MG 519 / BMS - LARVOL DELTA

Outcomes of Intermittent Intravenous Steroid Use During Infusion Therapy in Systemic Sclerosis (ACR Convergence 2024) - "With increasing use of biologic medications such as rituximab (RTX), we studied whether intermittent high dose IV corticosteroid premedication is associated with development of SRC in SSc patients. We performed a retrospective observational study of EMR data from 155 SSc patients seen long-term in Rheumatology Clinic at University of New Mexico Hospital between January 2009 and December 2023...In the infusion group, one patient developed SRC prior to first infusion, but across a total of 827 infusions with a mean of 21±23 infusions per patient and a mean IV steroid exposure of 135mg±66mg prednisone equivalents per infusion (mean 2983mg±5198mg prednisone equivalents per patient over the study period), none of the 39 total infusion patients developed SRC during or after infusion therapy... The present data suggest that intermittent high dose IV methylprednisolone premedication is not associated with development of new or relapsing SRC compared to patients..."

Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatology • Scleroderma • Systemic Sclerosis

Phosphatidylinositol 3-Kinase δ-Specific Inhibitor-Induced Changes in the Ovary and Testis in the Sprague Dawley Rat and Cynomolgus Monkey. (PubMed, Int J Toxicol) - "AMG2519493 was a PI3K δ-specific inhibitor in development for treatment of various inflammatory diseases...In contrast, the testicular changes in the cynomolgus monkey (decrease in seminiferous germ cells) occurred at very low doses associated with PI3K δ-specific inhibition, indicating that the PI3K δ isoform may be important in spermatogenesis maturation in the cynomolgus monkey. Our results suggest species-related differences in PI3K isoform-specific control on reproductive organs."

Journal • Preclinical • Hematological Disorders • Inflammation

Phosphatidylinositol 3-Kinase δ Inhibitor-Induced Immunomodulation and Secondary Opportunistic Infection in the Cynomolgus Monkey (Macaca fascicularis). (PubMed, Toxicol Pathol) - "Here, we report changes in the immune and digestive systems that were associated with AMG2519493, a highly selective small-molecule PI3Kδ inhibitor...Digestive tract changes were associated with moribundity and mortality at high-dose levels, and the effect level decreased with increased duration of exposure. These observations demonstrate the role of PI3Kδ in regulation of the immune system and of host resistance to opportunistic infections of the digestive tract."

Journal • Immune Modulation • Immunology • Inflammation

Molecular and clinical evidence of Aeromonas hydrophila and Fusarium solani co-infection in narrow-clawed crayfish Astacus leptodactylus. (PubMed, Dis Aquat Organ) - "...Partial sequence analysis of the F. solani ITS showed 100% sequence identity among all our samples, as well as a close genetic relationship between this isolate (GenBank accession number MG519784) and those previously reported from loggerhead sea turtle Caretta caretta in Cape Verde (FJ948133, AM412641, and DQ535186), black-blotched stingray Taeniura melanopsila in Japan (LC019016), and American manatee Trichechus manatus in Japan (AB775569). The results indicate that narrow-clawed crayfish can be infected by A. hydrophila and F. solani simultaneously, and to the best of our knowledge, this is the first report of just such a co-infection in this host. Further studies are necessary to investigate the pathogenicity of these organisms and their effects on narrow-clawed crayfish."

Clinical • Journal