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https://www.readbyqxmd.com/read/28529918/advances-in-dyslipidemia-management-for-prevention-of-atherosclerosis-pcsk9-monoclonal-antibody-therapy-and-beyond
#1
REVIEW
Nathan D Wong, Paul D Rosenblit, Robert S Greenfield
In 2003, select families with familial hypercholesterolemia were first identified to have gain-of-function mutations for proprotein convertase subtilisin kexin type 9 (PCSK9) followed, in 2006, by the identification of those with lifelong low levels of LDL-C and lowered atherosclerotic cardiovascular disease (ASCVD) risk who had loss-of-function PCSK9 mutations. These discoveries led to the rapid development of PSCK9-targeted monoclonal antibody (PCSK9 mAb) therapies and, in 2015, 2 'fully-humanized' PCSK9 mAbs (alirocumab and evolocumab) were marketed in the United States, Europe, and other countries...
April 2017: Cardiovascular Diagnosis and Therapy
https://www.readbyqxmd.com/read/28514302/safety-and-efficacy-evaluation-of-pertuzumab-in-patients-with-solid-tumors
#2
Chenjing Zhu, Wenwu Ling, Jing Zhang, Hui Gao, Kai Shen, Xuelei Ma
BACKGROUND: The development of targeted therapies benefits patients with certain markers in the treatment of breast cancer. Pertuzumab is a novel humanized monoclonal antibody that blocks human epidermal growth factor receptor 2 (HER2) dimerization. The Food and Drug Administration has approved pertuzumab in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer. METHODS: To assess the safety and efficacy profile of pertuzumab, we searched PubMed and Embase (articles from January 1966 to January 2015) using the keyword "pertuzumab"...
May 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28487450/pulmonary-malt-lymphoma-in-patients-with-sjogren-s-syndrome
#3
Ralph Yachoui, Chady Leon, Kajal Sitwala, Mazen Kreidy
To describe clinical features and outcomes of seven patients with pulmonary mucosa-associated lymphoid tissue (MALT) lymphoma in the setting of underlying primary Sjogren's syndrome from a single center, we reviewed medical records of consecutive patients with pulmonary MALT lymphoma evaluated at our facility from January 1, 1999 to December 31, 2015 for clinical features, laboratory, pathologic and radiographic findings, management, and outcomes. Out of 13 patients with pulmonary MALT lymphoma, 7 (54 %) met the criteria for Sjogren's syndrome...
May 9, 2017: Clinical Medicine & Research
https://www.readbyqxmd.com/read/28479751/uterine-cd56-dim-and-cd16-cells-in-refractory-antiphospholipid-antibody-related-pregnancy-loss-and-chromosomally-intact-abortuses-a-case-control-study
#4
Mostafa F Gomaa, Abdeiiatif G Elkhouly, Mohammad M Farghly, Laila A Farid, Nahla M Awad
AIM: To evaluate the role of uterine natural killer (uNK) CD56(dim) and CD16(+) cells in patients with refractory antiphospholipid, antibody-mediated, recurrent, pregnancy loss. SETTINGS AND DESIGN: A case-control study was conducted between 2012 and 2015 at a university hospital. PATIENTS AND METHODS: A group of 118 women with a history of antiphospholipid antibody syndrome experiencing fetal loss in spite of low dose aspirin (LDA) and low molecular weight heparin (LMWH) treatment in the current pregnancy were included in this study...
January 2017: Journal of Human Reproductive Sciences
https://www.readbyqxmd.com/read/28478972/long-term-management-of-moderate-to-severe-atopic-dermatitis-with-dupilumab-and-concomitant-topical-corticosteroids-liberty-ad-chronos-a-1-year-randomised-double-blinded-placebo-controlled-phase-3-trial
#5
Andrew Blauvelt, Marjolein de Bruin-Weller, Melinda Gooderham, Jennifer C Cather, Jamie Weisman, David Pariser, Eric L Simpson, Kim A Papp, H Chih-Ho Hong, Diana Rubel, Peter Foley, Errol Prens, Christopher E M Griffiths, Takafumi Etoh, Pedro Herranz Pinto, Ramon M Pujol, Jacek C Szepietowski, Karel Ettler, Lajos Kemény, Xiaoping Zhu, Bolanle Akinlade, Thomas Hultsch, Vera Mastey, Abhijit Gadkari, Laurent Eckert, Nikhil Amin, Neil M H Graham, Gianluca Pirozzi, Neil Stahl, George D Yancopoulos, Brad Shumel
BACKGROUND: Dupilumab (an anti-interleukin-4-receptor-α monoclonal antibody) blocks signalling of interleukin 4 and interleukin 13, type 2/Th2 cytokines implicated in numerous allergic diseases ranging from asthma to atopic dermatitis. Previous 16-week monotherapy studies showed that dupilumab substantially improved signs and symptoms of moderate-to-severe atopic dermatitis with acceptable safety, validating the crucial role of interleukin 4 and interleukin 13 in atopic dermatitis pathogenesis...
