Natalizumab use in pediatric patients with relapsing-remitting multiple sclerosis

Arnal-Garcia, Carmen; García-Montero, Ma. Rosa; Málaga, Ignacio; Millán-Pascual, Jorge; Oliva‐Nacarino, Pedro; Ramió-Torrentà, Lluı́s; Oreja‐Guevara, Celia

doi:10.1016/j.ejpn.2012.09.004

Cited by 47 publications

(39 citation statements)

References 23 publications

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“…A number of cohort studies evaluating the use of natalizumab in pediatric RRMS have demonstrated that natalizumab is well tolerated and appears to reduce ARR effectively, and sustain disability progression, and T2-hyperintense and gadoliniumenhancing lesion accrual [85][86][87][88][89][90][91].…”

Section: Natalizumabmentioning

confidence: 99%

Therapeutic Approach to the Management of Pediatric Demyelinating Disease: Multiple Sclerosis and Acute Disseminated Encephalomyelitis

Brenton

Banwell

2016

Neurotherapeutics

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Acquired pediatric demyelinating diseases manifest acutely with optic neuritis, transverse myelitis, acute disseminated encephalomyelitis, or with various other acute deficits in focal or polyfocal areas of the central nervous system. Patients may experience a monophasic illness (as in the case of acute disseminated encephalomyelitis) or one that may manifest as a chronic, relapsing disease [e.g., multiple sclerosis (MS)]. The diagnosis of pediatric MS and other demyelinating disorders of childhood has been facilitated by consensus statements regarding diagnostic definitions. Treatment of pediatric MS has been modeled after data obtained from clinical trials in adult-onset MS. There are now an increasing number of new therapeutic agents for MS, and many will be formally studied for use in pediatric patients. There are important efficacy and safety concerns regarding the use of these therapies in children and young adults. This review will discuss acute management as well as chronic immunotherapies in acquired pediatric demyelination.

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Section: Natalizumabmentioning

confidence: 99%

Therapeutic Approach to the Management of Pediatric Demyelinating Disease: Multiple Sclerosis and Acute Disseminated Encephalomyelitis

Brenton

Banwell

2016

Neurotherapeutics

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“…Available data in children with MS who did not respond to initial immunomodulatory treatments, suggest that natalizumab, in most cases, reduces clinical and MRI relapses but the risk profile must be balanced against potential benefits. 20,21 Concerning fingolimod, data is sparse regarding safety, tolerability and optimal dosing in children. Cyclophosphamide reduced relapse rate and halted disease progression in the majority of cases in a study of pediatric MS patients with inadequate treatment response to other immunosuppressive-immunomodulatory treatments but there is a risk of serious side effects.…”

mentioning

confidence: 99%

Pediatric Multiple Sclerosis in Portugal: A Multicentre Study

Correia

Augusto²,

Meireles³

et al. 2016

Acta Med Port

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RESUMOIntrodução: A esclerose múltipla é habitualmente diagnosticada em adultos jovens mas, mais raramente, pode manifestar-se durante a infância ou adolescência. Os dados sobre a esclerose múltipla pediátrica em Portugal são escassos. O objectivo principal deste estudo é a avaliação das características demográficas, clínicas, laboratoriais e neurorradiológicas da esclerose múltipla de início em idade pediátrica em Portugal. Os objetivos secundários consistem na comparação entre a esclerose múltipla de início na infância e a esclerose múltipla de início na adolescência e na caracterização dos tratamentos prescritos. Material e Métodos: Realizou-se um estudo retrospectivo, observacional e multicêntrico, que consistiu na análise dos dados de todos os doentes com apresentação da EM antes dos 18 anos. Resultados: Incluíram-se 46 doentes (72% do sexo feminino), com uma idade média de diagnóstico de 16,1 anos. Seis casos tiveram início na infância, 40 na adolescência. A esclerose múltipla apresentou-se em 98% dos casos com a forma surto-remissão. O estudo do líquor revelou bandas oligoclonais em 74% dos doentes. A ressonância magnética encefálica mostrou predominantemente lesões supratentoriais (98% dos casos), enquanto que a ressonância medular revelou que o segmento cervical foi o mais frequentemente afectado. Todos os doentes iniciaram terapêutica imunomoduladora (75% com interferão β). Relativamente às diferenças entre os dois grupos etários, encontrámos uma maior proporção de doentes do sexo masculino e com pleocitose no grupo com apresentação na infância. Discussão: Este trabalho fornece novos dados sobre as características da esclerose múltipla pediátrica em Portugal e os resultados são semelhantes aos reportados em outras partes do mundo. Conclusão: Este é o primeiro estudo multicêntrico português sobre a esclerose múltipla com apresentação na infância e adolescência. Mais estudos são necessários para clarificar os mecanismos subjacentes às particularidades da esclerose múltipla pediátrica. Palavras-chave: Adolescente; Criança; Esclerose Múltipla; Portugal. ABSTRACT Introduction:Multiple sclerosis is most often diagnosed among young adults but less frequently it may present during childhood or adolescence. In Portugal, there has been only one previous single-center, pediatric multiple sclerosis study. The main objective was the evaluation of the demographic, clinical, laboratorial and neuroradiological characteristics of patients with pediatric-onset multiple sclerosis in Portugal. The secondary objectives were to compare the characteristics of childhood-onset multiple sclerosis and adolescent-onset multiple sclerosis and to characterize the treatments prescribed. Material and Methods:We performed a retrospective observational, multicentric study. We reviewed data of all patients with multiple sclerosis younger than 18 years at the onset of their first multiple sclerosis symptoms. Results: There were 46 patients (72% female) included with a mean age at diagnosis of 16.1 years. Six cases had childhood-onset and...

