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https://www.readbyqxmd.com/read/29782224/efficacy-and-safety-of-dupilumab-in-glucocorticoid-dependent-severe-asthma
#1
Klaus F Rabe, Parameswaran Nair, Guy Brusselle, Jorge F Maspero, Mario Castro, Lawrence Sher, Hongjie Zhu, Jennifer D Hamilton, Brian N Swanson, Asif Khan, Jingdong Chao, Heribert Staudinger, Gianluca Pirozzi, Christian Antoni, Nikhil Amin, Marcella Ruddy, Bolanle Akinlade, Neil M H Graham, Neil Stahl, George D Yancopoulos, Ariel Teper
Background Dupilumab is a fully human anti-interleukin-4 receptor α monoclonal antibody that blocks both interleukin-4 and interleukin-13 signaling. Its effectiveness in reducing oral glucocorticoid use in patients with severe asthma while maintaining asthma control is unknown. Methods We randomly assigned 210 patients with oral glucocorticoid-treated asthma to receive add-on dupilumab (at a dose of 300 mg) or placebo every 2 weeks for 24 weeks. After a glucocorticoid dose-adjustment period before randomization, glucocorticoid doses were adjusted in a downward trend from week 4 to week 20 and then maintained at a stable dose for 4 weeks...
May 21, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29782217/dupilumab-efficacy-and-safety-in-moderate-to-severe-uncontrolled-asthma
#2
Mario Castro, Jonathan Corren, Ian D Pavord, Jorge Maspero, Sally Wenzel, Klaus F Rabe, William W Busse, Linda Ford, Lawrence Sher, J Mark FitzGerald, Constance Katelaris, Yuji Tohda, Bingzhi Zhang, Heribert Staudinger, Gianluca Pirozzi, Nikhil Amin, Marcella Ruddy, Bolanle Akinlade, Asif Khan, Jingdong Chao, Renata Martincova, Neil M H Graham, Jennifer D Hamilton, Brian N Swanson, Neil Stahl, George D Yancopoulos, Ariel Teper
Background Dupilumab is a fully human anti-interleukin-4 receptor α monoclonal antibody that blocks both interleukin-4 and interleukin-13 signaling. We assessed its efficacy and safety in patients with uncontrolled asthma. Methods We randomly assigned 1902 patients 12 years of age or older with uncontrolled asthma in a 2:2:1:1 ratio to receive add-on subcutaneous dupilumab at a dose of 200 or 300 mg every 2 weeks or matched-volume placebos for 52 weeks. The primary end points were the annualized rate of severe asthma exacerbations and the absolute change from baseline to week 12 in the forced expiratory volume in 1 second (FEV1 ) before bronchodilator use in the overall trial population...
May 21, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29779324/-application-of-low-dose-atg-for-gvhd-prophylaxis-in-patients-undergoing-pbsct-aged-over-forty-years-old
#3
C Liang, E L Jiang, J F Yao, Q L Ma, W H Zhai, A M Pang, Y Huang, J L Wei, S Z Feng, M Z Han
Objective: To explore the effectiveness of a novel GVHD prophylaxis regimen containing low-dose anti-T lymphocyte globulin (ATG) in patients undergoing peripheral blood stem cell transplantation (PBSCT) from HLA-matched sibling donors (MSD) given both the patients and donors were aged over forty years old. Methods: From March 2013 to April 2017, 98 patients with hematologic malignancies were enrolled in the study. Standard GVHD prophylaxis consisted of the administration of cyclosporine A/tacrolimus and a short course of methotrexate...
April 14, 2018: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/29779195/efficacy-and-safety-of-alirocumab-in-individuals-with-diabetes-mellitus-pooled-analyses-from-five-placebo-controlled-phase-3-studies
#4
Henry N Ginsberg, Michel Farnier, Jennifer G Robinson, Christopher P Cannon, Naveed Sattar, Marie T Baccara-Dinet, Alexia Letierce, Maja Bujas-Bobanovic, Michael J Louie, Helen M Colhoun
INTRODUCTION: Diabetes mellitus (DM) carries an elevated risk for cardiovascular disease. Here, we assessed alirocumab efficacy and safety in people with/without DM from five placebo-controlled phase 3 studies. METHODS: Data from up to 78 weeks were analyzed in individuals on maximally tolerated background statin. In three studies, alirocumab 75 mg every 2 weeks (Q2W) was increased to 150 mg Q2W at week 12 if week 8 low-density lipoprotein cholesterol (LDL-C) was ≥ 70 mg/dL; two studies used alirocumab 150 mg Q2W throughout...
