Effect of disease-modifying therapies on brain volume in relapsing–remitting multiple sclerosis: Results of a five-year brain MRI study

Khan, Omar; Bao, Fen; Shah, Megha; Caon, Christina; Tselis, Alexandros; Bailey, R.A.; Silverman, Bruce; Zak, Imad

doi:10.1016/j.jns.2011.08.034

Cited by 38 publications

(42 citation statements)

References 34 publications

(43 reference statements)

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“…In one study, BV loss occurring during the first 6 years of therapy moderately correlated with EDSS worsening during the same time period; however, the authors did not find any early MRI variable that could predict disability progression over time [40]. More recent open-label studies did include a control group consisting of RRMS patients who decided not to start any treatment [42][43][44]. Despite the limitations of open-label studies, all injectable DMDs were shown to reduce global BV loss [42][43][44] and grey matter (GM) atrophy [42,43] as compared to patients who did not receive any treatment.…”

Section: Effect Of Therapies On Bv: Open-label Observational Studies mentioning

confidence: 99%

“…More recent open-label studies did include a control group consisting of RRMS patients who decided not to start any treatment [42][43][44]. Despite the limitations of open-label studies, all injectable DMDs were shown to reduce global BV loss [42][43][44] and grey matter (GM) atrophy [42,43] as compared to patients who did not receive any treatment. Whereas one of the studies seemed to favour IFN-b treatment on preventing GM pathology (specially development of new cortical lesions) [43], another study showed a larger effect of GA on reducing global BV [44].…”

Section: Effect Of Therapies On Bv: Open-label Observational Studies mentioning

confidence: 99%

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Treating relapsing–remitting multiple sclerosis: therapy effects on brain atrophy

2015

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Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system with a complex and heterogeneous pathology that may ultimately lead to neurodegeneration and brain atrophy. Brain volume loss in MS is known to occur early in the disease course and to be clinically relevant, as it has been related to disability progression. Nowadays, brain volume loss is relatively easy to measure with different automated, reproducible and accurate software tools. Therefore, most of (if not all) the newest clinical trials have incorporated brain volume outcomes as a measure of treatment effect. With this review, we aimed to update and summarize all existing data regarding brain volume and RRMS treatment in clinical trials as well as in open-label observational studies of drugs with positive results in its primary outcome in at least one phase III trial as of March 2014.

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Section: Effect Of Therapies On Bv: Open-label Observational Studies mentioning

confidence: 99%

Section: Effect Of Therapies On Bv: Open-label Observational Studies mentioning

confidence: 99%

Treating relapsing–remitting multiple sclerosis: therapy effects on brain atrophy

2015

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“…A 5-year brain MRI retrospective open study provides some evidence of the efficacy of GA in reducing brain volume loss [74]: smaller reductions in brain volume were observed in patients with RRMS treated with subcutaneous GA than with high-dose IFN-β regimens (percentage change in brain volume -2.27 % vs. -3.21 %; p < 0.0001).…”

Section: Once-daily Formulation In Relapsing-remitting Multiple Sclermentioning

confidence: 99%

The heritage of glatiramer acetate and its use in multiple sclerosis

Comı

Amato

Bertolotto

et al. 2016

Mult Scler Demyelinating Disord

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Multiple sclerosis (MS) is a chronic and progressively debilitating disease of the central nervous system. Treatment of MS involves disease-modifying therapies (DMTs) to reduce the incidence of relapses and prevent disease progression. Glatiramer acetate (Copaxone®) was the first of the currently approved DMTs to be tested in human subjects, and it is still considered a standard choice for first-line treatment. The mechanism of action of glatiramer acetate appears to be relatively complex and has not been completely elucidated, but it is likely that it involves both immunomodulating and neuroprotective properties. The efficacy of glatiramer acetate 20 mg/mL once daily as first-line treatment in relapsingremitting MS is well established, with ample evidence of efficacy from both placebo-controlled and active-comparator controlled clinical trials as well as real-world studies. There is also a considerable body of evidence indicating that the efficacy of glatiramer acetate is maintained in the long term. Clinical trial and real-world data have also consistently shown glatiramer acetate to be safe and well tolerated. Notably, glatiramer acetate has a good safety profile in women planning a pregnancy, and is not associated with foetal toxicity. Until recently, glatiramer acetate was only approved as 20 mg/mL once daily, but a new formulation with less frequent administration, 40 mg/mL three times weekly, has been developed and is now approved in many countries, including Italy. This review examines the mechanism of action, clinical efficacy, safety and tolerability of glatiramer acetate to provide suggestions for optimizing the use of this drug in the current MS therapeutic scenario.

