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Vaccination is not associated with increased risk of MS
(MS), according to an analysis published July 30 in Neurology. Although the results suggest that vaccination is associated with a lower likelihood of incident MS within the following 5 years, “these data alone do not allow for any conclusion regarding a possible protective effect of vaccinations regarding the development of MS,” wrote Alexander Hapfelmeier, PhD, of the Technical University of Munich and colleagues.
In recent years, researchers have proposed and investigated various potential environmental risk factors for the development of MS. Vaccination is one proposed environmental risk factor, but case reports and small studies have yielded conflicting results about its association with incident MS.
To examine this question more closely, Dr. Hapfelmeier and colleagues performed a systematic retrospective analysis of ambulatory claims data held by the Bavarian Association of Statutory Health Insurance Physicians. They reviewed the data to identify patients with new-onset MS and at least two ICD-10 diagnoses of the disorder. They next identified two control cohorts of participants diagnosed with other autoimmune diseases: Crohn’s disease and psoriasis. Finally, they randomly selected a third control cohort of patients without any of these diagnoses and matched them by age, sex, and district to patients with MS in a 5:1 ratio. Eligible participants were younger than 70 years.
Dr. Hapfelmeier and colleagues reviewed the incidence and frequency of vaccinations (such as those targeting tick-borne encephalitis, human papillomavirus, and influenza virus) in all cohorts. They created unconditional logistic regression models to assess the association between vaccination and MS. They also created separate models to contrast the MS cohort with each of the control cohorts.
The researchers included 12,262 patients with MS, 19,296 patients with Crohn’s disease, 112,292 patients with psoriasis, and 79,185 participants without these autoimmune diseases in their analysis. They found 456 participants with Crohn’s disease and psoriasis, 216 participants with MS and psoriasis, 48 participants with Crohn’s disease and MS, and 2 participants with Crohn’s disease, psoriasis, and MS. Dr. Hapfelmeier and colleagues allocated these participants to each of the respective cohorts and did not analyze them differently because of the comparatively small sample sizes.
The investigators analyzed the occurrence of vaccination in all participants during the 5 years before first diagnosis. Among patients who received vaccination, the odds ratio of MS was 0.870 in participants without autoimmune disease, 0.919 in participants with Crohn’s disease, and 0.973 in participants with psoriasis. Decreased risk of MS was most notable for vaccinations against influenza and tick-borne encephalitis. The results were consistent regardless of time frame, control cohort, and definition of MS.
The subjective definition of the MS cohort was a limitation of the study, but the authors addressed it by also using several strict definitions of that cohort. Another limitation is that the source data may reflect entry errors and incorrect coding.
A grant from the German Federal Ministry of Education and Research Competence Network MS supported the study. The authors had no conflicts that were relevant to the topic of the study.
SOURCE: Hapfelmeier A et al. Neurology. 2019 Jul 30. doi: 10.1212/WNL.0000000000008012.
The analysis by Hapfelmeier et al. provides important evidence that vaccinations are not associated with multiple sclerosis (MS), said E. Ann Yeh, MD, a neurologist at the Hospital for Sick Children in Toronto, and Jennifer Graves, MD, PhD, a neurologist at the University of California, San Diego, in an accompanying editorial. On the contrary, the evidence supports a potential protective effect of vaccines on the risk of developing MS, they said.
“The reasons for this [finding] cannot be gleaned from this study and may range from biological to sociocultural/demographic reasons,” the authors added. “Infection, rather than vaccination, may be an MS trigger, or individuals obtaining vaccinations may be practicing other healthy behaviors protective for MS. These possibilities should be the subject of future studies.”
Until future studies are completed and their results published, the findings of Hapfelmeier et al. offer “strong evidence to share with worried patients and families when faced with the question of whether a vaccine in the recent or relatively distant past triggered the individual’s MS,” said Dr. Yeh and Dr. Graves.
The authors had various relationships with industry, including serving on advisory boards for and receiving funding from pharmaceutical companies.
The analysis by Hapfelmeier et al. provides important evidence that vaccinations are not associated with multiple sclerosis (MS), said E. Ann Yeh, MD, a neurologist at the Hospital for Sick Children in Toronto, and Jennifer Graves, MD, PhD, a neurologist at the University of California, San Diego, in an accompanying editorial. On the contrary, the evidence supports a potential protective effect of vaccines on the risk of developing MS, they said.
“The reasons for this [finding] cannot be gleaned from this study and may range from biological to sociocultural/demographic reasons,” the authors added. “Infection, rather than vaccination, may be an MS trigger, or individuals obtaining vaccinations may be practicing other healthy behaviors protective for MS. These possibilities should be the subject of future studies.”
Until future studies are completed and their results published, the findings of Hapfelmeier et al. offer “strong evidence to share with worried patients and families when faced with the question of whether a vaccine in the recent or relatively distant past triggered the individual’s MS,” said Dr. Yeh and Dr. Graves.
The authors had various relationships with industry, including serving on advisory boards for and receiving funding from pharmaceutical companies.
