Assessment: The use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidence-based review)

Goodin, D. S.; Cohen, Bruce A.; O’Connor, Paul; Kappos, Ludwig; Stevens, J. C.

doi:10.1212/01.wnl.0000320512.21919.d2

Cited by 113 publications

(73 citation statements)

References 41 publications

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“…The evidence therefore must be compelling. Other strategies include preventing cells from entering the target organ by inhibition of either adhesion or migration through endothelium (anti-a4-integrin (Natalizumab)) 84 or via preventing efflux from lymph nodes by blocking sphingosine-1-phosphate receptor (FTY720 (Fingolimod)), 85 both of which have demonstrated dramatic benefit in multiple sclerosis trials and indeed in experimental models of uveitis. 86 For BD, and also in other forms of non-infectious uveitis, IFN-a (which are delivered as monotherapy or in conjunction with corticosteroids) have also been successfully utilised, with both a small RCT and long-term prospective and retrospective studies demonstrating that almost 60% of patients can achieve remission and discontinue treatment.…”

Section: Recent and Future Treatmentsmentioning

confidence: 99%

Current concepts and future directions in the pathogenesis and treatment of non-infectious intraocular inflammation

Lee

Dick

2011

Eye

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The blockbuster drug paradigm is under increasing scrutiny across the biopharmaceutical industry. Intraocular inflammation poses particular challenges to this, given the heterogeneity of conditions in the uveitis spectrum, and the increasing acknowledgement of individual patient and disease variance in underlying immune responses. This need has triggered a drive towards personalised and stratified medicine, supported and enabled as a result of continued development of both experimental models and molecular biological techniques and improved clinical classification. As such we have the ability now to systematically appraise at a genomic, transcriptomic, and proteomic level individual immunophenotype, and the promise that in the eye this can be augmented by in vivo immune imaging to identify individual immunopathology. With such advances all running in parallel, we are entering an era of experimental medicine that will facilitate early diagnosis, generate biomarkers for accurate prognostication, and enable the development of individualised and targeted therapies, which can progress rapidly into clinical practice.

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Section: Recent and Future Treatmentsmentioning

confidence: 99%

Current concepts and future directions in the pathogenesis and treatment of non-infectious intraocular inflammation

Lee

Dick

2011

Eye

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“…1,2,12 These reactions are more common in patients with neutralizing antibodies. 5 • PML: a serious central nervous system infection due to JC virus, cases have been reported in patients with MS and Crohn disease.…”

Section: 4514mentioning

confidence: 99%

“…5 • PML: a serious central nervous system infection due to JC virus, cases have been reported in patients with MS and Crohn disease. 15 Natalizumab is recommended for use as a monotherapy in MS 12 and Crohn disease to minimize risk.…”

Section: 4514mentioning

confidence: 99%

“…It is generally reserved for patients who fail first-line therapies (Figs 3 and 4). 12 It must be given in conjunction with the TOUCH program, which is a national risk-minimization program designed to "minimize the risk of PML, minimize death and disability due to PML, and promote informed risk-benefit decisions regarding Natalizumab use." 6 This drug is being investigated for use in ulcerative colitis.…”

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confidence: 99%

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Natalizumab (Tysabri)

Selewski¹,

Shah²,

Segal³

et al. 2010

AJNR Am J Neuroradiol

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“…48 Despite extensive studies, no prognostic marker could be identified that allows determination of the risk of PML in advance. 49 …”

Section: Multiple Sclerosismentioning

confidence: 99%

Biological Markers of Prognostic Value in Multiple Sclerosis

Pauli¹,

Reindl²,

Berger³

2008

European Neurological Review

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Multiple sclerosis (MS), a chronic inflammatory disorder of the central nervous system (CNS), is the most common neurological disease among young adults, and carries the potential risk of permanent disability. The pathological hallmarks of the disease are multifocal white (and, most recently, also grey) matter lesions, which are characterised by variable extents of inflammation, demyelination, axonal loss, gliosis and atrophy. 1 MS has variable clinical presentations and highly heterogeneous disease courses, ranging from rare acute fulminate forms to benign MS without substantial disability. Eighty-five per cent of patients initially present with a clinically isolated syndrome (CIS); most of these patients go on to develop relapsing-remitting (RR) MS, with acute relapses alternating with periods of clinical remission or stability. 2 Ultimately, more than half of (untreated) RRMS patients convert to secondary chronic progressive (SP) MS, which is characterised by accumulating neurological disability with or without superimposed relapses. 3 The clinical outcome of MS is largely unpredictable for individual patients. The great variability of this complex disease highlights the need for reliable biological markers with high sensitivity and specificity that are able to predict the future disease course and treatment response. Furthermore, stratification of MS patients with regard to their dominating pathological processes would allow individualised differential therapeutic concepts. In this review, we discuss the prognostic value of biological markers that are currently under debate, including magnetic resonance imaging (MRI), cerebrospinal fluid (CSF) parameters and antibodies. Markers to Predict Disease Progression Magnetic Resonance Imaging as a Prognostic MarkerMRI is a well established tool for the diagnosis 4 and management of MS that allows disease activity and progression to be monitored. The lesions detected on T2-weighted and gadolinium (Gd)-contrast-enhanced T1-weighted MRI reflect the pathological hallmark of the disease: the T2 lesion burden seems to be correlated with the number of preceding relapses 5 and the use of Gd enables visualisation of blood-brain barrier disruption and therefore inflammatory disease activity. 6 Thus, MRI has become a relevant surrogate outcome marker in MS clinical trials. Doubtless, MRI has its greatest relevance in patients with a CIS: evidence of dissemination of MS lesions in space and time and the extent of MRI activity are robust predictors of a first relapse. 7,8 However, since commonly used MRI techniques show only a weak association with future disability, 9 their prognostic value is limited and they are not useful for predicting clinical outcome in individual patients. 10 Poor clinicoradiological correlations may be due to either insensitive clinical rating scales or methodological difficulties in the detection of pathological alterations, especially axonal damage, within the normal-appearing white (NAWM) and grey matter (NAGM). 10,11 Neuropathology demonstrates t...

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Assessment: The use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidence-based review)

Cited by 113 publications

References 41 publications

Current concepts and future directions in the pathogenesis and treatment of non-infectious intraocular inflammation

Current concepts and future directions in the pathogenesis and treatment of non-infectious intraocular inflammation

Natalizumab (Tysabri)

Biological Markers of Prognostic Value in Multiple Sclerosis

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