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“…43,50 Subsequent studies of 2 or 3 years' duration incorporating various study designs assessing the effects of IM IFNβ-1a alone or in combination have all demonstrated the ability of this DMT to reduce the progression of whole-brain atrophy or cortical-brain atrophy versus placebo or no treatment. [52][53][54][55] In addition, a recent study of patients with RRMS evaluating the effects of daily GA, weekly IM IFNβ-1a, or subcutaneous IFNβ (IFNβ-1a or IFNβ-1b) use on brain volume loss over 5 years 56 found that all DMTs significantly reduce the loss of brain volume in MS compared with no treatment. While it has been argued that early changes in brain volume, so-called pseudoatrophy, observed during the first year of treatment with anti-inflammatory treatments such as IFNβ, may be due to resolution of edema related to MS-associated inflammation; data on microglial activation in MS suggest that treatmentrelated inactivation and shrinkage of microglia may underlie the volume changes associated with pseudoatrophy.…”

Section: ■■ Evolving Mri Methods For Improved Imaging In Msmentioning

confidence: 99%

Emerging Methods for Evaluating the Effectiveness of Intramuscular Interferon Beta-1a for Relapsing-Remitting Multiple Sclerosis

Foley¹,

Barnes²,

Nair³

2013

JMCP

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Newer outcome-based assessment methods have been developed that complement and improve upon the ability of historical clinical and magnetic resonance imaging (MRI) outcome measures to measure multiple sclerosis (MS) disease activity, patient functionality, treatment efficacy, and the risk of MS disease progression. These newer MS outcome assessments include instruments to evaluate cognitive function and patient quality of life; enhanced measures of disability, such as the Multiple Sclerosis Functional Composite instrument; and newer MRI measures of MS disease activity and neuronal changes, such as permanent T 1 hypointensities and central nervous system atrophy. When utilized in conjunction with standard MS outcome measures, these newer MS outcomes provide a more comprehensive picture of disease status and course and hold promise as tools for use in the development and testing of future MS therapies. The well-established first-line MS therapy intramuscular interferon beta-1a, which has been evaluated using a broad range of assessment methods, was used as a reference MS disease-modifying therapy to provide specific examples of studies utilizing newer evaluation methods. Utilization of evolving disease and assessment measures for patients with MS should improve MS patient diagnosis, treatment decisions, and monitoring of therapy. • Multiple sclerosis (MS) is a chronic, immune-mediated neurologic disease that is associated with progressive patient disability and diminished quality of life (QoL).• Historical clinical outcomes, such as MS relapses, physical disability measures, and magnetic resonance imaging (MRI) endpoints, do not capture important elements of MS, such as the impact of MS and MS therapies on a patient's perceived QoL.• This article provides an overview of several key newer MS patient outcomes, including instruments used to assess MS patient cognition, QoL, composite disability measures, and emerging MRI clinical endpoints.• Newer MS patient outcomes have the potential to improve MS patient care and the development and testing of future therapeutics for the treatment of MS. Summary Points Presented in this ArticleHowever, older measures do not capture the entire impact of the disease (e.g., cognition, upper limb function, etc.) on patient function and well-being. Newer outcome measures are being developed with the purpose of capturing additional aspects of the disease and facilitating a more comprehensive assessment of MS disability, progression, and therapeutic efficacy. The primary purpose of this article is to provide the managed care audience with an overview of the most prominent newer MS measures. The potential benefits of these newer outcomes are illustrated using published clinical data on intramuscular interferon beta-1a (IM IFNβ-1a) as an extensively evaluated, representative first-line MS therapy.

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Effect of disease-modifying therapies on brain volume in relapsing–remitting multiple sclerosis: Results of a five-year brain MRI study

Cited by 38 publications

References 34 publications

Treating relapsing–remitting multiple sclerosis: therapy effects on brain atrophy

Treating relapsing–remitting multiple sclerosis: therapy effects on brain atrophy

The heritage of glatiramer acetate and its use in multiple sclerosis

Emerging Methods for Evaluating the Effectiveness of Intramuscular Interferon Beta-1a for Relapsing-Remitting Multiple Sclerosis

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