May 19, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29776750/safety-and-immunogenicity-of-a-vi-dt-typhoid-conjugate-vaccine-phase-i-trial-in-healthy-filipino-adults-and-children
#5
Maria Rosario Capeding, Samuel Teshome, Tarun Saluja, Khalid Ali Syed, Deok Ryun Kim, Ju Yeon Park, Jae Seung Yang, Yang Hee Kim, Jiwook Park, Sue-Kyoung Jo, Yun Chon, Sudeep Kothari, Seon-Young Yang, Dong Soo Ham, Ji Hwa Ryu, Hee-Seong Hwang, Ju-Hwan Mun, Julia Lynch, Jerome Kim, Hun Kim, Jean-Louis Excler, Sushant Sahastrabuddhe
BACKGROUND: Typhoid fever remains a major public health problem in low- and middle-income countries where children aged 2-14 years bear the greatest burden. Vi polysaccharide is poorly immunogenic in children <2 years of age, and protection in adults is modest. The limitations of Vi polysaccharide vaccines can be overcome by conjugation of the Vi to a carrier protein. A typhoid conjugate vaccine composed of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) has been developed...
May 15, 2018: Vaccine
https://www.readbyqxmd.com/read/29770892/identification-of-n-terminally-truncated-derivatives-of-insulin-analogs-formed-in-pharmaceutical-formulations
#6
Joanna Zielińska, Jacek Stadnik, Anna Bierczyńska-Krzysik, Dorota Stadnik
PURPOSE: Isolation and identification of unknown impurities of recombinant insulin lispro (produced at IBA) formed during accelerated stability testing of pharmaceutical solutions. For comparative purposes also commercially available formulations of recombinant human insulin (Humulin S®; Lilly), recombinant insulin lispro (Humalog®; Lilly), recombinant insulin aspart (NovoRapid® Penfill®; Novo Nordisk), recombinant insulin detemir (Levemir®; Novo Nordisk) and recombinant insulin glargine (Lantus®; Sanofi-Aventis) were analyzed...
May 16, 2018: Pharmaceutical Research
https://www.readbyqxmd.com/read/29760372/a-review-of-induction-with-rabbit-antithymocyte-globulin-in-pediatric-heart-transplant-recipients
#7
Martin Schweiger, Andreas Zuckermann, Andres Beiras-Fernandez, Michael Berchtolld-Herz, Udo Boeken, Jens Garbade, Stephan Hirt, Manfred Richter, Arjang Ruhpawar, Jan Dieter Schmitto, Felix Schönrath, Rene Schramm, Uwe Schulz, Markus J Wilhelm, Markus J Barten
Pediatric heart transplantation (pHTx) represents only a small proportion of cardiac transplants. Due to these low numbers, clinical data relating to induction therapy in this special population are far less extensive than for adults. Induction is used more widely in pHTx than in adults, mainly because of early steroid withdrawal or complete steroid avoidance. Antithymocyte globulin (ATG) is the most frequent choice for induction in pHTx, and rabbit antithymocyte globulin (rATG, Thymoglobulin®) (Sanofi Genzyme) is the most widely-used ATG preparation...
May 15, 2018: Annals of Transplantation: Quarterly of the Polish Transplantation Society
https://www.readbyqxmd.com/read/29747805/phentolamine-mesylate-may-be-a-safe-and-effective-option-to-reduce-discomfort-and-time-to-recovery-after-dental-care-with-local-anesthesia
#8
Mohammad Helmi, Muath AlDosari, Mary Tavares
ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION: Effectiveness and safety of phentolamine mesylate in routine dental care. Daubländer M, Liebaug F, Niedeggen G, Theobald K, Kürzinger M-L. J Am Dent Assoc 2017; 148(3):149-56. SOURCE OF FUNDING: The study was funded by Sanofi-Aventis Deutschland, Berlin, Germany TYPE OF STUDY/DESIGN: Two study designs were used: a prospective noninterventional, postauthorization efficacy (controlled observational) study, and a prospective noninterventional uncontrolled observational study...
June 2018: Journal of Evidence-based Dental Practice
https://www.readbyqxmd.com/read/29742460/low-grade-inflammation-decreases-emotion-recognition-evidence-from-the-vaccination-model-of-inflammation
#9
Leonie Jt Balter, Sasha Hulsken, Sarah Aldred, Mark T Drayson, Suzanne Higgs, Jet Jcs Veldhuijzen van Zanten, Jane E Raymond, Jos A Bosch
The ability to adequately interpret the mental state of another person is key to complex human social interaction. Recent evidence suggests that this ability, considered a hallmark of 'theory of mind' (ToM), becomes impaired by inflammation. However, extant supportive empirical evidence is based on experiments that induce not only inflammation but also induce discomfort and sickness, factors that could also account for temporary social impairment. Hence, an experimental inflammation manipulation was applied that avoided this confound, isolating effects of inflammation and social interaction...