The analysis by Hapfelmeier et al. provides important evidence that vaccinations are not associated with multiple sclerosis (MS), said E. Ann Yeh, MD, a neurologist at the Hospital for Sick Children in Toronto, and Jennifer Graves, MD, PhD, a neurologist at the University of California, San Diego, in an accompanying editorial. On the contrary, the evidence supports a potential protective effect of vaccines on the risk of developing MS, they said.
“The reasons for this [finding] cannot be gleaned from this study and may range from biological to sociocultural/demographic reasons,” the authors added. “Infection, rather than vaccination, may be an MS trigger, or individuals obtaining vaccinations may be practicing other healthy behaviors protective for MS. These possibilities should be the subject of future studies.”
Until future studies are completed and their results published, the findings of Hapfelmeier et al. offer “strong evidence to share with worried patients and families when faced with the question of whether a vaccine in the recent or relatively distant past triggered the individual’s MS,” said Dr. Yeh and Dr. Graves.
The authors had various relationships with industry, including serving on advisory boards for and receiving funding from pharmaceutical companies.
(MS), according to an analysis published July 30 in Neurology. Although the results suggest that vaccination is associated with a lower likelihood of incident MS within the following 5 years, “these data alone do not allow for any conclusion regarding a possible protective effect of vaccinations regarding the development of MS,” wrote Alexander Hapfelmeier, PhD, of the Technical University of Munich and colleagues.
In recent years, researchers have proposed and investigated various potential environmental risk factors for the development of MS. Vaccination is one proposed environmental risk factor, but case reports and small studies have yielded conflicting results about its association with incident MS.
To examine this question more closely, Dr. Hapfelmeier and colleagues performed a systematic retrospective analysis of ambulatory claims data held by the Bavarian Association of Statutory Health Insurance Physicians. They reviewed the data to identify patients with new-onset MS and at least two ICD-10 diagnoses of the disorder. They next identified two control cohorts of participants diagnosed with other autoimmune diseases: Crohn’s disease and psoriasis. Finally, they randomly selected a third control cohort of patients without any of these diagnoses and matched them by age, sex, and district to patients with MS in a 5:1 ratio. Eligible participants were younger than 70 years.
Dr. Hapfelmeier and colleagues reviewed the incidence and frequency of vaccinations (such as those targeting tick-borne encephalitis, human papillomavirus, and influenza virus) in all cohorts. They created unconditional logistic regression models to assess the association between vaccination and MS. They also created separate models to contrast the MS cohort with each of the control cohorts.
The researchers included 12,262 patients with MS, 19,296 patients with Crohn’s disease, 112,292 patients with psoriasis, and 79,185 participants without these autoimmune diseases in their analysis. They found 456 participants with Crohn’s disease and psoriasis, 216 participants with MS and psoriasis, 48 participants with Crohn’s disease and MS, and 2 participants with Crohn’s disease, psoriasis, and MS. Dr. Hapfelmeier and colleagues allocated these participants to each of the respective cohorts and did not analyze them differently because of the comparatively small sample sizes.
The investigators analyzed the occurrence of vaccination in all participants during the 5 years before first diagnosis. Among patients who received vaccination, the odds ratio of MS was 0.870 in participants without autoimmune disease, 0.919 in participants with Crohn’s disease, and 0.973 in participants with psoriasis. Decreased risk of MS was most notable for vaccinations against influenza and tick-borne encephalitis. The results were consistent regardless of time frame, control cohort, and definition of MS.
The subjective definition of the MS cohort was a limitation of the study, but the authors addressed it by also using several strict definitions of that cohort. Another limitation is that the source data may reflect entry errors and incorrect coding.
A grant from the German Federal Ministry of Education and Research Competence Network MS supported the study. The authors had no conflicts that were relevant to the topic of the study.
SOURCE: Hapfelmeier A et al. Neurology. 2019 Jul 30. doi: 10.1212/WNL.0000000000008012.
(MS), according to an analysis published July 30 in Neurology. Although the results suggest that vaccination is associated with a lower likelihood of incident MS within the following 5 years, “these data alone do not allow for any conclusion regarding a possible protective effect of vaccinations regarding the development of MS,” wrote Alexander Hapfelmeier, PhD, of the Technical University of Munich and colleagues.
In recent years, researchers have proposed and investigated various potential environmental risk factors for the development of MS. Vaccination is one proposed environmental risk factor, but case reports and small studies have yielded conflicting results about its association with incident MS.
To examine this question more closely, Dr. Hapfelmeier and colleagues performed a systematic retrospective analysis of ambulatory claims data held by the Bavarian Association of Statutory Health Insurance Physicians. They reviewed the data to identify patients with new-onset MS and at least two ICD-10 diagnoses of the disorder. They next identified two control cohorts of participants diagnosed with other autoimmune diseases: Crohn’s disease and psoriasis. Finally, they randomly selected a third control cohort of patients without any of these diagnoses and matched them by age, sex, and district to patients with MS in a 5:1 ratio. Eligible participants were younger than 70 years.
Dr. Hapfelmeier and colleagues reviewed the incidence and frequency of vaccinations (such as those targeting tick-borne encephalitis, human papillomavirus, and influenza virus) in all cohorts. They created unconditional logistic regression models to assess the association between vaccination and MS. They also created separate models to contrast the MS cohort with each of the control cohorts.
