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https://www.readbyqxmd.com/read/29695598/preapproval-and-postapproval-evidence-on-drugs-for-multiple-sclerosis
#1
REVIEW
Chiara Gerardi, Vittorio Bertele', Silvia Rossi, Silvio Garattini, Rita Banzi
OBJECTIVE: To review the evidence supporting the European Union marketing authorization of drugs for multiple sclerosis (MS) and assess how far postmarketing research addresses information gaps at the time of approval. METHODS: Through its database, we identified drugs approved by the European Medicines Agency and gathered data on pivotal trials from the European Public Assessment Reports and corresponding publications. We searched Medline, Embase, Cochrane Library, and trial registries for postmarketing randomized controlled trials testing the drugs identified in any form of the disease...
April 25, 2018: Neurology
https://www.readbyqxmd.com/read/29663814/new-biological-agents-in-the-treatment-of-multiple-sclerosis
#2
M Buc
Multiple sclerosis (MS) is an inflammatory disease induced by autoimmune processes. Their understanding has resulted in an introduction of biological agents to its treatment. Interferon beta and glatiramer acetate have been in clinical practice for more than 20 years. Nowadays, novel biologics, which target molecules involved in immunopathological processes more specifically have entered the scene. They are represented by monoclonal antibodies binding to molecules VLA4 (natalizumab), CD20 (ocrelizumab), CD52 (alemtuzumab) or alpha subunit of IL-2 receptor (daclizumab) or by small molecules such as those modulating the receptors involved in regulation of lymphocyte migration (fingolimod, ozanimod) or in induction of lymphopenia by apoptosis (dimethyl fumarate, cladribine)...
2018: Bratislavské Lekárske Listy
https://www.readbyqxmd.com/read/29661806/daclizumab-therapy-for-multiple-sclerosis
#3
Bibiana Bielekova
Daclizumab is a humanized monoclonal antibody that prevents formation of high-affinity interleukin (IL)-2 receptor (IL-2R). Because activated T cells up-regulate high-affinity IL-2R and IL-2 is used to grow activated T cells in vitro, daclizumab was envisioned to selectively inhibit activated T cells. However, the mechanism of action (MOA) of daclizumab is surprisingly broad and it includes many unanticipated effects on innate immunity. Specifically, daclizumab modulates the development of innate lymphoid cells, leading to expansion of immunoregulatory CD56bright natural killer (NK) cells...
April 16, 2018: Cold Spring Harbor Perspectives in Medicine
https://www.readbyqxmd.com/read/29645071/daclizumab-in-multiple-sclerosis
#4
REVIEW
F C Perez-Miralles
INTRODUCTION: Daclizumab is a monoclonal antibody directed against the CD25 subunit of the interleukin-2 receptor, investigated as a disease-modifying therapy in relapsing-remitting multiple sclerosis. The present review addresses how the drug was developed, the known mechanism of action of the drug and the up-to-date data of efficacy and safety. DEVELOPMENT: Daclizumab has shown superiority in prevention of relapses against placebo and low-dose interferon beta-1a at a level that puts it on par with the rest of current first-line drugs...
April 16, 2018: Revista de Neurologia
https://www.readbyqxmd.com/read/29600441/efficacy-and-safety-of-the-newer-multiple-sclerosis-drugs-approved-since-2010
#5
REVIEW
Simon Faissner, Ralf Gold
Multiple sclerosis treatment faces tremendous changes as a result of the approval of new medications. The new medications have differing safety considerations and risks after long-term treatment, which are important for treating physicians to optimize and individualize multiple sclerosis care. Since the approval of the first multiple sclerosis capsule, fingolimod, the armamentarium of multiple sclerosis therapy has grown with the orally available medications dimethyl fumarate and teriflunomide. Fingolimod is mainly associated with cardiac side effects, dimethyl fumarate with bowel symptoms...
March 2018: CNS Drugs
https://www.readbyqxmd.com/read/29565004/end-of-the-road-for-daclizumab-in-multiple-sclerosis
#6
EDITORIAL
The Lancet
No abstract text is available yet for this article.
March 17, 2018: Lancet
https://www.readbyqxmd.com/read/29519948/%C3%A2-daclizumab-withdrawn-from-the-market-worldwide
#7
(no author information available yet)
No abstract text is available yet for this article.
