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https://www.readbyqxmd.com/read/29337457/-pharmacovigilance-update
#1
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
#2
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...
December 18, 2017: 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
#3
M K Siddiqui, I S Khurana, S Budhia, R Hettle, G Harty, S 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 17, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29143589/biomarkers-in-the-evolution-of-multiple-sclerosis
#4
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
#5
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
#6
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
#7
(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
#8
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
#9
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
#10
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
#11
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/28803486/daclizumab-for-the-treatment-of-adults-with-relapsing-forms-of-multiple-sclerosis
#12
REVIEW
Michael Osherov, Ron Milo
The goal of the article is to review the mechanism of action and the use of daclizumab, a humanized monoclonal antibody (mAb) against the alpha subunit of the high affinity interleukin-2 (IL-2) receptor, in the treatment of Multiple Sclerosis (MS). Areas covered: PubMed was searched for the terms 'daclizumab' and 'multiple sclerosis'. The mechanisms of action, pharmacokinetics and pharmacodynamics, major studies, side effects and drug interactions of daclizumab in MS are discussed. Expert commentary: Monthly daclizumab-beta [DAC-beta, formerly daclizumab high yield process (DAC HYP), approved as ZINBRYTA®, which has a different form and structure than an earlier form of daclizumab], is an effective and convenient treatment option for patients with relapsing forms of MS who have failed other treatment, or as a first-line option in highly active MS patients...
October 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28752230/biological-therapies-for-the-treatment-of-beh%C3%A3-et-s-disease-related-uveitis-beyond-tnf-alpha-blockade-a-narrative-review
#13
REVIEW
Jurgen Sota, Donato Rigante, Giuseppe Lopalco, Bruno Frediani, Rossella Franceschini, Mauro Galeazzi, Florenzo Iannone, Gian Marco Tosi, Claudia Fabiani, Luca Cantarini
Intraocular inflammation is one of the more relevant complications of Behçet's disease (BD), which tends to respond poorly to different medications. The ocular histopathologic changes are basically identical to those occurring in other organs and consist in a necrotizing leukocytoclastic obliterative vasculitis, which is probably immune complex-mediated and affects both arteries and veins of all sizes. There are growing evidences showing the potential role of biologic agents other than anti-tumor necrosis factor (TNF)-α agents in the management of ocular-BD, which have been collected in this review, including interleukin-1 and interleukin-6 blockade, secukinumab, ustekinumab, daclizumab, rituximab, and alemtuzumab...
July 27, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28707278/daclizumab-development-clinical-trials-and-practical-aspects-of-use-in-multiple-sclerosis
#14
REVIEW
Laura E Baldassari, John W Rose
Daclizumab is a humanized monoclonal antibody directed towards CD25, the alpha subunit of the high-affinity interleukin (IL)-2 receptor. Daclizumab exerts its effects via multiple mechanisms, including reduction of IL-2-mediated lymphocyte activation and upregulation of CD56-bright natural killer cells. Intravenous daclizumab (Zenapax™) was initially approved for prevention of rejection in renal transplant. In subsequent early testing, followed by larger-scale phase II and phase III trials, both intravenous and subcutaneous daclizumab have demonstrated clinical efficacy in the treatment of multiple sclerosis...
July 13, 2017: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
https://www.readbyqxmd.com/read/28686222/multiple-sclerosis-immunopathology-and-treatment-update
#15
REVIEW
Narges Dargahi, Maria Katsara, Theodore Tselios, Maria-Eleni Androutsou, Maximilian de Courten, John Matsoukas, Vasso Apostolopoulos
The treatment of multiple sclerosis (MS) has changed over the last 20 years. All immunotherapeutic drugs target relapsing remitting MS (RRMS) and it still remains a medical challenge in MS to develop a treatment for progressive forms. The most common injectable disease-modifying therapies in RRMS include β-interferons 1a or 1b and glatiramer acetate. However, one of the major challenges of injectable disease-modifying therapies has been poor treatment adherence with approximately 50% of patients discontinuing the therapy within the first year...
