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Jennifer R Brown, Mehdi Hamadani, John Hayslip, Ann Janssens, Nina Wagner-Johnston, Oliver Ottmann, Jon Arnason, Hervé Tilly, Michael Millenson, Fritz Offner, Nashat Y Gabrail, Siddhartha Ganguly, Sikander Ailawadh, Siddha Kasar, Arnon P Kater, Jeanette K Doorduijn, Lei Gao, Joanne J Lager, Bin Wu, Coumaran Egile, Marie José Kersten
BACKGROUND: Patients with relapsed or refractory lymphoma or chronic lymphocytic leukaemia have a poor prognosis. Therapies targeting more than one isoform of PI3K, as well as mTOR, might increase antitumour activity. We aimed to investigate the efficacy and safety of voxtalisib (also known as XL765 or SAR245409), a pan-PI3K/mTOR inhibitor, in patients with relapsed or refractory lymphoma, or chronic lymphocytic leukaemia/small lymphocytic lymphoma. METHODS: We did a non-randomised, open-label, phase 2 trial at 30 oncology clinics in the USA, Belgium, Germany, France, the Netherlands, and Australia...
March 14, 2018: Lancet Haematology
Jessica A White, Marcus Estrada, William C Weldon, Konstantin Chumakov, Diana Kouiavskaia, Jacqueline Fournier-Caruana, Eric Stevens, Howard E Gary, Edmond F Maes, M Steven Oberste, Cynthia J Snider, Abhijeet Anand, Dexiang Chen
According to manufacturers, inactivated poliovirus vaccines (IPVs) are freeze sensitive and require storage between 2°C and 8°C, whereas oral poliovirus vaccine requires storage at -20 °C. Introducing IPV into ongoing immunization services might result in accidental exposure to freezing temperatures and potential loss of vaccine potency. To better understand the effect of freezing IPVs, samples of single-dose vaccine vials from Statens Serum Institut (VeroPol) and multi-dose vaccine vials from Sanofi Pasteur (IPOL) were exposed to freezing temperatures mimicking what a vaccine vial might encounter in the field...
March 14, 2018: Biologicals: Journal of the International Association of Biological Standardization
(no author information available yet)
▼Dupilumab (Dupixent - Sanofi-Aventis Groupe), a monoclonal antibody for the treatment of moderate-to-severe atopic dermatitis in adults who require systemic therapy, was licensed by the European Medicines Agency in September 2017. It is the first biological drug approved specifically for this condition. Here, we review the evidence for its efficacy and safety and consider its place in therapy.
March 2018: Drug and Therapeutics Bulletin
Gillian K Weston, Jette Hooper, Bruce E Strober
Dupilumab (Dupixent, Regeneron Pharmaceuticals and Sanofi Genzyme) is a novel biologic medication recently approved by the FDA for the treatment of moderate-to-severe atopic dermatitis in adults who have not achieved adequate control with topical medications. Dyshidrotic eczema is a distinct entity, often considered on the spectrum of atopic dermatitis, that primarily effects the palms and soles; it is often associated with considerable morbidity yet is frequently challenging to treat. We report two cases of recalcitrant dyshidrotic eczema treated successfully with dupilumab at standard dosing...
March 1, 2018: Journal of Drugs in Dermatology: JDD
Tianwei Gu, Ting Hong, Pengzi Zhang, Sunyinyan Tang, Yan Bi, Hai Lu, Lichuang Men, Dongwei Ma, Dalong Zhu
INTRODUCTION: In Asia, patients with type 2 diabetes mellitus (T2DM) often have suboptimal glycemic control for many years prior to initiating basal insulin. Active titration of basal insulin is also required to improve glycemic outcomes. This pooled analysis was conducted to determine the impact of patient baseline covariates on the required dose of basal insulin and treatment response, for the improved management of Asian patients with T2DM. METHODS: Data on insulin-naïve Asian patients with T2DM who initiated and fully titrated insulin glargine 100 U/mL (Gla-100) for ≥ 20 weeks were pooled from seven randomized, controlled, treat-to-target trials...
