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Natalizumab

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https://www.readbyqxmd.com/read/28916537/reversibility-of-the-effects-of-natalizumab-on-peripheral-immune-cell-dynamics-in-ms-patients
#1
Tatiana Plavina, Kumar Kandadi Muralidharan, Geoffrey Kuesters, Daniel Mikol, Karleyton Evans, Meena Subramanyam, Ivan Nestorov, Yi Chen, Qunming Dong, Pei-Ran Ho, Diogo Amarante, Alison Adams, Jerome De Sèze, Robert Fox, Ralf Gold, Douglas Jeffery, Ludwig Kappos, Xavier Montalban, Bianca Weinstock-Guttman, Hans-Peter Hartung, Bruce A C Cree
OBJECTIVE: To characterize the reversibility of natalizumab-mediated changes in pharmacokinetics/pharmacodynamics in patients with multiple sclerosis (MS) following therapy interruption. METHODS: Pharmacokinetic/pharmacodynamic data were collected in the Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis (AFFIRM) (every 12 weeks for 116 weeks) and Randomized Treatment Interruption of Natalizumab (RESTORE) (every 4 weeks for 28 weeks) studies...
September 15, 2017: Neurology
https://www.readbyqxmd.com/read/28913726/diagnosis-and-treatment-of-progressive-multifocal-leukoencephalopathy-associated-with-multiple-sclerosis-therapies
#2
REVIEW
Eric M L Williamson, Joseph R Berger
Progressive multifocal leukoencephalopathy (PML) is a rare, but serious, complication encountered in patients treated with a select number of disease-modifying therapies (DMTs) utilized in treating multiple sclerosis (MS). PML results from a viral infection in the brain for which the only demonstrated effective therapy is restoring the perturbed immune system-typically achieved in the patient with MS by removing the offending therapeutic agent or, in the case of HIV-associated PML, treatment with highly active antiretroviral therapies...
September 14, 2017: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
https://www.readbyqxmd.com/read/28910968/efficiency-of-antibody-therapy-in-demyelinating-diseases
#3
Tetsuya Akaishi, Ichiro Nakashima
Monoclonal antibody therapy is a new treatment strategy for many types of diseases including cancers and autoimmune diseases, realizing a high efficacy and tolerability. In multiple sclerosis (MS) and neuromyelitis optica (NMO) spectrum disorders, several monoclonal antibodies have been suggested to decrease the incidence of clinical relapse and the disease activity. In MS, anti-α4 integrin (natalizumab), anti-CD52 (alemtuzumab), anti-CD25 (daclizumab) and anti-CD20 (ocrelizumab) have been shown to effectively reduce the relapses in randomized controlled trials and have been approved by the Food and Drug Administration...
July 1, 2017: International Immunology
https://www.readbyqxmd.com/read/28905255/benefit-risk-profile-of-sphingosine-1-phosphate-receptor-modulators-in-relapsing-and-secondary-progressive-multiple-sclerosis
#4
Giancarlo Comi, Hans-Peter Hartung, Rajesh Bakshi, Ian M Williams, Heinz Wiendl
Since the approval of fingolimod, several selective sphingosine-1-phosphate receptor modulators have entered clinical development for multiple sclerosis. However, side effects can occur with sphingosine-1-phosphate receptor modulators. By considering short-term data across the drug class and longer term fingolimod data, we aim to highlight the potential of sphingosine-1-phosphate receptor modulators in multiple sclerosis, while offering reassurance that their benefit-risk profiles are suitable for long-term therapy...
September 13, 2017: Drugs
https://www.readbyqxmd.com/read/28901547/cognitive-functioning-following-one-year-natalizumab-treatment-a-non-randomized-clinical-trial
#5
I Rorsman, C Petersen, P C Nilsson
OBJECTIVES: Cognitive impairment is common in multiple sclerosis (MS) and can have serious impact on social and occupational functioning. Natalizumab reduces relapse rates, magnetic resonance imaging (MRI) lesions, and progression of disability. Previous studies on cognitive functioning have not based inclusion on cognitive performance criteria. The aim of the present study was to determine any potential natalizumab-related cognitive effects on MS patients performing below normal limits on neuropsychological testing...