The researchers included 12,262 patients with MS, 19,296 patients with Crohn’s disease, 112,292 patients with psoriasis, and 79,185 participants without these autoimmune diseases in their analysis. They found 456 participants with Crohn’s disease and psoriasis, 216 participants with MS and psoriasis, 48 participants with Crohn’s disease and MS, and 2 participants with Crohn’s disease, psoriasis, and MS. Dr. Hapfelmeier and colleagues allocated these participants to each of the respective cohorts and did not analyze them differently because of the comparatively small sample sizes.
The investigators analyzed the occurrence of vaccination in all participants during the 5 years before first diagnosis. Among patients who received vaccination, the odds ratio of MS was 0.870 in participants without autoimmune disease, 0.919 in participants with Crohn’s disease, and 0.973 in participants with psoriasis. Decreased risk of MS was most notable for vaccinations against influenza and tick-borne encephalitis. The results were consistent regardless of time frame, control cohort, and definition of MS.
The subjective definition of the MS cohort was a limitation of the study, but the authors addressed it by also using several strict definitions of that cohort. Another limitation is that the source data may reflect entry errors and incorrect coding.
A grant from the German Federal Ministry of Education and Research Competence Network MS supported the study. The authors had no conflicts that were relevant to the topic of the study.
SOURCE: Hapfelmeier A et al. Neurology. 2019 Jul 30. doi: 10.1212/WNL.0000000000008012.
FROM NEUROLOGY
MS Highlights From the AAN & CMSC Annual Meetings
This supplement to Neurology Reviews compiles MS-related news briefs from the 2019 annual meetings of the American Academy of Neurology, held in Philadelphia in early May, and the Consortium of Multiple Sclerosis Centers, held in Seattle in late May.
This supplement to Neurology Reviews compiles MS-related news briefs from the 2019 annual meetings of the American Academy of Neurology, held in Philadelphia in early May, and the Consortium of Multiple Sclerosis Centers, held in Seattle in late May.
This supplement to Neurology Reviews compiles MS-related news briefs from the 2019 annual meetings of the American Academy of Neurology, held in Philadelphia in early May, and the Consortium of Multiple Sclerosis Centers, held in Seattle in late May.
Functional GI Disorders Common in MS
Key clinical point: Managing comorbid psychiatric disorders in patients with MS could reduce the burden of functional GI disorders.
Major finding: Approximately 42% of patients with MS report functional GI disorders.
Study details: A survey of 6,312 participants in the North American Research Committee on MS Registry.
Disclosures: The study had no sponsor. Dr. Marrie had no disclosures, but other researchers had financial relationships with pharmaceutical companies, such as Merck, Novartis, Roche, Sanofi-Aventis, and Teva.
Citation: Marrie RA et al. CMSC 2019, Abstract QOL13.
Key clinical point: Managing comorbid psychiatric disorders in patients with MS could reduce the burden of functional GI disorders.
Major finding: Approximately 42% of patients with MS report functional GI disorders.
Study details: A survey of 6,312 participants in the North American Research Committee on MS Registry.
Disclosures: The study had no sponsor. Dr. Marrie had no disclosures, but other researchers had financial relationships with pharmaceutical companies, such as Merck, Novartis, Roche, Sanofi-Aventis, and Teva.
Citation: Marrie RA et al. CMSC 2019, Abstract QOL13.
Key clinical point: Managing comorbid psychiatric disorders in patients with MS could reduce the burden of functional GI disorders.
Major finding: Approximately 42% of patients with MS report functional GI disorders.
Study details: A survey of 6,312 participants in the North American Research Committee on MS Registry.
Disclosures: The study had no sponsor. Dr. Marrie had no disclosures, but other researchers had financial relationships with pharmaceutical companies, such as Merck, Novartis, Roche, Sanofi-Aventis, and Teva.
Citation: Marrie RA et al. CMSC 2019, Abstract QOL13.
Age Does Not Influence Cladribine’s Efficacy in MS
Key clinical point: Patients with relapsing-remitting MS gain comparable benefits from cladribine therapy, regardless of age.
Major finding: The annual rate of qualifying relapses was 0.14 for treated patients older than 45 years and 0.15 for treated patients aged 45 or younger.
Study details: A post hoc analysis of data from the CLARITY and CLARITY extension studies, which included 870 patients.
Disclosures: Merck KGaA, which manufactures and markets cladribine, supported the study. Several of the investigators have received speaker honoraria, consulting fees, or other funding from Merck KGaA.
Citation: REPORTING FROM CMSC 2019
Key clinical point: Patients with relapsing-remitting MS gain comparable benefits from cladribine therapy, regardless of age.
Major finding: The annual rate of qualifying relapses was 0.14 for treated patients older than 45 years and 0.15 for treated patients aged 45 or younger.
Study details: A post hoc analysis of data from the CLARITY and CLARITY extension studies, which included 870 patients.
Disclosures: Merck KGaA, which manufactures and markets cladribine, supported the study. Several of the investigators have received speaker honoraria, consulting fees, or other funding from Merck KGaA.
Citation: REPORTING FROM CMSC 2019
Key clinical point: Patients with relapsing-remitting MS gain comparable benefits from cladribine therapy, regardless of age.