March 9, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Andrea Bacigalupo, Rosi Oneto, Hubert Schrezenmeier, Britta Hochsmann, Carlo Dufour, Seiji Kojima, Xiaofan Zhu, Xiaojuan Chen, Surapol Issaragrisil, Suporn Chuncharunee, Dae Chul Jeong, Sabrina Giammarco, Maria Teresa Van Lint, Yizhou Zheng, Carlos Vallejo
The aim of this study was to assess the outcome of patients with aplastic anemia (AA), receiving rabbit anti-thymocyte globulin (Thymoglobulin, SANOFI) and cyclosporin, as first line treatment. Eligible were 955 patients with AA, treated first line with Thymoglobulin, between 2001 and 2008 (n=492), or between 2009-2012 (n=463). The median age of the patients was 21 years (range 1-84). Mortality within 90 days was 5.7% and 2.4%, respectively in the two time periods (p=0.007).The actuarial 10 year survival for the entire population was 70%; transplant free survival was 64%...
March 2, 2018: American Journal of Hematology
Sarah Eggert, Esther Zimmermann, Kamilla Begtrup
No abstract text is available yet for this article.
March 5, 2018: Expert Opinion on Pharmacotherapy
Shrikant Sharma, Veer Bahadur Singh, Sanjay Kumar, Vipul Prajapati, Jitendra Patel, Rajesh Vukkala, Sanjay Kumar Jangid, Jayesh Sanmukhani, Gaurav Gupta, Pradip Patel, Ravindra Mittal, Reinhard Glueck
This phase II / III clinical trial was conducted to evaluate the immunogenicity and safety of the Tetravalent Influenza vaccine (Split virion) I.P. (TetIV) developed indigenously in the country for the first time by M/s Cadila Healthcare Limited, India containing two influenza A and two influenza B strains, one of each, Yamagata (B/Phuket) and Victoria (B/Brisbane) lineage and also compare it to that of an licensed seasonal Trivalent Influenza vaccine (TriIV) of Sanofi Pasteur India Private Limited, containing the two influenza A and only the Yamagata lineage (B/Phuket) strain...
February 20, 2018: Human Vaccines & Immunotherapeutics
(no author information available yet)
Patient-reported outcomes (PROs), which provide a direct measure of a patient's health status or treatment preferences, represent a key component of the shift toward patient-centered health care. PROs can measure the state of a patient's disease-specific and overall health throughout the care continuum, enabling them to have a variety of uses for key health care stakeholders. Currently, PROs are used in drug development, aligning patient and clinician goals in care, quality-of-care measures, and coverage and reimbursement decisions...
February 20, 2018: Journal of Managed Care & Specialty Pharmacy
Jelica Bjekić-Macut, Teodora Beljić Živković, Radivoj Kocić
INTRODUCTION: Basal insulin analogues offer persons with type 2 diabetes mellitus (T2DM) adequate glycemic control combined with a favorable safety profile. BASAL-BALI-a prospective, noninterventional, multicenter disease registry-assessed the effectiveness and safety of basal insulin analogues in adult Serbians with T2DM previously inadequately controlled on other insulin types. METHODS: The primary objective was to assess the reduction in glycated hemoglobin (HbA1c ) from basal insulin analogue initiation to the end of a 6-month observation period...
February 19, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
NMdu Plessis, G Ntshoe, G Reubenson, R Kularatne, L Blumberg, J Thomas, T Avenant
BACKGROUND: In low and middle-income countries, including South Africa, the epidemiology of pertussis in relation to immunisation, nutritional and HIV status is poorly described. We report on risk factors in South African children hospitalised with pertussis. METHODS: We conducted a prospective, hospital-based, sentinel surveillance programme for pertussis in Gauteng Province, South Africa. Hospitalised children (≤10 years) meeting the surveillance criteria for clinically suspected pertussis were screened and enrolled...
