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https://www.readbyqxmd.com/read/27892793/physiologically-based-modeling-to-predict-the-clinical-behavior-of-monoclonal-antibodies-directed-against-lymphocyte-antigens
#1
Patrick M Glassman, Joseph P Balthasar
Many clinically approved and investigational monoclonal antibody (mAb)-based therapeutics are directed against proteins located in the systemic circulation, including cytokines, growth factors, lymphocyte proteins, and shed antigens. Interaction between mAb and target may lead to non-linear pharmacokinetics (PK), characterized by rapid, target-mediated elimination. Several groups have reported that determinants of target-mediated elimination could include mAb-target binding, target expression, and target turnover...
November 28, 2016: MAbs
https://www.readbyqxmd.com/read/27891572/safety-concerns-and-risk-management-of-multiple-sclerosis-therapies
#2
REVIEW
P Soelberg Sorensen
Currently, more than ten drugs have been approved for treatment of relapsing-remitting multiple sclerosis (MS). Newer treatments may be more effective, but have less favorable safety record. Interferon-β preparations and glatiramer acetate treatment require frequent subcutaneous or intramuscular injections and are only moderately effective, but have very rarely life-threatening adverse effects, whereas teriflunomide and dimethyl fumarate are administered orally and have equal or better efficacy, but have more potentially severe adverse effects...
November 27, 2016: Acta Neurologica Scandinavica
https://www.readbyqxmd.com/read/27888093/randomized-trial-of-ratg-daclizumab-vs-ratg-alemtuzumab-as-dual-induction-therapy-in-renal-transplantation-results-at-8-years-of-follow-up
#3
Gaetano Ciancio, Jeffrey J Gaynor, Giselle Guerra, Junichiro Sageshima, David Roth, Linda Chen, Warren Kupin, Adela Mattiazzi, Lissett Tueros, Sandra Flores, Lois Hanson, Phillip Ruiz, Rodrigo Vianna, George W Burke
Our goal in using dual induction therapy is to bring the kidney transplant recipient closer (through more effectively timed lymphodepletion) to an optimally immunosuppressed state. Here, we report long-term results of a prospective randomized trial comparing (Group I,N=100) rATG/Dac (3 rATG, 2 Dac doses) vs. (Group II,N=100) rATG/Alemtuzumab(C1H) (1 dose each), using reduced tacrolimus dosing, EC-MPS, and early corticosteroid withdrawal. Lower EC-MPS dosing was targeted in Group II to avoid severe leukopenia...
November 22, 2016: Transplant Immunology
https://www.readbyqxmd.com/read/27886802/advancements-in-the-management-of-uveitis
#4
REVIEW
Sergio Schwartzman
Uveitis may exist as a clinical manifestation of an underlying systemic disease or may represent an idiopathic entity, sometimes with a very characteristic pattern. Different forms of uveitis have been defined on the basis of three important variables: chronicity, anatomic location, and underlying etiology. The evolving understanding of the immune system has resulted in a more targeted approach to manage patients with different forms of uveitis, although clearly this approach is at a very early stage. Altered patterns of cellular processing and different cytokine expression, including TNF, IL-1, IL-2, IL-6, and IL17, have been defined in uveitis, and this has laid the pathway for targeted therapy...
April 2016: Best Practice & Research. Clinical Rheumatology
https://www.readbyqxmd.com/read/27849440/use-of-cidofovir-for-cytomegalovirus-disease-refractory-to-ganciclovir-in-solid-organ-recipients
#5
Hugo Bonatti, Costi D Sifri, Clara Larcher, Stefan Schneeberger, Camille Kotton, Christian Geltner
BACKGROUND: Solid organ transplantation (SOT) frequently is complicated by cytomegalovirus (CMV) infections. Cidofovir (CDV) is active against CMV, including many ganciclovir (GCV)-resistant mutants, but often is considered to be too nephrotoxic for use after organ transplantation. PATIENTS AND METHODS: Seven males and two females (median age 50.1 years), including two kidney/pancreas, four lung, one small bowel, and two hand recipients, received CDV for refractory CMV disease...