September 13, 2017: Acta Neurologica Scandinavica
https://www.readbyqxmd.com/read/28875861/therapeutic-monoclonal-antibodies-and-multiple-sclerosis-the-essentials
#6
Ioannis Heliopoulos, Athanasia Patousi
BACKGROUND: Monoclonal antibodies (mAbs) are now established as targeted therapies for malignancies, transplant rejection, autoimmune and infectious diseases. Two monoclonal antibodies are available for treatment and other antibodies are currently being tested in multiple sclerosis (MS) patients. OBJECTIVES: The purpose of the present review paper is to outline the antibody engineering technologies, the immunologic and pharmacologic concepts of mΑbs and the current status of treatment in MS with emphasis on clinical efficacy and safety...
September 6, 2017: Medicinal Chemistry
https://www.readbyqxmd.com/read/28870657/use-of-biologic-therapy-by-pregnant-women-with-inflammatory-bowel-disease-does-not-affect-infant-response-to-vaccines
#7
Dawn B Beaulieu, Ashwin N Ananthakrishnan, Christopher Martin, Russell D Cohen, Sunanda V Kane, Uma Mahadevan
BACKGROUND & AIMS: In women with inflammatory bowel diseases (IBD), exposure to immunomodulator or biologic therapy has not been associated with adverse events during pregnancy or outcomes of newborns. We investigated whether exposure of patients to these agents during pregnancy affects serologic responses to vaccines in newborns. METHODS: We collected data from the Pregnancy in IBD and Neonatal Outcomes registry, which records outcomes of pregnant women with diagnosis of IBD receiving care at multiple centers in the United States, from 2007 - 2016...
September 1, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28870565/corrigendum-to-is-maraviroc-useful-in-multiple-sclerosis-patients-with-natalizumab-related-progressive-multifocal-leukoencephalopathy-j-neurol-sci-378-2017-233-237
#8
C Scarpazza, L Prosperini, C R Mancinelli, N De Rossi, A Lugaresi, M Capobianco, L Moiola, P Naldi, L Imberti, S Gerevini, R Capra
No abstract text is available yet for this article.
September 15, 2017: Journal of the Neurological Sciences
https://www.readbyqxmd.com/read/28864818/the-italian-pharmacovigilance-program-an-observational-study-of-adverse-effects-of-natalizumab-in-multiple-sclerosis-therapy
#9
Sabrina Giacoppo, Maria Ruscica, Luigi Maria Grimaldi, Placido Bramanti, Emanuela Mazzon
BACKGROUND This study shows the results of a regional pharmacovigilance program on Natalizumab therapy in relapsing-remitting multiple sclerosis (RR-MS) patients after 3 years of experience. MATERIAL AND METHODS The primary objectives of this study were to estimate the incidence of expected and unexpected adverse effects correlated to Natalizumab therapy in a cohort of 88 RR-MS patients from Sicily, Italy, and to investigate the procedures adopted by the physicians to minimize the risk of developing severe adverse reactions correlated to Natalizumab therapy...
September 2, 2017: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
https://www.readbyqxmd.com/read/28861122/the-role-of-natalizumab-in-the-treatment-of-multiple-sclerosis-benefits-and-risks
#10
REVIEW
Barry A Singer
Natalizumab, a monoclonal antibody that blocks lymphocyte infiltration in the central nervous system, is a valuable tool in the treatment of relapsing forms of multiple sclerosis (MS). In a phase III clinical trial comparing natalizumab with placebo over 2 years, natalizumab reduced annualized relapse rate by 68%, 12-week confirmed disability progression by 42%, and reduced contrast-enhancing lesions by 92%. In post hoc analyses, natalizumab treatment was associated with 37% of patients achieving no evidence of disease activity (versus 7% on placebo) and 30% achieving sustained disability improvement (versus 19% on placebo)...
