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

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          Abstract

          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. Patients with 12, 24, and 36 months of follow-up were included. Persistence was defined as continuous use of the same DMT for the duration of follow-up regardless of treatment gaps. Regimen changes including re-initiation of therapy following gaps of 15 days or more, switching therapy, and DMT discontinuation were investigated. Descriptive statistics were used to summarize the results.

          Results

          Cohorts of GA users with 12 months (n = 12,144), 24 months (n = 7,386) and 36 months (n = 4,693) of follow-up were identified. Persistence rates with GA were 80% for all time periods; discontinuation rates declined over time while switching increased modestly. In contrast, the full DMT-treated cohorts showed persistent rates of 68.3% at 12 months (n = 35,312), 53.9% at 24 months (n = 21,927), and 70.1% at 36 months (n = 14,343). As with these full DMT-treated cohorts, the proportion of GA users remaining on their initial therapy without a gap of 15 days or more decreased with length of follow-up. However, the proportion of GA users with a gap in treatment who re-initiated GA increased over time (64.4% at 12 months; 75.1% at 24 months, and 80.1% at 36 months) while those in the full DMT-treated cohorts re-initiated therapy at rates of only 50-60%.

          Conclusions

          Persistence rates for GA were 80% for the 12-, 24- and 36-month time periods in contrast with the full DMT-treated cohorts whose persistence rates never exceeded 70.0%. Although there were more gaps in therapy of 15 days or more with all DMT over time, the proportion of GA users re-initiating therapy increased with follow-up contributing to the steady persistence. Therapy persistence is essential to achieve the desired outcomes in MS.

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          Most cited references21

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          Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.

          (1993)
          We report a multicenter, randomized, double-blind, placebo-controlled trial of interferon beta-1b (IFNB) in 372 ambulatory patients with relapsing-remitting multiple sclerosis (MS). Entry criteria included an Expanded Disability Status Scale (EDSS) score of 0 to 5.5 and at least two exacerbations in the previous 2 years. One-third of the patients received placebo, one-third 1.6 million international units (MIU) of IFNB, and one-third 8 MIU of IFNB, self-administered by subcutaneous injections every other day. The primary end points were differences in exacerbation rates and proportion of patients remaining exacerbation-free. The annual exacerbation rate for patients receiving placebo was 1.27; for 1.6 MIU IFNB, 1.17; and for 8 MIU IFNB, 0.84 after 2 years. Exacerbation rates were significantly lower in both treatment groups compared with the placebo group (8 MIU versus placebo, p = 0.0001; 1.6 MIU versus placebo, p = 0.0101; and 8 MIU versus 1.6 MIU, p = 0.0086), suggesting a dosage effect. The reduction in exacerbation severity in the 8 MIU group was attributable to a twofold reduction in the frequency of moderate and severe attacks. More patients in the 8 MIU group (n = 36) were exacerbation-free at 2 years compared with the placebo group (n = 18; p = 0.007). EDSS scores changed little from baseline in both the placebo and treatment arms. Accordingly, a significant change in disability could not be discerned in this trial. Finally, in serial MRIs, MS activity was significantly less in the high-dose IFNB group.(ABSTRACT TRUNCATED AT 250 WORDS)
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            Factors that influence adherence with disease-modifying therapy in MS.

            The complexity and cost of injection treatment can represent a formidable challenge for patients affected by a chronic illness, particularly those whose treatment is primarily preventative and only modestly effective on the more conspicuous symptomatic aspects of the disease process. The aim of this investigation was to identify which factors most influenced nonadherent behavior with the available disease-modifying injection therapies for multiple sclerosis (MS). A multicenter, observational (three-wave) study using surveys was developed and administered to patients with MS through the World Wide Web. Healthcare providers at 17 neurology clinics recruited patients for the study. A total of 798 patients responded to the baseline wave of the study (708 responded to all three waves). The nonadherence rates for all patients (missing one or more injections) across these waves remained relatively stable at 39%, 37%, and 36%, respectively. The most common reason participants listed for missing injections was that they simply forgot to administer the medication (58%). Other factors including injection-site reactions, quality of life, patients' perceptions on the injectable medications, hope, depression, and support were also assessed in relation to adherence. This study characterizes factors that are associated with failure to fully adhere with disease modifying injection therapy for MS and underscores the principles associated with optimizing adherence and its implications for effective treatment of the disease process in MS.
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              Incidence and prevalence of multiple sclerosis in Olmsted County, Minnesota, 1985-2000.

              Epidemiologic data for multiple sclerosis (MS) in Olmsted County, MN, have been recorded for almost 100 years and have indicated that the increasing prevalence rate was likely due in part to an increasing incidence rate. All cases of MS diagnosed from 1985 to 2000 were identified using the centralized diagnostic index at the Mayo Clinic and the Rochester Epidemiology Program Project, a shared database of all medical practitioners in the county. Patients were required to have established residency at least 1 year prior to diagnosis of MS. Results were also age- and sex-adjusted to control for shifts in the population structure. The raw prevalence of MS was determined to be 177 per 100,000 on December 1, 2000, and the raw incidence rate was 7.5 per 100,000 person-years at risk from 1985 to 2000. After age and sex adjustment to a common population, these prevalence and incidence rates of MS appear to have been stable rather than increasing over the past 20 years.
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                Author and article information

                Journal
                BMC Neurol
                BMC Neurol
                BMC Neurology
                BioMed Central
                1471-2377
                2014
                14 January 2014
                : 14
                : 11
                Affiliations
                [1 ]Outcomes Scribe, LLC, 664 Wynding Oaks, Kalamazoo, MI 49006, USA
                [2 ]Formerly, Health Economics and Outcomes Research, Teva Pharmaceuticals, 901 E. 104th Street, Suite 900, Kansas City, MO 64131, USA
                [3 ]OptumInsight Life Sciences, 13625 Technology Drive, Eden Prairie, MN 55344, USA
                Article
                1471-2377-14-11
                10.1186/1471-2377-14-11
                3897905
                24423119
                bc8e3824-110e-4355-8345-1779f962815d
                Copyright © 2014 Oleen-Burkey et al.; licensee BioMed Central Ltd.

                This is an open access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 August 2013
                : 9 January 2014
                Categories
                Research Article

                Neurology
                treatment gaps,therapy discontinuation,disease-modifying therapy,multiple sclerosis,therapy re-initiaton,persistence,therapy switching

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