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Abdorreza Naser Moghadasi, Soroor Advani, Shiva Rahimi
No abstract text is available yet for this article.
July 6, 2016: Iranian Journal of Neurology
Brent D Kerger, Autumn Bernal, Dennis J Paustenbach, Gavin Huntley-Fenner
BACKGROUND: Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a 'negative halo effect,' a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a 'negative halo effect' may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1) intrauterine contraceptive devices (IUDs); 2) silicone gel-filled breast implants (SGBI); 3) metal-on-metal hip implants (MoM); and 4) the drug Tysabri...
2016: BMC Public Health
Susan Friend, Sandra Richman, Gary Bloomgren, Lynda M Cristiano, Madé Wenten
BACKGROUND: Patients with multiple sclerosis (MS) or Crohn's disease (CD) being treated with natalizumab (Tysabri®, Biogen) who are planning to become pregnant or discover they are pregnant after exposure to natalizumab are currently advised to balance the potential benefits and potential risks of exposure when considering treatment options. This study was undertaken to evaluate pregnancy outcomes of women with MS or CD who were exposed to natalizumab at any time within 3 months prior to conception or during pregnancy...
2016: BMC Neurology
Elena Curto, Elvira Munteis-Olivas, Eva Balcells, M Marisol Domínguez-Álvarez
Natalizumab (Tysabri(®)) is a leukocytes chemotaxis inhibitor that decreases the leukocytes passage through the hematoencephalic barrier and it is currently used in relapsing-remitting forms of multiple sclerosis (MS). We present a patient with allergic rhinoconjunctivitis diagnosed with MS who started treatment with natalizumab. She began to show mild asthmatic symptoms until she needed admission to the hospital due to respiratory insufficiency. Blood tests showed peripheral eosinophilia and the thoracic computed tomography scan demonstrated pulmonary infiltrates...
July 2016: Annals of Thoracic Medicine
Tim Spelman, Tomas Kalincik, Vilija Jokubaitis, Annie Zhang, Fabio Pellegrini, Heinz Wiendl, Shibeshih Belachew, Robert Hyde, Freek Verheul, Alessandra Lugaresi, Eva Havrdová, Dana Horáková, Pierre Grammond, Pierre Duquette, Alexandre Prat, Gerardo Iuliano, Murat Terzi, Guillermo Izquierdo, Raymond M M Hupperts, Cavit Boz, Eugenio Pucci, Giorgio Giuliani, Patrizia Sola, Daniele L A Spitaleri, Jeannette Lechner-Scott, Roberto Bergamaschi, François Grand'Maison, Franco Granella, Ludwig Kappos, Maria Trojano, Helmut Butzkueven
BACKGROUND: We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-β (IFN-β)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries. METHODS: The study population initiated IFN-β/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had ≥3 months of on-treatment follow-up, and had active RRMS, defined as ≥1 gadolinium-enhancing lesion on cerebral MRI at baseline or ≥1 relapse within the 12 months prior to baseline...
April 2016: Neurology. Clinical Practice
Justin M Honce, Lidia Nagae, Eric Nyberg
Natalizumab (Tysabri) is a monoclonal antibody (α4 integrin antagonist) approved for treatment of multiple sclerosis, both for patients who fail therapy with other disease modifying agents and for patients with aggressive disease. Natalizumab is highly effective, resulting in significant decreases in rates of both relapse and disability accumulation, as well as marked decrease in MRI evidence of disease activity. As such, utilization of natalizumab is increasing, and the presentation of its associated complications is increasing accordingly...
2015: Multiple Sclerosis International
Xiaoyu Yang, Fengqiang Wang, Ying Zhang, Larry Wang, Svetlana Antonenko, Shuli Zhang, Yi Wei Zhang, Mohammad Tabrizifard, Grigori Ermakov, Derek Wiswell, Maribel Beaumont, Liming Liu, Daisy Richardson, Mohammed Shameem, Alexandre Ambrogelly
IgG4 antibodies are evolving as an important class of cancer immunotherapies. However, human IgG4 can undergo Fab arm (half molecule) exchange with other IgG4 molecules in vivo. The hinge modification by a point mutation (S228P) prevents half molecule exchange of IgG4. However, the experimental confirmation is still expected by regulatory agencies. Here, we report for the first time the extensive analysis of half molecule exchange for a hinge-modified therapeutic IgG4 molecule, pembrolizumab (Keytruda) targeting programmed death 1 (PD1) receptor that was approved for advanced melanoma...
