The STAR Study: A Real-World, International, Observational Study of the Safety and Tolerability of, and Adherence to, Serum-Free Subcutaneous Interferon β-1a in Patients With Relapsing Multiple Sclerosis

Hupperts, Raymond; Ghazi-Visser, Lizette; Silva, Ana Martins; Arvanitis, Michalis; Kuusisto, Hanna; Marhardt, Kurt; Vlaikidis, Nikolaos

doi:10.1016/j.clinthera.2014.04.002

Cited by 25 publications

(18 citation statements)

References 28 publications

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“…2 In the controlled clinical trials and long-term follow-up studies for IFN β-1a SC tiw, the most commonly reported AEs were injection-site disorders. 4,5,23 While injection-site disorders are commonly reported AEs for injectable IFN β formulations in general (particularly those administered SC), our results showed low IRs for this AE.…”

Section: Irs Of Adverse Reactions Included In Postmarketing Sectionmentioning

confidence: 54%

“…[21][22][23] Such AEs included influenza-like symptoms, skin or injection problems, depression, headache, injection-site pain, fatigue, pyrexia, myalgia, transaminase level increased, pain in extremity, and liver function test abnormality. [21][22][23] One untapped source of long-term, real-world safety information on IFN β-1a SC tiw patients is that found in large health care insurer/payer claims datasets. Administrative claims datasets contain longitudinal information on patient prescription drug history, safety outcomes, and health care utilization in actual clinical care settings and the broader patient population and can be used to describe a range of AEs, despite the fact that some miscoding can occur.…”

Section: What Is Already Known About This Subjectmentioning

confidence: 99%

“…Other postmarketing studies have shown influenza-like symptoms to be a common AE associated with IFN β therapy. [21][22][23]30,31 Typically, these symptoms have been shown to abate, in terms of frequency and severity, with increased time on treatment. In particular, clinical trial results showed that 69% of patients reported influenza-like symptoms over the course of 1 to 4 years, but only 12% did so after up to 8 years of follow-up.…”

Section: Irs Of Adverse Reactions Included In Postmarketing Sectionmentioning

confidence: 99%

See 2 more Smart Citations

Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis

Smith

Sabidó-Espin²,

Trochanov³

et al. 2015

JMCP

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Section: Irs Of Adverse Reactions Included In Postmarketing Sectionmentioning

confidence: 54%

Section: What Is Already Known About This Subjectmentioning

confidence: 99%

Section: Irs Of Adverse Reactions Included In Postmarketing Sectionmentioning

confidence: 99%

See 1 more Smart Citation

Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis

Smith

Sabidó-Espin²,

Trochanov³

et al. 2015

JMCP

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“…Poor adherence is a common problem among patients with many types of chronic disease, including MS, and improvements in treatment adherence may have a larger effect on society and health than most therapeutic advances [2, 19]. Many factors that contribute to poor adherence to long-term therapy in patients with MS are recognised; [6] indeed, recent retrospective [7, 20] and prospective [19] observational studies indicate that the most common reasons to discontinue IFN-β therapy in real-world settings are adverse events (such as influenza-like symptoms, depression and injection-site reactions) and increased disease activity (including radiographic progression, relapses, and disability progression). Although in this study indices of disability progression were not reported, an association between relapses and discontinuation was observed at years 2 and 3, and the association with an increasing number of MRI scans may be an indicator of radiographic progression.…”

Section: Discussionmentioning

confidence: 99%

Reasons for discontinuation of subcutaneous interferon β-1a three times a week among patients with multiple sclerosis: a real-world cohort study

