Results 151 to 160 of about 2,733,451 (251)

Pharmacokinetics, Effectiveness and Safety of Certolizumab Pegol in Children and Adolescents With Active Juvenile Idiopathic Arthritis: 9+‐Year Results From a Multicenter, Open‐Label Study

Arthritis &Rheumatology, EarlyView.
Objective The purpose of this study was to assess the pharmacokinetics, effectiveness, safety, and immunogenicity of certolizumab pegol (CZP) in polyarticular‐course juvenile idiopathic arthritis (pcJIA). Methods Pediatric Arthritis Study of Certolizumab Pegol (NCT01550003), a multicenter, open‐label study, enrolled patients aged 2 to 17 years with ...
Hermine I. Brunner, Lyudmila Grebenkina, Irina Nikishina, Ekaterina Alexeeva, Vyacheslav Chasnyk, Carlos Abud‐Mendoza, Nadina Rubio‐Pérez, Heinrike Schmeling, María del Rocio Maldonado‐Velázquez, Diane Brown, Andrew Zeft, Esi Morgan, C. Egla Rabinovich, Daniel Kingsbury, Hulya Bukulmez, Beth Gottlieb, Thomas Griffin, Lisa Imundo, Stacey Tarvin, Earl Silverman, Laura Shaughnessy, Saori Shimizu, Paulette Williams, Rocío Lledó‐García, Gauri Utturkar, Baran Ufuktepe, Alberto Martini, Daniel J. Lovell, Nicolino Ruperto, the Paediatric Rheumatology International Trials Organisation (PRINTO); the Pediatric Rheumatology Collaborative Study Group (PRCSG), Hermine I. Brunner, Lyudmila Grebenkina, Irina Nikishina, Ekaterina Alexeeva, Vyacheslav Chasnyk, Carlos Abud‐Mendoza, Nadina Rubio‐Pérez, Heinrike Schmeling, María del Rocio Maldonado‐Velázquez, Diane Brown, Andrew Zeft, Esi Morgan, C. Egla Rabinovich, Daniel Kingsbury, Hulya Bukulmez, Beth Gottlieb, Thomas Griffin, Lisa Imundo, Stacey Tarvin, Earl Silverman, Alberto Martini, Daniel L. Lovell, Nicolino Ruperto   +52 more
wiley   +1 more source

Updated COVID‐19 Vaccines and Health Outcomes in Patients With Autoimmune Rheumatic Conditions

