6. In addition, 34% of alemtuzumab-treated patients in CARE-MS I and 43% of alemtuzumab-treated patients in CARE-MS II achieved 6-month confirmed disability improvement. The relationship between baseline disability levels and the achievement of disability improvement is not well understood, however.
Dr. Hunter and colleagues conducted a pooled analysis of CARE-MS I and CARE-MS II data to evaluate how baseline disability affects improvements in each functional system in patients treated with alemtuzumab over 6 years. In those studies, patients received two 12-mg/day courses of alemtuzumab: a 5-day course at baseline and a 3-day course 12 months later. Additional treatment with alemtuzumab or other disease-modifying therapies was provided as needed during the extension study.
The investigators defined confirmed disability improvement as a decrease of 1 or more points in EDSS score confirmed over 6 months among patients with a baseline EDSS score of 2 or higher. Improvement (i.e., a decrease of 1 or more points) or stability (i.e., no change) in each of the functional system scores was assessed in patients with confirmed disability improvement, stratified by baseline EDSS scores. Patients were grouped according to whether their baseline EDSS scores were 2.0-2.5, 3.0-3.5, 4.0-4.5, 5.0-5.5, or 6.0-6.5.
A total of 208 of 565 patients (37%) achieved 6-month confirmed disability improvement through year 6. This outcome was achieved by the highest percentages of patients with baseline EDSS scores of 4.0-4.5 (57%) and 3.0-3.5 (44%), followed by those with baseline EDSS scores of 5.0-5.5 (28%) and 2.0-2.5 (27%). No patients with baseline EDSS scores of 6.0-6.5 achieved confirmed disability improvement.
At 6 months after onset of confirmed disability improvement, patients within each baseline EDSS group showed stability or improvement in each individual functional system. The proportion of stable or improved patients was 94% or greater in the 2.0-2.5 group, 92% or greater in the 3.0-3.5 group, 88% or greater in the 4.0-4.5 group, and 75% or greater in the 5.0-5.5 group. Between 67% and 76% of patients achieved improvements in two or more functional systems. Improvements were most frequent in the pyramidal (13% to 50%), sensory (42% to 50%), and cerebellar (13% to 55%) functional systems.
Sanofi, Bayer HealthCare Pharmaceuticals supported the study. Dr. Hunter received grants and financial support from AbbVie, Actelion, Acorda, Adamas, Alkermes, Avanir, Bayer HealthCare, Biogen, Novartis, Osmotica, Questcor, Roche, Sanofi, Synthon, and Teva.
SOURCE: Hunter SF et al. CMSC 2019. Abstract DXT08.
REPORTING FROM CMSC 2019
Immunotherapy Induces Improvements in PML
Key clinical point: Adoptive transfer of donor-derived T cells represents a potentially life-saving strategy for patients with progressive multifocal leukoencephalopathy.
Major finding: Seven of 12 patients stabilized and, in some cases, experienced significant neurological improvement.
Study details: A pilot study including 12 patients with refractory PML.
Disclosures: The study was funded by NINDS. The investigators disclosed no conflicts related to the study.
Citation: Cortese I et al. AAN 2019, Abstract Plen01.002.
Key clinical point: Adoptive transfer of donor-derived T cells represents a potentially life-saving strategy for patients with progressive multifocal leukoencephalopathy.
Major finding: Seven of 12 patients stabilized and, in some cases, experienced significant neurological improvement.
Study details: A pilot study including 12 patients with refractory PML.
Disclosures: The study was funded by NINDS. The investigators disclosed no conflicts related to the study.
Citation: Cortese I et al. AAN 2019, Abstract Plen01.002.
Key clinical point: Adoptive transfer of donor-derived T cells represents a potentially life-saving strategy for patients with progressive multifocal leukoencephalopathy.
Major finding: Seven of 12 patients stabilized and, in some cases, experienced significant neurological improvement.
Study details: A pilot study including 12 patients with refractory PML.
Disclosures: The study was funded by NINDS. The investigators disclosed no conflicts related to the study.
Citation: Cortese I et al. AAN 2019, Abstract Plen01.002.
Criterion Based on the Central Vein Sign Distinguishes Between MS and Mimics
Key clinical point: Applying a criterion of three lesions with the central vein sign distinguishes between multiple sclerosis and its mimics.
Major finding: The criterion has a sensitivity and specificity of 61.9% and 89.0%, respectively.
Study details: A multicenter study of 606 participants with clinically isolated syndrome, multiple sclerosis, and multiple sclerosis mimics.
Disclosures: Dr. Sinnecker reported receiving personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion.
Citation: Sinnecker T et al. AAN 2019, Abstract S6.002.
Key clinical point: Applying a criterion of three lesions with the central vein sign distinguishes between multiple sclerosis and its mimics.
Major finding: The criterion has a sensitivity and specificity of 61.9% and 89.0%, respectively.
Study details: A multicenter study of 606 participants with clinically isolated syndrome, multiple sclerosis, and multiple sclerosis mimics.
Disclosures: Dr. Sinnecker reported receiving personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion.
Citation: Sinnecker T et al. AAN 2019, Abstract S6.002.
Key clinical point: Applying a criterion of three lesions with the central vein sign distinguishes between multiple sclerosis and its mimics.
Major finding: The criterion has a sensitivity and specificity of 61.9% and 89.0%, respectively.
Study details: A multicenter study of 606 participants with clinically isolated syndrome, multiple sclerosis, and multiple sclerosis mimics.
