Fingolimod for relapsing-remitting multiple sclerosis

Mantia, L. La; Tramacere, Irene; Firwana, Belal; Pacchetti, Ilaria; Palumbo, Roberto; Filippini, Graziella

doi:10.1002/14651858.cd009371.pub2

Cited by 55 publications

(55 citation statements)

References 101 publications

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“…In contrast, although we observed a measurable increased risk of infection with the second-generation DMTs, in particular for natalizumab, none of the short-term clinical trials for these drugs (natalizumab, fingolimod or dimethyl fumarate) reported significant increased infection rates 31–36. While the number of people on these drugs in our study was modest, with the phase III randomised clinical trials often including more individuals, still, concerns regarding infection risk have been raised, including in an independent review of trial data,37 and within the relevant product monographs. Since these drugs were approved, much focus has been on the relatively rare, but serious, progressive multifocal leukoencephalopathy 38.…”

Section: Discussionmentioning

confidence: 97%

Disease-modifying drugs for multiple sclerosis and infection risk: a cohort study

Wijnands

Zhu

Kingwell

et al. 2018

J Neurol Neurosurg Psychiatry

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Section: Discussionmentioning

confidence: 97%

Disease-modifying drugs for multiple sclerosis and infection risk: a cohort study

Wijnands

Zhu

Kingwell

et al. 2018

J Neurol Neurosurg Psychiatry

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“…Six randomized controlled trials of FTY versus placebo in RRMS patients who met various selection criteria showed that FTY 0.5 mg increased the probability of being relapse‐free at 24 months (risk ratio [RR] 1.44, 95% CI 1.28–1.63), but in contrast, had little or no effect in preventing disability progression (RR 1.07, 95% CI 1.02–1.11) 8. Benefit was also observed in terms of gadolinium‐enhancing lesions in MRI (RR 1.36, 95% CI 1.27–1.45).…”

Section: Clinical Utility Of Fingolimodmentioning

confidence: 99%

Neurological safety of fingolimod: An updated review

Yoshii

Moriya

Ohnuki

et al. 2017

Clinical & Exp Neuroim

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Fingolimod (FTY) is the first oral medication approved for treatment of relapsing–remitting multiple sclerosis (RRMS). Its effectiveness and safety were confirmed in several phase III clinical trials, but proper evaluation of safety in the real patient population requires long‐term post‐marketing monitoring. Since the approval of FTY for RRMS in Japan in 2011, it has been administered to approximately 5000 MS patients, and there have been side‐effect reports from 1750 patients. Major events included infectious diseases, hepatobiliary disorders, nervous system disorders and cardiac disorders. In the present review, we focus especially on central nervous system adverse events. The topics covered are: (i) clinical utility of FTY; (ii) safety profile; (iii) post‐marketing adverse events in Japan; (iv) white matter (tumefactive) lesions; (v) rebound after FTY withdrawal; (vi) relationship between FTY and progressive multifocal leukoencephalopathy; (vii) FTY and progressive multifocal leukoencephalopathy‐related immune reconstitution inflammatory syndrome; and (viii) neuromyelitis optica and leukoencephalopathy.

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“…An alternative approach is to arrest lymphocyte egress from lymphatic organs. Again, this principle has been successfully applied in MS using the sphingosine receptor blocker fingolimod [61].…”

Section: Stroke Trials Targeting Adaptive Immune Cellsmentioning

confidence: 99%

Clinical Trials of Immunomodulation in Ischemic Stroke

2016

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Inflammatory mechanisms are currently considered as a prime target for stroke therapy. There is evidence from animal studies that immune signals and mediators can have both detrimental and beneficial effects in particular stages of the disease process. Moreover, several of these mechanisms are turned on with sufficient delay after ischemia onset to make them amenable to therapeutic intervention. Several clinical proof-of concept trials have investigated the efficacy of different immunomodulatory approaches in patients with stroke. Trials targeting the innate immune system have focused on reduction of microglial activation, inhibition of neutrophil migration, and interleukin-1 receptor blockade, suggesting that interleukin-1 receptor blockade may be a promising strategy. Studies aiming at halting T-cell migration have also been undertaken with controversial findings regarding prevention of infarct growth in neuroimaging studies. Consistently, recent proof-of-concept trials targeting lymphocytes with drugs such as natalizumab and fingolimod have yielded some promising results on clinical endpoints, but confirmation in larger trials is needed. At present, the understanding of the role of immune mechanisms in neurorepair and neurodegeneration is limited. Improving long-term brain function by mitigating prolonged neuroinflammation that was triggered by acute brain injury could be a strategy in addition to neuroprotection.

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Fingolimod for relapsing-remitting multiple sclerosis

Cited by 55 publications

References 101 publications

Disease-modifying drugs for multiple sclerosis and infection risk: a cohort study

Disease-modifying drugs for multiple sclerosis and infection risk: a cohort study

Neurological safety of fingolimod: An updated review

Clinical Trials of Immunomodulation in Ischemic Stroke

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