Literature Monitor

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.

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

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.

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.

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

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

Key clinical point: Ibudilast’s treatment effect in a phase 2 trial for progressive multiple sclerosis (MS) primarily was driven by patients with primary progressive MS.

Major finding: The rate of brain atrophy for untreated patients with primary progressive MS was about twice as fast as that for those with secondary progressive MS.

Study details: The randomized, placebo-controlled phase 2 SPRINT-MS trial of ibudilast included 134 patients with primary progressive MS and 121 with secondary progressive MS.

Disclosures: The SPRINT-MS trial was funded by the National Institute of Neurological Disorders and Stroke. The National Multiple Sclerosis Society and MediciNova also supported the study. Dr. Goodman reported receiving research support from pharmaceutical companies, as well as personal compensation from companies for consulting, serving on a scientific advisory board, and speaking.

Citation: Goodman A et al. AAN 2019, Abstract S12.007.

Key clinical point: Ibudilast’s treatment effect in a phase 2 trial for progressive multiple sclerosis (MS) primarily was driven by patients with primary progressive MS.

Major finding: The rate of brain atrophy for untreated patients with primary progressive MS was about twice as fast as that for those with secondary progressive MS.

Study details: The randomized, placebo-controlled phase 2 SPRINT-MS trial of ibudilast included 134 patients with primary progressive MS and 121 with secondary progressive MS.

Disclosures: The SPRINT-MS trial was funded by the National Institute of Neurological Disorders and Stroke. The National Multiple Sclerosis Society and MediciNova also supported the study. Dr. Goodman reported receiving research support from pharmaceutical companies, as well as personal compensation from companies for consulting, serving on a scientific advisory board, and speaking.

Citation: Goodman A et al. AAN 2019, Abstract S12.007.

Key clinical point: Ibudilast’s treatment effect in a phase 2 trial for progressive multiple sclerosis (MS) primarily was driven by patients with primary progressive MS.

Major finding: The rate of brain atrophy for untreated patients with primary progressive MS was about twice as fast as that for those with secondary progressive MS.

Study details: The randomized, placebo-controlled phase 2 SPRINT-MS trial of ibudilast included 134 patients with primary progressive MS and 121 with secondary progressive MS.

Disclosures: The SPRINT-MS trial was funded by the National Institute of Neurological Disorders and Stroke. The National Multiple Sclerosis Society and MediciNova also supported the study. Dr. Goodman reported receiving research support from pharmaceutical companies, as well as personal compensation from companies for consulting, serving on a scientific advisory board, and speaking.

Citation: Goodman A et al. AAN 2019, Abstract S12.007.

Key clinical point: Treatment with eculizumab substantially reduced risk of relapse versus placebo in patients with aquaporin-4 positive neuromyelitis optica spectrum disorder.

Major finding: Time to first adjudicated relapse on trial, the primary endpoint of the study, showed a significant (P less than .0001) effect in favor of monoclonal antibody treatment over placebo, with a 94.2% reduction in risk of relapse.

Study details: A phase 3, randomized, double-blind, placebo-controlled, multicenter trial (PREVENT) including 143 adult patients.

Disclosures: The study was supported by Alexion Pharmaceuticals. Dr. Pittock provided disclosures related to Alexion Pharmaceuticals, MedImmune, and Grifols, along with patents related to administration of eculizumab and cancer markers in neuromyelitis optica.

Citation: Pittock SJ et al. AAN 2019, Emerging Science Abstract 009.

Key clinical point: Treatment with eculizumab substantially reduced risk of relapse versus placebo in patients with aquaporin-4 positive neuromyelitis optica spectrum disorder.

Major finding: Time to first adjudicated relapse on trial, the primary endpoint of the study, showed a significant (P less than .0001) effect in favor of monoclonal antibody treatment over placebo, with a 94.2% reduction in risk of relapse.

Study details: A phase 3, randomized, double-blind, placebo-controlled, multicenter trial (PREVENT) including 143 adult patients.

Disclosures: The study was supported by Alexion Pharmaceuticals. Dr. Pittock provided disclosures related to Alexion Pharmaceuticals, MedImmune, and Grifols, along with patents related to administration of eculizumab and cancer markers in neuromyelitis optica.