Disclosures: Dr. Sinnecker reported receiving personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion.
Citation: Sinnecker T et al. AAN 2019, Abstract S6.002.
Multiple Sclerosis May Not Flare Up After Pregnancy
Key clinical point: Women with MS may be able to have children, breastfeed, and resume treatment without experiencing an increased risk of relapse during the postpartum period.
Major finding: Patients’ annualized relapse rate was 0.39 pre-pregnancy, 0.07-0.14 during pregnancy, 0.27 in the first 3 months postpartum, and 0.37 at 4-6 months postpartum.
Study details: An analysis of prospectively collected data from 466 pregnancies among 375 women with MS between 2008 and 2016.
Disclosures: The study was supported by the National Multiple Sclerosis Society. The researchers had no disclosures.
Citation: Langer-Gould A et al. AAN 2019, Abstract S6.007.
Key clinical point: Women with MS may be able to have children, breastfeed, and resume treatment without experiencing an increased risk of relapse during the postpartum period.
Major finding: Patients’ annualized relapse rate was 0.39 pre-pregnancy, 0.07-0.14 during pregnancy, 0.27 in the first 3 months postpartum, and 0.37 at 4-6 months postpartum.
Study details: An analysis of prospectively collected data from 466 pregnancies among 375 women with MS between 2008 and 2016.
Disclosures: The study was supported by the National Multiple Sclerosis Society. The researchers had no disclosures.
Citation: Langer-Gould A et al. AAN 2019, Abstract S6.007.
Key clinical point: Women with MS may be able to have children, breastfeed, and resume treatment without experiencing an increased risk of relapse during the postpartum period.
Major finding: Patients’ annualized relapse rate was 0.39 pre-pregnancy, 0.07-0.14 during pregnancy, 0.27 in the first 3 months postpartum, and 0.37 at 4-6 months postpartum.
Study details: An analysis of prospectively collected data from 466 pregnancies among 375 women with MS between 2008 and 2016.
Disclosures: The study was supported by the National Multiple Sclerosis Society. The researchers had no disclosures.
Citation: Langer-Gould A et al. AAN 2019, Abstract S6.007.
Evobrutinib demonstrates efficacy, safety in relapsing MS
PHILADELPHIA – Higher doses of evobrutinib significantly improved that study endpoint, and were associated with numerical decreases in the annualized relapse rate versus placebo, according to a report presented at the annual meeting of the American Academy of Neurology.
Some grade 3-4 transaminase elevations were associated with evobrutinib, though these were asymptomatic, reversible, and occurred within the first 24 weeks of the 48-week treatment period, said investigator Xavier Montalban, MD, PhD, chairman and director of the department of neurology-neuroimmunology at Vall d’Hebron University Hospital in Barcelona.
“Overall, we do believe the results of the phase 2 study support further clinical development in relapsing multiple sclerosis,” Dr. Montalban said.
This study builds on previous observations that BTK plays an important role in immune functions related to the pathogenesis of MS, Dr. Montalban said. Evobrutinib in particular impacts B cells and myeloid cells along with pathways involved in MS-related inflammation, he added.
In the current randomized, phase 2, placebo-controlled study, 267 patients with relapsing MS were randomized to one of five arms: placebo, evobrutinib 25-mg daily, 75-mg daily, or 75-mg twice daily, or an open-label reference arm of dimethyl fumarate 240 mg twice daily.
Dr. Montalban presented the results of a 24-week treatment period plus a 24-week blinded extension period, during which placebo-treated patients crossed over to evobrutinib 25 mg daily, for a total of 48 weeks of treatment.
The primary study endpoint was the cumulative number of MRI-assessed T1 Gd+ lesions at weeks 12, 16, 20, and 24. Dr. Montalban said that evobrutinib in the two 75-mg arms significantly reduced enhancing lesions versus placebo over weeks 12-24, with lesion rate ratios of 0.30 for the 75-mg daily arm, and 0.44 for the 75-mg twice-daily arm, with unadjusted P values of .002 and .031, respectively. By contrast, the evobrutinib 25-mg arm did not significantly reduce the cumulative number of enhancing lesions versus placebo over that time period.
There was a rapid reduction in the mean number of enhancing lesions from baseline to the week-12 visit for those 75-mg dosing arms, which was sustained through subsequent visits, Dr. Montalban said.
There were no significant differences between arms in the annualized relapse rate at week 24, a key secondary endpoint of the study, according to the investigators. The annualized relapse rate was 0.37 for placebo, 0.57 for evobrutinib 25 mg daily, 0.13 for the 75-mg daily dose, 0.08 for the 75-mg twice-daily dose, and 0.20 for dimethyl fumarate. The magnitude of reduction was maintained at the 48-week evaluation for evobrutinib 75 mg twice daily, with an annualized relapse rate of 0.11, Dr. Montalban reported.
Most treatment-emergent adverse events were mild or moderate, according to the investigators.
Reported ALT elevations in the evobrutinib arms were mainly grade 1. While some grade 3-4 elevations were seen in the first 24 weeks of the study, they were reversible and did not have clinical consequences, according to Dr. Montalban.
Results of the study were published concurrently in the New England Journal of Medicine.
Dr. Montalban provided disclosures related to Biogen, Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis, Teva Pharmaceuticals, Roche, Celgene, Actelion, National Multiple Sclerosis Society, and Multiple Sclerosis International Federation.
