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Drug Safety: An International Journal of Medical Toxicology and Drug Experience

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https://www.readbyqxmd.com/read/30649752/evaluation-of-antibody-properties-and-clinically-relevant-immunogenicity-anaphylaxis-and-hypersensitivity-reactions-in-two-phase-iii-trials-of-tralokinumab-in-severe-uncontrolled-asthma
#1
Mats Carlsson, Martin Braddock, Yuling Li, Jihong Wang, Weichen Xu, Nicholas White, Ayman Megally, Gillian Hunter, Gene Colice
INTRODUCTION: Tralokinumab is a monoclonal antibody (mAb) that neutralizes interleukin (IL)-13, a cytokine involved in the pathogenesis of asthma. OBJECTIVE: The objectives of this study were to characterize the potential immunogenic properties of tralokinumab and report data for anti-drug antibodies (ADAs) and hypersensitivity reactions from two phase III clinical trials. METHODS: The oligosaccharide structure of tralokinumab, Fab-arm exchange, and ADAs were characterized by standard techniques...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649751/safety-and-tolerability-of-phosphatidylinositol-3-kinase-pi3k-inhibitors-in-oncology
#2
REVIEW
Giuseppe Curigliano, Rashmi R Shah
Activation of phosphatidylinositol-3-kinase (PI3K) and downstream signalling by AKT/mammalian target of rapamycin (mTOR) modulates cellular processes such as increased cell growth, cell proliferation and increased cell migration as well as deregulated apoptosis and oncogenesis. The PI3K/AKT/mTOR pathway (particularly Class I PI3K isoforms) is frequently activated in a variety of solid tumours and haematological malignancies, making PI3K an attractive therapeutic target in oncology. Inhibitors of PI3K also have the potential to restore sensitivity to other modalities of treatments when administered as part of combination regimens...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649750/safety-and-tolerability-of-adoptive-cell-therapy-in-cancer
#3
REVIEW
Benita Wolf, Stefan Zimmermann, Caroline Arber, Melita Irving, Lionel Trueb, George Coukos
Adoptive T cell therapy (ACT) is a safe and effective personalized cancer immunotherapy that can comprise naturally occurring ex vivo expanded cells (e.g., tumor-infiltrating lymphocytes [TIL]) or T cells genetically engineered to confer antigen specificity (T-cell receptor [TCR] or chimeric antigen receptor [CAR] engineered T cells) to mediate cancer rejection. In recent years, some ACTs have produced unprecedented breakthrough responses: TIL therapy has moved from melanoma to solid tumor applications, TCR-engineered cells are developed for hematologic and solid tumors, and CAR-engineered T cells have received Food and Drug Administration (FDA) approval for the treatment of patients with certain B-cell malignancies...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649749/development-of-a-controlled-vocabulary-based-adverse-drug-reaction-signal-dictionary-for-multicenter-electronic-health-record-based-pharmacovigilance
#4
Suehyun Lee, Jongsoo Han, Rae Woong Park, Grace Juyun Kim, John Hoon Rim, Jooyoung Cho, Kye Hwa Lee, Jisan Lee, Sujeong Kim, Ju Han Kim
INTRODUCTION: Integration of controlled vocabulary-based electronic health record (EHR) observational data is essential for real-time large-scale pharmacovigilance studies. OBJECTIVE: To provide a semantically enriched adverse drug reaction (ADR) dictionary for post-market drug safety research and enable multicenter EHR-based extensive ADR signal detection and evaluation, we developed a comprehensive controlled vocabulary-based ADR signal dictionary (CVAD) for pharmacovigilance...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649748/safety-and-tolerability-of-c-met-inhibitors-in-cancer
#5
REVIEW
Alberto Puccini, Nagore I Marín-Ramos, Francesca Bergamo, Marta Schirripa, Sara Lonardi, Heinz-Josef Lenz, Fotios Loupakis, Francesca Battaglin
The role of aberrant hepatocyte growth factor receptor (c-MET, also known as tyrosine-protein kinase MET)/hepatocyte growth factor (HGF) signaling in cancer progression and invasion has been extensively studied. c-MET inhibitors have shown promising pre-clinical and early phase clinical trial anti-tumor activity in several tumor types, although results of most phase III trials with these agents have been negative. To date, two small molecule c-MET inhibitors, cabozantinib and crizotinib, have been approved by regulatory authorities for the treatment of selected cancer types, but several novel c-MET inhibitors (either monoclonal antibodies or small molecule c-MET tyrosine kinase inhibitors) and treatment combinations are currently under study in different settings...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649747/safety-and-tolerability-of-antibody-drug-conjugates-in-cancer
#6
REVIEW
Anna Wolska-Washer, Tadeusz Robak
Antibody-drug conjugates are monoclonal antibodies attached to biologically active drugs through chemical linkers that deliver and release cytotoxic agents at the tumor site, reducing the likelihood of systemic exposure and therefore toxicity. Currently, there are about 110 ongoing studies implementing antibody-drug conjugates in the treatment of multiple human malignancies. Antibody-drug conjugates carry a feature of the specificity of a monoclonal antibody and the anti-neoplastic potential of a cytotoxin...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649746/benefit-risk-assessment-of-plecanatide-in-the-treatment-of-chronic-idiopathic-constipation
#7
REVIEW
Philip B Miner
