Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes.

Background: Data sources for MS research are numerous but rarely provide an objective measure of drug therapy compliance coupled with patient-reported health outcomes. The objective of this paper is to describe the methods and baseline characteristics of the Therapy Optimization in MS (TOP MS) study designed to investigate the relationship between disease-modifying therapy compliance and health outcomes.

Methods: TOP MS was designed as a prospective, observational, nationwide patient-focused study using an internet portal for data entry.

Retrospective US database analysis of persistence with glatiramer acetate vs. available disease-modifying therapies for multiple sclerosis: 2001-2010.

Background: Long-term persistence to treatment for chronic disease is difficult for patients to achieve, regardless of the disease or medication being used. The objective of this investigation was to examine treatment persistence with glatiramer acetate (GA) relative to available disease-modifying therapies (DMT) for multiple sclerosis (MS) over 12-, 24- and 36-month periods.

Methods: Data from Clinformatics™ for DataMart affiliated with OptumInsight was used to identify patients using DMT between 2001 and 2010.

Treatment patterns in multiple sclerosis: administrative claims analysis over 10 years.

Objective: Treatment patterns for the MS disease-modifying therapies (DMT) have changed over time. The objective of this study was to examine and describe treatment patterns in MS over a 10-year period.

Methods: MS patients who filled a DMT prescription between January 1, 2001 and December 31, 2010 were identified from Clinformatics for DataMart affiliated with OptumInsight.

Burden of a multiple sclerosis relapse: the patient's perspective.

Background: Relapses are a common feature of relapsing-remitting multiple sclerosis (RRMS) and increasing severity has been shown to be associated with higher healthcare costs, and to result in transient increases in disability. Increasing disability likely impacts work and leisure productivity, and lowers quality of life.

Objective: The objective of this study was to characterize from the patient's perspective the impact of a multiple sclerosis (MS) relapse in terms of the economic cost, work and leisure productivity, functional ability, and health-related quality of life (HR-QOL), for a sample of patients with RRMS in the US treated with immunomodulatory agents.

A multicenter study of the predictors of adherence to self-injected glatiramer acetate for treatment of relapsing-remitting multiple sclerosis.

Treatment with disease-modifying immunomodulators is recommended for patients with relapsing-remitting MS (RRMS). However, continuous adherence to treatment with these injected therapies can be challenging. The main objective was to examine the predictors of adherence to glatiramer acetate using a study model derived from Prochaska's transtheoretical model of change.

Medical chart validation of an algorithm for identifying multiple sclerosis relapse in healthcare claims.

Objective: Relapse is a common measure of disease activity in relapsing-remitting multiple sclerosis (MS). The objective of this study was to test the content validity of an operational algorithm for detecting relapse in claims data.

Methods: A claims-based relapse detection algorithm was tested by comparing its detection rate over a 1-year period with relapses identified based on medical chart review.

Glatiramer acetate and interferon beta-1a for intramuscular administration: a study of outcomes among multiple sclerosis intent-to-treat and persistent-use cohorts.

Objective: To study outcomes of multiple sclerosis (MS) patients treated with either glatiramer acetate (Copaxone) or interferon beta-1a for once-weekly, intramuscular administration (Avonex).

Methods: An 'intent-to-treat' (ITT) cohort (n=1282) was established, consisting of patients diagnosed with MS who began therapy on either glatiramer acetate (GA) or intramuscular interferon beta-1a (IFN beta-1a-IM) and had continuous insurance coverage from 6 months before to 24 months after the date when they began taking the medication. A 'persistent use' (PU) cohort (n=639) was also constructed, consisting of individuals who, in addition to the criteria listed above, had a claim for GA or IFN beta-1a-IM within 28 days of the end of the 2-year post-period.

Effect of oral antihistamine on local injection site reactions with self-administered glatiramer acetate.

Patients with multiple sclerosis often use injectable medication such as glatiramer acetate or interferons to treat their disease. Subcutaneous injections may be associated with local injection site reactions (LISRs), which can include itching, pain, swelling, or redness. Although not serious, these side effects are bothersome and can have a negative impact on adherence to the therapeutic regimen, particularly in early phases of treatment.

Cost effectiveness of glatiramer acetate and natalizumab in relapsing-remitting multiple sclerosis.