December 2015: Journal of Pharmaceutical Sciences
Timothy Spelman, Tomas Kalincik, Annie Zhang, Fabio Pellegrini, Heinz Wiendl, Ludwig Kappos, Larisa Tsvetkova, Shibeshih Belachew, Robert Hyde, Freek Verheul, Francois Grand-Maison, Guillermo Izquierdo, Pierre Grammond, Pierre Duquette, Alessandra Lugaresi, Jeannette Lechner-Scott, Celia Oreja-Guevara, Raymond Hupperts, Thor Petersen, Michael Barnett, Maria Trojano, Helmut Butzkueven
OBJECTIVE: To compare treatment efficacy and persistence in patients who switched to natalizumab versus those who switched between glatiramer acetate (GA) and interferon-beta (IFNβ) after an on-treatment relapse on IFNβ or GA using propensity score matched real-world datasets. METHODS: Patients included were registered in MSBase or the TYSABRI Observational Program (TOP), had relapsed on IFNβ or GA within 12 months prior to switching to another therapy, and had initiated natalizumab or IFNβ/GA treatment ≤6 months after discontinuing prior therapy...
April 2015: Annals of Clinical and Translational Neurology
(no author information available yet)
The standard disease-modifying treatment for patients with relapsing-remitting multiple sclerosis is interferon beta injection, in the absence of a better alternative. In 2007, natalizumab had an unfavourable harm-benefit balance in patients with severe multiple sclerosis in whom interferon beta was ineffective, due to insufficient evidence of efficacy and a risk of life-threatening progressive multifocal leukoencephalopathy. In 2014, we found no new comparative trials focusing on the efficacy of natalizumab monotherapy in its authorised indications in the EU...
March 2015: Prescrire International
L De Giglio, C Gasperini, C Tortorella, M Trojano, C Pozzilli
BACKGROUND: The humanized monoclonal alpha4-integrin antibody Natalizumab (NTZ) (Tysabri(©) , Biogen Idec, Cambridge, MA, USA) has shown to be effective in multiple sclerosis (MS) therapy; however, the interruption of the drug has been related to a disease restart. This risk has to be carefully considered in case of accidental or desired pregnancies. AIM OF THE STUDY: To report the risk of disease restart in patients who interrupted NTZ because of pregnancy and discuss the implication of NTZ choice in female childbearing patients with MS...
May 2015: Acta Neurologica Scandinavica
Teresa E Baker, Shaun D Cooper, Lacy Kessler, Thomas W Hale
Natalizumab (Tysabri) is a recombinant humanized antibody to α4-integrin that is approved by the Food and Drug Administration for the treatment of multiple sclerosis (MS) and Crohn disease. This is a case report of a 28-year-old woman with MS who was taking natalizumab (300 mg intravenously infused over 1 hour every 4 weeks) while breastfeeding her 11.5-month-old daughter 3 times a day. Breast milk samples were collected over a 50-day period after the patient's first drug infusion. The average concentration of natalizumab was 0...
May 2015: Journal of Human Lactation: Official Journal of International Lactation Consultant Association
Sreeram Ramagopalan, Radek Wasiak, Andrew P Cox
BACKGROUND: Multiple sclerosis (MS) is a common complex disorder, with new treatment options emerging each year. Social media is being increasingly used to investigate opinions about drugs, diseases and procedures. In this descriptive exploratory study, we sought to investigate opinions about currently available MS treatments. METHODS: The Twitter resource Topsy was searched for tweets mentioning the following MS treatments: Aubagio, Avonex, Betaferon or Betaseron, Copaxone, Extavia, Gilenya, Lemtrada, Novantrone, Rebif, Tysabri and Tecfidera between 1 Jan 2006 to 31 Jul 2014...
2014: F1000Research
Neda Ebrahimi, Sandra Herbstritt, Ralph Gold, Lilyana Amezcua, Gideon Koren, Kerstin Hellwig
BACKGROUND: Safety data on first-trimester natalizumab exposure are scarce, as natalizumab is usually withdrawn three months before pregnancy. OBJECTIVE: The objective of this paper is to investigate the fetal safety of exposure to natalizumab (Tysabri(®)) during the first trimester of pregnancy using disease-matched (DM) and healthy control (HC) comparison groups. METHODS: A total of 101 German women with RRMS exposed to natalizumab during the first trimester of pregnancy were identified...
February 2015: Multiple Sclerosis: Clinical and Laboratory Research
Simó Magdolna
No abstract text is available yet for this article.