Citation: Pittock SJ et al. AAN 2019, Emerging Science Abstract 009.

Key clinical point: Treatment with eculizumab substantially reduced risk of relapse versus placebo in patients with aquaporin-4 positive neuromyelitis optica spectrum disorder.

Major finding: Time to first adjudicated relapse on trial, the primary endpoint of the study, showed a significant (P less than .0001) effect in favor of monoclonal antibody treatment over placebo, with a 94.2% reduction in risk of relapse.

Study details: A phase 3, randomized, double-blind, placebo-controlled, multicenter trial (PREVENT) including 143 adult patients.

Disclosures: The study was supported by Alexion Pharmaceuticals. Dr. Pittock provided disclosures related to Alexion Pharmaceuticals, MedImmune, and Grifols, along with patents related to administration of eculizumab and cancer markers in neuromyelitis optica.

Citation: Pittock SJ et al. AAN 2019, Emerging Science Abstract 009.

Key clinical point: Physicians face considerable uncertainty regarding how to treat pediatric patients with MS.

Major finding: About 65% of pediatric patients with multiple sclerosis do not receive disease-modifying therapy within 1 year of diagnosis.

Study details: Retrospective, observational study of claims data from 288 patients with pediatric MS.

Disclosures: Novartis funded the study, and Dr. Deshpande, who presented the findings, and a coauthor are employees of Novartis. Other coauthors reported consulting fees from Novartis, as well as consulting fees and grant funding from other pharmaceutical companies.

Citation: Greenberg B et al. CMSC 2019, Abstract DXM02.

Key clinical point: Physicians face considerable uncertainty regarding how to treat pediatric patients with MS.

Major finding: About 65% of pediatric patients with multiple sclerosis do not receive disease-modifying therapy within 1 year of diagnosis.

Study details: Retrospective, observational study of claims data from 288 patients with pediatric MS.

Disclosures: Novartis funded the study, and Dr. Deshpande, who presented the findings, and a coauthor are employees of Novartis. Other coauthors reported consulting fees from Novartis, as well as consulting fees and grant funding from other pharmaceutical companies.

Citation: Greenberg B et al. CMSC 2019, Abstract DXM02.

Key clinical point: Physicians face considerable uncertainty regarding how to treat pediatric patients with MS.

Major finding: About 65% of pediatric patients with multiple sclerosis do not receive disease-modifying therapy within 1 year of diagnosis.

Study details: Retrospective, observational study of claims data from 288 patients with pediatric MS.

Disclosures: Novartis funded the study, and Dr. Deshpande, who presented the findings, and a coauthor are employees of Novartis. Other coauthors reported consulting fees from Novartis, as well as consulting fees and grant funding from other pharmaceutical companies.

Citation: Greenberg B et al. CMSC 2019, Abstract DXM02.

Key clinical point: Providers should consider screening for hazardous cannabis use, especially if patients report depression, anxiety, or difficulty sleeping.

Major finding: Patients with MS who are depressed, anxious, or have poor sleep may be more likely to misuse or abuse cannabis.

Study details: 100 patients with a confirmed MS diagnosis who were receiving outpatient care in a university-affiliated MS center.

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

Citation: REPORTING FROM CMSC 2019

Key clinical point: Providers should consider screening for hazardous cannabis use, especially if patients report depression, anxiety, or difficulty sleeping.

Major finding: Patients with MS who are depressed, anxious, or have poor sleep may be more likely to misuse or abuse cannabis.

Study details: 100 patients with a confirmed MS diagnosis who were receiving outpatient care in a university-affiliated MS center.

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

Citation: REPORTING FROM CMSC 2019

Key clinical point: Providers should consider screening for hazardous cannabis use, especially if patients report depression, anxiety, or difficulty sleeping.

Major finding: Patients with MS who are depressed, anxious, or have poor sleep may be more likely to misuse or abuse cannabis.

Study details: 100 patients with a confirmed MS diagnosis who were receiving outpatient care in a university-affiliated MS center.

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

Citation: REPORTING FROM CMSC 2019