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  • Articles  (10)
  • Springer Nature  (10)
  • Molecular Diversity Preservation International (MDPI)
  • 2015-2019  (10)
  • 1945-1949
  • 2016  (10)
  • Clinical Pharmacology & Therapeutics  (10)
  • 9718
  • 1
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    Therapeutic Application of Monoclonal Antibodies in Multiple Sclerosis (2016)
    Springer Nature
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    Publication Date: 2016
    Description: Multiple sclerosis (MS) is a heterogeneous inflammatory demyelinating disorder of the central nervous system (CNS). People with MS typically have a relapsing remitting disease course, with episodic neurological dysfunction corresponding to inflammation in the brain or spinal cord. Some relapsing patients develop a secondary progressive disease course, with accumulation of disability over time, yet other people with MS only experience a primary progressive course. Over the past 20 years, 14 immunomodulatory therapies have been approved in MS in order to reduce the frequency of inflammatory relapses and prevent CNS damage. Of the available types of therapies, the monoclonal antibodies are generally the most effective at dampening MS disease activity. In this review we will discuss the development of effective monoclonal antibody therapies coinciding with a better understanding of the complex immunopathogenesis of MS, both successes and failures, as well as targets for future development that address the mechanisms underlying progressive disease.
    Print ISSN: 0009-9236
    Electronic ISSN: 1532-6535
    Topics: Chemistry and Pharmacology , Medicine
    Published by Springer Nature
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  • 2
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    Role of Clinical Pharmacology in the Development and Approval of Immunotherapies Targeting Immune Checkpoints (2016)
    Springer Nature
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    Publication Date: 2016
    Description: Immune surveillance plays a critical role in preventing the development and progression of cancer. Immune modulators, such as interferon‐gamma or interleukin‐2, have been a part of the cancer treatment armament over the past few decades. However, new understandings regarding the role of the costimulatory and coinhibitory molecules associated with T‐cells and antigen‐presenting cells as well as tumor necrosis factor receptors and ligands have ushered the new era of immunotherapy for cancer treatment. We now know that primary cancer cells evade screening by the innate immune system, proliferate, and form metastases by upregulating immune inhibitory pathways referred to as immune checkpoints. The recent development of therapies that target immune checkpoints, such as cytotoxic T lymphocyte antigen 4, programmed cell death 1, programmed cell death ligand 1, indoleamine 2,3‐dioxygenase, T‐cell immunoglobulin and mucin domain 3, and lymphocyte activation gene 3 precisely target the immune system and give new hope for treating various types of cancer. In select marker‐enriched populations, immunotherapies provide high response rates as well as durable responses in terms of progression‐free survival and overall survival. Numerous factors, such as patient's immune system, the expression of targets on both immune and cancer cells, maintenance of an effective drug exposure, and tolerability to these agents may play a role in this unique observation.
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    Topics: Chemistry and Pharmacology , Medicine
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  • 3
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    Implementing Algorithm‐Guided Warfarin Dosing in an Ethnically Diverse Patient Population Using Electronic Health Records and Preemptive CYP2C9 and VKORC1 Genetic Testing (2016)
    Springer Nature
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    Publication Date: 2016
    Description: Implementation of pharmacogenetic‐guided warfarin dosing has been hindered by inconsistent results from reported clinical trials and a lack of available algorithms that include alleles prevalent in non‐white populations. However, current evidence indicates that algorithm‐guided dosing is more accurate than empirical dosing. To facilitate multiethnic algorithm‐guided warfarin dosing using preemptive genetic testing, we developed a strategy that accounts for the complexity of race and leverages electronic health records for algorithm variables and deploying point‐of‐care dose recommendations.
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  • 4
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    Should Therapeutic Drug Monitoring for Monoclonal Antibodies Remain the Exception or Become the Norm? (2016)
    Springer Nature
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    Publication Date: 2016
    Description: Therapeutic drug monitoring (TDM) aims to maintain circulating drug concentrations at a desired level to optimize clinical outcome. The vast majority of marketed drugs do not require TDM, suggesting the clinical benefit of TDM has not been sufficiently demonstrated in most cases. With the continued emergence and prominence of monoclonal antibodies (mAbs) as drugs, especially in inflammation and cancer therapeutic areas, we are at a juncture to consider applicability of TDM for mAbs.
