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Detection of risk signals for ustekinumab in the real world using the FDA Adverse Event Reporting System (FAERS).
Expert Opin Drug Saf
December 2024
Department of Pharmacy, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Background: Ustekinumab is a fully human interleukin-12/23 (p40) inhibitor used to treat immune-mediated diseases. However, the limitations of clinical trials and the expanding target population necessitate an update on the ustekinumab-associated adverse events (AEs). We conducted signal mining for ustekinumab-related AEs using the United States Food and Drug Administration Adverse Event Reporting System (FAERS).
View Article and Find Full Text PDFAssociation Between Biologics and Janus Kinase Inhibitors With Inflammatory Bowel Disease as Paradoxical Reactions: A Real-World Assessment.
United European Gastroenterol J
December 2024
Division of Gastroenterology and Hepatology, NHC Key Laboratory of Digestive Diseases, State Key Laboratory for Oncogenes and Related Genes, School of Medicine, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiao Tong University, Shanghai, China.
Background And Objective: With limited evidence connecting paradoxical inflammatory bowel disease (paradoxical IBD) to the newest biologics and Janus kinase inhibitors, our study aims to investigate the occurrence of paradoxical IBD induced by these agents in treating other immune-mediated inflammatory diseases (IMIDs). We aim to identify associated risk signals, the primary affected population, and the risk profile changes over time.
Methods: We performed disproportionality analysis to evaluate paradoxical IBD risk signals using data from the FDA Adverse Event Reporting System.
Assessing Functional Similarity of Biosimilar ABP 654 and Ustekinumab in Samples from Patients with Crohn's Disease.
J Inflamm Res
December 2024
Biosimilar Process Development, Amgen Inc., Thousand Oaks, CA, 91320, USA.
Purpose: ABP 654 is the first FDA-approved interchangeable biosimilar for ustekinumab reference product (RP). To support the totality of evidence (TOE), in vitro pharmacology studies were conducted in peripheral blood mononuclear cells (PBMCs) from healthy human donors and Crohn's disease (CD) patients to evaluate IL-23 and IL-12 inhibition by ABP 654 and ustekinumab RP relevant to the mechanism of action of chronic inflammation.
Methods: ABP 654 and ustekinumab RP were assessed using inhibition of IL-23 and IL-12-mediated IFN-γ release, signal transducer and activator of transcription (STAT)3 and STAT4 phosphorylation, and IL-17 release.
Osteonecrosis of the jaw associated with ustekinumab in the treatment of Crohn's.
Heliyon
October 2024
Department of oral and maxillofacial surgery, Cliniques universitaires Saint-Luc, Avenue Hippocrate,10, 1200, Brussels, Belgium.
MRONJ is a well-known side effect of antiresorptive and antiangiogenic drug treatment. Crohn's disease involves pro-inflammatory interleukins IL-12 and IL-23. Ustekinumab is a targeted therapy antagonist of the p40 subunit of IL-12 and -23 indicated in the treatment of immune-mediated inflammatory diseases.
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