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https://www.readbyqxmd.com/read/28431609/benefit-risk-perception-of-natalizumab-therapy-in-neurologists-and-a-large-cohort-of-multiple-sclerosis-patients
#1
Christoph Heesen, Ingo Kleiter, Sven G Meuth, Julia Krämer, Jürgen Kasper, Sascha Köpke, Wolfgang Gaissmaier
BACKGROUND: Natalizumab (NAT) is associated with the risk of progressive multifocal leukoencephalopathy (PML). Risk stratification algorithms have been developed, however, without detectable reduction of PML incidence. OBJECTIVE: To evaluate to which extent patients and physicians understand and accept risks associated with NAT treatment. METHODS: Prospective observational cohort study in German MS centers (n=73) among NAT-treated MS patients (n=801) and their neurologists (n=99)...
May 15, 2017: Journal of the Neurological Sciences
https://www.readbyqxmd.com/read/28428206/current-and-emerging-therapies-in-multiple-sclerosis-implications-for-the-radiologist-part-2-surveillance-for-treatment-complications-and-disease-progression
#2
REVIEW
C McNamara, G Sugrue, B Murray, P J MacMahon
An understanding of the new generation of MS drugs in conjunction with the key role MR imaging plays in the detection of disease progression, opportunistic infections, and drug-related adverse effects is of vital importance to the neuroradiologist. Part 1 of this review outlined the current treatment options available for MS and examined the mechanisms of action of the various medications. It also covered specific complications associated with each form of therapy. Part 2, in turn deals with the subject of pharmacovigilance and the optimal frequency of MRI monitoring for each individual patient, depending on his or her unique risk profile...
April 20, 2017: AJNR. American Journal of Neuroradiology
https://www.readbyqxmd.com/read/28428119/timing-of-high-efficacy-therapy-in-relapsing-remitting-multiple-sclerosis-a-systematic-review
#3
REVIEW
Bernd Merkel, Helmut Butzkueven, Anthony L Traboulsee, Eva Havrdova, Tomas Kalincik
BACKGROUND: Immunotherapy initiated early after first presentation of relapsing-remitting multiple sclerosis is associated with improved long-term outcomes. One can therefore speculate that early initiation of highly effective immunotherapies, with an average efficacy that is superior to the typical first-line therapies, could further improve relapse and disability outcomes. However, the most common treatment strategy is to commence first-line therapies, followed by treatment escalation in patients who continue to experience on-treatment disease activity...
April 17, 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28426702/natalizumab-stabilizes-physical-cognitive-mri-and-oct-markers-of-disease-activity-a-prospective-non-randomized-pilot-study
#4
Garrick D Talmage, Oscar J M Coppes, Adil Javed, Jacqueline Bernard
Natalizumab is an effective therapy for multiple sclerosis (MS). Its effectiveness has been demonstrated in several clinical and imaging studies. The objective of this study was to further demonstrate the efficacy of natalizumab using a comprehensive battery of clinical and imaging markers in the same cohort of patients followed longitudinally, hence capturing the multi-faceted nature of the MS disease process. A prospective, open-label, pilot study of 20 MS patients treated with natalizumab was conducted. High resolution MRI, Symbol-Digit Modalities Test (SDMT), and Optical Coherence Tomography (OCT) scans were obtained at baseline, 48, and 96 weeks...
2017: PloS One
https://www.readbyqxmd.com/read/28413713/catastrophic-outcome-of-patients-with-a-rebound-after-natalizumab-treatment-discontinuation
#5
Inés González-Suarez, Luis Rodríguez de Antonio, Aida Orviz, Sara Moreno-García, María D Valle-Arcos, Jordi A Matias-Guiu, Cristina Valencia, Manuela Jorquera Moya, Celia Oreja-Guevara
INTRODUCTION: Natalizumab (NTZ) is an effective drug for the treatment of relapsing-remitting multiple sclerosis. In some patients discontinuation is mandatory due to the risk of progressive multifocal leukoencephalopathy. However, severe clinical and radiological worsening has been described after drug cessation. Our aim was to describe the clinical and radiological features of the rebound phenomenon. MATERIAL AND METHODS: Patients switched from NTZ to Fingolimod (FTY) who had presented a rebound after discontinuation were selected...
