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Immune regulatory adjuvant approach to mitigate subcutaneous immunogenicity of monoclonal antibodies.
Front Immunol
December 2024
Department of Pharmaceutical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, United States.
Introduction: Immunogenicity continues to be a challenge for development and clinical utility of monoclonal antibodies, and there are gaps in our current ability to prevent anti-drug antibody development in a safe and antigen-specific manner.
Methods: To mitigate immunogenicity of monoclonal antibodies administered subcutaneously, O-phospho-L-serine (OPLS)-the head group of the tolerance-inducing phospholipid, phosphatidylserine-was investigated as an immunoregulatory adjuvant.
Results: Formulations of adalimumab, trastuzumab or rituximab with OPLS showed reduction in relative immunogenicity in mice compared to vehicle formulations, indicated by reduced anti-drug antibody development and significant reductions in CD138+ plasma cell differentiation in bone marrow.
Profile of Ofatumumab in the Treatment of Multiple Sclerosis: Design, Development and Place in Therapy.
Drug Des Devel Ther
December 2024
Northwell Comprehensive Multiple Sclerosis Center, Department of Neurology, Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra, New York, NY, USA.
Targeting B cells through monoclonal antibodies against CD20 has emerged as a highly effective strategy in managing disease activity in patients with relapsing forms of multiple sclerosis. This efficacy was initially demonstrated with rituximab and further affirmed with ocrelizumab. Ofatumumab is the first fully human IgG1 monoclonal antibody (mAb) approved for the treatment of MS.
View Article and Find Full Text PDFInvention and characterization of a systemically administered, attenuated and killed bacteria-based multiple immune receptor agonist for anti-tumor immunotherapy.
Front Immunol
November 2024
Indaptus Therapeutics, Inc., New York, NY, United States.
Activation of immune receptors, such as Toll-like (TLR), NOD-like (NLR) and Stimulator of Interferon Genes (STING) is critical for efficient innate and adaptive immunity. Gram-negative bacteria (G-NB) contain multiple TLR, NOD and STING agonists. Potential utility of G-NB for cancer immunotherapy is supported by observations of tumor regression in the setting of infection and Coley's Toxins.
View Article and Find Full Text PDFEfficacy and Safety of Subcutaneous Rituximab in Idiopathic Nephrotic Syndrome.
Kidney Int Rep
November 2024
Nephrology, Dialysis, and Transplantation Unit, IRCCS Istituto Giannina Gaslini, Genoa, Italy.
Real-world safety profile of zanubrutinib: a disproportionality analysis based on the FAERS database.
BMJ Open
October 2024
Center for Clinical Pharmacy, Cancer Center, Department of Pharmacy, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, Zhejiang, People's Republic of China
Article Synopsis
- Zanubrutinib, a second-generation Bruton's tyrosine kinase inhibitor, is being studied for its adverse effects based on real-world data from the FDA’s AE Reporting System between 2019-2023.
- A comprehensive analysis identified 846 AE reports related to zanubrutinib, revealing 74 positive signals across various organ systems, with key issues in blood disorders and significant signals like 'haemorrhage subcutaneous'.
- The study indicates that switching from monotherapy to combination therapy with rituximab or chemotherapy escalates the risk of serious adverse events, with some unexpected off-label AEs also noted, such as skin discoloration and cardiac arrest.
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