Biological agents are widely used across medicine, including for immune-mediated skin conditions such as psoriasis and atopic dermatitis. When used to treat a relevant pathological process, they demonstrate impressive efficacy and credible safety, helping to achieve remission and improved function and quality of life. However, with their expanded use, awareness and understanding of adverse reactions to biologicals have also increased. Herein, we discuss the pathomechanism of adverse reactions to biological agents used to treat skin conditions and apply these to Pichler's classification system. This classification differentiates five distinct types, namely overstimulation (type α), hypersensitivity or immunogenicity (β), immunodeviation (γ), cross-reactivity (δ) and nonimmunologic adverse reactions (ε). This classification covers most types of adverse reactions associated with use of biological agents and could be used to better understand the reaction pathogenesis and manage the clinical features of biological adverse effects.
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http://dx.doi.org/10.1111/cea.14583 | DOI Listing |
Objective: Sodium-glucose cotransporter (SGLT) 2 inhibitors are expected to demonstrate secondary effects against malignancy. However, long-term and large-scale data are required to evaluate the effects of SGLT2 inhibitors on malignancy, which has not been sufficiently studied in clinical practice. This study aimed to evaluate the association between SGLT2 inhibitors and malignancy using the spontaneous adverse reaction database.
View Article and Find Full Text PDFClin Pharmacol Drug Dev
January 2025
Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.
Pizuglanstat is a novel hematopoietic prostaglandin D synthase inhibitor and investigational treatment for Duchenne muscular dystrophy. This Phase 1 mass balance study aimed to characterize the absorption, metabolism, and excretion of carbon-14 (C)-labeled pizuglanstat in healthy adults (ClinicalTrials.gov, NCT04825431).
View Article and Find Full Text PDFSci Prog
January 2025
School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Purpose: The aim of this study was to evaluate the efficacy and safety of the Ahmed glaucoma valve in pediatric patients with refractory glaucoma.
Methods: A comprehensive literature search was conducted across multiple major databases, including PubMed, Embase, the Cochrane Library of Systematic Reviews, Science Direct, China's National Knowledge Infrastructure, and the Wanfang database. We retrieved studies published before December 2022 that met the inclusion criteria, including clinical controlled trials (randomized controlled trials) and clinical noncontrolled trials (non-randomized controlled trials) on the use of Ahmed glaucoma valve in pediatric patients with refractory glaucoma.
Front Pharmacol
January 2025
Department of Fetal Medicine, The First Affiliated Hospital of Jinan University, Guangzhou, China.
Onasemnogene Abeparvovec (Zolgensma) is a gene therapy for the treatment of Spinal Muscular Atrophy (SMA) with improved motor neuron function and the potential for a singular treatment. Information on its adverse drug reactions is mainly from clinical trials and real-world studies with extensive sample sizes are lacking. In this study, we analyzed the U.
View Article and Find Full Text PDFFront Pharmacol
January 2025
Department of Oncology, Zibo Municipal Hospital, Zibo, ShanDong, China.
Background: Neurofibromatosis type 1 (NF1) is a rare neurogenetic disorder with limited treatment options. Selumetinib, a MEK1/2 inhibitor, has emerged as a promising therapy for inoperable NF1-related plexiform neurofibromas.
Methods: Our retrospective pharmacovigilance study utilized the FDA Adverse Event Reporting System (FAERS) to comprehensively evaluate Selumetinib's safety profile in real-world settings.
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