May 6, 2018: Brain, Behavior, and Immunity
https://www.readbyqxmd.com/read/29726390/the-my-child-matters-programme-effect-of-public-private-partnerships-on-paediatric-cancer-care-in-low-income-and-middle-income-countries
#10
REVIEW
Scott C Howard, Alia Zaidi, Xueyuan Cao, Olivier Weil, Pierre Bey, Catherine Patte, Angelica Samudio, Laurie Haddad, Catherine G Lam, Claude Moreira, Augusto Pereira, Mhamed Harif, Laila Hessissen, Salma Choudhury, Ligia Fu, Miguela A Caniza, Julius Lecciones, Fousseyni Traore, Raul C Ribeiro, Anne Gagnepain-Lacheteau
In low-income and middle-income countries, an excess in treatment failure for children with cancer usually results from misdiagnosis, inadequate access to treatment, death from toxicity, treatment abandonment, and relapse. The My Child Matters programme of the Sanofi Espoir Foundation has funded 55 paediatric cancer projects in low-income and middle-income countries over 10 years. We assessed the impact of the projects in these regions by using baseline assessments that were done in 2006. Based on these data, estimated 5-year survival in 2016 increased by a median of 5·1%, ranging from -1·5% in Venezuela to 17·5% in Ukraine...
May 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29725983/liberty-asthma-quest-phase-3-randomized-double-blind-placebo-controlled-parallel-group-study-to-evaluate-dupilumab-efficacy-safety-in-patients-with-uncontrolled-moderate-to-severe-asthma
#11
William W Busse, Jorge F Maspero, Klaus F Rabe, Alberto Papi, Sally E Wenzel, Linda B Ford, Ian D Pavord, Bingzhi Zhang, Heribert Staudinger, Gianluca Pirozzi, Nikhil Amin, Bolanle Akinlade, Laurent Eckert, Jingdong Chao, Neil M H Graham, Ariel Teper
INTRODUCTION: Dupilumab, a fully human anti-IL-4Rα monoclonal antibody, inhibits signaling of both interleukin (IL)-4 and IL-13, which are key drivers of type 2-mediated inflammation. Dupilumab is approved in the EU, USA, and other countries for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis. Following positive phase 2 results in asthma, the phase 3 Liberty Asthma QUEST trial was initiated to provide further evidence for dupilumab efficacy and safety in patients with uncontrolled, moderate-to-severe asthma...
May 3, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29719974/global-medicinal-chemistry-and-gcpr-conference
#12
Laurent Schio
Laurent Schio speaks to Benjamin Walden, Commissioning Editor. Laurent Schio is leading the group of Integrated Drug Discovery of Sanofi, France. He joined Sanofi more than 25 years ago and is an organic chemist by training. He has made most of his career in medicinal chemistry supporting and leading projects, especially in the anti-infective and then in the oncology fields. He has developed a strong expertise in kinases and lately has contributed to the discovery of several clinical candidates for cancer treatment...
May 3, 2018: Future Medicinal Chemistry
https://www.readbyqxmd.com/read/29694283/letter-incorporating-real-world-evidence-and-patient-value-criteria-into-value-based-frameworks-for-relapsed-refractory-multiple-myeloma
#13
Robert Z Orlowski
Orlowski has received research funding from Amgen, BioTheryX, Bristol-Myers Squibb, Celgene Corporation, and Takeda Pharmaceuticals; honoraria from Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Millennium Pharmaceuticals, and Onyx Pharmaceuticals; and is a member of advisory boards for Amgen, Bristol-Myers Squibb, Celgene Corporation, Incyte, Kite, Legend Biotech, Sanofi-Aventis, and Takeda Pharmaceuticals.
May 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29680205/comparative-risk-of-major-congenital-malformations-with-eight-different-antiepileptic-drugs-a-prospective-cohort-study-of-the-eurap-registry
#14
Torbjörn Tomson, Dina Battino, Erminio Bonizzoni, John Craig, Dick Lindhout, Emilio Perucca, Anne Sabers, Sanjeev V Thomas, Frank Vajda
BACKGROUND: Evidence for the comparative teratogenic risk of antiepileptic drugs is insufficient, particularly in relation to the dosage used. Therefore, we aimed to compare the occurrence of major congenital malformations following prenatal exposure to the eight most commonly used antiepileptic drugs in monotherapy. METHODS: We did a longitudinal, prospective cohort study based on the EURAP international registry. We included data from pregnancies in women who were exposed to antiepileptic drug monotherapy at conception, prospectively identified from 42 countries contributing to EURAP...
