Title : Clinical pharmacology of sotatercept - The novel quality advancement in biological therapy of pulmonary arterial hypertension
Abstract:
Pulmonary arterial hypertension (PAH) remains a debilitating disease with high morbidity and mortality. It is a rare, progressive and ultimately life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart. Patients with PAH have an abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue. Because disease progresses rapidly for many patients, and frequently accompanied with serious clinical presentation, new treatment opinions continue to be needed. Sotatercept is the first FDA- and EMEA-approved activin signaling inhibitor therapy for PAH, characterizing a new class of pharmacological management that acts by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH. This drug induces cellular changes that are associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. Sotatercept is used in combination with other PAH medicines in patients with moderate or marked limitations of physical activity (corresponding to WHO functional class II or III respectively). Patients and caregivers must be trained by a health care provider or nurse on how to mix, prepare, measure and inject sotatercept. Given the previous facts, the main objectives of this presentation will be to clarify the pharmacological properties of sotatercept, including pharmacodynamics, pharmacokinetics, indications, and contraindications for use, adverse drug reactions, as well as the most important drug interactions. This will provide a better understanding of this orphan and the first-in-class biological drug for PAH, consequently helping clinicians in its suitable prescribing and adequate clinical use.