Plecanatide, a uroguanylin analog, activates the guanylate cyclase C receptors in the epithelial lining of the gastrointestinal tract in a pH-dependent fashion initiating (1) the conversion of intracellular guanosine triphosphate to cyclic guanosine monophosphate, which increases the activity of the cystic fibrosis transmembrane conductance regulator to increase chloride and bicarbonate secretion into the intestinal lumen and (2) a decrease in activity of the sodium-hydrogen ion exchanger. The resulting ionic shifts cause an increase in lumenal fluid to facilitate digestion...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649745/safety-and-tolerability-of-sonic-hedgehog-pathway-inhibitors-in-cancer
#8
REVIEW
Richard L Carpenter, Haimanti Ray
The hedgehog pathway, for which sonic hedgehog (Shh) is the most prominent ligand, is highly conserved and is tightly associated with embryonic development in a number of species. This pathway is also tightly associated with the development of several types of cancer, including basal cell carcinoma (BCC) and acute promyelocytic leukemia, among many others. Inactivating mutations in Patched-1 (PTCH1), leading to ligand-independent pathway activation, are frequent in several cancer types, but most prominent in BCC...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649744/safety-and-tolerability-of-anti-angiogenic-protein-kinase-inhibitors-and-vascular-disrupting-agents-in-cancer-focus-on-gastrointestinal-malignancies
#9
REVIEW
Letizia Procaccio, Vera Damuzzo, Francesca Di Sarra, Alberto Russi, Federica Todino, Vincenzo Dadduzio, Francesca Bergamo, Alessandra Anna Prete, Sara Lonardi, Hans Prenen, Angelo Claudio Palozzo, Fotios Loupakis
Angiogenesis is an essential process for tumor growth and metastasis. Inhibition of angiogenesis as an anticancer strategy has shown significant results in a plethora of tumors. Anti-angiogenic agents are currently part of many standard-of-care options for several metastatic gastrointestinal cancers. Bevacizumab, aflibercept, ramucirumab, and regorafenib have significantly improved both progression-free and overall survival in different lines of treatment in metastatic colorectal cancer. Second-line ramucirumab and third-line apatinib are effective anti-angiogenic treatments for patients with metastatic gastric cancer...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649743/safety-and-tolerability-of-epidermal-growth-factor-receptor-egfr-tyrosine-kinase-inhibitors-in-oncology
#10
REVIEW
Rashmi R Shah, Devron R Shah
Tyrosine kinase inhibitors (TKIs) that target epidermal growth factor receptor (EGFR) have dramatically improved progression-free survival in non-small-cell lung cancer (NSCLC) patients who carry sensitizing EGFR-activating mutations and in patients with breast and pancreatic cancers. However, EGFR-TKIs are associated with significant and disabling undesirable effects that adversely impact on quality of life and compliance. These effects include dermatological reactions, diarrhoea, hepatotoxicity, stomatitis, interstitial lung disease and ocular toxicity...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649742/safety-and-tolerability-of-immune-checkpoint-inhibitors-pd-1-and-pd-l1-in-cancer
#11
REVIEW
Iosune Baraibar, Ignacio Melero, Mariano Ponz-Sarvise, Eduardo Castanon
Immunotherapy has emerged in recent years and has revolutionized the treatment of cancer. Immune checkpoint inhibitors, including anti-cytotoxic T lymphocyte antigen-4 (CTLA-4), anti-programmed cell death-1 (PD-1) and anti-programmed cell death ligand-1 (PD-L1) agents, are the first of this new generation of treatments. Anti-PD-1/PD-L1 agents target immune cells by blocking the PD-1/PD-L1 pathway. This blockade leads to enhancement of the immune system and therefore restores the tumour-induced immune deficiency selectively in the tumour microenvironment...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649741/safety-and-tolerability-of-anaplastic-lymphoma-kinase-inhibitors-in-non-small-cell-lung-cancer
#12
REVIEW
Danilo Rocco, Ciro Battiloro, Luigi Della Gravara, Cesare Gridelli
The chimeric protein echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase, resulting from the rearrangement of the homonym genes, is one of the currently targetable oncogenic drivers in anaplastic lymphoma kinase-positive non-small-cell lung cancer. In fact, four first- and second-generation anaplastic lymphoma kinase tyrosine kinase inhibitors, crizotinib (PF-02341066), ceritinib (LDK378), alectinib (CH5424802), and brigatinib (AP26113), are presently approved for clinical practice; however, these agents are not devoid of complications and thus should be administered meaningfully...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649740/safety-and-tolerability-of-histone-deacetylase-hdac-inhibitors-in-oncology
#13
REVIEW
Rashmi R Shah
Histone deacetylases (HDACs) are expressed at increased levels in cells of various malignancies, and the use of HDAC inhibitors has improved outcomes in patients with haematological malignancies (T-cell lymphomas and multiple myeloma). However, they are not as effective in solid tumours. Five agents are currently approved under various jurisdictions, namely belinostat, chidamide, panobinostat, romidepsin and vorinostat. These agents are associated with a range of class-related and agent-specific serious and/or severe adverse effects, notably myelosuppression, diarrhoea and various cardiac effects...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649739/safety-of-novel-targeted-therapies-in-oncology
#14
EDITORIAL
Rashmi R Shah, Giuseppe Curigliano
No abstract text is available yet for this article.