Major finding: The annual rate of qualifying relapses was 0.14 for treated patients older than 45 years and 0.15 for treated patients aged 45 or younger.
Study details: A post hoc analysis of data from the CLARITY and CLARITY extension studies, which included 870 patients.
Disclosures: Merck KGaA, which manufactures and markets cladribine, supported the study. Several of the investigators have received speaker honoraria, consulting fees, or other funding from Merck KGaA.
Citation: REPORTING FROM CMSC 2019
Evobrutinib Demonstrates Efficacy, Safety in Relapsing MS
Key clinical point: Treatment with evobrutinib reduced the number of enhancing lesions versus placebo in patients with relapsing multiple sclerosis, supporting further development of this Bruton’s tyrosine kinase (BTK) inhibitor.
Major finding: The cumulative number of MRI-assessed T1 Gd+ lesions from weeks 12-24 was significantly reduced versus placebo; lesion rate ratios were 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.
Study details: Forty-eight-week results of a randomized, phase 2, placebo-controlled study of 267 patients with relapsing multiple sclerosis.
Disclosures: 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.
Citation: Montalban X et al. AAN 2019. Abstract S56.004.
Key clinical point: Treatment with evobrutinib reduced the number of enhancing lesions versus placebo in patients with relapsing multiple sclerosis, supporting further development of this Bruton’s tyrosine kinase (BTK) inhibitor.
Major finding: The cumulative number of MRI-assessed T1 Gd+ lesions from weeks 12-24 was significantly reduced versus placebo; lesion rate ratios were 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.
Study details: Forty-eight-week results of a randomized, phase 2, placebo-controlled study of 267 patients with relapsing multiple sclerosis.
Disclosures: 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.
Citation: Montalban X et al. AAN 2019. Abstract S56.004.
Key clinical point: Treatment with evobrutinib reduced the number of enhancing lesions versus placebo in patients with relapsing multiple sclerosis, supporting further development of this Bruton’s tyrosine kinase (BTK) inhibitor.
Major finding: The cumulative number of MRI-assessed T1 Gd+ lesions from weeks 12-24 was significantly reduced versus placebo; lesion rate ratios were 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.
Study details: Forty-eight-week results of a randomized, phase 2, placebo-controlled study of 267 patients with relapsing multiple sclerosis.
Disclosures: 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.
Citation: Montalban X et al. AAN 2019. Abstract S56.004.
Extended-Release Arbaclofen Reduces MS-related Spasticity
Key clinical point: Twice-daily, extended-release arbaclofen effectively reduces MS-related spasticity.
Major finding: Mean change in TNmAS-MAL was −2.90 with arbaclofen and −1.95 with placebo.
Study details: A multicenter, double-blind, parallel-group study of 341 adults with MS and spasticity.
Disclosures: The study did not have funding support. Dr. Kantor reported having received consulting fees from AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech/Roche, Mylan, Novartis, Osmotica, and Sanofi Genzyme.
Citation: Kantor D et al. CMSC 2019, Abstract SXM07.
Key clinical point: Twice-daily, extended-release arbaclofen effectively reduces MS-related spasticity.
Major finding: Mean change in TNmAS-MAL was −2.90 with arbaclofen and −1.95 with placebo.
Study details: A multicenter, double-blind, parallel-group study of 341 adults with MS and spasticity.
Disclosures: The study did not have funding support. Dr. Kantor reported having received consulting fees from AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech/Roche, Mylan, Novartis, Osmotica, and Sanofi Genzyme.
Citation: Kantor D et al. CMSC 2019, Abstract SXM07.
Key clinical point: Twice-daily, extended-release arbaclofen effectively reduces MS-related spasticity.
Major finding: Mean change in TNmAS-MAL was −2.90 with arbaclofen and −1.95 with placebo.
Study details: A multicenter, double-blind, parallel-group study of 341 adults with MS and spasticity.
Disclosures: The study did not have funding support. Dr. Kantor reported having received consulting fees from AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech/Roche, Mylan, Novartis, Osmotica, and Sanofi Genzyme.
Citation: Kantor D et al. CMSC 2019, Abstract SXM07.
Three-Step Algorithm for the Management of MS Relapse
Key clinical point: Management of multiple sclerosis relapse consists of three main steps: timely and careful evaluation; treatment, if necessary; and assessment of treatment response, according to an algorithm developed by MS clinicians.
Major finding: Between 3 and 5 weeks after the initial evaluation, the group recommends clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire.
Study details: A consensus statement developed by a work group of MS clinicians based on a literature review and clinical experience.
Disclosures: The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
Citation: REPORTING FROM CMSC 2019
Key clinical point: Management of multiple sclerosis relapse consists of three main steps: timely and careful evaluation; treatment, if necessary; and assessment of treatment response, according to an algorithm developed by MS clinicians.
Major finding: Between 3 and 5 weeks after the initial evaluation, the group recommends clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire.
Study details: A consensus statement developed by a work group of MS clinicians based on a literature review and clinical experience.
Disclosures: The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
Citation: REPORTING FROM CMSC 2019
Key clinical point: Management of multiple sclerosis relapse consists of three main steps: timely and careful evaluation; treatment, if necessary; and assessment of treatment response, according to an algorithm developed by MS clinicians.