May 4, 2017: Lancet
https://www.readbyqxmd.com/read/28476944/impact-of-age-on-outcomes-with-immunotherapy-for-patients-with-melanoma
#6
Allison S Betof, Ryan D Nipp, Anita Giobbie-Hurder, Romany A N Johnpulle, Krista Rubin, Samuel M Rubinstein, Keith T Flaherty, Donald P Lawrence, Douglas B Johnson, Ryan J Sullivan
BACKGROUND: Monoclonal antibodies (mAb) targeting PD-1/PD-L1 have revolutionized melanoma treatment, yet data regarding effectiveness and tolerability across age groups is limited. We sought to determine the impact of age on overall survival (OS), progression-free survival (PFS), and rates of immune-mediated toxicities in patients treated with anti-PD-1/anti-PD-L1 mAb at two academic medical centers. METHODS: We retrospectively collected data on all patients with metastatic melanoma treated with anti-PD-1/PD-L1 mAb between May 2009 and April 2015...
May 5, 2017: Oncologist
https://www.readbyqxmd.com/read/28460892/safety-and-efficacy-of-erenumab-for-preventive-treatment-of-chronic-migraine-a-randomised-double-blind-placebo-controlled-phase-2-trial
#7
Stewart Tepper, Messoud Ashina, Uwe Reuter, Jan L Brandes, David Doležil, Stephen Silberstein, Paul Winner, Dean Leonardi, Daniel Mikol, Robert Lenz
BACKGROUND: The calcitonin gene-related peptide (CGRP) pathway is important in migraine pathophysiology. We assessed the efficacy and safety of erenumab, a fully human monoclonal antibody against the CGRP receptor, in patients with chronic migraine. METHODS: This was a phase 2, randomised, double-blind, placebo-controlled, multicentre study of erenumab for adults aged 18-65 years with chronic migraine, enrolled from 69 headache and clinical research centres in North America and Europe...
April 28, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28460541/why-do-trials-for-alzheimer-s-disease-drugs-keep-failing-a-discontinued-drug-perspective-for-2010-2015
#8
Dev Mehta, Robert Jackson, Gaurav Paul, Jiong Shi, Marwan Sabbagh
There are dozens of drugs in development for AD with billions of dollars invested. Despite the massive investment in AD drugs and a burgeoning pipeline, there have been more setbacks and failures than treatment successes. Areas Covered: The classes of drugs that have failed to date include the monoclonal antibodies, the gamma secretase inhibitors, dimebon, neurochemical enhances and one tau drug. Data for these compounds was sought through pubmed search and clinicaltrials.gov search. Expert opinion: The obvious question to be posed is: Why are they failing? Is the treatment of symptomatic dementia too late? Are the therapeutic targets incorrect? Are the clinical methodologies imprecise, misleading or inaccurate? This review summarizes the drugs that have failed 2010-2015 and offers possible theories as to why they have failed...
May 2, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28453692/safety-and-antitumor-activity-of-the-anti-pd-1-antibody-pembrolizumab-in-patients-with-recurrent-carcinoma-of-the-anal-canal
#9
P A Ott, S A Piha-Paul, P Munster, M J Pishvaian, E M J van Brummelen, R B Cohen, C Gomez-Roca, S Ejadi, M Stein, E Chan, M Simonelli, A Morosky, S Saraf, K Emancipator, M Koshiji, J Bennouna
Background: Safety and efficacy of pembrolizumab, a humanized programmed death 1 monoclonal antibody, was assessed in KEYNOTE-028, a multicohort, phase Ib trial for patients with programmed death ligand 1 (PD-L1)-positive advanced solid tumors. We report results for the cohort of patients with advanced anal carcinoma. Patients and methods: Patients with PD-L1-positive tumors (≥1%) received intravenous pembrolizumab 10 mg/kg once every 2 weeks for up to 2 years or until confirmed progression or unacceptable toxicity...
May 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28434255/daratumumab-for-the-treatment-of-multiple-myeloma
#10
Cyrille Touzeau, Philippe Moreau
Proteasome inhibitors and immunomodulatory drugs have contributed to the dramatic improvement in survival for patients with myeloma over the past decades. However, the disease typically relapses and new classes of drugs are needed. In 2015, two monoclonal antibodies were approved for the treatment of patients with relapsed multiple myeloma, and immunotherapy has rapidly become indispensable in the management of myeloma patients. Areas covered: Here, the authors discuss the published data regarding the mechanism of action, safety and clinical efficacy of the CD38-targeted monoclonal antibody daratumumab for the treatment of patients with multiple myeloma...
