Publications by authors named "Mitali Gaurav"
Article Synopsis
- * Enhanced exposure-response and pharmacokinetic/pharmacodynamic modeling revealed that higher concentrations of sotatercept improve key clinical outcomes including 6MWD and the likelihood of achieving lower NT-proBNP levels, while maintaining safety measures like hemoglobin levels.
- * Key factors influencing the treatment's response include patient age and iron supplementation, but their overall impact on outcomes was minimal, supporting the selected dosing strategy of 0.7 mg/kg administered subcutaneously every three weeks as effective and safe.
Introduction: The recommended standard dose for α-proteinase inhibitor (A1PI) augmentation therapy is 60 mg/kg once-weekly (QW) intravenous (IV) infusions that aim to maintain systemic A1PI levels >11 μM, the biochemical efficacy threshold, in patients with α-antitrypsin deficiency (AATD). However, this standard dose may not be optimal for all patients. Body weight-based dosing, alternative dosing regimens, and treatment interruption periods were evaluated using population pharmacokinetic (PopPK) modeling and simulations.
View Article and Find Full Text PDF