SOURCE: Montalban X et al. AAN 2019. Abstract S56.004.
PHILADELPHIA – Higher doses of evobrutinib significantly improved that study endpoint, and were associated with numerical decreases in the annualized relapse rate versus placebo, according to a report presented at the annual meeting of the American Academy of Neurology.
Some grade 3-4 transaminase elevations were associated with evobrutinib, though these were asymptomatic, reversible, and occurred within the first 24 weeks of the 48-week treatment period, said investigator Xavier Montalban, MD, PhD, chairman and director of the department of neurology-neuroimmunology at Vall d’Hebron University Hospital in Barcelona.
“Overall, we do believe the results of the phase 2 study support further clinical development in relapsing multiple sclerosis,” Dr. Montalban said.
This study builds on previous observations that BTK plays an important role in immune functions related to the pathogenesis of MS, Dr. Montalban said. Evobrutinib in particular impacts B cells and myeloid cells along with pathways involved in MS-related inflammation, he added.
In the current randomized, phase 2, placebo-controlled study, 267 patients with relapsing MS were randomized to one of five arms: placebo, evobrutinib 25-mg daily, 75-mg daily, or 75-mg twice daily, or an open-label reference arm of dimethyl fumarate 240 mg twice daily.
Dr. Montalban presented the results of a 24-week treatment period plus a 24-week blinded extension period, during which placebo-treated patients crossed over to evobrutinib 25 mg daily, for a total of 48 weeks of treatment.
The primary study endpoint was the cumulative number of MRI-assessed T1 Gd+ lesions at weeks 12, 16, 20, and 24. Dr. Montalban said that evobrutinib in the two 75-mg arms significantly reduced enhancing lesions versus placebo over weeks 12-24, with lesion rate ratios of 0.30 for the 75-mg daily arm, and 0.44 for the 75-mg twice-daily arm, with unadjusted P values of .002 and .031, respectively. By contrast, the evobrutinib 25-mg arm did not significantly reduce the cumulative number of enhancing lesions versus placebo over that time period.
There was a rapid reduction in the mean number of enhancing lesions from baseline to the week-12 visit for those 75-mg dosing arms, which was sustained through subsequent visits, Dr. Montalban said.
There were no significant differences between arms in the annualized relapse rate at week 24, a key secondary endpoint of the study, according to the investigators. The annualized relapse rate was 0.37 for placebo, 0.57 for evobrutinib 25 mg daily, 0.13 for the 75-mg daily dose, 0.08 for the 75-mg twice-daily dose, and 0.20 for dimethyl fumarate. The magnitude of reduction was maintained at the 48-week evaluation for evobrutinib 75 mg twice daily, with an annualized relapse rate of 0.11, Dr. Montalban reported.
Most treatment-emergent adverse events were mild or moderate, according to the investigators.
Reported ALT elevations in the evobrutinib arms were mainly grade 1. While some grade 3-4 elevations were seen in the first 24 weeks of the study, they were reversible and did not have clinical consequences, according to Dr. Montalban.
Results of the study were published concurrently in the New England Journal of Medicine.
Dr. Montalban provided disclosures related to Biogen, Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis, Teva Pharmaceuticals, Roche, Celgene, Actelion, National Multiple Sclerosis Society, and Multiple Sclerosis International Federation.
SOURCE: Montalban X et al. AAN 2019. Abstract S56.004.
PHILADELPHIA – Higher doses of evobrutinib significantly improved that study endpoint, and were associated with numerical decreases in the annualized relapse rate versus placebo, according to a report presented at the annual meeting of the American Academy of Neurology.
Some grade 3-4 transaminase elevations were associated with evobrutinib, though these were asymptomatic, reversible, and occurred within the first 24 weeks of the 48-week treatment period, said investigator Xavier Montalban, MD, PhD, chairman and director of the department of neurology-neuroimmunology at Vall d’Hebron University Hospital in Barcelona.
“Overall, we do believe the results of the phase 2 study support further clinical development in relapsing multiple sclerosis,” Dr. Montalban said.
This study builds on previous observations that BTK plays an important role in immune functions related to the pathogenesis of MS, Dr. Montalban said. Evobrutinib in particular impacts B cells and myeloid cells along with pathways involved in MS-related inflammation, he added.
In the current randomized, phase 2, placebo-controlled study, 267 patients with relapsing MS were randomized to one of five arms: placebo, evobrutinib 25-mg daily, 75-mg daily, or 75-mg twice daily, or an open-label reference arm of dimethyl fumarate 240 mg twice daily.
Dr. Montalban presented the results of a 24-week treatment period plus a 24-week blinded extension period, during which placebo-treated patients crossed over to evobrutinib 25 mg daily, for a total of 48 weeks of treatment.
The primary study endpoint was the cumulative number of MRI-assessed T1 Gd+ lesions at weeks 12, 16, 20, and 24. Dr. Montalban said that evobrutinib in the two 75-mg arms significantly reduced enhancing lesions versus placebo over weeks 12-24, with lesion rate ratios of 0.30 for the 75-mg daily arm, and 0.44 for the 75-mg twice-daily arm, with unadjusted P values of .002 and .031, respectively. By contrast, the evobrutinib 25-mg arm did not significantly reduce the cumulative number of enhancing lesions versus placebo over that time period.
There was a rapid reduction in the mean number of enhancing lesions from baseline to the week-12 visit for those 75-mg dosing arms, which was sustained through subsequent visits, Dr. Montalban said.