April 2017: Brain and Behavior
https://www.readbyqxmd.com/read/28406921/is-the-risk-of-progressive-multifocal-leukoencephalopathy-the-real-reason-for-natalizumab-discontinuation-in-patients-with-multiple-sclerosis
#6
Julia Krämer, Jan-Gerd Tenberge, Ingo Kleiter, Wolfgang Gaissmaier, Tobias Ruck, Christoph Heesen, Sven G Meuth
BACKGROUND: Progressive multifocal leukoencephalopathy (PML) is one of the major risks of natalizumab therapy. Despite introduction of the currently employed PML risk stratification algorithm, the incidence of natalizumab-associated PML cases is not decreasing. OBJECTIVES: We addressed the following questions: How do natalizumab-treated multiple sclerosis patients and their treating physicians assess and deal with PML risk? Is PML risk the real reason for natalizumab discontinuation? METHODS: 699 natalizumab-treated multiple sclerosis patients and 99 physicians were included in this prospective observational study...
2017: PloS One
https://www.readbyqxmd.com/read/28403930/neonatal-pancytopenia-in-a-child-born-after-maternal-exposure-to-natalizumab-throughout-pregnancy
#7
L Guilloton, A Pegat, J Defrance, L Quesnel, G Barral, A Drouet
Natalizumab is a monoclonal antibody indicated for the treatment of patients with relapsing-remitting multiple sclerosis. Its use is prohibited during pregnancy. However, natalizumab exposures throughout the gestation period or during the third trimester, because of intense disease activity, are possible and begin to be reported. There are enough reassuring arguments against a teratogenicity, through pregnancy registries; but deleterious effects in the monitoring of newborn, are not well known. A disorder of hematopoiesis is possible with anemia, thrombocytopenia or pancytopenia, as discussed by the author through an observation...
March 2017: J Gynecol Obstet Hum Reprod
https://www.readbyqxmd.com/read/28398628/population-pharmacokinetics-and-target-engagement-of-natalizumab-in-patients-with-multiple-sclerosis
#8
Kumar Kandadi Muralidharan, Geoffrey Kuesters, Tatiana Plavina, Meena Subramanyam, Daniel D Mikol, Sreeja Gopal, Ivan Nestorov
Natalizumab (humanized immunoglobulin G4 antibody targeting alpha-4 integrins) is a highly efficacious treatment for relapsing-remitting multiple sclerosis (RRMS) that has been in clinical use since 2006. However, natalizumab pharmacokinetic (PK) characteristics and concentration alpha-4 integrin saturation relationships have not been well described in the scientific literature. Therefore, clinical data from 11 studies were pooled and analyzed to characterize the PK and pharmacodynamic (PD) properties of natalizumab in RRMS subjects...
April 11, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28392137/brain-derived-neurotrophic-factor-levels-under-chronic-natalizumab-treatment-in-multiple-sclerosis-a-preliminary-report
#9
Vitalie Văcăraş, Zoltán Zsigmond Major, Anca Dana Buzoianu
AIM OF THE STUDY: Our main purpose was to investigate if the chronic treatment with the disease-modifying drug natalizumab shows quantifiable effect on BDNF levels in multiple sclerosis patients. MATERIALS AND METHODS: BDNF plasma concentration was evaluated using enzyme-linked immunosorbent assay in healthy individuals, not treated multiple sclerosis patients and patients treated with natalizumab. RESULTS: Multiple sclerosis patients have a significantly lower amount of peripheral BDNF than healthy individuals...
March 31, 2017: Neurologia i Neurochirurgia Polska
https://www.readbyqxmd.com/read/28391741/unexpected-exacerbations-following-initiation-of-disease-modifying-drugs-in-neuromyelitis-optica-spectrum-disorder-which-factor-is-responsible-anti-aquaporin-4-antibodies-b-cells-th1-cells-th2-cells-th17-cells-or-others
#10
Jun-Ichi Kira
Some disease-modifying drugs for multiple sclerosis, which mainly act on T cells, are ineffective for neuromyelitis optica spectrum disorder and induce unexpected relapses. These include interferon beta, glatiramer acetate, fingolimod, natalizumab, and alemtuzumab. The cases reported here suggest that dimethyl fumarate, which reduces the number of Th1 and Th17 cells and induces IL-4-producing Th2 cells, is also unsuitable for neuromyelitis optica spectrum disorder, irrespective of anti-aquaporin 4 IgG serostatus...