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649738/adverse-drug-events-detection-in-clinical-notes-by-jointly-modeling-entities-and-relations-using-neural-networks
#15
Bharath Dandala, Venkata Joopudi, Murthy Devarakonda
BACKGROUND AND SIGNIFICANCE: Adverse drug events (ADEs) occur in approximately 2-5% of hospitalized patients, often resulting in poor outcomes or even death. Extraction of ADEs from clinical narratives can accelerate and automate pharmacovigilance. Using state-of-the-art deep-learning neural networks to jointly model concept and relation extraction, we achieved the highest integrated task score in the 2018 Medication and Adverse Drug Event (MADE) 1.0 challenge. METHODS: We used a combined bidirectional long short-term memory (BiLSTM) and conditional random fields (CRF) neural network to detect medical entities relevant to ADEs and a combined BiLSTM and attention network to determine relations, including the adverse drug reaction relation between medication and sign or symptom entities...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649737/detecting-adverse-drug-events-with-rapidly-trained-classification-models
#16
Alec B Chapman, Kelly S Peterson, Patrick R Alba, Scott L DuVall, Olga V Patterson
INTRODUCTION: Identifying occurrences of medication side effects and adverse drug events (ADEs) is an important and challenging task because they are frequently only mentioned in clinical narrative and are not formally reported. METHODS: We developed a natural language processing (NLP) system that aims to identify mentions of symptoms and drugs in clinical notes and label the relationship between the mentions as indications or ADEs. The system leverages an existing word embeddings model with induced word clusters for dimensionality reduction...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649736/adverse-drug-event-detection-from-electronic-health-records-using-hierarchical-recurrent-neural-networks-with-dual-level-embedding
#17
Susmitha Wunnava, Xiao Qin, Tabassum Kakar, Cansu Sen, Elke A Rundensteiner, Xiangnan Kong
INTRODUCTION: Adverse drug event (ADE) detection is a vital step towards effective pharmacovigilance and prevention of future incidents caused by potentially harmful ADEs. The electronic health records (EHRs) of patients in hospitals contain valuable information regarding ADEs and hence are an important source for detecting ADE signals. However, EHR texts tend to be noisy. Yet applying off-the-shelf tools for EHR text preprocessing jeopardizes the subsequent ADE detection performance, which depends on a well tokenized text input...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649735/overview-of-the-first-natural-language-processing-challenge-for-extracting-medication-indication-and-adverse-drug-events-from-electronic-health-record-notes-made-1-0
#18
Abhyuday Jagannatha, Feifan Liu, Weisong Liu, Hong Yu
INTRODUCTION: This work describes the Medication and Adverse Drug Events from Electronic Health Records (MADE 1.0) corpus and provides an overview of the MADE 1.0 2018 challenge for extracting medication, indication, and adverse drug events (ADEs) from electronic health record (EHR) notes. OBJECTIVE: The goal of MADE is to provide a set of common evaluation tasks to assess the state of the art for natural language processing (NLP) systems applied to EHRs supporting drug safety surveillance and pharmacovigilance...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30649734/towards-drug-safety-surveillance-and-pharmacovigilance-current-progress-in-detecting-medication-and-adverse-drug-events-from-electronic-health-records
#19
EDITORIAL
Feifan Liu, Abhyuday Jagannatha, Hong Yu
No abstract text is available yet for this article.
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30637598/building-an-evidence-base-on-the-place-of-industry-sponsored-programs-in-drug-safety-surveillance
#20
Peter Arlett
No abstract text is available yet for this article.
January 13, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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