There were no significant differences between arms in the annualized relapse rate at week 24, a key secondary endpoint of the study, according to the investigators. The annualized relapse rate was 0.37 for placebo, 0.57 for evobrutinib 25 mg daily, 0.13 for the 75-mg daily dose, 0.08 for the 75-mg twice-daily dose, and 0.20 for dimethyl fumarate. The magnitude of reduction was maintained at the 48-week evaluation for evobrutinib 75 mg twice daily, with an annualized relapse rate of 0.11, Dr. Montalban reported.
Most treatment-emergent adverse events were mild or moderate, according to the investigators.
Reported ALT elevations in the evobrutinib arms were mainly grade 1. While some grade 3-4 elevations were seen in the first 24 weeks of the study, they were reversible and did not have clinical consequences, according to Dr. Montalban.
Results of the study were published concurrently in the New England Journal of Medicine.
Dr. Montalban provided disclosures related to Biogen, Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis, Teva Pharmaceuticals, Roche, Celgene, Actelion, National Multiple Sclerosis Society, and Multiple Sclerosis International Federation.
SOURCE: Montalban X et al. AAN 2019. Abstract S56.004.
FROM AAN 2019
Fingolimod reduced disease activity more than glatiramer acetate in RRMS: ASSESS study results
PHILADELPHIA – reported at the annual meeting of the American Academy of Neurology. The optimal efficacious dose of fingolimod was 0.5 mg once daily, according to the results of the ASSESS study, which also evaluated a 0.25-mg daily dose of fingolimod versus a 20-mg daily dose of glatiramer acetate.
Adverse events seen with fingolimod were consistent with the established safety profile of the immunomodulatory drug, according to investigator Bruce Cree, MD, PhD, of the UCSF Weill Institute for Neurosciences, department of neurology, University of California, San Francisco.
“I believe this is the first study to go head to head versus glatiramer acetate to show superiority,” Dr. Cree said in a podium presentation of the results.
While fingolimod 0.5 mg has shown superior efficacy over placebo and interferon beta-1a in previous phase 3 trials, head-to-head comparisons versus disease-modifying therapies can help inform treatment decisions in clinical practice, Dr. Cree and coinvestigators noted in the abstract that describes their results.
The randomized, three-armed, phase 3b ASSESS study included 12 months of dose-blinded treatment and 3 months of follow-up. Investigators enrolled 1,054 patients with relapsing-remitting MS, of whom about 74% were women and the average age was 40 years, Dr. Cree said in his presentation.
Annualized relapse rate, the primary endpoint of the study, was 0.153 for the fingolimod 0.5-mg arm, versus 0.258 for the glatiramer acetate 20-mg arm, for a 40.7% relative reduction (P = .013), Dr. Cree reported. By contrast, he said, the annualized relapse rate within the fingolimod 0.25-mg arm was 0.221, which was not statistically different versus glatiramer acetate.
The fingolimod 0.5-mg arm was also superior to glatiramer acetate on a number of radiographic endpoints at month 12, including new or newly enlarged T2 lesion count, change in T2 lesion volume, gadolinium-positive T1 lesion count, and gadolinium-positive T1 lesion volume, Dr. Cree said.
Adverse events and serious adverse events were “much as expected” in all three study groups, Dr. Cree said.
The observed safety with fingolimod was consistent with previously available data on fingolimod 0.5 mg, and the safety profile of the lower 0.25-mg dose seemed to be comparable with the 0.5-mg dose, according to his presentation.
Adverse events with fingolimod were “largely laboratory abnormalities,” that occurred more frequently in the fingolimod arms, he said. Although there was an apparent dose-dependent effect between the 0.25-mg and 0.5-mg doses, the overall proportion of patients experiencing low white blood cell counts or elevations in liver enzymes was low, he added.
Bradycardia was “infrequent” in both fingolimod groups in first-dose observations, though it did again occur with a dose-dependent effect, Dr. Cree said.
He reported bradycardia in two patients (0.5%) in the fingolimod 0.25-mg group and four (1.2%) in the fingolimod 0.5-mg group, while the number of patients requiring overnight hospitalizations was one (0.3%) and five (1.5%) in the 0.25- and 0.5-mg groups, respectively.
Hepatic enzyme abnormalities were the leading reason for discontinuation of fingolimod, while in contrast, drug hypersensitivity and injection site reactions led to discontinuations in the glatiramer acetate arm, he added.
Novartis sponsored the study. Dr. Cree provided disclosures related to Abbvie, Akili, Biogen, EMD Serono, GeNeuro and Novartis.
SOURCE: Cree B et al. AAN 2019, Abstract 56.009.
PHILADELPHIA – reported at the annual meeting of the American Academy of Neurology. The optimal efficacious dose of fingolimod was 0.5 mg once daily, according to the results of the ASSESS study, which also evaluated a 0.25-mg daily dose of fingolimod versus a 20-mg daily dose of glatiramer acetate.
Adverse events seen with fingolimod were consistent with the established safety profile of the immunomodulatory drug, according to investigator Bruce Cree, MD, PhD, of the UCSF Weill Institute for Neurosciences, department of neurology, University of California, San Francisco.
“I believe this is the first study to go head to head versus glatiramer acetate to show superiority,” Dr. Cree said in a podium presentation of the results.
