One‐year MRI scan predicts clinical response to interferon beta in multiple sclerosis

Prosperini, Luca; Gallo, Valentina; Petsas, Nikolaos; Borriello, Giovanna; Pozzilli, Carlo

doi:10.1111/j.1468-1331.2009.02708.x

Cited by 126 publications

(110 citation statements)

References 32 publications

(36 reference statements)

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“…18,59,[90][91][92][93][94][95][96][97][98][99][100] For example, RRMS and CIS patients with elevated Gd+ and T2 lesion activity, in terms of number or volume of lesions before or after therapy, have a greater likelihood of subsequent clinical relapses, disability progression, cognitive impairment, decreased quality of life, and even death as compared with patients with lower or absent MRI activity. 18,59,[90][91][92][93][94][95][96][97][98][99][100] Although most of these studies have been relatively short term, some have followed study cohorts for 20 or more years. [100][101][102] …”

Section: Discussionmentioning

confidence: 99%

Use of Magnetic Resonance Imaging as Well as Clinical Disease Activity in the Clinical Classification of Multiple Sclerosis and Assessment of Its Course

Cook¹,

Dhib‐Jalbut²,

Dowling³

et al. 2012

International Journal of MS Care

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It has recently been suggested that the Lublin-Reingold clinical classification of multiple sclerosis (MS) be modified to include the use of magnetic resonance imaging (MRI). An international consensus conference sponsored by the Consortium of Multiple Sclerosis Centers (CMSC) was held from March 5to 7, 2010, to review the available evidence on the need for such modification of the Lublin-Reingold criteria and whether the addition of MRI or other biomarkers might lead to a better understanding of MS pathophysiology and disease course over time. The conference participants concluded that evidence of new MRI gadolinium-enhancing (Gd+) T1-weighted lesions and unequivocally new or enlarging T2-weighted lesions (subclinical activity, subclinical relapses) should be added to the clinical classification of MS in distinguishing relapsing inflammatory from progressive forms of the disease. The consensus was that these changes to the classification system would provide more rigorous definitions and categorization of MS course, leading to better insights as to the evolution and treatment of MS. Int J MS Care. 2012;14:105-114. It was recently suggested by Lincoln et al. 1 that the Lublin-Reingold clinical classification of multiple sclerosis (MS) 2 for the assessment of MS phenotypes and patient evolution over time be modified to include magnetic resonance imaging (MRI). It was recommended that the classification incorporate the "conventional," generally available MRI techniques of gadolinium (Gd) T1-weighted sequences and dual-echo and fluid-attenuated inversion recovery (T2-weighted and FLAIR) images ( course over time and, in turn, more informed clinical trials and a better understanding of appropriate therapies.Prior to the meeting, a survey of members of the CMSC was conducted on the need to modify the Lublin-Reingold classification. Over a 1-week period, 141 responses were received, representing 16% of the CMSC members polled. The results were as follows: A total of 70% of respondents indicated that the LublinReingold classification did not sufficiently distinguish the different forms of MS; 87% felt that the LublinReingold classification did not sufficiently distinguish MS disease activity even within a given category of the disease; and 84% indicated that it would be useful to include certain subclinical indices of disease activity in the clinical classification, such as MRI gadoliniumother MRI modalities that are not currently widely available and other validated biomarkers might be added to the classification in the future.In response to the publication of Lincoln et al., 1 the Consortium of Multiple Sclerosis Centers (CMSC) sponsored an international consensus conference, which was held in Short Hills, New Jersey, from March 5 to 7, 2010. Participating in the conference were 28 invited MS experts from North and South America and Europe who were well versed in clinical trials, the management of MS, biostatistics, neuropathology, neuroimaging, and neuroimmunology. The goal of the meeting was to review the available...

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Section: Discussionmentioning

confidence: 99%

Use of Magnetic Resonance Imaging as Well as Clinical Disease Activity in the Clinical Classification of Multiple Sclerosis and Assessment of Its Course

Cook¹,

Dhib‐Jalbut²,

Dowling³

et al. 2012

International Journal of MS Care

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“…While the value of MRI measurements in treatment trials is acceptable, the utilization in everyday clinical practice has only been established in recent years. Several studies have demonstrated that the occurrence of new T2 lesions or Gd-enhancing T1 lesions during the first year of a treatment (most studies have investigated treatment with interferon-β) correlates with progression of disability [31,32]. Thus, the Fig.…”

Section: Mr Imaging In Monitoring and Predicting Treatment Responsementioning

confidence: 99%

MRI in the Diagnosis and Monitoring of Multiple Sclerosis: An Update

2015

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“…46,47 While it is generally understood that relapses in MS result in cumulative disability, the direct relationship between successive relapses and disability progression has been difficult to demonstrate in clinical trials. 49 An observational study that examined the effect of relapses (defined as the appearance of a new neurological symptom [or a worsening in a previous symptom], lasting more than 48 hours, without fever) on disability progression found that having 1 or more relapses during the first 2 years of IFNβ treatment was associated with earlier progression of disability.…”