September 2017: Therapeutic Advances in Neurological Disorders
https://www.readbyqxmd.com/read/28857686/natalizumab-during-pregnancy-and-lactation
#11
Undine Proschmann, Katja Thomas, Sandra Thiel, Kerstin Hellwig, Tjalf Ziemssen
BACKGROUND: Managing medication during pregnancy and lactation in multiple sclerosis (MS) patients needs to balance potential risks to the newborn with the substantial risks of ongoing disease activity. OBJECTIVE: To evaluate the potential transfer of natalizumab (NAT) into breast milk and into the serum of newborn babies in women who continued NAT treatment during pregnancy and lactation. METHODS: Serum samples of 11 mother-infant pairs and mother milk samples of a further 4 women were analyzed for free NAT using a HL60 cell-based fluorescence-activated cell sorting (FACS) assay...
August 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28857680/cladribine-versus-fingolimod-natalizumab-and-interferon-%C3%AE-for-multiple-sclerosis
#12
Tomas Kalincik, Vilija Jokubaitis, Tim Spelman, Dana Horakova, Eva Havrdova, Maria Trojano, Jeannette Lechner-Scott, Alessandra Lugaresi, Alexandre Prat, Marc Girard, Pierre Duquette, Pierre Grammond, Claudio Solaro, Francois Grand'Maison, Raymond Hupperts, Julie Prevost, Patrizia Sola, Diana Ferraro, Murat Terzi, Ernest Butler, Mark Slee, Allan Kermode, Marzena Fabis-Pedrini, Pamela McCombe, Michael Barnett, Cameron Shaw, Suzanne Hodgkinson, Helmut Butzkueven
OBJECTIVE: This propensity score-matched analysis from MSBase compared the effectiveness of cladribine with interferon β, fingolimod or natalizumab. METHODS: We identified all patients with relapse-onset multiple sclerosis, exposure to the study therapies and ⩾1-year on-treatment follow-up from MSBase. Three pairwise propensity score-matched analyses compared treatment outcomes over 1 year. The outcomes were hazards of first relapse, disability accumulation and disability improvement events...
August 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28856176/%C3%AE-4-integrin-receptor-desaturation-and-disease-activity-return-after-natalizumab-cessation
#13
Tobias Derfuss, John M Kovarik, Ludwig Kappos, Marina Savelieva, Richa Chhabra, Avinash Thakur, Ying Zhang, Heinz Wiendl, Davorka Tomic
OBJECTIVE: To describe the time course of α4-integrin receptor desaturation and disease activity return in patients with relapsing-remitting MS who discontinued natalizumab and to investigate baseline and on-study predictors for the recurrence of disease activity. METHODS: In the course of TOFINGO, a 32-week, patient- and rater-blinded multicenter, parallel-group study, we performed MRI, counted relapses, and measured α4-integrin receptor occupancy (RO) at baseline and 8, 12, 16, 20, and 24 weeks...
September 2017: Neurology® Neuroimmunology & Neuroinflammation
https://www.readbyqxmd.com/read/28844615/anti-jcv-antibody-serostatus-and-longitudinal-evaluation-in-a-portuguese-multiple-sclerosis-population
#14
I Correia, J Jesus-Ribeiro, S Batista, A I Martins, C Nunes, M C Macário, L Cunha, L Sousa
Multiple Sclerosis (MS) treatment with natalizumab is associated with Progressive Multifocal Leukoencephalopathy (PML). The risk of PML being related to the anti-JCV antibody index is well established, but there is less known about seroconversion rates in natalizumab-treated patients and longitudinal variation in the anti-JCV antibody index. Our objective was to assess anti-JCV antibody prevalence in an MS population and to evaluate the evolution of the anti-JCV antibody index in natalizumab-treated patients...
August 24, 2017: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
https://www.readbyqxmd.com/read/28844068/dimethyl-fumarate-a-possible-exit-strategy-from-natalizumab-treatment-in-patients-with-multiple-sclerosis-at-risk-for-severe-adverse-events
#15
Massimiliano Calabrese, Marco Pitteri, Gabriele Farina, Albulena Bajrami, Marco Castellaro, Roberta Magliozzi, Salvatore Monaco
INTRODUCTION: Among disease-modifying treatments for multiple sclerosis, natalizumab (NTZ) is highly effective, well tolerated and generally safe. Major concerns regard the risk of developing progressive multifocal leukoencephalopathy (PML), and the occurrence of rebounds or disease activity after its discontinuation. The aim of this study was to explore the efficacy of dimethyl fumarate (DMF) in preventing disease reactivation after NTZ discontinuation. METHODS: Thirty-nine patients with relapsing remitting multiple sclerosis, at high risk of PML, were switched from NTZ to DMF and underwent neurological and 3T MRI monitoring for 2 years...