February 1, 2018: International Journal of Infectious Diseases: IJID
Joel Charrow, Cristina Fraga, Xuefan Gu, Hiroyuki Ida, Nicola Longo, Elena Lukina, Alexandre Nonino, Sebastiaan J M Gaemers, Marie-Helene Jouvin, Jing Li, Yaoshi Wu, Yong Xue, M Judith Peterschmitt
Eliglustat is a first-line oral therapy for adults with Gaucher disease type 1 (GD1) with compatible CYP2D6-metabolizer phenotypes (>90% of patients). The randomized, double-blind EDGE trial (NCT01074944, Sanofi Genzyme) evaluated once-daily eliglustat dosing compared with the approved twice-daily regimen at the same total daily dose in adults with GD1. Subjects received twice-daily dosing during a 6- to 18-month lead-in period. Only subjects who attained prespecified treatment goals for hemoglobin, platelet count, spleen and liver volumes, and bone symptoms during the lead-in period were randomized to once- or twice-daily dosing...
January 4, 2018: Molecular Genetics and Metabolism
Shaloo Gupta, Hongwei Wang, Neil Skolnik, Liyue Tong, Ryan M Liebert, Lulu K Lee, Peter Stella, Anna Cali, Ronald Preblick
INTRODUCTION: Usage patterns and effectiveness of a longer-acting formulation of insulin glargine at a strength of 300 units per milliliter (Gla-300) have not been studied in real-world clinical practice. This study evaluated differences in dosing and clinical outcomes before and after Gla-300 treatment initiation in patients with type 2 diabetes starting or switching to treatment with Gla-300 to assess whether the benefits observed in clinical trials translate into real-world settings...
January 8, 2018: Advances in Therapy
Josh J Carlson, Gregory F Guzauskas, Richard H Chapman, Patricia G Synnott, Shanshan Liu, Elizabeth T Russo, Steven D Pearson, Elizabeth D Brouwer, Daniel A Ollendorf
BACKGROUND: New 3-drug regimens have been developed and approved to treat multiple myeloma (MM). The absence of direct comparative data and the high cost of treatment support the need to assess the relative clinical and economic outcomes across all approved regimens. OBJECTIVE: To evaluate the cost-effectiveness of treatments for relapsed and/or refractory MM from a U.S. health system perspective. METHODS: We developed a partition survival model with 3 health states (progression-free, progression, and death) to evaluate the following regimens: carfilzomib (CFZ), elotuzumab (ELO), ixazomib (IX), daratumumab (DAR), and panobinostat (PAN) in combination with lenalidomide (LEN) or bortezomib (BOR) plus dexamethasone (DEX) in the second and/or third line of therapy...
January 2018: Journal of Managed Care & Specialty Pharmacy
Loren Rodgers, Lauren Shaw, Raymond Strikas, Beth Hibbs, JoEllen Wolicki, Cristina V Cardemil, Cindy Weinbaum
OBJECTIVE: To quantify vaccinations administered outside minimum and maximum recommended ages and to determine attendant costs of revaccination by analyzing immunization information system (IIS) records. STUDY DESIGN: We analyzed deidentified records of doses administered during 2014 to persons aged <18 years within 6 IIS sentinel sites (10% of the US population). We quantified doses administered outside of recommended ages according to the Advisory Committee on Immunization Practices childhood immunization schedule and prescribing information in package inserts, and calculated revaccination costs...
December 14, 2017: Journal of Pediatrics
Stephen Tottey, Yoko Shoji, R Mark Jones, Jessica A Chichester, Brian J Green, Konstantin Musiychuk, Huaxin Si, Slobodanka D Manceva, Amy Rhee, Moneim Shamloul, Joey Norikane, Rosane C Guimarães, Elena Caride, Andrea N M R Silva, Marisol Simões, Patricia C C Neves, Renato Marchevsky, Marcos S Freire, Stephen J Streatfield, Vidadi Yusibov
Yellow fever (YF) is a viral disease transmitted by mosquitoes and endemic mostly in South America and Africa with 20-50% fatality. All current licensed YF vaccines, including YF-Vax® (Sanofi-Pasteur, Lyon, France) and 17DD-YFV (Bio-Manguinhos, Rio de Janeiro, Brazil), are based on live attenuated virus produced in hens' eggs and have been widely used. The YF vaccines are considered safe and highly effective. However, a recent increase in demand for YF vaccines and reports of rare cases of YF vaccine-associated fatal adverse events have provoked interest in developing a safer YF vaccine that can be easily scaled up to meet this increased global demand...
