Final analysis of 379 pregnancy outcomes after exposure to dimethyl fumarate in a prospective international registry.

Background: Dimethyl fumarate (DMF) has a favorable benefit-risk profile treating people with multiple sclerosis and should be used in pregnant women only if the potential benefits outweigh potential risks to the fetus.

Objective: Assess pregnancy outcomes in a completed international registry (TecGistry) of women with MS exposed to DMF.

Methods: TecGistry included pregnant women with MS exposed to DMF, with data collected at enrollment, 6-7 months gestation, 4 weeks after estimated due date, and at postpartum weeks 4, 12, and 52.

Family planning considerations in people with multiple sclerosis.

Multiple sclerosis is often diagnosed in patients who are planning on having children. Although multiple sclerosis does not negatively influence most pregnancy outcomes, less is known regarding the effects of fetal exposure to novel disease-modifying therapies (DMTs). The withdrawal of some DMTs during pregnancy can modify the natural history of multiple sclerosis, resulting in a substantial risk of pregnancy-related relapse and disability.

Estimating the association between physical activity and health-related quality of life in individuals with multiple sclerosis.

Background: Higher levels of total physical activity (PA) are associated with better health-related quality of life (HRQOL) in individuals with multiple sclerosis (MS). The benefits of PA across the activity continuum have not been well-studied. The goal of this study was to compare the associations between total PA, strenuous PA, moderate PA, and mild PA and HRQOL in a large cohort of individuals with MS using both generic and neurologic disease-specific questionnaires.

Demand with low supply: A pipeline for personalized integrative medicine in multiple sclerosis.

Timely personalized medicine is an unmet, critical need in multiple sclerosis (MS). A major barrier to providing individualized care is the lack of information on which interventions are most appropriate for whom. In this viewpoint, we submit a rationale and three-step roadmap to personalized integrative medicine.

Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry.

Background And Objectives: Oral delayed-release dimethyl fumarate (DMF) is not recommended during pregnancy and should only be used if the potential benefit justifies the potential fetal risk. Although DMF was well tolerated in clinical trials with consistent safety results in postmarketing surveillance, data are limited in pregnant women. The objective was to provide pregnancy outcomes and DMF exposure information from an interim analysis from a prospective, international registry (TecGistry; NCT01911767).

Patient-reported outcomes associated with transition to secondary progressive multiple sclerosis.

Purpose: To investigate patient-reported outcome (PRO) measures in patients with relapsing-remitting multiple sclerosis (RRMS) who transition to secondary progressive multiple sclerosis (SPMS).

Methods: Subjects enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at Brigham and Women's Hospital (CLIMB) who completed PRO measures in the RRMS and SPMS phases were identified (n = 52). The PRO measures were Medical Outcomes Study Short-Form 36 Health Survey (SF-36), the Modified Fatigue Impact Scale (MFIS), and the Center for Epidemiologic Studies Depression Scale (CESD).

Risk factors for peripartum depression in women with multiple sclerosis.

Background: Peripartum depression (PPD) is underexplored in multiple sclerosis (MS).

Objective: To evaluate prevalence of and risk factors for PPD in women with MS.

Methods: Retrospective single-center analysis of women with MS with a live birth.

Teriflunomide Safety and Efficacy in Advanced Progressive Multiple Sclerosis.

Objectives: To explore the safety and efficacy profile of teriflunomide in progressive multiple sclerosis.

Methods: We conducted a single-center retrospective observational analysis of a progressive multiple sclerosis population, assessing safety and efficacy in patients treated at least one year with teriflunomide or glatiramer acetate. Sustained progression of expanded disability status scale and sustained worsening of timed 25-foot walk were compared using a Cox proportional hazards model.

Improved relapse recovery in paediatric compared to adult multiple sclerosis.

Incomplete relapse recovery contributes to disability accrual and earlier onset of secondary progressive multiple sclerosis. We sought to investigate the effect of age on relapse recovery. We identified patients with multiple sclerosis from two longitudinal prospective studies, with an Expanded Disability Status Scale (EDSS) score within 30 days after onset of an attack, and follow-up EDSS 6 months after attack.

Regional microglial activation in the substantia nigra is linked with fatigue in MS.

Objective: The goal of our study is to assess the role of microglial activation in MS-associated fatigue (MSAF) using [F-18]PBR06-PET.

Methods: Fatigue severity was measured using the Modified Fatigue Impact Scale (MFIS) in 12 subjects with MS (7 relapsing-remitting and 5 secondary progressive) and 10 healthy control participants who underwent [F-18]PBR06-PET. The MFIS provides a total fatigue score as well as physical, cognitive, and psychosocial fatigue subscale scores.

A possible case of serum sickness after ocrelizumab infusion.

A 41-year-old female diagnosed with multiple sclerosis began ocrelizumab treatment. She received her first treatment course without significant complication. After receiving the first maintenance dose 6 months later, she developed weakness, myalgias, gastrointestinal symptoms, headache, and intermittent fever persisting for 4 weeks.

