Winrevair (sotatercept) has been approved for treating adults with pulmonary arterial hypertension (PAH), classified under World Health Organization (WHO) Group 1. This medication is designed to enhance physical endurance and slow disease progression in affected individuals.
PAH is a rare and life-threatening condition that gradually worsens over time. It can develop at any stage of life, severely impacting a person's ability to engage in physical activities and diminishing overall quality of life.
Winrevair stands out as the first activin signaling inhibitor approved by Anvisa for managing PAH. This approval introduces a novel therapeutic class targeting the vascular cell signaling and abnormal cell growth that contribute to PAH.
The effectiveness of Winrevair was assessed in adult PAH patients through the global STELLAR clinical trial—a double-blind, placebo-controlled, multicenter study with parallel groups. In this trial, 323 patients with WHO Group 1 PAH (functional class II or III) were randomly assigned in a 1:1 ratio to receive either Winrevair (at a target dose of 0.7 mg/kg, administered subcutaneously every three weeks) or a placebo. Specifically, 163 participants received Winrevair, while 160 received the placebo.
The STELLAR study excluded patients diagnosed with pulmonary hypertension from WHO Groups 2, 3, 4, or 5, as well as those with PAH linked to HIV, portal hypertension, schistosomiasis, or pulmonary veno-occlusive disease, among other conditions.
The primary goal was to measure the change in distance walked during the 6-minute walk test (6MWT) after 24 weeks of treatment. Patients treated with Winrevair showed a median improvement of 40.8 meters in the 6MWT compared to the placebo group (95% CI: 27.5, 54.1; p < 0.001). Beyond enhancing exercise capacity, Winrevair also lowered the risk of disease progression and reduced the likelihood of death, demonstrating positive outcomes in several secondary measures.
Before administering Winrevair, healthcare providers should monitor hemoglobin and platelet levels before each dose for the first five treatments—or longer if these levels are unstable—and continue regular checks thereafter to adjust dosing as needed. Winrevair can elevate hemoglobin levels, potentially leading to erythrocytosis, which heightens the risk of blood clots or hyperviscosity syndrome. Additionally, it may reduce platelet counts, causing severe thrombocytopenia, which increases bleeding risks. This side effect was more common in patients also on prostacyclin infusion therapy. Starting treatment is not recommended for patients with platelet counts below 50,000/mm³.
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