May 30, 2014: Ideggyógyászati Szemle
Vincent van Pesch, Emmanuel Bartholomé, Véronique Bissay, Olivier Bouquiaux, Michel Bureau, Jo Caekebeke, Jan Debruyne, Inge Declercq, Dany Decoo, Pierre Denayer, Eric De Smet, Marie D'hooghe, Bénédicte Dubois, Michel Dupuis, Souraya El Sankari, Karine Geens, Daniel Guillaume, William van Landegem, Andreas Lysandropoulos, Alain Maertens de Noordhout, Robert Medaer, Annick Melin, Katelijne Peeters, Rémy Phan Ba, Cécile Retif, Pierrette Seeldrayers, Anoek Symons, Etienne Urbain, Patrick Vanderdonckt, Erwin Van Ingelghem, Ludo Vanopdenbosch, Erwin Vanroose, Bart Van Wijmeersch, Barbara Willekens, Christiana Willems, Christian Sindic
Natalizumab (Tysabri(®)) is highly efficacious in controlling disease activity in relapsing multiple sclerosis (MS) patients. As it is one of the more recent therapies for MS, there remains a need for long-term safety and efficacy data of natalizumab in a clinical practice setting. The Tysabri observational program (TOP) is an open-label, multicenter, multinational, prospective observational study, aiming to recruit up to 6,000 patients with relapsing-remitting MS from Europe, Canada and Australia. The objectives of this study are to collect long-term safety and efficacy data on disease activity and disability progression...
September 2014: Acta Neurologica Belgica
Paul O'Connor, Andrew Goodman, Ludwig Kappos, Fred Lublin, Chris Polman, Richard A Rudick, Kathy Hauswirth, Lynda M Cristiano, Fiona Forrestal, Petra Duda
OBJECTIVES: Report long-term safety and effectiveness of natalizumab over 240 weeks in the prospective, observational, open-label Safety of TYSABRI Re-dosing and Treatment (STRATA) Study. METHODS: Patients (N = 1,094) previously enrolled in natalizumab multiple sclerosis clinical trials received natalizumab 300 mg IV every 4 weeks, up to 240 weeks. Serious adverse events, Expanded Disability Status Scale (EDSS) scores, and annualized relapse rates were analyzed...
July 1, 2014: Neurology
Cormac Sheridan
No abstract text is available yet for this article.
March 2014: Nature Biotechnology
Helmut Butzkueven, Ludwig Kappos, Fabio Pellegrini, Maria Trojano, Heinz Wiendl, Radhika N Patel, Annie Zhang, Christophe Hotermans, Shibeshih Belachew
BACKGROUND: Clinical trials established the efficacy and safety of natalizumab. Data are needed over longer periods of time and in the clinical practice setting. OBJECTIVE: To evaluate long-term safety of natalizumab and its impact on annualised relapse rate and Expanded Disability Status Scale (EDSS) progression in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: The Tysabri (natalizumab) Observational Program (TOP) is an open-label, multinational, 10-year prospective study in clinical practice settings...
November 2014: Journal of Neurology, Neurosurgery, and Psychiatry
Andrew P Robinson, Christopher T Harp, Avertano Noronha, Stephen D Miller
While no single model can exactly recapitulate all aspects of multiple sclerosis (MS), animal models are essential in understanding the induction and pathogenesis of the disease and to develop therapeutic strategies that limit disease progression and eventually lead to effective treatments for the human disease. Several different models of MS exist, but by far the best understood and most commonly used is the rodent model of experimental autoimmune encephalomyelitis (EAE). This model is typically induced by either active immunization with myelin-derived proteins or peptides in adjuvant or by passive transfer of activated myelin-specific CD4+ T lymphocytes...
2014: Handbook of Clinical Neurology
Bianca Weinstock-Guttman
Disease-modifying therapies (DMTs), known to actively reduce relapses and delay disability progression, have been used for the treatment of relapsing-remitting multiple sclerosis (RRMS) for over a decade. These well-known therapies include intramuscular (IM) interferon (IFN) beta-1a (Avonex), subcutaneous (SC) IFN beta-1a (Rebif), SC IFN beta- 1b (Betaseron; Extavia), and SC glatiramer acetate (Copaxone). These first-line therapies have shown only partial benefits for controlling multiple sclerosis (MS) disease activity and are often associated with inadequate patient adherence...
November 2013: American Journal of Managed Care
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