Major finding: Between 3 and 5 weeks after the initial evaluation, the group recommends clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire.
Study details: A consensus statement developed by a work group of MS clinicians based on a literature review and clinical experience.
Disclosures: The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
Citation: REPORTING FROM CMSC 2019
High-efficacy DMTs May Reduce Depressive Symptoms in MS
Key clinical point: Initial treatment with high-efficacy DMT is associated with a reduction in depressive symptoms, compared with an initial low-efficacy DMT.
Major finding: Initiation of high-efficacy DMT was associated with a reduction of 0.58 points/year in depression scores, compared with initiation of low-efficacy DMT.
Study details: An interim analysis of data for 1,501 participants in the ongoing MS PATHS study.
Disclosures: The study was not supported by outside funding. Ellen M. Mowry, MD, one of the investigators, reported having performed contracted research for Biogen, Genzyme, and Sun Pharma. Ms Youkyung and another two investigators reported disclosures or conflicts of interest.
Citation: REPORTING FROM CMSC 2019
Key clinical point: Initial treatment with high-efficacy DMT is associated with a reduction in depressive symptoms, compared with an initial low-efficacy DMT.
Major finding: Initiation of high-efficacy DMT was associated with a reduction of 0.58 points/year in depression scores, compared with initiation of low-efficacy DMT.
Study details: An interim analysis of data for 1,501 participants in the ongoing MS PATHS study.
Disclosures: The study was not supported by outside funding. Ellen M. Mowry, MD, one of the investigators, reported having performed contracted research for Biogen, Genzyme, and Sun Pharma. Ms Youkyung and another two investigators reported disclosures or conflicts of interest.
Citation: REPORTING FROM CMSC 2019
Key clinical point: Initial treatment with high-efficacy DMT is associated with a reduction in depressive symptoms, compared with an initial low-efficacy DMT.
Major finding: Initiation of high-efficacy DMT was associated with a reduction of 0.58 points/year in depression scores, compared with initiation of low-efficacy DMT.
Study details: An interim analysis of data for 1,501 participants in the ongoing MS PATHS study.
Disclosures: The study was not supported by outside funding. Ellen M. Mowry, MD, one of the investigators, reported having performed contracted research for Biogen, Genzyme, and Sun Pharma. Ms Youkyung and another two investigators reported disclosures or conflicts of interest.
Citation: REPORTING FROM CMSC 2019
Obesity tied to relapse in young patients with multiple sclerosis
, results of a recent large, single-center study show. The rate of switching to second-line disease-modifying therapy was consequently about 50% higher among the obese children in the study, which included a total of 453 pediatric patients.
The link between obesity and treatment response suggests that the management of these younger patients with MS could be improved through weight loss or body mass index (BMI)-adjusted dosing, according to Peter Huppke, MD, of Georg August University in Göttingen, Germany, and co-investigators.
“The findings do not indicate that obesity promotes greater disease activity, but pharmacokinetic factors are more likely associated with treatment response,” Dr. Huppke and co-authors said in a report on their study, which was published online ahead of print July 15 in JAMA Neurology.
This is believed to be the first-ever study to find an association between BMI and treatment response in pediatric patients with MS, according to the authors, who said they also confirmed a link between obesity and MS.
Specifically, obesity increased MS susceptibility by two-fold as compared with healthy controls, a finding that they said adds to a small but growing body of evidence that high BMI is associated with increased risk of the disease in these younger individuals.
This retrospective study included 453 pediatric patients with MS treated at the Center for MS in Childhood and Adolescence in Göttingen, Germany between 1990 and 2016. About two-thirds were female and the mean age at MS diagnosis was about 14 years.
Of those patients, 126 (27.8%) were classified as obese based on a BMI greater than the 90th percentile, according to the report.
Dr. Huppke and co-investigators found that high BMI was linked to a significantly increased odds of pediatric MS, with odds ratios of 2.19 (95% CI, 1.5-3.1; P < 0.001) in girls and 2.14 (95% CI, 1.3-3.5; P = 0.003) in boys.
A total of 277 of these pediatric patients received a first-line disease-modifying therapy for 6 months or longer, including 249 treated with interferon beta and 51 treated with glatiramer.
Relapses were more common in obese patients, according to the report. with an annualized relapse rate of 1.29, compared to just 0.72 for those who were not overweight (P < 0.001).
Consequently, likelihood of receiving a second-line treatment was about 1.5 times higher in the obese or extremely obese patients, investigators said.
“A healthy weight may potentially optimize treatment outcomes and reduce disease-related burden and health care costs,” they concluded in the report, adding that BMI-adjusted dosing may “increase the value” of first-line disease-modifying therapies.
Dr. Huppke reported disclosures related to Bayer Health Care, Merck Serono, and Novartis not associated with the current study.
SOURCE: Huppke B, et al. JAMA Neurol. 2019 Jul 15. doi: 10.1001/jamaneurol.2019.1997
, results of a recent large, single-center study show. The rate of switching to second-line disease-modifying therapy was consequently about 50% higher among the obese children in the study, which included a total of 453 pediatric patients.