While fingolimod 0.5 mg has shown superior efficacy over placebo and interferon beta-1a in previous phase 3 trials, head-to-head comparisons versus disease-modifying therapies can help inform treatment decisions in clinical practice, Dr. Cree and coinvestigators noted in the abstract that describes their results.
The randomized, three-armed, phase 3b ASSESS study included 12 months of dose-blinded treatment and 3 months of follow-up. Investigators enrolled 1,054 patients with relapsing-remitting MS, of whom about 74% were women and the average age was 40 years, Dr. Cree said in his presentation.
Annualized relapse rate, the primary endpoint of the study, was 0.153 for the fingolimod 0.5-mg arm, versus 0.258 for the glatiramer acetate 20-mg arm, for a 40.7% relative reduction (P = .013), Dr. Cree reported. By contrast, he said, the annualized relapse rate within the fingolimod 0.25-mg arm was 0.221, which was not statistically different versus glatiramer acetate.
The fingolimod 0.5-mg arm was also superior to glatiramer acetate on a number of radiographic endpoints at month 12, including new or newly enlarged T2 lesion count, change in T2 lesion volume, gadolinium-positive T1 lesion count, and gadolinium-positive T1 lesion volume, Dr. Cree said.
Adverse events and serious adverse events were “much as expected” in all three study groups, Dr. Cree said.
The observed safety with fingolimod was consistent with previously available data on fingolimod 0.5 mg, and the safety profile of the lower 0.25-mg dose seemed to be comparable with the 0.5-mg dose, according to his presentation.
Adverse events with fingolimod were “largely laboratory abnormalities,” that occurred more frequently in the fingolimod arms, he said. Although there was an apparent dose-dependent effect between the 0.25-mg and 0.5-mg doses, the overall proportion of patients experiencing low white blood cell counts or elevations in liver enzymes was low, he added.
Bradycardia was “infrequent” in both fingolimod groups in first-dose observations, though it did again occur with a dose-dependent effect, Dr. Cree said.
He reported bradycardia in two patients (0.5%) in the fingolimod 0.25-mg group and four (1.2%) in the fingolimod 0.5-mg group, while the number of patients requiring overnight hospitalizations was one (0.3%) and five (1.5%) in the 0.25- and 0.5-mg groups, respectively.
Hepatic enzyme abnormalities were the leading reason for discontinuation of fingolimod, while in contrast, drug hypersensitivity and injection site reactions led to discontinuations in the glatiramer acetate arm, he added.
Novartis sponsored the study. Dr. Cree provided disclosures related to Abbvie, Akili, Biogen, EMD Serono, GeNeuro and Novartis.
SOURCE: Cree B et al. AAN 2019, Abstract 56.009.
PHILADELPHIA – reported at the annual meeting of the American Academy of Neurology. The optimal efficacious dose of fingolimod was 0.5 mg once daily, according to the results of the ASSESS study, which also evaluated a 0.25-mg daily dose of fingolimod versus a 20-mg daily dose of glatiramer acetate.
Adverse events seen with fingolimod were consistent with the established safety profile of the immunomodulatory drug, according to investigator Bruce Cree, MD, PhD, of the UCSF Weill Institute for Neurosciences, department of neurology, University of California, San Francisco.
“I believe this is the first study to go head to head versus glatiramer acetate to show superiority,” Dr. Cree said in a podium presentation of the results.
While fingolimod 0.5 mg has shown superior efficacy over placebo and interferon beta-1a in previous phase 3 trials, head-to-head comparisons versus disease-modifying therapies can help inform treatment decisions in clinical practice, Dr. Cree and coinvestigators noted in the abstract that describes their results.
The randomized, three-armed, phase 3b ASSESS study included 12 months of dose-blinded treatment and 3 months of follow-up. Investigators enrolled 1,054 patients with relapsing-remitting MS, of whom about 74% were women and the average age was 40 years, Dr. Cree said in his presentation.
Annualized relapse rate, the primary endpoint of the study, was 0.153 for the fingolimod 0.5-mg arm, versus 0.258 for the glatiramer acetate 20-mg arm, for a 40.7% relative reduction (P = .013), Dr. Cree reported. By contrast, he said, the annualized relapse rate within the fingolimod 0.25-mg arm was 0.221, which was not statistically different versus glatiramer acetate.
The fingolimod 0.5-mg arm was also superior to glatiramer acetate on a number of radiographic endpoints at month 12, including new or newly enlarged T2 lesion count, change in T2 lesion volume, gadolinium-positive T1 lesion count, and gadolinium-positive T1 lesion volume, Dr. Cree said.
Adverse events and serious adverse events were “much as expected” in all three study groups, Dr. Cree said.
The observed safety with fingolimod was consistent with previously available data on fingolimod 0.5 mg, and the safety profile of the lower 0.25-mg dose seemed to be comparable with the 0.5-mg dose, according to his presentation.
Adverse events with fingolimod were “largely laboratory abnormalities,” that occurred more frequently in the fingolimod arms, he said. Although there was an apparent dose-dependent effect between the 0.25-mg and 0.5-mg doses, the overall proportion of patients experiencing low white blood cell counts or elevations in liver enzymes was low, he added.
Bradycardia was “infrequent” in both fingolimod groups in first-dose observations, though it did again occur with a dose-dependent effect, Dr. Cree said.
He reported bradycardia in two patients (0.5%) in the fingolimod 0.25-mg group and four (1.2%) in the fingolimod 0.5-mg group, while the number of patients requiring overnight hospitalizations was one (0.3%) and five (1.5%) in the 0.25- and 0.5-mg groups, respectively.