August 26, 2017: Journal of Neurology, Neurosurgery, and Psychiatry
https://www.readbyqxmd.com/read/28836899/association-between-bkpyv-serotype-i-antibody-level-and-natalizumab-associated-progressive-multifocal-leukoencephalopathy
#16
Francesca Rossi, Luca Prosperini, Nicola De Rossi, Ruggero Capra, Daniela Rivanera, Xiuhong Li, Paola Cinque, Laura Passeri, Carlo Pozzilli, Raphael Viscidi
To determine the association between BK polyomavirus (BKPyV) types 1 and 4 capsid antibody and natalizumab-associated progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis (MS), serum samples were obtained from 10 natalizumab-associated PML cases and 130 control MS patients treated with natalizumab, and 82 control MS patients never exposed to natalizumab. In a sex- and age-adjusted regression model, BKPyV serotype 1 antibody levels were significantly higher in natalizumab-treated controls (p = 0...
August 24, 2017: Viral Immunology
https://www.readbyqxmd.com/read/28832222/natalizumab-in-the-treatment-of-crohn-s-disease-patients
#17
Cristiano Pagnini, Kristen O Arseneau, Fabio Cominelli
Amongst the available therapies for moderate to severe Crohn's disease (CD) patients who are refractory to conventional therapy, anti-TNF blockers are the most effective biological treatment option. However, many patients experience a primary or secondary non-response to anti-TNF therapy, creating the need for alternative biological drugs that target different mechanisms of action and inflammatory pathways. Natalizumab, the first non-anti-TNF biological drug to be approved for treatment of CD patients, is a recombinant humanized antibody that targets the α4-subunit of both α4β1 and α4β7 integrins, thus preventing activated leukocyte homing to the intestinal mucosa...
August 23, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28831768/jcpyv-microrna-in-plasma-inversely-correlates-with-jcpyv-seropositivity-among-long-term-natalizumab-treated-relapsing-remitting-multiple-sclerosis-patients
#18
Pabitra Basnyat, Elina Virtanen, Irina Elovaara, Sanna Hagman, Eeva Auvinen
Sensitive biomarkers are needed to better manage multiple sclerosis (MS) patients for natalizumab (NTZ)-associated risk of progressive multifocal leukoencephalopathy (PML). A currently used risk stratification algorithm, mainly based on JC polyomavirus (JCPyV) serology, has not led to a reduction of PML incidence. Therefore, this study was designed to evaluate the presence and prevalence of JCPyV miRNAs in plasma of NTZ-treated MS patients, and to explore their biomarker potential for NTZ-associated PML risk assessment...
August 22, 2017: Journal of Neurovirology
https://www.readbyqxmd.com/read/28805095/letter-to-the-editor-on-the-paper-the-majority-of-natalizumab-treated-ms-patients-have-high-natalizumab-concentrations-at-time-of-re-dosing
#19
Tony Sehr, Undine Proschmann, Katja Thomas, Tjalf Ziemssen
No abstract text is available yet for this article.
August 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28791614/age-as-a-risk-factor-for-early-onset-of-natalizumab-related-progressive-multifocal-leukoencephalopathy
#20
Luca Prosperini, Cristina Scarpazza, Luisa Imberti, Cinzia Cordioli, Nicola De Rossi, Ruggero Capra
Progressive multifocal leukoencephalopathy (PML) is a rare but potentially fatal opportunistic infection that arises almost exclusively in immunocompromised patients or in those treated with monoclonal antibodies, especially natalizumab. Here, we aimed at exploring if age at treatment start affects the time to onset of natalizumab-related PML. PubMed was searched for the terms "natalizumab and progressive multifocal leukoencephalopathy" in articles published from January 2005 to March 2017. We collected information on each identified PML case, including demographic and clinical variables at natalizumab start and at PML onset...
August 8, 2017: Journal of Neurovirology
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