The link between obesity and treatment response suggests that the management of these younger patients with MS could be improved through weight loss or body mass index (BMI)-adjusted dosing, according to Peter Huppke, MD, of Georg August University in Göttingen, Germany, and co-investigators.
“The findings do not indicate that obesity promotes greater disease activity, but pharmacokinetic factors are more likely associated with treatment response,” Dr. Huppke and co-authors said in a report on their study, which was published online ahead of print July 15 in JAMA Neurology.
This is believed to be the first-ever study to find an association between BMI and treatment response in pediatric patients with MS, according to the authors, who said they also confirmed a link between obesity and MS.
Specifically, obesity increased MS susceptibility by two-fold as compared with healthy controls, a finding that they said adds to a small but growing body of evidence that high BMI is associated with increased risk of the disease in these younger individuals.
This retrospective study included 453 pediatric patients with MS treated at the Center for MS in Childhood and Adolescence in Göttingen, Germany between 1990 and 2016. About two-thirds were female and the mean age at MS diagnosis was about 14 years.
Of those patients, 126 (27.8%) were classified as obese based on a BMI greater than the 90th percentile, according to the report.
Dr. Huppke and co-investigators found that high BMI was linked to a significantly increased odds of pediatric MS, with odds ratios of 2.19 (95% CI, 1.5-3.1; P < 0.001) in girls and 2.14 (95% CI, 1.3-3.5; P = 0.003) in boys.
A total of 277 of these pediatric patients received a first-line disease-modifying therapy for 6 months or longer, including 249 treated with interferon beta and 51 treated with glatiramer.
Relapses were more common in obese patients, according to the report. with an annualized relapse rate of 1.29, compared to just 0.72 for those who were not overweight (P < 0.001).
Consequently, likelihood of receiving a second-line treatment was about 1.5 times higher in the obese or extremely obese patients, investigators said.
“A healthy weight may potentially optimize treatment outcomes and reduce disease-related burden and health care costs,” they concluded in the report, adding that BMI-adjusted dosing may “increase the value” of first-line disease-modifying therapies.
Dr. Huppke reported disclosures related to Bayer Health Care, Merck Serono, and Novartis not associated with the current study.
SOURCE: Huppke B, et al. JAMA Neurol. 2019 Jul 15. doi: 10.1001/jamaneurol.2019.1997
, results of a recent large, single-center study show. The rate of switching to second-line disease-modifying therapy was consequently about 50% higher among the obese children in the study, which included a total of 453 pediatric patients.
The link between obesity and treatment response suggests that the management of these younger patients with MS could be improved through weight loss or body mass index (BMI)-adjusted dosing, according to Peter Huppke, MD, of Georg August University in Göttingen, Germany, and co-investigators.
“The findings do not indicate that obesity promotes greater disease activity, but pharmacokinetic factors are more likely associated with treatment response,” Dr. Huppke and co-authors said in a report on their study, which was published online ahead of print July 15 in JAMA Neurology.
This is believed to be the first-ever study to find an association between BMI and treatment response in pediatric patients with MS, according to the authors, who said they also confirmed a link between obesity and MS.
Specifically, obesity increased MS susceptibility by two-fold as compared with healthy controls, a finding that they said adds to a small but growing body of evidence that high BMI is associated with increased risk of the disease in these younger individuals.
This retrospective study included 453 pediatric patients with MS treated at the Center for MS in Childhood and Adolescence in Göttingen, Germany between 1990 and 2016. About two-thirds were female and the mean age at MS diagnosis was about 14 years.
Of those patients, 126 (27.8%) were classified as obese based on a BMI greater than the 90th percentile, according to the report.
Dr. Huppke and co-investigators found that high BMI was linked to a significantly increased odds of pediatric MS, with odds ratios of 2.19 (95% CI, 1.5-3.1; P < 0.001) in girls and 2.14 (95% CI, 1.3-3.5; P = 0.003) in boys.
A total of 277 of these pediatric patients received a first-line disease-modifying therapy for 6 months or longer, including 249 treated with interferon beta and 51 treated with glatiramer.
Relapses were more common in obese patients, according to the report. with an annualized relapse rate of 1.29, compared to just 0.72 for those who were not overweight (P < 0.001).
Consequently, likelihood of receiving a second-line treatment was about 1.5 times higher in the obese or extremely obese patients, investigators said.
“A healthy weight may potentially optimize treatment outcomes and reduce disease-related burden and health care costs,” they concluded in the report, adding that BMI-adjusted dosing may “increase the value” of first-line disease-modifying therapies.
Dr. Huppke reported disclosures related to Bayer Health Care, Merck Serono, and Novartis not associated with the current study.
SOURCE: Huppke B, et al. JAMA Neurol. 2019 Jul 15. doi: 10.1001/jamaneurol.2019.1997
FROM JAMA NEUROLOGY
Key clinical point: Obese children and adolescents with MS had about twice as many relapses on first-line treatment as compared with their non-obese counterparts.
Major finding: The annualized relapse rate was 1.29 for obese pediatric patients, compared to 0.72 for those who were not overweight (P < 0.001).
Study details: Retrospective study including 453 patients with pediatric MS treated at a center in Göttingen, Germany between 1990 and 2016.
Disclosures: The senior author reported disclosures related to Bayer Health Care, Merck Serono, and Novartis unrelated to the this study.