Comparison of health-related quality of life across treatment groups in individuals with multiple sclerosis.

Background: Outcome measures typically used to evaluate disease modifying therapies (DMTs) provide important information regarding their effects on disease activity, but they do not capture the full impact of living with multiple sclerosis (MS). Patient reported outcome measures (PROs) are increasingly being used to capture an individual's subjective experience of disease. We compared DMTs across a wide range of PRO outcomes in individuals with MS.

An argument for broad use of high efficacy treatments in early multiple sclerosis.

Two different treatment paradigms are most often used in multiple sclerosis (MS). An escalation or induction approach is considered when treating a patient early in the disease course. An escalator prioritizes safety, whereas an inducer would favor efficacy.

Gray matter microglial activation in relapsing vs progressive MS: A [F-18]PBR06-PET study.

Objective: To determine the value of [F-18]PBR06-PET for assessment of microglial activation in the cerebral gray matter in patients with MS.

Methods: Twelve patients with MS (7 relapsing-remitting and 5 secondary progressive [SP]) and 5 healthy controls (HCs) had standardized uptake value (SUV) PET maps coregistered to 3T MRI and segmented into cortical and subcortical gray matter regions. SUV ratios (SUVRs) were global brain normalized.

The impact of cervical spinal cord atrophy on quality of life in multiple sclerosis.

Background: Spinal cord demyelination is common in multiple sclerosis (MS) and has been linked to increased disability and progressive clinical course. Spinal cord atrophy shows an especially close relationship to MS-related physical disability, though the relationship between spinal cord lesions/atrophy and health-related quality of life (QOL) has not been explored.

Methods: 62 patients (53 relapsing MS, 7 secondary progressive, 2 clinically isolated syndrome) from our center underwent 3 T MRI within 30 days of clinical examination and QOL assessment.

Food allergies are associated with increased disease activity in multiple sclerosis.

Objective: The association between allergy and multiple sclerosis (MS) is still unclear. In our study, we assessed the association between a self-reported history of allergic conditions with MS clinical and MRI disease activity.

Methods: A subset of 1349 patients enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women's Hospital (CLIMB) study completed a self-administered questionnaire on environmental, food and drug allergies.

Pregnancy rates and outcomes in women with and without MS in the United States.

Objective: To compare pregnancy prevalence and complications in women with and without multiple sclerosis (MS).

Methods: This retrospective US administrative claims study used data from January 1, 2006, to June 30, 2015. All data for women with MS were included.

Relapses and disease-modifying drug treatment in pregnancy and live birth in US women with MS.

Objective: To evaluate relapse rates and disease-modifying drug (DMD) treatment in US women with multiple sclerosis (MS) and a live birth.

Methods: This retrospective administrative claims database study used US commercial health plan data from women with MS and a live birth from January 1, 2006, to June 30, 2015. Relapses and DMD treatment were evaluated 1-year prepregnancy, during pregnancy, during puerperium (6 weeks postpregnancy), and 1-year postpregnancy.

Brain and spinal cord MRI lesions in primary progressive vs. relapsing-remitting multiple sclerosis.

Background: Primary progressive (PP) multiple sclerosis (MS) is considered a clinically distinct entity from the spectrum of relapsing-remitting (RR) forms of the disease.

Objective: To compare the presence of brain and spinal cord lesions between PP and RR subjects.

Methods: We studied people with PPMS [ = 40, 17 (42.

A case for gender-based approach to multiple sclerosis therapeutics.

Despite established sex differences in multiple sclerosis (MS) risk and course, sex-specific efficacy and toxicity of existing MS therapies, and possible sex-specific therapeutic approaches, remain underexplored. We systematically reviewed published sex differences from Phase III pivotal trials for FDA or EMA-approved MS disease modifying therapies (DMTs), along with additional information from pharmaceutical companies, for pre-specified or post-hoc baseline characteristics, efficacy and safety outcomes by sex, and sex-specific concerns. Then, we reviewed trials testing hormonal therapies in MS.

Quantitative MRI analysis of cerebral lesions and atrophy in post-partum patients with multiple sclerosis.

Objective: To assess the change in cerebral lesions and atrophy associated with pregnancy in patients with multiple sclerosis (MS).

Background: Multiple sclerosis often affects women of reproductive age. Disease stabilization typically occurs during pregnancy, with transient recrudescence post-partum.

Whole-brain atrophy assessed by proportional- versus registration-based pipelines from 3T MRI in multiple sclerosis.

Background And Purpose: Whole-brain atrophy is a standard outcome measure in multiple sclerosis (MS) clinical trials as assessed by various software tools. The effect of processing method on the validity of such data obtained from high-resolution 3T MRI is not known. We compared two commonly used methods of quantifying whole-brain atrophy.