Arthritis &Rheumatology, EarlyView.
Objective We aimed to assess the association between COVID‐19 vaccination status and COVID‐19‐related hospital admissions, need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO), and death in people with autoimmune rheumatic conditions. Methods We conducted a retrospective cohort study using National Clinical Cohort Collaborative
Lesley E. Jackson, A. Jerrod Anzalone, Kenneth G. Saag, Rahima Begum, AKM F. Rahman, Namrata Singh, Kaleb Michaud, Jasvinder A. Singh, Rena C. Patel, Maria I. Danila, on behalf of the National Clinical Cohort Collaborative Consortium, Adam B. Wilcox, Adam M. Lee, Alexis Graves, Alfred (Jerrod) Anzalone, Amin Manna, Amit Saha, Amy Olex, Andrea Zhou, Andrew E. Williams, Andrew M. Southerland, Andrew T. Girvin, Anita Walden, Anjali Sharathkumar, Benjamin Amor, Benjamin Bates, Brian Hendricks, Brijesh Patel, G. Caleb Alexander, Carolyn T. Bramante, Cavin Ward‐Caviness, Charisse Madlock‐Brown, Christine Suver, Christopher G. Chute, Christopher Dillon, Chunlei Wu, Clare Schmitt, Cliff Takemoto, Dan Housman, Davera Gabriel, David A. Eichmann, Diego Mazzotti, Donald E. Brown, Eilis Boudreau, Elaine L. Hill, Emily Carlson Marti, Emily R. Pfaff, Evan French, Farrukh M. Koraishy, Federico Mariona, Fred Prior, George Sokos, Greg Martin, Harold P. Lehmann, Heidi Spratt, Hemalkumar B. Mehta, J. W. Awori Hayanga, Jami Pincavitch, Jaylyn Clark, Jeremy Richard Harper, Jessica Yasmine Islam, Jin Ge, Joel Gagnier, Johanna J. Loomba, John B. Buse, Jomol Mathew, Joni L. Rutter, Julie A. McMurry, Justin Guinney, Justin Starren, Karen Crowley, Katie Rebecca Bradwell, Kellie M. Walters, Ken Wilkins, Kenneth R. Gersing, Kenrick Cato, Kimberly Murray, Kristin Kostka, Lavance Northington, Lee Pyles, Lesley Cottrell, Lili M. Portilla, Mariam Deacy, Mark M. Bissell, Marshall Clark, Mary Emmett, Matvey B. Palchuk, Melissa A. Haendel, Meredith Adams, Meredith Temple‐O'Connor, Michael G. Kurilla, Michele Morris, Nasia Safdar, Nicole Garbarini, Noha Sharafeldin, Ofer Sadan, Patricia A. Francis, Penny Wung Burgoon, Philip R. O. Payne, Randeep Jawa, Rebecca Erwin‐Cohen, Rena C. Patel, Richard A. Moffitt, Richard L. Zhu, Rishikesan Kamaleswaran, Robert Hurley, Robert T. Miller, Saiju Pyarajan, Sam G. Michael, Samuel Bozzette, Sandeep K. Mallipattu, Satyanarayana Vedula, Scott Chapman, Shawn T. O'Neil, Soko Setoguchi, Stephanie S. Hong, Steven G. Johnson, Tellen D. Bennett, Tiffany J. Callahan, Umit Topaloglu, Valery Gordon, Vignesh Subbian, Warren A. Kibbe, Wenndy Hernandez, Will Beasley, Will Cooper, William Hillegass, Xiaohan Tanner Zhang   +127 more
wiley   +1 more source

Current evidence and insights on single vs. double dose of basiliximab in adult solid organ transplant recipients: A systematic review

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this systematic review was to assess all available clinical data regarding the use of a single dose of basiliximab in solid organ transplantation compared to the standard double dosage, with particular interest in efficacy, safety and cost‐savings.
Alessio Provenzani, Braidon A. Lape, Anneliese M. Harp, Victoria Weisbrod, Lavinia Piazza   +4 more
wiley   +1 more source

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

British Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló, Attila Imre, Gábor Varga, Sándor Kovács, György Tímár, Balázs Nagy   +5 more
wiley   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Efficacy, safety and cost‐effectiveness of CAR‐T therapy

British Journal of Clinical Pharmacology, EarlyView.
CAR T‐cells demonstrate high efficacy in blood cancers, including ALL, MM and DLBCL. Innovations target solid tumours despite challenges such as antigen escape. Combination therapies enhance the delivery and infiltration of CAR T cells. Toxicity, cost and resistance remain major barriers to clinical use.
Emina Karahmet Sher, Amina Džidić‐Krivić, Emma Pinjic, Nejra Selak, Kanita Omerbasic, Alexandar Chupin, Andrej Belancic, Almir Fajkic   +7 more
wiley   +1 more source

Unravelling the enhanced vaccine immunity by heterologous KCONVAC/Ad5-nCoV COVID-19 vaccination

Signal Transduction and Targeted Therapy, 2022
Weijun Zhao, Huajun Zhao, Baoying Huang, Tongyi Zhao, Limei Wang, Jian Zhang, Yong Yang, Xinying Tang, Wenjie Tan, Ang Lin   +9 more
doaj   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Myths and facts about immunization: World Health Organization vaccine safety supporting document

, 2015
4 p.Vaccine-safety-related events, and how we respond to them, can affect public trust in vaccines and health authorities. These events may or may not be linked to vaccines and include: adverse events following immunization (AEFIs), vaccination programme
World Health Organization. Regional Office for Europe
core  

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aim Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine‐derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.
Comfort Kunak Ogar, Malede Mequanent Sisay, Leonardo Roque‐Pereira, Christine Leopold, Patrick C. Souverein, Aukje K. Mantel‐Teeuwisse, Marie L. De Bruin   +6 more
wiley   +1 more source