November 16, 2016: Surgical Infections
https://www.readbyqxmd.com/read/27813419/anti-interleukin-2-receptor-antibodies-for-the-prevention-of-rejection-in-liver-transplant-recipients-a-systematic-review-and-meta-analysis
#6
Yi Zhang, Weidong Jin, Xun Cai
BACKGROUND: Antibody induction therapy aims to prevent acute cellular rejection by reducing T-cell proliferation and activation. We evaluated the efficacy and side effects of two anti-interleukin-2 receptor antibodies (IL2RA), basiliximab and daclizumab, for prevention of liver transplant rejection in adult patients. METHODS: Randomized controlled trials on basiliximab or daclizumab were identified by searching multiple databases and reference lists published up to July, 2015...
November 4, 2016: Annals of Medicine
https://www.readbyqxmd.com/read/27788794/impact-of-trough-levels-of-tacrolimus-on-kidney-function-and-graft-survival-in-short-and-longer-periods-after-renal-transplantation
#7
Z Žilinská, I Dedinská, J Breza, L Laca
BACKGROUND: Optimizing immunosuppressive treatment in the early posttransplant period is important for achieving long-term graft function and survival. MATERIAL AND METHODS: There were 205 renal transplant recipients involved in this study. Patients were divided into groups according to the induction therapy (no induction vs basiliximab/daclizumab vs rabbit antithymocyte globulin), maintenance therapy at the time of transplantation (tacrolimus [TAC] vs cyclosporine), the average trough TAC levels in months 4 to 6 after TO and serum creatinine 5 years after renal transplantation...
October 2016: Transplantation Proceedings
https://www.readbyqxmd.com/read/27756999/pharmaceutical-approval-update
#8
Michele B Kaufman
Obeticholic acid (Ocaliva) for primary biliary cholangitis; sofosbuvir 400 mg/velpatasvir 100 mg (Epclusa) for chronic hepatitis C virus infection; and daclizumab (Zinbryta) for relapsing multiple sclerosis.
October 2016: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/27756172/safety-of-monoclonal-antibodies-for-the-treatment-of-multiple-sclerosis
#9
Marisa P McGinley, Brandon P Moss, Jeffrey A Cohen
Monoclonal antibodies are a potent therapeutic approach for relapsing-remitting multiple sclerosis. This group of medications comprises diverse mechanisms of action resulting in both shared and unique adverse effects. Areas covered: The major trials and safety profiles of natalizumab, alemtuzumab, daclizumab, rituximab, and ocrelizumab are discussed. While each drug has a unique safety profile, one of the potential safety concerns for all of these drugs is infection, including for some progressive multifocal leukoencephalopathy...
October 19, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27672308/therapeutic-efficacy-of-monthly-subcutaneous-injection-of-daclizumab-in-relapsing-multiple-sclerosis
#10
REVIEW
Stanley Cohan
Despite the availability of multiple disease-modifying therapies for relapsing multiple sclerosis (MS), there remains a need for highly efficacious targeted therapy with a favorable benefit-risk profile and attributes that encourage a high level of treatment adherence. Daclizumab is a humanized monoclonal antibody directed against CD25, the α subunit of the high-affinity interleukin 2 (IL-2) receptor, that reversibly modulates IL-2 signaling. Daclizumab treatment leads to antagonism of proinflammatory, activated T lymphocyte function and expansion of immunoregulatory CD56(bright) natural killer cells, and has the potential to, at least in part, rectify the imbalance between immune tolerance and autoimmunity in relapsing MS...
2016: Biologics: Targets & Therapy
https://www.readbyqxmd.com/read/27645341/safety-and-tolerability-profile-of-daclizumab-in-patients-with-relapsing-remitting-multiple-sclerosis-an-integrated-analysis-of-clinical-studies
#11
Gavin Giovannoni, Ludwig Kappos, Ralf Gold, Bhupendra O Khatri, Krzysztof Selmaj, Kimberly Umans, Steven J Greenberg, Marianne Sweetser, Jacob Elkins, Peter McCroskery
BACKGROUND: Daclizumab has been evaluated in multicentre, randomised, double-blind studies for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Safety and tolerability are key considerations in MS treatment selection, as they influence adherence to medication. OBJECTIVE: Evaluate the safety of daclizumab in patients with RRMS from an integrated analysis of six clinical studies. METHODS: Patients treated with at least one dose of subcutaneous daclizumab 150mg or 300mg monthly in three completed and three ongoing clinical studies were included in this integrated analysis...