April 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28389054/the-use-of-natalizumab-in-pediatric-patients-with-active-relapsing-multiple-sclerosis-a-prospective-study
#11
Raed Alroughani, Samar Farouk Ahmed, Raed Behbehani, Jasem Al-Hashel
BACKGROUND: Pediatric multiple sclerosis (MS) has been increasingly recognized. In the absence of approved disease-modifying therapies (DMTs) for pediatric patients, clinicians resort to data extrapolated from clinical trials conducted in adults with MS. The objective of this article was to study the effectiveness and safety of natalizumab in with pediatric MS. METHODS: Patients with pediatric MS (aged < 18 years) who had been treated with natalizumab were followed up prospectively as part of the national MS registry...
February 2, 2017: Pediatric Neurology
https://www.readbyqxmd.com/read/28378895/monitoring-cd49d-receptor-occupancy-a-method-to-optimize-and-personalize-natalizumab-therapy-in-multiple-sclerosis-patients
#12
Joan Puñet-Ortiz, José Vicente Hervás-García, Aina Teniente-Serra, Antonio Cano-Orgaz, Maria José Mansilla, Bibiana Quirant-Sánchez, Juan Navarro-Barriuso, Marco A Fernández-Sanmartín, Silvia Presas-Rodríguez, Cristina Ramo-Tello, Eva María Martínez-Cáceres
BACKGROUND: In natalizumab-treated relapsing-remitting MS (RRMS) patients, various extended interval dosing strategies are under evaluation to minimize severe treatment-associated side effects, mainly progressive multifocal leukoencephalopathy development. Up to now, it has not been presented any approach, even in form of assay design, to determine the optimal percentage of CD49d receptor occupancy (RO) associated with a favorable clinical, radiological, and immunological response. METHODS: A multiparametric quantitative flow cytometry method was settled to measure CD49d RO on peripheral blood lymphocytes...
April 5, 2017: Cytometry. Part B, Clinical Cytometry
https://www.readbyqxmd.com/read/28372806/multiple-immune-disorders-after-natalizumab-discontinuation-after-the-ciris-the-siris
#13
E K Van Obberghen, M Cohen, F Rocher, C Lebrun-Frenay
Natalizumab (NTZ) is an effective treatment for patients with highly active relapsing remitting multiple sclerosis (MS). However, when the therapy must be interrupted, it is important to anticipate the withdrawal to avoid reactivation or disease rebound. Described here is the case of a 35-year-old woman, with a past history of beta thalassemia, bulimia and asthma, who was diagnosed with MS at age 26. She was treated initially with first-line subcutaneous (sc) immunomodulatory treatments. However, due to liver toxicity, interferon beta-1a sc was interrupted and replaced by glatiramer acetate treatment, which was well tolerated and used for several years...
March 31, 2017: Revue Neurologique
https://www.readbyqxmd.com/read/28362522/multiple-sclerosis-update-use-of-mri-for-early-diagnosis-disease-monitoring-and-assessment-of-treatment-related-complications
#14
Mark S Igra, David Paling, Mike P Wattjes, Daniel Ja Connolly, Nigel Hoggard
MRI has long been established as the most sensitive in vivo technique for detecting multiple sclerosis (MS) lesions. The 2010 revisions of the McDonald Criteria have simplified imaging criteria, such that a diagnosis of MS can be made on a single contrast-enhanced MRI scan in the appropriate clinical context. New disease modifying therapies have proven effective in reducing relapse rate and severity. Several of these therapies, most particularly natalizumab, but also dimethyl fumarate and fingolimod have been associated with progressive multifocal leucoencephalopathy (PML)...