April 24, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28416406/acute-stroke-despite-dabigatran-anticoagulation-treated-with-idarucizumab-and-intravenous-tissue-plasminogen-activator
#11
David Bissig, Rashmi Manjunath, Brittany R Traylor, David P Richman, Kwan L Ng
Dabigatran is a direct thrombin inhibitor used to reduce the risk of stroke in patients with nonvalvular atrial fibrillation. For patients who present with an acute stroke despite dabigatran therapy, clinical data on the use of intravenous tissue plasminogen activator (IV-tPA) is limited. There is an anticipated increased risk of symptomatic intracranial hemorrhage (sICH) when using IV-tPA in patients on dabigatran therapy. In 2015, the humanized monoclonal antibody fragment idarucizumab was approved for rapid (minutes) reversal of anticoagulant effects of dabigatran...
April 14, 2017: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
https://www.readbyqxmd.com/read/28413654/hepatic-perivascular-epithelioid-cell-neoplasm-a-clinical-and-pathological-experience-in-diagnosis-and-treatment
#12
Wenying Chen, Yeqing Liu, Yanyan Zhuang, Juanfei Peng, Fengting Huang, Shineng Zhang
Hepatic perivascular epithelioid cell neoplasm (PEComa) is a rare type of neoplasm derived from mesenchymal tumors that is often misdiagnosed as hepatocellular carcinoma (HCC), hepatic hemangioma or other liver malignancies. The clinical and histological characteristics of PEComa have yet to be fully documented. To optimize the diagnosis and treatment of the disease, a retrospective analysis was performed to investigate the clinicopathological characteristics of 7 patients diagnosed with hepatic PEComa in the Sun Yat-Sen Memorial Hospital between January 2004 and December 2015...
April 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28411872/induction-therapy-with-the-selective-interleukin-23-inhibitor-risankizumab-in-patients-with-moderate-to-severe-crohn-s-disease-a-randomised-double-blind-placebo-controlled-phase-2-study
#13
Brian G Feagan, William J Sandborn, Geert D'Haens, Julián Panés, Arthur Kaser, Marc Ferrante, Edouard Louis, Denis Franchimont, Olivier Dewit, Ursula Seidler, Kyung-Jo Kim, Markus F Neurath, Stefan Schreiber, Paul Scholl, Chandrasena Pamulapati, Bojan Lalovic, Sudha Visvanathan, Steven J Padula, Ivona Herichova, Adina Soaita, David B Hall, Wulf O Böcher
BACKGROUND: The interleukin-23 pathway is implicated genetically and biologically in the pathogenesis of Crohn's disease. We aimed to assess the efficacy and safety of risankizumab (BI 655066, Boehringer Ingelheim, Ingelheim, Germany), a humanised monoclonal antibody targeting the p19 subunit of interleukin-23, in patients with moderately-to-severely active Crohn's disease. METHODS: In this randomised, double-blind, placebo-controlled phase 2 study, we enrolled patients at 36 referral sites in North America, Europe, and southeast Asia...
April 29, 2017: Lancet
https://www.readbyqxmd.com/read/28401443/prevalence-of-hypophysitis-in-a-cohort-of-patients-with-metastatic-melanoma-and-prostate-cancer-treated-with-ipilimumab
#14
Lucia Brilli, Riccardo Danielli, Cristina Ciuoli, Luana Calabrò, Anna Maria Di Giacomo, Alfonso Cerase, Patrizia Paffetti, Fausta Sestini, Brunetta Porcelli, Michele Maio, Furio Pacini
OBJECTIVE: Ipilimumab is a human monoclonal antibody directed against cytotoxic T-lymphocyte antigen-4, that has been shown to significantly improve survival in patients with metastatic melanoma. Blocking cytotoxic T-lymphocyte antigen-4 elicits T cell activation, proliferation and anti-tumor response, but can also trigger immune-related adverse events. Among immune-related endocrinopathies, hypophysitis represents the most frequent, with an incidence up to 17% in patients treated with ipilimumab...
April 12, 2017: Endocrine
https://www.readbyqxmd.com/read/28395936/efficacy-of-mepolizumab-add-on-therapy-on-health-related-quality-of-life-and-markers-of-asthma-control-in-severe-eosinophilic-asthma-musca-a-randomised-double-blind-placebo-controlled-parallel-group-multicentre-phase-3b-trial
#15
Geoffrey L Chupp, Eric S Bradford, Frank C Albers, Daniel J Bratton, Jie Wang-Jairaj, Linda M Nelsen, Jennifer L Trevor, Antoine Magnan, Anneke Ten Brinke
BACKGROUND: Mepolizumab, an anti-interleukin-5 monoclonal antibody approved as add-on therapy to standard of care for patients with severe eosinophilic asthma, has been shown in previous studies to reduce exacerbations and dependency on oral corticosteroids compared with placebo. We aimed to further assess mepolizumab in patients with severe eosinophilic asthma by examining its effect on health-related quality of life (HRQOL). METHODS: We did a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial (MUSCA) in 146 hospitals or research centres in 19 countries worldwide...
