Long-term follow-up of a randomized study of combination interferon and glatiramer acetate in multiple sclerosis: Efficacy and safety results up to 7 years.

Background: To report the long-term results of the blinded extension phase of the randomized, controlled study of the combined use of interferon beta-1a (IFN) 30μg IM weekly and glatiramer acetate (GA) 20mg daily compared to each agent alone in relapsing-remitting multiple sclerosis (RRMS).

Methods: 1008 RRMS patients were followed on protocol until the last participant enrolled completed 3 years, allowing some subjects to be followed for up to 7 years. The primary endpoint was reduction in annualized relapse rate.

Streamlined EDSS for use in multiple sclerosis clinical practice: Development and cross-sectional comparison to EDSS.

Background: The Expanded Disability Status Scale (EDSS) is the standard measure of disability in multiple sclerosis clinical trials. The EDSS has limited application in the clinical setting due to required completion time and scoring complexity. Systematically recording an objective, simplified, less time-intensive, and neurologist-derived disability score would be beneficial for patient care.

Potentially Modifiable Factors Associated With Physical Activity in Individuals With Multiple Sclerosis.

Physical activity levels among persons with multiple sclerosis (MS) are worryingly low. We aimed to identify the factors associated with physical activity for people with MS, with an emphasis on factors that have not been studied previously (bladder and hand dysfunction) and are potentially modifiable. This study was a secondary analysis of data collected in the spring of 2012 during the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry.

Assessment of Caregiver Inventory for Rett Syndrome.

Rett syndrome (RTT) requires total caregiver attention and leads to potential difficulties throughout life. The Caregiver Burden Inventory, designed for Alzheimer disease, was modified to a RTT Caregiver Inventory Assessment (RTT CIA). Reliability and face, construct, and concurrent validity were assessed in caregivers of individuals with RTT.

Disability Progression After Switching from Natalizumab to Fingolimod or Interferon Beta/Glatiramer Acetate Therapies: A NARCOMS Analysis.

Physicians must weigh the benefits against the risk of progressive multifocal leukoencephalopathy (PML) in patients treated with natalizumab, especially beyond 2 years. However, disability progression associated with switching therapies versus continuing natalizumab therapy after 2 years has not been fully evaluated. In this retrospective analysis using the NARCOMS Registry, disability progression (Patient-Determined Disease Steps [PDDS] scale) and physical health-related quality of life (HRQOL) worsening (12-item Short Form Health Status Survey Physical Component Score [SF-12 PCS]) were compared between participants switching to fingolimod (n = 50) or interferon beta (IFNβ)/glatiramer acetate (GA) (n = 71) therapy and those continuing natalizumab (n = 406) after 2 years or more of treatment (median follow-up: natalizumab, 4 years; fingolimod, 4.

Health insurance affects the use of disease-modifying therapy in multiple sclerosis.

Objective: To evaluate the association between health insurance coverage and disease-modifying therapy (DMT) use for multiple sclerosis (MS).

Methods: In 2014, we surveyed participants in the North American Research Committee on MS registry regarding health insurance coverage. We investigated associations between negative insurance change and (1) the type of insurance, (2) DMT use, (3) use of free/discounted drug programs, and (4) insurance challenges using multivariable logistic regressions.

Symptomatic Management of Multiple Sclerosis-Associated Tremor Among Participants in the NARCOMS Registry.

Background: Tremor affects 25% to 58% of patients with multiple sclerosis (MS) and is associated with poor prognosis and increased disability. MS-related tremor is difficult to treat, and data regarding patient-reported characterization and response to treatment are limited. We describe the symptomatic treatment of tremor in 508 enrollees in the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry who self-reported tremor.

Relationship between symptom change, relapse activity and disability progression in multiple sclerosis.

Background: Symptom changes may serve as a risk factor for relapse activity (RA) and disability progression (DP), which could facilitate multiple sclerosis (MS) treatment decisions.

Objective: To assess the relationship of symptom change with RA and DP.

Methods: We evaluated the relationship of symptom change with subsequent RA and DP using NARCOMS registry data reported over a five-year period.

Prevalence of multiple sclerosis symptoms across lifespan: data from the NARCOMS Registry.

The North American Research Committee on Multiple Sclerosis is a voluntary patient registry with more than 38,000 registrants as of 2015. In a recent collaborative project, longitudinal data on patient-perceived impairment in 11 domains commonly affected by multiple sclerosis were examined and tabulated as a function of disease duration. The patterns of disability accumulation differed by domain.

Causes of death among persons with multiple sclerosis.

Background: Multiple Sclerosis (MS) is a leading cause of disability among young Americans. Reports suggest that life expectancy (i.e.

Impact of multiple sclerosis relapse: The NARCOMS participant perspective.

Acute relapses continue to be a significant aspect of multiple sclerosis (MS) on both the epidemiologic level and the individual patient level. Past work demonstrates residual disability from relapses as well as high patient-reported rates of ineffective relapse treatment. To better characterize the impact of MS relapses on the patient, a relapse-specific survey was administered through the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry to 1000 registry participants who had reported at least one relapse in the past 12 months.