March 31, 2017: British Journal of Radiology
https://www.readbyqxmd.com/read/28337205/high-interferon-%C3%AE-uniquely-in-v%C3%AE-1-t-cells-correlates-with-markers-of-inflammation-and-axonal-damage-in-early-multiple-sclerosis
#15
Avadhesh Kumar Singh, Lenka Novakova, Markus Axelsson, Clas Malmeström, Henrik Zetterberg, Jan Lycke, Susanna L Cardell
We have identified a population of T lymphocytes in peripheral blood, Vδ1 TCRγδ T lymphocytes, which unexpectedly was uniquely expressing high production of interferon-γ in newly diagnosed, untreated multiple sclerosis (MS) patients. IFN-γ production in this population distinctly correlated to parameters of clinical disease activity, inflammation, and neuronal damage. These Vδ1 T lymphocytes belong to a population of innate T lymphocytes that recognize antigen in the context of CD1d/CD1c and which include reactivity to the myelin glycosphingolipid sulfatide...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28331881/severe-cytomegalovirus-gastritis-during-natalizumab-mediated-immunosuppression
#16
Stephen P Persaud, Adil Hassan, Anjum Hassan, Tariq Hassan
We report a 35-year-old female receiving natalizumab as monotherapy for multiple sclerosis who subsequently developed severe cytomegalovirus gastritis. As cytomegalovirus gastritis has not been previously described during natalizumab treatment, we discuss the biological plausibility of this potential association and avenues for further study.
2017: ACG Case Reports Journal
https://www.readbyqxmd.com/read/28328761/drug-efficacy-monitoring-in-pharmacotherapy-of-multiple-sclerosis-with-biological-agents
#17
M Caldano, W Raoul, T Rispens, A Bertolotto
Multiple Sclerosis (MS) is a heterogeneous disease. Although several EMA approved Disease Modifying Treatments including biopharmaceuticals are available, their efficacy is limited and a certain percentage of patients are always non-responsive. Drug Efficacy Monitoring is an important tool to identify these non-responsive patients early on. Currently, Detection of Anti-Drug Antibodies and quantification of Biological Activity are used as methods of efficacy monitoring for Interferon beta (IFNβ) and Natalizumab (NAT) therapies...
March 22, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28323224/progressive-multifocal-leukoencephalopathy-and-rheumatoid-arthritis-treatments
#18
Gaëlle Clavel, Antoine Moulignier, Luca Semerano
Progressive multifocal leukoencephalopathy (PML) is a demyelinating disease of the central nervous system due to reactivation of the JC virus (JCV). PML is extremely uncommon despite the high prevalence of the virus in the general population. No specific treatment is available, and the prognosis is bleak. The diagnosis is based on brain imaging findings, detection of the JCV genome in cerebrospinal fluid samples and, in some cases, histological studies of the brain lesions. The pathophysiological mechanisms that drive the development of PML are incompletely understood...
March 16, 2017: Joint, Bone, Spine: Revue du Rhumatisme
https://www.readbyqxmd.com/read/28319193/stability-and-predictive-value-of-anti-jcv-antibody-index-in-multiple-sclerosis-a-6-year-longitudinal-study
#19
Harald Hegen, Michael Auer, Gabriel Bsteh, Franziska Di Pauli, Tatiana Plavina, Janette Walde, Florian Deisenhammer, Thomas Berger
BACKGROUND: Risk of natalizumab-related progressive multifocal leukoencephalopathy is associated with the presence of anti-JC-virus (JCV) antibodies. OBJECTIVE: To investigate the longitudinal evolution of anti-JCV antibody index and to determine the predictive value of baseline anti-JCV antibody index for long-term stability of anti-JCV antibody status. METHODS: MS patients from the MS centre of Medical University of Innsbruck, who had serum sampling for a time period of 4-6 years at intervals of 6±3 months, were included in this retrospective, longitudinal study...
2017: PloS One
https://www.readbyqxmd.com/read/28318370/patient-to-patient-transmission-of-natalizumab-associated-pml
#20
Reinhard Hohlfeld, Joachim Havla, Tania Kümpfel
No abstract text is available yet for this article.
March 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
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