September 2016: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/27640189/multiple-sclerosis-in-pediatrics-current-concepts-and-treatment-options
#12
REVIEW
Jasna Jancic, Blazo Nikolic, Nikola Ivancevic, Vesna Djuric, Ivan Zaletel, Dejan Stevanovic, Sasa Peric, John N van den Anker, Janko Samardzic
Multiple sclerosis (MS) is a chronic, autoimmune, inflammatory, demyelinating disease of the central nervous system. MS is increasingly recognized in the pediatric population, and it is usually diagnosed around 15 years of age. The exact etiology of MS is still not known, although autoimmune, genetic, and environmental factors play important roles in its development, making it a multifactorial disease. The disease in children almost always presents in the relapsing-remittent form. The therapy involves treatment of relapses, and immunomodulatory and symptomatic treatment...
December 2016: Neurology and Therapy
https://www.readbyqxmd.com/read/27603962/daclizumab-zinbryta-for-multiple-sclerosis
#13
(no author information available yet)
No abstract text is available yet for this article.
September 12, 2016: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/27461166/safety-and-efficacy-of-daclizumab-in-relapsing-remitting-multiple-sclerosis-3-year-results-from-the-selected-open-label-extension-study
#14
Ralf Gold, Ernst-Wilhelm Radue, Gavin Giovannoni, Krzysztof Selmaj, Eva Havrdova, Dusan Stefoski, Till Sprenger, Xavier Montalban, Stanley Cohan, Kimberly Umans, Steven J Greenberg, Gulden Ozen, Jacob Elkins
BACKGROUND: Daclizumab is a humanized monoclonal antibody against CD25 that modulates interleukin 2 signaling. The SELECT TRILOGY of clinical studies (SELECT/SELECTION/SELECTED) evaluated the safety and efficacy of daclizumab in patients with relapsing-remitting multiple sclerosis (RRMS). We report the long-term safety and efficacy of daclizumab 150 mg subcutaneous every 4 weeks in patients with RRMS in the SELECTED open-label extension study. METHODS: An interim intent-to-treat analysis of all enrolled patients was performed in January 2014 for this ongoing study...
2016: BMC Neurology
https://www.readbyqxmd.com/read/27411694/pregnancy-experience-nonclinical-studies-and-pregnancy-outcomes-in-the-daclizumab-clinical-study-program
#15
Ralf Gold, Dusan Stefoski, Krzysztof Selmaj, Eva Havrdova, Christopher Hurst, Joan Holman, Belen Tornesi, Surekha Akella, Peter McCroskery
INTRODUCTION: Multiple sclerosis (MS) is more common in women and can occur during childbearing years; thus, information on outcomes following exposure to MS therapy during pregnancy is important. No formal studies of daclizumab have been conducted in pregnant women. Here, we report available nonclinical and clinical data on pregnancy outcomes from the daclizumab clinical study program. METHODS: Reproductive and developmental toxicity studies were conducted in cynomolgus monkeys...
December 2016: Neurology and Therapy
https://www.readbyqxmd.com/read/27367933/the-cd25-binding-antibody-daclizumab-high-yield-process-has-a-distinct-glycosylation-pattern-and-reduced-antibody-dependent-cell-mediated-cytotoxicity-in-comparison-to-zenapax%C3%A2
#16
Bishu Ganguly, Balaji Balasa, Lyubov Efros, Paul R Hinton, Stephen Hartman, Archana Thakur, Joanna M Xiong, Brian Schmidt, Randy R Robinson, Thierry Sornasse, Vladimir Vexler, James P Sheridan
The CD25-binding antibody daclizumab high-yield process (DAC HYP) is an interleukin (IL)-2 signal modulating antibody that shares primary amino acid sequence and CD25 binding affinity with Zenapax®, a distinct form of daclizumab, which was approved for the prevention of acute organ rejection in patients receiving renal transplants as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. Comparison of the physicochemical properties of the two antibody forms revealed the glycosylation profile of DAC HYP differs from Zenapax in both glycan distribution and the types of oligosaccharides, most notably high-mannose, galactosylated and galactose-alpha-1,3-galactose (alpha-Gal) oligosaccharides, resulting in a DAC HYP antibody material that is structurally distinct from Zenapax...