February 2018: American Journal of Tropical Medicine and Hygiene
Mi Young Kim, Alastair Copland, Kaustuv Nayak, Anmol Chandele, Muhammad S Ahmed, Qibo Zhang, Gil R Diogo, Matthew J Paul, Sven Hofmann, Moon-Sik Yang, Yong-Suk Jang, Julian K-C Ma, Rajko Reljic
Dengue is a major global disease requiring improved treatment and prevention strategies. The recently licensed Sanofi Pasteur Dengvaxia vaccine does not protect children under the age of nine, and additional vaccine strategies are thus needed to halt this expanding global epidemic. Here, we employed a molecular engineering approach and plant expression to produce a humanized and highly immunogenic poly-immunoglobulin G scaffold (PIGS) fused to the consensus dengue envelope protein III domain (cEDIII). The immunogenicity of this IgG Fc receptor-targeted vaccine candidate was demonstrated in transgenic mice expressing human FcγRI/CD64, by induction of neutralizing antibodies and evidence of cell-mediated immunity...
December 9, 2017: Plant Biotechnology Journal
Alan Kivitz, Lydie Baret-Cormel, Hubert van Hoogstraten, Sheldon Wang, Janie Parrino, Christine Xu, Marina Stanislav
INTRODUCTION: Sarilumab is a human monoclonal antibody that blocks the interleukin-6 receptor alpha (IL-6Rα). The phase 3 SARIL-RA-EASY study (EASY) assessed the robustness of an autoinjector (pen) for administering sarilumab when used by adults with active moderate-to-severe rheumatoid arthritis (RA) who are candidates for anti-IL-6R therapy in an unsupervised real-world setting. METHODS: EASY was a 12-week, multicenter, randomized, open-label, parallel-group usability study of the sarilumab pen and prefilled syringe...
December 5, 2017: Rheumatology and Therapy
Viviane Gresset-Bourgeois, Phillip S Leventhal, Stéphanie Pepin, Rosalind Hollingsworth, Marie-Pierre Kazek-Duret, Iris De Bruijn, Sandrine I Samson
VaxigripTetra™ (IIV4; Sanofi Pasteur) is a quadrivalent split-virion influenza vaccine approved in Europe in 2016 for individuals ≥ 3 years of age. IIV4 builds on the well-established record of the trivalent split-virion influenza vaccine (Vaxigrip®). Areas covered: This literature review summarizes the rationale for developing quadrivalent influenza vaccines and discusses the phase III clinical trial results supporting the immunogenicity, safety, and tolerability of IIV4. Expert commentary: IIV4 is immunogenic and well tolerated...
January 2018: Expert Review of Vaccines
Federica Porcaro, Maria Giovanna Paglietti, Antonella Diamanti, Francesca Petreschi, Alessandra Schiavino, Valentina Negro, Valentina Pecora, Alessandro Fiocchi, Renato Cutrera
BACKGROUND: Medications with methyl-prednisolone sodium succinate containing lactose, which potentially contains traces of cow's milk proteins (CMP), could cause allergic reactions or compromise treatment of acute allergic reactions in sensitized patients. CASE PRESENTATION: We describe the unusual case of a one-year-old child affected by short bowel syndrome and history of severe cow's milk allergy (CMA) and anaphylactic reaction due to intravenous administration of methyl-prednisolone sodium succinate (Solu-Medrol 40 mg, Pfizer)...
November 17, 2017: Italian Journal of Pediatrics
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