Hepatic enzyme abnormalities were the leading reason for discontinuation of fingolimod, while in contrast, drug hypersensitivity and injection site reactions led to discontinuations in the glatiramer acetate arm, he added.
Novartis sponsored the study. Dr. Cree provided disclosures related to Abbvie, Akili, Biogen, EMD Serono, GeNeuro and Novartis.
SOURCE: Cree B et al. AAN 2019, Abstract 56.009.
REPORTING FROM AAN 2019
Ocrelizumab effective, safe in relapsing-remitting MS patients
PHILADELPHIA – Ocrelizumab is effective and safe in patients with relapsing-remitting multiple sclerosis who had inadequate responses to previous disease-modifying treatments, said an investigator reporting interim results of a recent nonrandomized study.
The findings of the 600+ patient CHORDS study suggest a positive risk-to-benefit ratio over nearly 1 year for this anti-CD20 monoclonal antibody, said Thomas P. Leist, MD, of Thomas Jefferson University, Philadelphia, at the annual meeting of the American Academy of Neurology (AAN).
“MRI activity has been significantly attenuated in these individuals, particularly, in the period from 24 to 48 weeks, and the overall safety that has been observed to date has been in line with what has been observed in clinical trials with this medication,” Dr. Leist said in a podium presentation.
While previous investigations demonstrated superiority to treatment with interferon in patients with relapsing multiple sclerosis, this phase IIIb study was needed to further clarify the effects of the treatment following suboptimal response to several disease modifying treatments, according to Dr. Leist and his co-investigators.
The intention-to-treat population of CHORDS consisted of 608 patients who received disease-modifying therapy for 6 or more months and discontinued it due to suboptimal response, which was defined as one or more clinically reported relapses, one or more T1 gadolinium-enhancing lesions, or two or more enlarging T2 lesions. They all received a 600 mg dose of ocrelizumab every 24 weeks for as many as 96 weeks.
With 48 weeks of follow-up, the majority of patients had no relapses, no enhancing T1 lesions, no new or enlarging T2 lesions, and no confirmed progression of disability. In all, 54.5% of the patients experienced none of those events, according to Dr. Leist.
The adjusted annualized relapse rate in this cohort was 0.065, he reported.
New MRI activity included 48 new T1 gadolinium-enhancing lesions in 1,174 MRI scans, for an adjusted rate of 0.023, he also reported, while there were 679 new or enlarging T2 lesions on 1,175 scans, for an adjusted rate of 0.581.
The safety in this population was comparable to the overall safety profile of ocrelizumab seen in other studies, according to Dr. Leist. A total of 25 patients, or 4.1%, experienced a serious adverse event, though none led to treatment withdrawal and only one led to a dose modification or interruption, the data show.
Dr. Leist reported disclosures related to Alkermes, Bayer, Biogen, EMD Serono, Genentech, Inc., Novartis, Sanofi Genzyme, Sun Pharma, and Teva Neuroscience.
SOURCE: Leist TP, et al. Presented at the 2019 American Academy of Neurology (AAN) Annual Meeting, May 4-10, 2019. Philadelphia. Presentation S56.007.
PHILADELPHIA – Ocrelizumab is effective and safe in patients with relapsing-remitting multiple sclerosis who had inadequate responses to previous disease-modifying treatments, said an investigator reporting interim results of a recent nonrandomized study.
The findings of the 600+ patient CHORDS study suggest a positive risk-to-benefit ratio over nearly 1 year for this anti-CD20 monoclonal antibody, said Thomas P. Leist, MD, of Thomas Jefferson University, Philadelphia, at the annual meeting of the American Academy of Neurology (AAN).
“MRI activity has been significantly attenuated in these individuals, particularly, in the period from 24 to 48 weeks, and the overall safety that has been observed to date has been in line with what has been observed in clinical trials with this medication,” Dr. Leist said in a podium presentation.
While previous investigations demonstrated superiority to treatment with interferon in patients with relapsing multiple sclerosis, this phase IIIb study was needed to further clarify the effects of the treatment following suboptimal response to several disease modifying treatments, according to Dr. Leist and his co-investigators.
The intention-to-treat population of CHORDS consisted of 608 patients who received disease-modifying therapy for 6 or more months and discontinued it due to suboptimal response, which was defined as one or more clinically reported relapses, one or more T1 gadolinium-enhancing lesions, or two or more enlarging T2 lesions. They all received a 600 mg dose of ocrelizumab every 24 weeks for as many as 96 weeks.
With 48 weeks of follow-up, the majority of patients had no relapses, no enhancing T1 lesions, no new or enlarging T2 lesions, and no confirmed progression of disability. In all, 54.5% of the patients experienced none of those events, according to Dr. Leist.
The adjusted annualized relapse rate in this cohort was 0.065, he reported.
New MRI activity included 48 new T1 gadolinium-enhancing lesions in 1,174 MRI scans, for an adjusted rate of 0.023, he also reported, while there were 679 new or enlarging T2 lesions on 1,175 scans, for an adjusted rate of 0.581.
The safety in this population was comparable to the overall safety profile of ocrelizumab seen in other studies, according to Dr. Leist. A total of 25 patients, or 4.1%, experienced a serious adverse event, though none led to treatment withdrawal and only one led to a dose modification or interruption, the data show.