July 1, 2016: MAbs
https://www.readbyqxmd.com/read/27333593/population-pk-pd-analyses-of-cd25-occupancy-cd56-bright-nk-cell-expansion-and-regulatory-t-cell-reduction-by-daclizumab-hyp-in-subjects-with-multiple-sclerosis
#17
Lei Diao, Yaming Hang, Ahmed A Othman, Devangi Mehta, Lakshmi Amaravadi, Ivan Nestorov, Jonathan Q Tran
AIM: Daclizumab high yield process (HYP) is a humanized IgG1 monoclonal antibody that binds to the α-subunit of the interleukin-2 receptor and is being developed for treatment of multiple sclerosis (MS). This manuscript characterized the pharmacokinetic-pharmacodynamic (PK-PD) relationships of daclizumab HYP in subjects with MS. METHODS: Approximately 1400 subjects and 7000 PD measurements for each of three biomarkers [CD25 occupancy, CD56(bright) natural killer (NK) cell count, regulatory T cell (Treg) count] from four clinical trials were analyzed using non-linear mixed effects modelling...
November 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27314428/use-of-disease-modifying-therapies-in-pediatric-ms
#18
REVIEW
Marta Simone, Tanuja Chitnis
Pediatric multiple sclerosis (PedMS) is a rare disease with a more severe prognosis compared to adult-onset MS. It remains a challenging condition to treat because of the highly inflammatory nature of the disease, the prominent cognitive issues, and the limited knowledge about the efficacy and safety of current available disease-modifying therapies. Over the past decade, there has been a dramatic increase in the number of drugs licensed for adult-onset MS and several of them, although not tested in PedMS, are currently being used off-label in this population...
August 2016: Current Treatment Options in Neurology
https://www.readbyqxmd.com/read/27312167/immunological-treatment-of-multiple-sclerosis
#19
Martin Diebold, Tobias Derfuss
Treatment of multiple sclerosis (MS) has been a challenge since its first description by Charcot. The advent of immunomodulatory drugs in the mid 1990s brought the first big change in the treatment of MS patients. During the last 10 years there has been an ongoing tremendous evolution of novel treatment options for relapsing-remitting MS. These options include monoclonal antibodies, which inhibit migration of lymphocytes (natalizumab), deplete lymphocytes (alemtuzumab), or block the cytokine receptor interleukin (IL)-2 (daclizumab), teriflunomide that inhibits proliferation of activated lymphocytes, fingolimod that modulates the sphingosine-receptor system, and dimethylfumarate that combines features of immunomodulatory and immunosuppressive drugs...
April 2016: Seminars in Hematology
https://www.readbyqxmd.com/read/27285580/g-csf-and-exenatide-might-be-associated-with-increased-long-term-survival-of-allogeneic-pancreatic-islet-grafts
#20
Alessia Zoso, Paolo Serafini, Giacomo Lanzoni, Eduardo Peixoto, Shari Messinger, Alejandro Mantero, Nathalia D Padilla-Téllez, David A Baidal, Rodolfo Alejandro, Camillo Ricordi, Luca Inverardi
BACKGROUND: Allogeneic human islet transplantation is an effective therapy for the treatment of patients with Type 1 Diabetes (T1D). The low number of islet transplants performed worldwide and the different transplantation protocols used limit the identification of the most effective therapeutic options to improve the efficacy of this approach. METHODS: We present a retrospective analysis on the data collected from 44 patients with T1D who underwent islet transplantation at our institute between 2000 and 2007...
2016: PloS One
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