Source: Huppke B, et al. JAMA Neurol. 2019 Jul 15.
Interview with Mary Alissa Willis, MD, on MS and Mental Health
Mary Alissa Willis, MD, is the Medical Director for the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. We spoke with Dr. Willis about mental health issues in persons with MS and what health care facilities can do to better care for these patients.
What is the prevalence of depression in patients with MS?
Depression and anxiety are common in persons with multiple sclerosis (PwMS). In a systematic review, Ruth Ann Marrie, MD, PhD, and colleagues estimated the prevalence of depression in PwMS to be 23.7%. Approximately half of all PwMS experience depression at some point after their diagnosis.1-3 This makes depression nearly twice as common in MS as in the general population.
What are some reasons patients with MS might begin to experience depression? What are some warning signs to look out for?
Many people assume that PwMS experience depression because of psychosocial stressors, unpredictability of disease progression, or poor coping strategies. Although these factors do contribute to depression, there is increasing evidence that immune dysregulation and structural changes in the brain caused by MS disease activity make some PwMS uniquely vulnerable to depression. Functional MRI studies have shown abnormalities in the prefrontal-subcortical network connectivity, which is involved in mood regulation. In addition, persistent somatic symptoms such as severe pain and fatigue limit daily activities and social participation—generally considered to be protective factors in depression.4 Warning signs for depression include loss of interest in activities, weight loss or weight gain, changes in sleep—too much or too little, an increase in fatigue, expressions of hopelessness or guilt, or increasing drug or alcohol use.
What are some special considerations for patients with MS battling suicidal ideation?
Anthony Feinstein, MBBCh, MPhil, PhD, and colleagues reported that more than 28% of PwMS had suicidal ideation at some point.5 This is a huge number of people struggling with thoughts of suicide. Depression is a risk factor for suicide but other risks specific to PwMS include perceived loss of control, loss of job/income/social roles, loss of driving privileges, and marked physical or cognitive difficulties. While we are doing a better job screening for depression with quick screening tools such as the PHQ9, we could do better in suicide risk assessment.
What can health care providers do better to address depression and risk for suicide? What safety/preventative measures can they take?
The first step in better addressing depression and risk for suicide is to directly ask patients. Pay attention to changes in appearance, behavior, requests for prescription refills, frequency of appointments, and who accompanies patients to appointments. Explore the reasons for these changes. It is important to respond proactively when comments or behavior suggest a patient at risk. Ask specific questions about plan, access to means, previous suicide attempts, and support network. Refer promptly for emergency or mental health services when appropriate. Familiarity with mental health colleagues, local crisis centers, and helplines can be helpful in engaging a team of people to provide assistance to a patient in need.
References
1. Marrie RA, Fisk JD, Tremlett H, et al. Differences in the burden of psychiatric comorbidity in MS vs the general population. Neurology. 2015;85(22):1972-1979.
2. Minden SL, Schiffer RB. Affective disorders in multiple sclerosis. Review and recommendations for clinical research. Arch Neurol. 1990;47(1):98-104.
3. Marrie RA, Walld R, Bolton JM, et al; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Estimating annual prevalence of depression and anxiety disorder in multiple sclerosis using administrative data. BMC Res Notes. 2017;10(1):619.
4. Passamonti L. Cerasa A, Liguori M, et al. Neurobiological mechanisms underlying emotional processing in relapsing-remitting multiple sclerosis. Brain. 2009;132(pt 12):3380-3391.
5. Feinstein A. An examination of suicidal intent in patients with multiple sclerosis. Neurology. 2002;59(5):674-678.
Mary Alissa Willis, MD, is the Medical Director for the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. We spoke with Dr. Willis about mental health issues in persons with MS and what health care facilities can do to better care for these patients.
What is the prevalence of depression in patients with MS?
Depression and anxiety are common in persons with multiple sclerosis (PwMS). In a systematic review, Ruth Ann Marrie, MD, PhD, and colleagues estimated the prevalence of depression in PwMS to be 23.7%. Approximately half of all PwMS experience depression at some point after their diagnosis.1-3 This makes depression nearly twice as common in MS as in the general population.
What are some reasons patients with MS might begin to experience depression? What are some warning signs to look out for?
Many people assume that PwMS experience depression because of psychosocial stressors, unpredictability of disease progression, or poor coping strategies. Although these factors do contribute to depression, there is increasing evidence that immune dysregulation and structural changes in the brain caused by MS disease activity make some PwMS uniquely vulnerable to depression. Functional MRI studies have shown abnormalities in the prefrontal-subcortical network connectivity, which is involved in mood regulation. In addition, persistent somatic symptoms such as severe pain and fatigue limit daily activities and social participation—generally considered to be protective factors in depression.4 Warning signs for depression include loss of interest in activities, weight loss or weight gain, changes in sleep—too much or too little, an increase in fatigue, expressions of hopelessness or guilt, or increasing drug or alcohol use.
What are some special considerations for patients with MS battling suicidal ideation?