July 7, 2017: Brain Sciences
https://www.readbyqxmd.com/read/28603462/immune-response-to-seasonal-influenza-vaccine-in-patients-with-relapsing-remitting-multiple-sclerosis-receiving-long-term-daclizumab-beta-a-prospective-open-label-single-arm-study
#16
Lahar Mehta, Kimberly Umans, Gulden Ozen, Randy R Robinson, Jacob Elkins
BACKGROUND: For patients with relapsing-remitting multiple sclerosis (RRMS) undergoing continuous immunomodulatory therapy, understanding whether vaccinations can be performed safely and effectively is important. We tested the immune response to inactivated seasonal influenza vaccine during long-term daclizumab beta treatment. METHODS: In this prospective, open-label, single-arm extension SELECTED study, an optional vaccine substudy was performed on patients with RRMS who had already received daclizumab beta for 1 to 2 years in previous studies...
May 2017: International Journal of MS Care
https://www.readbyqxmd.com/read/28485186/improved-cognitive-outcomes-in-patients-with-relapsing-remitting-multiple-sclerosis-treated-with-daclizumab-beta-results-from-the-decide-study
#17
Ralph Hb Benedict, Stanley Cohan, Sharon G Lynch, Katherine Riester, Ping Wang, Wanda Castro-Borrero, Jacob Elkins, Guido Sabatella
BACKGROUND: Cognitive impairment is common in multiple sclerosis (MS), with cognitive processing speed being the most frequently affected domain. OBJECTIVE: Examine the effects of daclizumab beta versus intramuscular (IM) interferon (IFN) beta-1a on cognitive processing speed as assessed by Symbol Digit Modalities Test (SDMT). METHODS: In DECIDE, patients with relapsing-remitting multiple sclerosis (RRMS) (age: 18-55 years; Expanded Disability Status Scale (EDSS) score 0-5...
May 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28452165/cutaneous-toxicities-from-transplantation-related-medications
#18
REVIEW
M Ilyas, O R Colegio, B Kaplan, A Sharma
Despite the abundance of information on cutaneous malignancies associated with solid organ transplantation in the transplant literature, there is limited information regarding nonmalignant skin changes after transplantation. There are numerous skin toxicities secondary to immunosuppressive and other transplant-related medications that can vary in presentation, severity, and prognosis. To limit associated morbidity and mortality, solid organ transplant recipient care providers should effectively identify and manage cutaneous manifestations secondary to drug toxicity...
April 27, 2017: American Journal of Transplantation
https://www.readbyqxmd.com/read/28450896/daclizumab-high-yield-process-in-the-treatment-of-relapsing-remitting-multiple-sclerosis
#19
REVIEW
Jana Lizrova Preiningerova, Marta Vachova
Daclizumab is a humanized monoclonal antibody that binds to the α subunit (CD25) of the interleukin-2 receptor and favorably modulates the immune environment in multiple sclerosis (MS). Blockage of CD25, among other effects, causes expansion and enhanced function of regulatory CD56(bright) natural killer cells, which seems to be the leading mechanism of action in MS. Phase II and III clinical trials have demonstrated that monthly subcutaneous injections of daclizumab high yield process (DAC HYP) 150 mg in patients with relapsing MS led to a significant reduction of annualized relapse rate and decreased number of contrast-enhanced lesions on brain magnetic resonance imaging...
January 2017: Therapeutic Advances in Neurological Disorders
https://www.readbyqxmd.com/read/28444889/invasive-fungal-infections-in-paediatric-patients-treated-with-macromolecular-immunomodulators-other-than-tumour-necrosis-alpha-inhibitors
#20
REVIEW
Ioannis Kyriakidis, Athanasios Tragiannidis, Ilse Zündorf, Andreas H Groll
An expanding list of immunomodulatory or immunosuppressive monoclonal antibodies (mAbs) and biologic therapeutics is currently entering clinical practice, particularly in the areas of oncology, transplantation and autoimmune disorders. These agents are directed against molecules or cells involved in inflammation and immunity and may therefore be associated with serious and opportunistic infections. The purpose of this review was to critically analyse the literature on invasive fungal infections (IFIs) occurring in association with mAbs and fusion proteins other than tumour necrosis alpha (TNF-α) inhibitors, including therapeutics modulating T-cell-mediated pathologies (muromonab, abatacept, belatacept, ipilimumab, basiliximab, daclizumab), inducing lymphopenia (alemtuzumab), depleting CD20+ B cells (rituximab) and interfering with various targets (anakinra, natalizumab, blodalumab, ixekizumab and others) with a focus on children, and to provide a framework of evaluating the risk for IFIs in this population...
April 26, 2017: Mycoses
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