Improvement of multiple sclerosis-associated tremor as a treatment effect of natalizumab.

Background: Tremor is among the most physically disabling symptoms associated with MS. The effect of MS disease modifying therapies (DMTs) on the severity of MS tremor is unclear.

Objective: To compare the change over time in scores reflecting tremor severity between subjects treated with natalizumab and other disease modifying drugs.

Prevalence and characteristics of tremor in the NARCOMS multiple sclerosis registry: a cross-sectional survey.

Objectives: (1)To describe the prevalence and severity of tremor in patients with multiple sclerosis (MS) registered within a large North American MS registry; (2) to provide detailed descriptions on the characteristics and severity of tremor in a subset of registrants and (3) to compare several measures of tremor severity for strength of agreement.

Setting: The North American Research Committee on MS (NARCOMS) registry.

Participants: Registrants of NARCOMS reporting mild or greater tremor severity.

Patient perspectives on switching disease-modifying therapies in the NARCOMS registry.

Introduction: The evolving landscape of disease-modifying therapies (DMTs) for multiple sclerosis raises important questions about why patients change DMTs. Physicians and patients could benefit from a better understanding of the reasons for switching therapy.

Purpose: To investigate the reasons patients switch DMTs and identify characteristics associated with the decision to switch.

Treatment discontinuation and disease progression with injectable disease-modifying therapies: findings from the north american research committee on multiple sclerosis database.

Injectable first-line disease-modifying therapies (DMTs) for multiple sclerosis (MS) are generally prescribed for continuous use. Accordingly, the various factors that influence patient persistence with treatment and that can lead some patients to switch medications or discontinue treatment may affect clinical outcomes. Using data from the North American Research Committee on Multiple Sclerosis (NARCOMS) database, this study evaluated participants' reasons for discontinuation of injectable DMTs as well as the relationship between staying on therapy and sustained patient-reported disease progression and annualized relapse rates.

Natural history of multiple sclerosis symptoms.

The North American Research Committee on Multiple Sclerosis (NARCOMS) Registry is a database that contains information from over 35,000 patient volunteers on symptom severity in 11 domains commonly affected in multiple sclerosis (MS): mobility, hand function, vision, fatigue, cognition, bowel/bladder function, sensory, spasticity, pain, depression, and tremor/coordination. The Registry affords a unique opportunity to study the frequency and severity of domain-specific impairment in a contemporary, mostly treated MS cohort over the course of the disease. The objective of this work was to calculate symptom prevalence in each of the 11 domains for years 0 to 30 from symptom onset.

Preferred sources of health information in persons with multiple sclerosis: degree of trust and information sought.

Background: Effective health communication is important for informed decision-making, yet little is known about the range of information sources used by persons with multiple sclerosis (MS), the perceived trust in those information sources, or how this might vary according to patient characteristics.

Objective: We aimed to investigate the sources of health information used by persons with MS, their preferences for the source of health information, and levels of trust in those information sources. We also aimed to evaluate how these findings varied according to participant characteristics.

Disability in multiple sclerosis: a reference for patients and clinicians.

Objective: To create a reference table of disability outcomes in multiple sclerosis (MS) that would enable patients to rank their disability relative to others' with similar disease duration and to develop a cost-effective research tool for comparing MS severity across patient populations and time periods.

Methods: The North American Research Committee on Multiple Sclerosis (NARCOMS) Registry collects disability data from patients with MS on a validated, 9-point Patient-Determined Disease Steps (PDDS) scale. We compiled the Disability Expectancy Table, which displays cumulative frequencies of PDDS scores for each year of disease duration, from 0 to 45 years.

Randomized study combining interferon and glatiramer acetate in multiple sclerosis.

Objective: A double-blind, randomized, controlled study was undertaken to determine whether combined use of interferon β-1a (IFN) 30 μg intramuscularly weekly and glatiramer acetate (GA) 20 mg daily is more efficacious than either agent alone in relapsing-remitting multiple sclerosis.

Methods: A total of 1,008 participants were randomized and followed until the last participant enrolled completed 3 years. The primary endpoint was reduction in annualized relapse rate utilizing a strict definition of relapse.

"Seeing" in NARCOMS: a look at vision-related quality of life in the NARCOMS registry.

Background: Research on vision-related quality of life (QOL) in multiple sclerosis (MS) is still limited. Tools such as the Visual Functioning Questionnaire-25 (VFQ-25) and the Vision Performance Scale (VPS) facilitate assessments of the severity of visual impairment and its impact on daily life.

Objective: The objective of this paper is to examine vision-related QOL, comorbid eye conditions, use of visual aids and utilization of eye-care providers in the North American Research Committee on Multiple Sclerosis (NARCOMS) population, and to explore these issues in those with a history of optic neuritis (ON) and diplopia.