April 2018: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/29429031/the-changing-multiple-sclerosis-treatment-landscape-impact-of-new-drugs-and-treatment-recommendations
#8
Irene Eriksson, Joris Komen, Fredrik Piehl, Rickard E Malmström, Björn Wettermark, Mia von Euler
PURPOSE: The purpose of this study is to describe the utilization of disease-modifying treatments (DMTs) in relapsing-remitting multiple sclerosis (MS) and assess the impact of both the introduction of new drugs and treatment recommendations (local recommendation on rituximab use issued at the largest MS clinic in Stockholm and regional Drug and Therapeutics Committee (DTC) recommendation on how dimethyl fumarate should be used). METHODS: Interrupted time series analyses using monthly data on all MS patients treated with DMTs in the Stockholm County, Sweden, from January 2011 to December 2017...
May 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29363337/pharmacokinetic-drug-evaluation-of-daclizumab-for-the-treatment-of-relapsing-remitting-multiple-sclerosis
#9
REVIEW
Francesco Patti, Clara G Chisari, Emanuele D'Amico, Mario Zappia
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system. Despite the availability of several disease-modifying therapies for relapsing MS, there is a need for highly efficacious targeted therapy with a favorable benefit-risk profile and 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. Areas covered: Daclizumab blocks the activation and expansion of autoreactive T cells that plays a role in the immune pathogenesis of MS...
March 2018: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/29337457/-pharmacovigilance-update
#10
Françoise Livio
The main pharmacovigilance updates in 2017 are reviewed. Denosumab : rebound-associated multiple vertebral fractures after discontinuation. Canagliflozine: increased risk of foot/leg amputations. Biologic and targeted cancer therapies, direct-acting antivirals for chronic hepatitis C: risk of hepatitis B reactivation. Checkpoint inhibitors : immune-related adverse events and graft rejection. Fingolimod : rebound-associated reactivation of MS following withdrawal. Daclizumab: risk of severe liver injury leading to restricted use in MS patients...
January 10, 2018: Revue Médicale Suisse
https://www.readbyqxmd.com/read/29276998/pulmonary-sarcoidosis-in-a-patient-with-multiple-sclerosis-on-daclizumab-monotherapy
#11
Elijah Edward Rhone, Peter Siu Pan Cho, Surinder S Birring, James Galloway, Eli Silber
As new immunomodulatory therapies continue to be licensed for use in Multiple Sclerosis, it is important to remain vigilant for new, unexpected associations relating to these medications. We highlight this by reporting on a case of a 45-year-old man who developed systemic, non-specific symptoms following long term use of daclizumab and was subsequently diagnosed with sarcoidosis. We go on to briefly discuss the action of daclizumab, in particular the effect it has on CD56bright natural killer cells, a cell type that has been investigated in relation to sarcoidosis...
February 2018: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/29149804/systematic-literature-review-and-network-meta-analysis-of-cladribine-tablets-versus-alternative-disease-modifying-treatments-for-relapsing-remitting-multiple-sclerosis
#12
Mohd Kashif Siddiqui, Inderpreet Singh Khurana, Sangeeta Budhia, Robert Hettle, Gerard Harty, Schiffon L Wong
OBJECTIVE: To assess the comparative efficacy and safety of cladribine tablets versus alternative disease modifying treatments (DMTs) in patients with active relapsing-remitting multiple sclerosis (RRMS), and in a subgroup with high disease activity (HRA + DAT), using systematic literature review (SLR) and network meta-analysis (NMA). METHODS: MEDLINE, Embase, MEDLINE In-Process and CENTRAL databases were systematically searched to identify English-language publications of relevant studies of approved DMTs for RRMS...
November 28, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29143589/biomarkers-in-the-evolution-of-multiple-sclerosis
#13
Thomas Berger
Nonimaging biomarkers can be applied in differential diagnosis, evaluation of disease progression and therapy monitoring of multiple sclerosis (MS). Presence of oligoclonal IgG bands in cerebrospinal fluid is a diagnostic element and a negative predictor of MS evolution. AQP4 antibodies are pathogenic and diagnostic for neuromyelitis optica spectrum disorder. Antibodies to myelin oligodendrocyte glycoprotein develop in about 50% of predominantly pediatric patients with acute disseminated encephalomyelitis, but their possible role in pathogenesis is unknown...
November 2017: Neurodegenerative Disease Management
https://www.readbyqxmd.com/read/29055471/consistent-efficacy-of-daclizumab-beta-across-patient-demographic-and-disease-activity-subgroups-in-patients-with-relapsing-remitting-multiple-sclerosis
#14
John W Rose, Gavin Giovannoni, Heinz Wiendl, Ralf Gold, Eva Havrdová, Ludwig Kappos, Krzysztof W Selmaj, Jun Zhao, Katherine Riester, L Claire Tsao, Steven J Greenberg
BACKGROUND: Daclizumab beta is a humanized monoclonal antibody specific for the human interleukin-2 receptor alpha chain (CD25). In two pivotal studies in relapsing multiple sclerosis (MS), patients treated with daclizumab beta exhibited lower annualized relapse rates (ARR) when compared with placebo or with intramuscular (IM) interferon beta-1a. OBJECTIVES: To determine if the efficacy of daclizumab beta demonstrated in the phase 2 SELECT study and the phase 3 DECIDE study was consistent in patient subgroups...