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  • 5
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    Immune‐Related Adverse Events From Immune Checkpoint Inhibitors (2016)
    Springer Nature
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    Publication Date: 2016
    Description: Immunotherapy for cancer treatment has come of age, specifically with the use of immune checkpoint antibodies directed against molecules such as CTLA‐4, PD‐1, and PD‐L1. Single‐agent and combinatorial approaches utilizing these agents and other immunotherapies that may enhance antitumor effects are under investigation. With increasing clinical use of these agents, an appreciation for their toxicities comes to the fore. Adverse events that occur as a result of the immunologic effects of these therapies are termed “immune‐related adverse events” (irAEs), and range in both frequency and severity in reported single‐agent and combination studies. Improvements in our understanding of how and why irAEs develop and how to effectively manage them are needed. Herein we provide a state‐of‐the‐art synopsis of the incidence, clinical features, mechanisms, and management of selected irAEs with immune checkpoint inhibitors currently in use.
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  • 6
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    Genetic testing to guide warfarin dosing: Impact of direct oral anticoagulants (2016)
    Springer Nature
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    Publication Date: 2016
    Description: Despite rapid growth in the use of direct oral anticoagulants (DOACs), warfarin remains a widely prescribed anticoagulant drug. It is likely that the overall use of warfarin will continue to decline, but not completely disappear, as indications for DOACs expand. This changing anticoagulation landscape, along with the likelihood that personalized genomic information will become increasingly available, has several implications for the future of warfarin dosing strategies.
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  • 7
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    CD19‐Targeted chimeric antigen receptor‐modified T‐cell immunotherapy for B‐cell malignancies (2016)
    Springer Nature
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    Publication Date: 2016
    Description: Chimeric antigen receptors (CARs) comprise a tumor‐targeting moiety, often in the form of a single chain variable fragment derived from a monoclonal antibody, fused to one or more intracellular T‐cell signaling sequences. Lymphodepletion chemotherapy followed by infusion of T cells that are genetically modified to express a CD19‐specific CAR is a promising therapy for patients with refractory CD19+ B‐cell malignancies, producing rates of complete remission that are remarkably high in acute lymphoblastic leukemia and encouraging in non‐Hodgkin lymphoma and chronic lymphocytic leukemia. Responses are often durable, although additional studies are needed to define the role of CAR‐T cell immunotherapy in the context of other treatments. CAR‐modified T‐cell immunotherapy can be complicated by cytokine release syndrome and neurologic toxicity, which in most cases are manageable and reversible. Here we review recent clinical trial data and discuss issues for the field.
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  • 8
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    Anticoagulants: What is new and what is the standard? (2016)
    Springer Nature
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    Publication Date: 2016
    Description: This commentary focuses on the status of oral anticoagulants, namely, warfarin and the novel oral anticoagulants (NOACs) such as dabigatran, rivaroxaban, apixaban, and edoxaban.
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  • 9
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    Anticoagulants: Major Advances Without Clear Consensus (2016)
    Springer Nature
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    Publication Date: 2016
    Description: Abstract Therapeutics for thrombosis were discovered because of observations made nearly one hundred years ago. The mainstays of these treatments have been either heparin or warfarin, with the latter being preferred for long‐term anticoagulation. In the last six years, newer agents with antigoagulant activities have been approved for clinical use. These agents have advantages and disadvantages over warfarin and consensus for their use is still being formed, as is the manner in which the more traditional agents, such as warfarin, should be used and monitored.
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  • 10
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    Mechanistic Projection of First‐in‐Human Dose for Bispecific Immunomodulatory P‐Cadherin LP‐DART: An Integrated PK/PD Modeling Approach (2016)
    Springer Nature
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    Publication Date: 2016
    Description: A bispecific immunomodulatory biotherapeutic molecule (P‐cadherin LP‐DART) based on the Dual Affinity Re‐Targeting (DART) scaffold has been developed as a potential antitumor treatment showing efficacy in preclinical testing. A minimal anticipated biological effect level (MABEL) approach was applied to project the first‐in‐human (FIH) dose, because of its immune agonistic properties following target engagement. The pharmacological activity of P‐cadherin LP‐DART is driven by binding to both P‐cadherin on the tumor cells and CD3 on T cells. Therefore, the concentration of the tri‐molecular synapse formed between drug, T cell, and tumor cell, rather than drug concentration, is responsible for efficacy. A mechanistic pharmacokinetic/pharmacodynamic (PK/PD)‐driven approach was explored to understand the exposure–response relationship based on the synapse concentration to project the MABEL dose. Orthogonal approaches including PK‐driven and receptor occupancy calculations were also investigated. This study showcases the application of PK/PD modeling in immune‐oncology, and could potentially be implemented for other bispecific biotherapeutics.
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