Anthony Feinstein, MBBCh, MPhil, PhD, and colleagues reported that more than 28% of PwMS had suicidal ideation at some point.5 This is a huge number of people struggling with thoughts of suicide. Depression is a risk factor for suicide but other risks specific to PwMS include perceived loss of control, loss of job/income/social roles, loss of driving privileges, and marked physical or cognitive difficulties. While we are doing a better job screening for depression with quick screening tools such as the PHQ9, we could do better in suicide risk assessment.
What can health care providers do better to address depression and risk for suicide? What safety/preventative measures can they take?
The first step in better addressing depression and risk for suicide is to directly ask patients. Pay attention to changes in appearance, behavior, requests for prescription refills, frequency of appointments, and who accompanies patients to appointments. Explore the reasons for these changes. It is important to respond proactively when comments or behavior suggest a patient at risk. Ask specific questions about plan, access to means, previous suicide attempts, and support network. Refer promptly for emergency or mental health services when appropriate. Familiarity with mental health colleagues, local crisis centers, and helplines can be helpful in engaging a team of people to provide assistance to a patient in need.
References
1. Marrie RA, Fisk JD, Tremlett H, et al. Differences in the burden of psychiatric comorbidity in MS vs the general population. Neurology. 2015;85(22):1972-1979.
2. Minden SL, Schiffer RB. Affective disorders in multiple sclerosis. Review and recommendations for clinical research. Arch Neurol. 1990;47(1):98-104.
3. Marrie RA, Walld R, Bolton JM, et al; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Estimating annual prevalence of depression and anxiety disorder in multiple sclerosis using administrative data. BMC Res Notes. 2017;10(1):619.
4. Passamonti L. Cerasa A, Liguori M, et al. Neurobiological mechanisms underlying emotional processing in relapsing-remitting multiple sclerosis. Brain. 2009;132(pt 12):3380-3391.
5. Feinstein A. An examination of suicidal intent in patients with multiple sclerosis. Neurology. 2002;59(5):674-678.
Mary Alissa Willis, MD, is the Medical Director for the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. We spoke with Dr. Willis about mental health issues in persons with MS and what health care facilities can do to better care for these patients.
What is the prevalence of depression in patients with MS?
Depression and anxiety are common in persons with multiple sclerosis (PwMS). In a systematic review, Ruth Ann Marrie, MD, PhD, and colleagues estimated the prevalence of depression in PwMS to be 23.7%. Approximately half of all PwMS experience depression at some point after their diagnosis.1-3 This makes depression nearly twice as common in MS as in the general population.
What are some reasons patients with MS might begin to experience depression? What are some warning signs to look out for?
Many people assume that PwMS experience depression because of psychosocial stressors, unpredictability of disease progression, or poor coping strategies. Although these factors do contribute to depression, there is increasing evidence that immune dysregulation and structural changes in the brain caused by MS disease activity make some PwMS uniquely vulnerable to depression. Functional MRI studies have shown abnormalities in the prefrontal-subcortical network connectivity, which is involved in mood regulation. In addition, persistent somatic symptoms such as severe pain and fatigue limit daily activities and social participation—generally considered to be protective factors in depression.4 Warning signs for depression include loss of interest in activities, weight loss or weight gain, changes in sleep—too much or too little, an increase in fatigue, expressions of hopelessness or guilt, or increasing drug or alcohol use.
What are some special considerations for patients with MS battling suicidal ideation?
Anthony Feinstein, MBBCh, MPhil, PhD, and colleagues reported that more than 28% of PwMS had suicidal ideation at some point.5 This is a huge number of people struggling with thoughts of suicide. Depression is a risk factor for suicide but other risks specific to PwMS include perceived loss of control, loss of job/income/social roles, loss of driving privileges, and marked physical or cognitive difficulties. While we are doing a better job screening for depression with quick screening tools such as the PHQ9, we could do better in suicide risk assessment.
What can health care providers do better to address depression and risk for suicide? What safety/preventative measures can they take?
The first step in better addressing depression and risk for suicide is to directly ask patients. Pay attention to changes in appearance, behavior, requests for prescription refills, frequency of appointments, and who accompanies patients to appointments. Explore the reasons for these changes. It is important to respond proactively when comments or behavior suggest a patient at risk. Ask specific questions about plan, access to means, previous suicide attempts, and support network. Refer promptly for emergency or mental health services when appropriate. Familiarity with mental health colleagues, local crisis centers, and helplines can be helpful in engaging a team of people to provide assistance to a patient in need.
References
1. Marrie RA, Fisk JD, Tremlett H, et al. Differences in the burden of psychiatric comorbidity in MS vs the general population. Neurology. 2015;85(22):1972-1979.
2. Minden SL, Schiffer RB. Affective disorders in multiple sclerosis. Review and recommendations for clinical research. Arch Neurol. 1990;47(1):98-104.
3. Marrie RA, Walld R, Bolton JM, et al; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Estimating annual prevalence of depression and anxiety disorder in multiple sclerosis using administrative data. BMC Res Notes. 2017;10(1):619.
4. Passamonti L. Cerasa A, Liguori M, et al. Neurobiological mechanisms underlying emotional processing in relapsing-remitting multiple sclerosis. Brain. 2009;132(pt 12):3380-3391.
5. Feinstein A. An examination of suicidal intent in patients with multiple sclerosis. Neurology. 2002;59(5):674-678.