April 18, 2018: Lancet Neurology
https://www.readbyqxmd.com/read/29678901/who-recommends-additional-tests-for-sanofi-s-dengue-vaccine-after-safety-concerns
#15
Gareth Iacobucci
No abstract text is available yet for this article.
April 20, 2018: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29675797/treatment-intensification-in-type-2-diabetes-a-real-world-study-of-2-oad-regimens-glp-1-ras-or-basal-insulin
#16
Lawrence Blonde, Denis Raccah, Elisheva Lew, Juliana Meyers, Elena Nikonova, Mayank Ajmera, Keith L Davis, Monica Bertolini, Bruno Guerci
INTRODUCTION: Treatment guidelines recommend a stepwise approach to glycemia management in patients with type 2 diabetes (T2D), but this may result in uncontrolled glycated hemoglobin A1c (HbA1c) between steps. This retrospective analysis compared clinical and economic outcomes among patients with uncontrolled T2D initiating two oral antidiabetes drugs (OADs), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or basal insulin in a real-world setting. METHODS: Adults with T2D on OAD monotherapy were identified in the MarketScan claims database (2007-2014)...
April 19, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29674306/diabeo-app-software-and-telemedicine-versus-usual-follow-up-in-the-treatment-of-diabetic-patients-protocol-for-the-telesage-randomized-controlled-trial
#17
Nathalie Jeandidier, Lucy Chaillous, Sylvia Franc, Pierre-Yves Benhamou, Pauline Schaepelynck, Hélène Hanaire, Bogdan Catargi, Anne Farret, Pierre Fontaine, Bruno Guerci, Yves Reznik, Alfred Penfornis, Sophie Borot, Pierre Serusclat, Yacine Kherbachi, Geneviève D'Orsay, Bruno Detournay, Pierre Simon, Guillaume Charpentier
BACKGROUND: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians...
April 19, 2018: JMIR Research Protocols
https://www.readbyqxmd.com/read/29664981/intravitreal-ziv-aflibercept-for-diabetic-macular-edema-48-week-outcomes
#18
Gabriel Costa de Andrade, João Rafael de Oliveira Dias, André Maia, Michel Eid Farah, Carsten H Meyer, Eduardo Buchele Rodrigues
BACKGROUND AND OBJECTIVE: To study the safety and efficacy of intravitreal injections of ziv-aflibercept (IVI-ZA) (Zaltrap; Sanofi-Aventis and Regeneron Pharmaceuticals, Tarrytown, NY) during a period of 48 weeks in patients with diabetic macular edema (DME). PATIENTS AND METHODS: Seven consecutive patients with DME were enrolled and submitted to 12 consecutive IVI-ZA with a 4-week interval. The safety parameters included changes in full-field electroretinogram (ERG) and systemic or ocular complications, and the efficacy parameters were the mean change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT)...
April 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/29664430/-kounis-syndrome-a-paradoxal-non-st-elevation-myocardial-infarction-case-after-triamcinolone-treatment-for-dermatitis
#19
Mücahid Yılmaz, Hasan Korkmaz
Kounis syndrome is defined as the clinical development of acute coronary syndrome caused by the activation of inflammatory cells due to an allergy, hypersensitivity, anaphylaxis, or anaphylactic reaction. Corticosteroids that are used in the treatment of many inflammatory conditions may paradoxically cause allergic reactions and even anaphylaxis. This article is a description of the case of a 52-yearold female patient who had a non-ST elevation myocardial infarction after the administration of triamcinolone that was relieved with antihistaminic treatment...
April 2018: Türk Kardiyoloji Derneği Arşivi: Türk Kardiyoloji Derneğinin Yayın Organıdır
https://www.readbyqxmd.com/read/29600507/probability-of-achieving-glycemic-control-with-basal-insulin-in-patients-with-type-2-diabetes-in-real-world-practice-in-the-usa
#20
Lawrence Blonde, Luigi Meneghini, Xuejun Victor Peng, Anders Boss, Kyu Rhee, Alka Shaunik, Supriya Kumar, Sidhartha Balodi, Claire Brulle-Wohlhueter, Rory J McCrimmon
INTRODUCTION: Basal insulin (BI) plays an important role in treating type 2 diabetes (T2D), especially when oral antidiabetic (OAD) medications are insufficient for glycemic control. We conducted a retrospective, observational study using electronic medical records (EMR) data from the IBM® Explorys database to evaluate the probability of achieving glycemic control over 24 months after BI initiation in patients with T2D in the USA. METHODS: A cohort of 6597 patients with T2D who started BI following OAD(s) and had at least one valid glycated hemoglobin (HbA1c) result recorded both within 90 days before and 720 days after BI initiation were selected...
March 29, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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