Sabidó-Espin¹,

Munschauer

2017

BMC Neurol

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BackgroundContinuation of interferon (IFN) β-based therapies is important for maximum treatment effectiveness in patients with multiple sclerosis (MS); however, few real-world data are available on discontinuation from IFN β. The aim of this cohort analysis was to estimate real-world discontinuation rates up to 3 years among MS patients in the United States taking subcutaneous (sc) IFN β-1a three times a week (tiw) and to identify whether the factors associated with discontinuation change over time.MethodsPatient data were pooled from the MarketScan© Commercial and Medicare Supplemental healthcare claims databases. Patients with ≥1 multiple sclerosis diagnosis who were sc IFN β-1a tiw naïve, had ≥1 year of continuous eligibility before treatment, and ≥1 prescription were followed from first prescription (index date) until date of discontinuation, switch, or end of observation. Treatment status was analysed at exactly 1, 2 or 3 years after index. Multivariable models were used to identify drivers of discontinuation.ResultsData from 5956 patients were included; 2862 patients (48.1%) discontinued therapy. Discontinuation rates were 36.9% (1 year), 49.5% (2 years) and 55.8% (3 years). A greater proportion of discontinuing patients had poor adherence (<80% [94.0%] versus ≥80% [51.7%]) or were taking additional medication at follow-up versus the overall population. Factors independently associated with discontinuation irrespective of time on therapy were increasing number of magnetic resonance imaging scans (1 year adjusted odds ratio 1.45, 95% confidence interval 1.26–1.67; 2 years 1.18, 1.06–1.32; 3 years 1.20, 1.07–1.34) and adherence <80% versus ≥80% (1 year 180.95, 135.84–241.03; 2 years 135.80, 100.10–184.23; 3 years 174.89, 115.27–265.38). Factors associated only with early discontinuation (at 1 year) were ≥3 sets of laboratory investigations versus none (2.54, 1.20–5.38), and anxiolytic use at follow-up (1.40, 1.06–1.82). Factors associated only with later discontinuation (at 2 years and/or at 3 years) were antidepressant use at follow-up (2 years 1.46, 1.10–1.94) and greater number of relapses (2 years 1.60, 1.11–2.30; 3 years 2.31, 1.27–4.22).ConclusionsPotential drivers of discontinuation change over time. Improved awareness of the drivers of discontinuation could lead to targeted interventions to improve adherence.Electronic supplementary materialThe online version of this article (doi:10.1186/s12883-017-0831-4) contains supplementary material, which is available to authorized users.

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“…In addition, the analysis incorporated probabilities of adherence to the IFN treatment, when combined with a PSP, that were extrapolated from the literature ( Table 1). [11][12][13][14] The following network meta-analyses were used to incorporate efficacy data into the model: Tolley et al [15] (2015), Tramacere et al [16] (2015) and Fogarty et al [17] (2016), as well as available head-to-head comparative clinical trials.…”

Section: Methodsmentioning

confidence: 99%

Cost-effectiveness of interferon therapy for multiple sclerosis in Peru: impact of treatment adherence

Bolaños-Díaz

Sanabria

Custodio

2019

Journal of Pharmaceutical Health Services Research

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Objective To analyse the cost‐effectiveness (C‐E) of interferon therapy for MS and the impact of adherence associated with a patient support programme (PSP). Methods Markov model was structured based on systematic review of the evidence and the opinion of local experts. The model has three health states: (1) Baseline treatment (BT), (2) Interferon‐β (IFN) with patient support programme (PSP) and (3) IFN without PSP. Annual cycles were considered, with a time horizon of 30 years. The analysis perspective was based on the Ministry of Health (MoH). Key findings Interferon‐β + PSP dominates the treatment of IFN without PSP. The incremental C‐E rate (ICER) for IFN + PSP was estimated at S/. 26 408 per Quality Adjusted Life Year (QALY) in relation to BT. IFN without PSP was dominated by the IFN + PSP treatment. The cost per QALY of IFN + PSP was below the payment threshold in almost 100% of the model simulations. The acceptability curves show that the treatment with PSP + IFN is probabilistically more cost effective from a payment threshold of 1.25 annual Gross Domestic Product per capita (GDP‐pc). The Tornado analysis for the ICER between IFN + PSP and BT shows that the most sensitive variables of the model are the relative risk (RR) for treatment adherence and the cost of IFN + PSP treatment. Conclusion The addition of a PSP had a significant effect on adherence and C‐E of the intervention. The ICER for IFN + PSP was below 1.5 annual GDP‐pc of payment threshold with an incremental cost near to 3 GDP‐pc. IFN without PSP was dominated by the IFN + PSP.

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The STAR Study: A Real-World, International, Observational Study of the Safety and Tolerability of, and Adherence to, Serum-Free Subcutaneous Interferon β-1a in Patients With Relapsing Multiple Sclerosis

Cited by 25 publications

References 28 publications

Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis

Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis

Reasons for discontinuation of subcutaneous interferon β-1a three times a week among patients with multiple sclerosis: a real-world cohort study

Cost-effectiveness of interferon therapy for multiple sclerosis in Peru: impact of treatment adherence

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