May 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28395555/alirocumab-for-the-treatment-of-hypercholesterolaemia
#16
Giuseppe Della Pepa, Lutgarda Bozzetto, Giovanni Annuzzi, Angela Albarosa Rivellese
Prescription of statins for low-density lipoprotein cholesterol (LDL-C) reduction is the standard of care in primary and secondary prevention of cardiovascular disease; nevertheless, a large number of patients treated with statins are unable to reach the recommended LDL-C targets. Therefore, there is need for safe and effective novel therapies for the pharmacological management of hypercholesterolaemia, in addition or as alternative to lipid-lowering therapies (LLT) currently in use. Areas covered: In 2015, the Food and Drug Administration and the European Medicines Agency approved alirocumab (Praluent®; Sanofi), a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), for the treatment of hypercholesterolaemic patients unable to meet LDL-C targets, as an adjunct to diet in addition/alternative to LLT...
June 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28387984/practical-issues-in-using-eculizumab-for-children-with-atypical-hemolytic-uremic-syndrome-in-the-acute-phase-a-review-of-4-patients
#17
Chikako Terano, Kenji Ishikura, Riku Hamada, Yasuhiro Yoshida, Wataru Kubota, Yusuke Okuda, Shunsuke Shinozuka, Ryoko Harada, Sunao Iyoda, Yoshihiro Fujimura, Yuko Hamasaki, Hiroshi Hataya, Masataka Honda
AIM: Recently eculizumab, a monoclonal antibody to C5, was found to improve the disease course of atypical hemolytic uremic syndrome (aHUS) and has been recommended as the first line treatment by an international consensus guideline. However, several practical issues in the use of eculizumab for the acute phase of aHUS have yet to be resolved. METHODS: Children who received eculizumab with diagnosis of aHUS between March 2010 and December 2015 at Tokyo Metropolitan Children's Medical Center were enrolled...
April 7, 2017: Nephrology
https://www.readbyqxmd.com/read/28383418/new-evidence-guiding-extent-of-lymphadenectomy-for-esophagogastric-junction-tumor-application-of-ber-ep4-joint-with-cd44v6-staining-on-the-detection-of-lower-mediastinal-lymph-node-micrometastasis-and-survival-analysis
#18
Bin Zheng, Chen-Hui Ni, Hao Chen, Wei-Dong Wu, Zhao-Hui Guo, Yong Zhu, Wei Zheng, Chun Chen
For Siewert type II adenocarcinoma of the esophagogastric junction (AEJ), the optimal surgical approach and extent of lymph nodes dissection remain controversial. Immunohistochemistry (IHC) has been reported to be available for identifying lymph node micrometastasis (LNMM) in patients with AEJ. This was a prospective case series of patients who underwent R0 resection and lower mediastinal lymphadenectomy from January 2010 to June 2015 in Fujian Medical University Union Hospital for Siewert type II AEJ. The outcomes were analyzed retrospectively...
April 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28346048/mabdelivery-administration-routes-for-antibody-therapy-third-labex-mabimprove-industrial-workshop-july-2-2015-tours-france
#19
Elsa Bodier-Montagutelli, Renaud Respaud, Hervé Watier, Audrey Guillon-Munos
The annual "LabEx MAbImprove Industrial Workshops" are primarily intended to provide a comprehensive view about topics of interest for the pharmaceutical industry to scientists involved in research on therapeutic antibodies. The third workshop in this series, held July 2, 2015 in Tours, was dedicated to the optimization of delivery, namely all processes leading monoclonal antibodies to reach their target site. The commonly used intravenous (IV) route, although advantageous in terms of pharmacokinetics and pharmacodynamics, presents some disadvantages in terms of patients' convenience, therapeutic target access or treatment cost...
May 2017: MAbs
https://www.readbyqxmd.com/read/28328015/pcsk9-inhibitor-access-barriers-issues-and-recommendations-improving-the-access-process-for-patients-clinicians-and-payers
#20
REVIEW
Seth J Baum, Peter P Toth, James A Underberg, Paul Jellinger, Joyce Ross, Katherine Wilemon
The proprotein convertase subtilisin/kexin type 9 inhibitors or monoclonal antibodies likely represent the greatest advance in lipid management in 30 years. In 2015 the US Food and Drug Administration approved both alirocumab and evolocumab for high-risk patients with familial hypercholesterolemia (FH) and clinical atherosclerotic cardiovascular disease requiring additional lowering of low-density lipoprotein cholesterol. Though many lipid specialists, cardiovascular disease prevention experts, endocrinologists, and others prescribed the drugs on label, they found their directives denied 80% to 90% of the time...
April 2017: Clinical Cardiology
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