Results 51 to 60 of about 16,542 (247)

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Outcomes of Upadacitinib following Dupilumab for Dupilumab-Associated Facial and Neck Erythema: A Systematic Review

Dupilumab, an anti-IL-13 and anti-IL-4 antibody, is a mainstay of treatment for moderate-to-severe atopic dermatitis. However, dupilumab-associated facial and/or neck erythema (DA-FNE) has been reported to be a relatively common adverse event. There have
Simpson, R (via Mendeley Data)
core   +5 more sources

Pharmacokinetics, efficacy and safety of dupilumab administered with prefilled pen devices in patients aged <12 years with atopic dermatitis

British Journal of Clinical Pharmacology, EarlyView.
Aim For children with atopic dermatitis (AD), dupilumab is available as a prefilled syringe (PFS) from the age of 6 months and as a prefilled pen (PFP) for patients aged ≥2 years, in 200‐ and 300‐mg devices. This substudy of an ongoing open‐label extension study evaluated the pharmacokinetics, efficacy and safety of switching from a dupilumab PFS ...
Amy S. Paller, Elaine C. Siegfried, Ashish Bansal, Jing Xiao, Faisal A. Khokhar, Michael Van Spall, Xia Liu, Christine Xu, Ariane Dubost‐Brama, Matthew P. Kosloski   +9 more
wiley   +1 more source

Dupilumab Induced Psoriasiform Dermatitis [PDF]

, 2019
Atopic dermatitis (AD) is a common inflammatory skin condition that affects up to 20-30% of children and 2-10% of adults. In the past, therapeutic options were limited to emollients, topical glucocorticoids and calcineurin inhibitors, phototherapy, and ...
Veenstra, Jesse, Kerr, Holly, Novice, Karlee, Siegel, Dana   +3 more
core   +1 more source

Impact of exacerbation history on long-term efficacy of dupilumab in patients with asthma

ERJ Open Research, 2023
Background The phase 3 QUEST (NCT02414854) and TRAVERSE (NCT02134028) studies demonstrated the efficacy of dupilumab 200/300 mg versus placebo every 2 weeks for 52 weeks (QUEST) and dupilumab 300 mg up to an additional 96 weeks (TRAVERSE) in patients ≥12 
Jonathan Corren, Constance H. Katelaris, Mario Castro, Jorge F. Maspero, Marc Humbert, David M.G. Halpin, Arman Altincatal, Nami Pandit-Abid, Xavier Soler, Amr Radwan, Juby A. Jacob-Nara, Yamo Deniz, Paul J. Rowe   +12 more
doaj   +1 more source

Knowledge and practice regarding eosinophilic gastrointestinal disorders other than eosinophilic esophagitis among pediatric gastroenterologists of the Latin American Society for Pediatric Gastroenterology, Hepatology, and Nutrition

JPGN Reports, EarlyView.
Abstract Objective Evaluating clinical practices in the management of non‐esophageal eosinophilic gastrointestinal disorders (non‐EoE EGIDs) among pediatric gastroenterologists in Latin America. Methods A cross‐sectional descriptive study was conducted using a survey distributed via the REDCap platform.
Sofia Paz, Michelle Higuera Carrillo, Alonso Rafael Echavez Agudelo, Mário Cesar Vieira, Juan Pablo Riveros López, Natali González Rozó, Gustavo Javier Tagliaferro, Fabiola Sánchez Hernández, Catalina Ortiz Piedrahita, Wilson Daza Carreño, Ailim Margarita Carias Domínguez, José Fernando Vera Chamorro, Sabine Krüger Truppel, Maximiliano Fernández Rivas, César Augusto Moreno Serrano, Pablo Torres Córdova, Carlos Marcelo Timossi, Pablo Vásquez   +17 more
wiley   +1 more source

Distinct ocular safety profiles of dupilumab and upadacitinib in atopic dermatitis: a real-world study with ophthalmological and microbiological assessment

Journal of Dermatological Treatment
Background Dupilumab is highly effective in atopic dermatitis (AD) but is associated with ocular surface disease, whereas Janus kinase (JAK) inhibitors may have a more favorable ocular safety profile.Objectives To compare ocular outcomes and conjunctival
Paulina Stepinska, Kamila Zawadzinska-Halat, Maciej Pastuszczak   +2 more
doaj   +1 more source

Type II achalasia unmasked by EndoFLIP and high‐resolution manometry in a child with eosinophilic esophagitis

JPGN Reports, EarlyView.
ABSTRACT Eosinophilic esophagitis (EoE) is a chronic immune‐mediated disease characterized by esophageal dysfunction and eosinophilic inflammation. Persistent dysphagia despite histologic remission should prompt evaluation for alternative etiologies. A 10‐year‐old male with asthma and eczema presented with progressive solid food dysphagia, daily non ...
Rasha Abi Radi Abou Jaoudeh, Jose M. Garza, Chathruckan Rajendra   +2 more
wiley   +1 more source

Effect of dupilumab on otitis media associated with eosinophilic chronic rhinosinusitis

Brazilian Journal of Otorhinolaryngology
Objective: Eosinophilic Otitis Media (EOM) is an intractable disease caused by type 2 inflammation, such as Eosinophilic Chronic Rhinosinusitis (ECRS) and bronchial asthma. Biologics have recently been used to treat ECRS and bronchial asthma.
Seiichiro Kamimura, Keisuke Ishitani, Ryota Morozumi, Eiji Kondo, Takahiro Azuma, Go Sato, Yoshiaki Kitamura   +6 more
doaj   +1 more source

Efficacy and Safety of Dupilumab in Moderate-to-Severe Bullous Pemphigoid

Frontiers in Immunology, 2021
BackgroundBullous pemphigoid (BP) is an autoimmune blistering disorder that predominantly affects the elderly. As the main treatment for BP, systemic corticosteroids are often limited by their side effects. Safer treatment modalities are therefore needed.
Yihua Zhang, Qiuyun Xu, Lihong Chen, Jiawen Chen, Jing Zhang, Ying Zou, Ting Gong, Chao Ji   +7 more
doaj   +1 more source