Section: 42mentioning

confidence: 99%

“…36 Relapses are also important to quantify because they can be associated with significant residual deficits, and relapse rate in the early stages of the disease can be a key determinant of later accumulation of disability. 46,47 Relapse outcomes in most clinical trials are measured by (a) annualized relapse rate, (b) average number of relapses per patient, (c) proportion of patients who are relapse free, and (d) the cumulative probability of relapse. 48 While annualized relapse rate, or the number of confirmed relapses per patient per year, is commonly used as the primary outcome measure in MS studies, 48 it is difficult to compare annualized relapse rate with the relapse results of older trials of IM IFNβ-1a, 8 SC IFNβ-1b, 3 SC IFNβ-1a, 17 and glatiramer acetate 12 that used relapse counts per year as the primary outcome measure.…”

Section: 42mentioning

confidence: 99%

Evidence for Long-Term Use of Intramuscular Interferon Beta-1a: An Overview of Relapse, Disability, and MRI Data from Selected Clinical Trials

Foley¹,

Zerkowski²,

Nair³

2013

JMCP

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The treatment options for multiple sclerosis are rapidly changing. With the increasing number of products available to treat this disease, treatment decisions are becoming more complex. Over the years, diagnosis and assessment of treatment efficacy in multiple sclerosis have evolved, but the primary endpoints used to evaluate patients have remained relatively consistent. Relapse rates, magnetic resonance imaging parameters, and disability progression are all key considerations when assessing efficacy for multiple sclerosis treatments. As selection of therapy becomes increasingly complex for both patients and physicians, risk-benefit considerations that incorporate long-term efficacy and safety on an individualized basis will be of greater importance. The information provided in this article will help to elucidate these considerations. • Multiple sclerosis (MS) is a chronic, immune-mediated neurologic disease that is associated with progressive disability and diminished quality of life by interfering with a person's ability to work, pursue leisure activities, and conduct typical life activities.• Several approved disease-modifying therapies (DMTs) are available to treat MS. These DMTs have demonstrated efficacy in key traditional MS outcome measures, including relapses, disability progression, and magnetic resonance imaging (MRI) measures.• This article provides an overview of the key traditional outcomes assessed in MS studies and critically evaluates phase 3 and longterm follow-up outcomes data for intramuscular interferon beta1a (IM IFNβ-1a), one of the frequently prescribed treatments for patients with MS.• IM IFNβ-1a administered once weekly has demonstrated efficacy in reducing relapse rates, disability progression, and disease activity visible on MRI in multiple MS studies.• IM IFNβ-1a has been an effective first-line treatment option for patients with MS for more than 15 years. Its efficacy and safety profiles have been well established in the post-marketing setting, and no new safety considerations have emerged. The adverse reactions most commonly reported in patients associated with the use of IM IFNβ-1a are flu-like symptoms occurring within hours to days following an injection. Summary Points Presented in this ArticleMS will result in significant changes in treatment. Fingolimod is the most recently approved DMT for treatment of relapsing forms of MS, and several other drugs are currently in late-stage development. The pivotal studies for these latest therapies, which include laquinimod, 27,28 teriflunomide, 29-31 dimethyl fumarate (BG-12), 32,33 alemtuzumab, 34 and PEGylated interferon beta-1a, 35 have primary endpoints (relapse rates, disability progression, MRI activity) similar to those used in the registration trials of currently approved DMTs.Because traditional measures of efficacy in MS do not capture other important aspects of the disease, additional measures, including the Multiple Sclerosis Functional Composite (MSFC), cognition, and quality of life (QoL), as well as newer imaging t...

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One‐year MRI scan predicts clinical response to interferon beta in multiple sclerosis

Abstract: Developing new T2-hyperintense lesions during IFNB treatment was the best predictor of long-term poor response to therapy. MRI scans performed after 1 year of IFNB treatment may be useful in contributing to early identification of poor responders.

Cited by 126 publications

References 32 publications

Use of Magnetic Resonance Imaging as Well as Clinical Disease Activity in the Clinical Classification of Multiple Sclerosis and Assessment of Its Course

Use of Magnetic Resonance Imaging as Well as Clinical Disease Activity in the Clinical Classification of Multiple Sclerosis and Assessment of Its Course

MRI in the Diagnosis and Monitoring of Multiple Sclerosis: An Update

Evidence for Long-Term Use of Intramuscular Interferon Beta-1a: An Overview of Relapse, Disability, and MRI Data from Selected Clinical Trials

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