Background: Disease-modifying drugs are a significant expenditure for treating multiple sclerosis. Natalizumab (NZ) has been shown to be effective in reducing relapses and disease progression. However, assessment of the cost effectiveness of NZ compared with other disease-modifying drugs in the presence of long-term data has been limited.

Glatiramer acetate and interferon beta-1b: a study of outcomes among patients with multiple sclerosis.

Introduction: To study the medical cost and probability of relapse in patients with multiple sclerosis (MS) treated with either glatiramer acetate (GA) or interferon beta-1b (IFN beta.1b).

Methods: Data were obtained from the i3 InVision Data Mart Database from July 2001 to June 2006.

Fatigue characteristics in multiple sclerosis: the North American Research Committee on Multiple Sclerosis (NARCOMS) survey.

Background: Fatigue is a common disabling symptom of multiple sclerosis (MS) and has a significantly negative impact on quality of life. Persons with MS enrolled in the North American Research Committee on Multiple Sclerosis (NARCOMS) Patient Registry are invited to complete follow-up surveys every six months to update their original registration information. One of these surveys was designed to focus on the severity and impact of fatigue, and its association with other clinical parameters of MS such as physical disability.

Impact of co-prescribed glatiramer acetate and antihistamine therapy on the likelihood of relapse among patients with multiple sclerosis.

We conducted a retrospective database study to examine the risk of relapse among patients with multiple sclerosis (MS) who were simultaneously prescribed glatiramer acetate (GA) and antihistamine (AH) therapy. Medical and pharmacy claims data were culled from the PharMetrics Patient-Centric Database from January 1997 to March 2004. GA users were identified and followed until discontinuation or end of health-plan enrollment.

Impact of warm compresses on local injection-site reactions with self-administered glatiramer acetate.

Patients with multiple sclerosis (MS) report a number of adverse events related to immunomodulator injections, including local injection-site reactions (LISRs). Reactions characterized by pain, swelling, redness, or inflammation have been experienced by patients who self-inject glatiramer acetate, interferon beta-1b, or interferon beta-1a. Although these reactions rarely are serious, they can foster negative attitudes about self-injection and undermine a patient's commitment to treatment, especially in the early stages of therapy.

Glatiramer acetate versus interferon beta-1a for subcutaneous administration: comparison of outcomes among multiple sclerosis patients.

Introduction: We compared the outcomes of multiple sclerosis (MS) patients treated with either glatiramer acetate (GA) (Copaxone, Teva Pharmaceutical Industries, Israel) or interferon beta-1a for subcutaneous administration (IFN beta-1a-SC) (Rebif, Merck Serono, Switzerland).

Methods: Data were obtained from i3's Lab Rx Database from July 2001 to June 2006. We established an 'intent-to-treat' (ITT) cohort (n=845) of patients diagnosed with MS who began therapy on either GA (n=542) or IFN beta-1a-SC (n=303) and had continuous insurance coverage from 6 months before to 24 months after the date they began taking the medication.

Cost-effectiveness of four immunomodulatory therapies for relapsing-remitting multiple sclerosis: a Markov model based on long-term clinical data.

Background: Before the introduction of the immunomodulatory therapies for multiple sclerosis (MS), treatment options for MS consisted of symptomatic management (physical therapy and pharmacological treatment for symptom management). Symptomatic management for MS has been supplemented in the past decade by 2 new classes of immunomodulatory therapies that have been approved as first-line treatments for relapsing-remitting multiple sclerosis (RRMS): subcutaneous glatiramer acetate (SC GA) and 3 beta-interferons: intramuscular interferon beta-1a (IM IFNbeta-1a), SC IFNbeta-1a, and SC IFNbeta-1b.

Objective: To estimate the economic outcomes of 5 treatment strategies: symptom management alone, symptom management combined with SC GA, IM IFNbeta1-a, SC IFNbeta1-a, or SC IFNbeta1-b in patients diagnosed with RRMS.

Clinical and economic impact of glatiramer acetate versus beta interferon therapy among patients with multiple sclerosis in a managed care population.

Objective: To examine the outcomes of use of glatiramer acetate (GA) versus beta interferons-1a (intramuscular) (1A) and -1b (1B) in patients with multiple sclerosis (MS) in a managed care setting.

Methods: Data were obtained from a national retrospective claims database from January 1996 to June 2001. Patients were followed from the first prescription for immunomodulatory therapy until plan disenrollment or end of study time frame.