October 2017: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/28984179/efficacy-of-daclizumab-beta-versus-intramuscular-interferon-beta-1a-on-disability-progression-across-patient-demographic-and-disease-activity-subgroups-in-decide
#15
Stanley Cohan, Ludwig Kappos, Gavin Giovannoni, Heinz Wiendl, Krzysztof Selmaj, Eva Kubala Havrdová, John Rose, Steven Greenberg, Glenn Phillips, Wei Ma, Ping Wang, Gabriel Lima, Guido Sabatella
BACKGROUND: Demonstration of clinical benefits on disability progression measures is an important attribute of effective multiple sclerosis (MS) treatments. OBJECTIVE: Examine efficacy of daclizumab beta versus intramuscular (IM) interferon beta-1a on measures of disability progression in patient subgroups from DECIDE. METHODS: Twenty-four-week confirmed disability progression (CDP), 24-week sustained worsening on a modified Multiple Sclerosis Functional Composite (MSFCS) where 3-Second Paced Auditory Serial Addition Test was replaced by Symbol Digit Modalities Test, and proportion of patients with clinically meaningful worsening in 29-Item Multiple Sclerosis Impact Scale physical impact subscale (MSIS-29 PHYS) score from baseline to week 96 were examined in the overall population and subgroups defined by baseline demographic/disease characteristics...
October 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28978627/risk-of-severe-liver-injury-with-%C3%A2-daclizumab-zinbryta
#16
(no author information available yet)
No abstract text is available yet for this article.
October 4, 2017: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/28975400/disease-reactivation-after-switching-from-natalizumab-to-daclizumab
#17
Timo Uphaus, Christoph Oberwittler, Sergiu Groppa, Frauke Zipp, Stefan Bittner
Discontinuation of natalizumab can lead to severe rebound of disease activity in patients with relapsing-remitting multiple sclerosis (RRMS); nevertheless, the treatment regimen in this clinical situation remains controversial. We report the case of a 25-year-old male patient with RRMS who was clinically stable under 3 years of natalizumab before treatment was stopped due to progressive multifocal leucencephalopathy (PML) safety concerns. After initiation of daclizumab, the patient suffered from disease reactivation, which was ultimately controlled by intravenous methylprednisolone and alemtuzumab treatment...
December 2017: Journal of Neurology
https://www.readbyqxmd.com/read/28914581/circulating-lymphocyte-levels-and-relationship-with-infection-status-in-patients-with-relapsing-remitting-multiple-sclerosis-treated-with-daclizumab-beta
#18
Gavin Giovannoni, Heinz Wiendl, Benjamin Turner, Kimberly Umans, Oksana Mokliatchouk, Wanda Castro-Borrero, Steven J Greenberg, Peter McCroskery, Giorgio Giannattasio
BACKGROUND: Reversible lymphocyte count reductions have occurred following daclizumab beta treatment for relapsing-remitting multiple sclerosis. OBJECTIVE: To analyse total and differential lymphocyte levels and relationship with infection status. METHODS: In DECIDE, blood samples were collected at 12-week intervals from daclizumab beta- ( n = 919) or intramuscular interferon beta-1a-treated ( n = 922) patients. Infections/serious infections were assessed proximate to grade 2/3 lymphopenia or low CD4(+)/CD8(+) T-cell counts...
September 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28913785/evolution-of-patient-reported-outcomes-and-their-role-in-multiple-sclerosis-clinical-trials
#19
REVIEW
Cindy J Nowinski, Deborah M Miller, David Cella
Patient-reported outcomes (PROs) are playing an increasing role in multiple sclerosis (MS) research and practice, and are essential for understanding the effects that MS and MS treatments have on patients' lives. PROs are captured directly from patients and include symptoms, function, health status, and health-related quality of life. In this article, we review different categories (e.g., generic, targeted, preference-based) of PRO measures and considerations in selecting a measure. The PROs included in MS clinical research have evolved over time, as have the measures used to assess them...
October 2017: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
https://www.readbyqxmd.com/read/28910968/efficiency-of-antibody-therapy-in-demyelinating-diseases
#20
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
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