Dr. Leist reported disclosures related to Alkermes, Bayer, Biogen, EMD Serono, Genentech, Inc., Novartis, Sanofi Genzyme, Sun Pharma, and Teva Neuroscience.
SOURCE: Leist TP, et al. Presented at the 2019 American Academy of Neurology (AAN) Annual Meeting, May 4-10, 2019. Philadelphia. Presentation S56.007.
PHILADELPHIA – Ocrelizumab is effective and safe in patients with relapsing-remitting multiple sclerosis who had inadequate responses to previous disease-modifying treatments, said an investigator reporting interim results of a recent nonrandomized study.
The findings of the 600+ patient CHORDS study suggest a positive risk-to-benefit ratio over nearly 1 year for this anti-CD20 monoclonal antibody, said Thomas P. Leist, MD, of Thomas Jefferson University, Philadelphia, at the annual meeting of the American Academy of Neurology (AAN).
“MRI activity has been significantly attenuated in these individuals, particularly, in the period from 24 to 48 weeks, and the overall safety that has been observed to date has been in line with what has been observed in clinical trials with this medication,” Dr. Leist said in a podium presentation.
While previous investigations demonstrated superiority to treatment with interferon in patients with relapsing multiple sclerosis, this phase IIIb study was needed to further clarify the effects of the treatment following suboptimal response to several disease modifying treatments, according to Dr. Leist and his co-investigators.
The intention-to-treat population of CHORDS consisted of 608 patients who received disease-modifying therapy for 6 or more months and discontinued it due to suboptimal response, which was defined as one or more clinically reported relapses, one or more T1 gadolinium-enhancing lesions, or two or more enlarging T2 lesions. They all received a 600 mg dose of ocrelizumab every 24 weeks for as many as 96 weeks.
With 48 weeks of follow-up, the majority of patients had no relapses, no enhancing T1 lesions, no new or enlarging T2 lesions, and no confirmed progression of disability. In all, 54.5% of the patients experienced none of those events, according to Dr. Leist.
The adjusted annualized relapse rate in this cohort was 0.065, he reported.
New MRI activity included 48 new T1 gadolinium-enhancing lesions in 1,174 MRI scans, for an adjusted rate of 0.023, he also reported, while there were 679 new or enlarging T2 lesions on 1,175 scans, for an adjusted rate of 0.581.
The safety in this population was comparable to the overall safety profile of ocrelizumab seen in other studies, according to Dr. Leist. A total of 25 patients, or 4.1%, experienced a serious adverse event, though none led to treatment withdrawal and only one led to a dose modification or interruption, the data show.
Dr. Leist reported disclosures related to Alkermes, Bayer, Biogen, EMD Serono, Genentech, Inc., Novartis, Sanofi Genzyme, Sun Pharma, and Teva Neuroscience.
SOURCE: Leist TP, et al. Presented at the 2019 American Academy of Neurology (AAN) Annual Meeting, May 4-10, 2019. Philadelphia. Presentation S56.007.
FROM AAN 2019
Sugary drink intake may be associated with MS severity
PHILADELPHIA – presented at the annual meeting of the American Academy of Neurology. Overall diet quality, however, is not associated with disability, the study showed.
The results do not establish that sugary drinks cause disability, and the potential association needs to be confirmed in larger, longitudinal studies, the researchers said. Nevertheless, “we do know that sodas have no nutritional value, and people with MS may want to consider reducing or eliminating them from their diet,” study lead author Elisa Meier-Gerdingh, MD, of St. Josef Hospital in Bochum, Germany, said in a written statement.
Diet may influence metabolic comorbidities, immune function, oxidative stress, and gut microbiota in patients with MS, but data about diet’s effects on MS progression are limited, the researchers said.
To examine dietary intake and disability in patients with MS, Dr. Meier-Gerdingh and her colleagues conducted a cross-sectional study of 135 participants with MS who were treated at a large referral center in Germany. Participants had a mean age of 44.6 years and mean body mass index of 24.5. Mean disease duration was 13.8 years, and 73% were women. Participants completed a 102-item food frequency questionnaire, which the investigators used to calculate each participant’s Dietary Approaches to Stop Hypertension (DASH) score. The score is a composite measure of dietary quality that favorably scores intake of fruits, vegetables, nuts and legumes, whole grains, and dairy and unfavorably scores intake of sodium, sugar-sweetened beverages, and red and processed meats.
“We chose to study the DASH diet because adherence to the DASH diet is associated with lower risk of other chronic diseases like high blood pressure, diabetes, and cardiovascular diseases,” Dr. Meier-Gerdingh said.
The researchers considered severe disability to be an Expanded Disability Status Scale (EDSS) score of 6 or greater. They assessed the association between overall DASH scores and disability status using logistic regression models that adjusted for age, sex, body mass index, smoking, and symptom duration. They also assessed the association between disability and each nutritional component of the DASH score.
In all, 30 participants had severe disability. “Overall DASH scores were not associated with disability status,” Dr. Meier-Gerdingh and her colleagues said. When they looked at individual DASH score components, patients with higher intakes of sugar-sweetened beverages had a higher risk of severe disability (P for trend = .01). Participants in the highest quartile consumed about 290 calories of sugar-sweetened beverages per day on average, compared with 7 calories per day for patients in the lowest quartile. The top quartile had an average EDSS of 4.1, and the bottom quartile had an average EDSS of 3.4. Other DASH score components were not associated with disability status.
Dr. Meier-Gerdingh had no disclosures. Her coauthors reported research support and personal compensation from pharmaceutical companies.
