Read by QxMD icon Read


Veronica Lanza Cariccio, Placido Bramanti, Emanuela Mazzon
Natalizumab (NTZ, Tysabri®; Biogen-Idec, Cambridge, MA, USA) is a humanized anti-α4 integrin monoclonal antibody, largely used in the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). Although the drug has shown great efficacy in clinical trials (AFFIRM and SENTINEL) and in post-marketing observational studies (TYGRIS), by reducing clinical signs as disability status progression, brain lesions and annual relapse rate, there are numerous papers concerning the associated risk of progressive multifocal leukoencephalopathy (PML)...
February 2018: Multiple Sclerosis and related Disorders
Rachel A Sabol, Virginia Noxon, Oliver Sartor, Joseph R Berger, Zaina Qureshi, Dennis W Raisch, LeAnn B Norris, Paul R Yarnold, Peter Georgantopoulos, William J Hrushesky, Laura Bobolts, Paul Ray, Akida Lebby, Robert C Kane, Charles L Bennett
A 43-year-old female with multiple sclerosis developed urethral melanoma. The only potential risk factor was treatment with natalizumab, a humanized monoclonal antibody against α4 integrins. To investigate the risk-exposure relationship, we reviewed this case, all other published cases, and cases of natalizumab-associated melanoma reported to regulatory agencies. Data sources included the Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) (2004-2014), a FDA Advisory Committee Meeting Report, and peer-reviewed publications...
July 2017: Cancer Medicine
Ludwig Kappos, Helmut Butzkueven, Heinz Wiendl, Timothy Spelman, Fabio Pellegrini, Yi Chen, Qunming Dong, Harold Koendgen, Shibeshih Belachew, Maria Trojano
BACKGROUND: Confirmed Expanded Disability Status Scale (EDSS) progression occurring after a fixed-study entry baseline is a common measure of disability increase in relapsing-remitting multiple sclerosis (RRMS) studies but may not detect all disability progression events, especially those unrelated to overt relapses. OBJECTIVE: To evaluate possible measures of disability progression unrelated to relapse using EDSS data over ≈5.5 years from the Tysabri(®) Observational Program (TOP)...
May 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
B Polistena, F Spandonaro, C Gasperini, G B Zimatore, L Santoni, S Fantaccini, R Capra
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Tiffany Shih, Craig Wakeford, Dennis Meletiche, Jesse Sussell, Adrienne Chung, Yanmei Liu, Jin Joo Shim, Darius Lakdawalla
OBJECTIVES: To illustrate a more comprehensive view of value associated with medicines treating a highly severe illness and to apply these insights to estimate the costs and benefits of 3 treatments for multiple sclerosis (MS): Avonex, Tysabri, and Tecfidera. STUDY DESIGN: Retrospective study spanning 2002 to 2013. We used economic theory to derive the value of therapy to patients with MS and to individuals who face the risk of contracting MS in the future, under the alternative assumptions that therapies were fully insured or paid for out of pocket...
November 1, 2016: American Journal of Managed Care
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...
September 15, 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...
August 24, 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
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"