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“…In an Italian cohort of 55 patients (mean age 14.4 years), significant improvement in mean EDSS scores was reported (from 2.7 to 1.9 at the last visit; p < 0.001) [32]. Similarly, in a Spanish cohort of nine patients (mean age 15.3 years), eight demonstrated a median improvement in EDSS score from 3.0 to 1.0, and a reduction in median ARR from 3.0 to 0 [33]. Natalizumab also appears to be generally well tolerated in this patient population [34].…”

Section: Efficacy Of Natalizumabmentioning

confidence: 95%

“…However, some studies have evaluated its use in paediatric cohorts [32][33][34]. In an Italian cohort of 55 patients (mean age 14.4 years), significant improvement in mean EDSS scores was reported (from 2.7 to 1.9 at the last visit; p < 0.001) [32].…”

Section: Efficacy Of Natalizumabmentioning

confidence: 99%

Natalizumab treatment for multiple sclerosis: Middle East and North Africa regional recommendations for patient selection and monitoring

Alroughani¹,

Aref²,

Bohlega³

et al. 2014

Multiple Sclerosis and Related Disorders

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Background: Natalizumab, a highly specific α4-integrin antagonist, , has recently been registered across the Middle East and North Africa region. It improves clinical and magnetic resonance imaging (MRI) outcomes and reduces the rate of relapse and disability progression in relapsing-remitting multiple sclerosis (MS). Natalizumab is recommended for patients who fail first-line disease-modifying therapy or who have very active disease. Progressive multifocal leukoencephalopathy is a rare, serious adverse event associated with natalizumab. We aim to develop regional recommendations for the selection and monitoring of MS patients to be treated with natalizumab in order to guide local neurological societies. Methods: After a review of available literature, a group of neurologists with expertise in the management of MS met to discuss the evidence and develop regional recommendations to guide appropriate use of natalizumab in the region. Results: Disease breakthrough is defined as either clinical (relapse or disability progression) or radiological activity (new T2 lesion or gadolinium-enhancing lesions on MRI), or a combination of both. Natalizumab is recommended as an escalation therapy in patients with breakthrough disease based on its established efficacy in Phase III studies. Several factors including prior immunosuppressant therapy, anti-John Cunningham virus (JCV) antibody status and patient choice will affect the selection of natalizumab. In highly active MS, natalizumab is considered as a first-line therapy for naive patients with disabling relapses in association with MRI activity. The anti-JCV antibody test is used to assess anti-JCV antibody status and identify the risk of PML. While seronegative patients should continue treatment with natalizumab, anti-JCV antibody testing every 6 months and annual MRI scans are recommended as part of patient monitoring. In seropositive patients, the expected benefits of natalizumab treatment have to be weighed against the risks of PML. Clinical vigilance and follow-up MRI scans remain the cornerstone of monitoring. After 2 years of natalizumab therapy, monitoring should include more frequent MRI scans (every 3-4 months) for seropositive patients, and the risk-benefit ratio should be reassessed and discussed with patients. Conclusions: Recommendations have been developed to guide neurologists in the Middle East and North Africa on patient selection for natalizumab treatment and monitoring.

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Natalizumab use in pediatric patients with relapsing-remitting multiple sclerosis

Cited by 47 publications

References 23 publications

Therapeutic Approach to the Management of Pediatric Demyelinating Disease: Multiple Sclerosis and Acute Disseminated Encephalomyelitis

Therapeutic Approach to the Management of Pediatric Demyelinating Disease: Multiple Sclerosis and Acute Disseminated Encephalomyelitis

Pediatric Multiple Sclerosis in Portugal: A Multicentre Study

Natalizumab treatment for multiple sclerosis: Middle East and North Africa regional recommendations for patient selection and monitoring

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