SOURCE: Meier-Gerdingh E et al. AAN 2019, Abstract P4.2-063.
PHILADELPHIA – presented at the annual meeting of the American Academy of Neurology. Overall diet quality, however, is not associated with disability, the study showed.
The results do not establish that sugary drinks cause disability, and the potential association needs to be confirmed in larger, longitudinal studies, the researchers said. Nevertheless, “we do know that sodas have no nutritional value, and people with MS may want to consider reducing or eliminating them from their diet,” study lead author Elisa Meier-Gerdingh, MD, of St. Josef Hospital in Bochum, Germany, said in a written statement.
Diet may influence metabolic comorbidities, immune function, oxidative stress, and gut microbiota in patients with MS, but data about diet’s effects on MS progression are limited, the researchers said.
To examine dietary intake and disability in patients with MS, Dr. Meier-Gerdingh and her colleagues conducted a cross-sectional study of 135 participants with MS who were treated at a large referral center in Germany. Participants had a mean age of 44.6 years and mean body mass index of 24.5. Mean disease duration was 13.8 years, and 73% were women. Participants completed a 102-item food frequency questionnaire, which the investigators used to calculate each participant’s Dietary Approaches to Stop Hypertension (DASH) score. The score is a composite measure of dietary quality that favorably scores intake of fruits, vegetables, nuts and legumes, whole grains, and dairy and unfavorably scores intake of sodium, sugar-sweetened beverages, and red and processed meats.
“We chose to study the DASH diet because adherence to the DASH diet is associated with lower risk of other chronic diseases like high blood pressure, diabetes, and cardiovascular diseases,” Dr. Meier-Gerdingh said.
The researchers considered severe disability to be an Expanded Disability Status Scale (EDSS) score of 6 or greater. They assessed the association between overall DASH scores and disability status using logistic regression models that adjusted for age, sex, body mass index, smoking, and symptom duration. They also assessed the association between disability and each nutritional component of the DASH score.
In all, 30 participants had severe disability. “Overall DASH scores were not associated with disability status,” Dr. Meier-Gerdingh and her colleagues said. When they looked at individual DASH score components, patients with higher intakes of sugar-sweetened beverages had a higher risk of severe disability (P for trend = .01). Participants in the highest quartile consumed about 290 calories of sugar-sweetened beverages per day on average, compared with 7 calories per day for patients in the lowest quartile. The top quartile had an average EDSS of 4.1, and the bottom quartile had an average EDSS of 3.4. Other DASH score components were not associated with disability status.
Dr. Meier-Gerdingh had no disclosures. Her coauthors reported research support and personal compensation from pharmaceutical companies.
SOURCE: Meier-Gerdingh E et al. AAN 2019, Abstract P4.2-063.
PHILADELPHIA – presented at the annual meeting of the American Academy of Neurology. Overall diet quality, however, is not associated with disability, the study showed.
The results do not establish that sugary drinks cause disability, and the potential association needs to be confirmed in larger, longitudinal studies, the researchers said. Nevertheless, “we do know that sodas have no nutritional value, and people with MS may want to consider reducing or eliminating them from their diet,” study lead author Elisa Meier-Gerdingh, MD, of St. Josef Hospital in Bochum, Germany, said in a written statement.
Diet may influence metabolic comorbidities, immune function, oxidative stress, and gut microbiota in patients with MS, but data about diet’s effects on MS progression are limited, the researchers said.
To examine dietary intake and disability in patients with MS, Dr. Meier-Gerdingh and her colleagues conducted a cross-sectional study of 135 participants with MS who were treated at a large referral center in Germany. Participants had a mean age of 44.6 years and mean body mass index of 24.5. Mean disease duration was 13.8 years, and 73% were women. Participants completed a 102-item food frequency questionnaire, which the investigators used to calculate each participant’s Dietary Approaches to Stop Hypertension (DASH) score. The score is a composite measure of dietary quality that favorably scores intake of fruits, vegetables, nuts and legumes, whole grains, and dairy and unfavorably scores intake of sodium, sugar-sweetened beverages, and red and processed meats.
“We chose to study the DASH diet because adherence to the DASH diet is associated with lower risk of other chronic diseases like high blood pressure, diabetes, and cardiovascular diseases,” Dr. Meier-Gerdingh said.
The researchers considered severe disability to be an Expanded Disability Status Scale (EDSS) score of 6 or greater. They assessed the association between overall DASH scores and disability status using logistic regression models that adjusted for age, sex, body mass index, smoking, and symptom duration. They also assessed the association between disability and each nutritional component of the DASH score.
In all, 30 participants had severe disability. “Overall DASH scores were not associated with disability status,” Dr. Meier-Gerdingh and her colleagues said. When they looked at individual DASH score components, patients with higher intakes of sugar-sweetened beverages had a higher risk of severe disability (P for trend = .01). Participants in the highest quartile consumed about 290 calories of sugar-sweetened beverages per day on average, compared with 7 calories per day for patients in the lowest quartile. The top quartile had an average EDSS of 4.1, and the bottom quartile had an average EDSS of 3.4. Other DASH score components were not associated with disability status.
Dr. Meier-Gerdingh had no disclosures. Her coauthors reported research support and personal compensation from pharmaceutical companies.
SOURCE: Meier-Gerdingh E et al. AAN 2019, Abstract P4.2-063.
REPORTING FROM AAN 2019