FRIDAY, March 10, 2023 (HealthDay News) -- Sotatercept is associated with a greater improvement in exercise capacity than placebo among patients with pulmonary arterial hypertension (PAH) receiving stable background therapy, according to a study published online March 6 in the New England Journal of Medicine to coincide with the annual meeting of the American College of Cardiology, held from March 4 to 6 in New Orleans.
Marius M. Hoeper, M.D., from Hannover Medical School in Germany, and colleagues randomly assigned (1:1) adults with PAH (World Health Organization functional class II or III), who were receiving stable background therapy, to receive subcutaneous sotatercept (163 patients; starting dose, 0.3 mg per kg of body weight; target dose, 0.7 mg per kg) or placebo (160 patients) every three weeks.
The researchers found that the median change from baseline to week 24 in the six-minute walk distance was 34.4 m (95 percent confidence interval, 33.0 to 35.5) in the sotatercept group and 1.0 m (95 percent confidence interval, −0.3 to 3.5) in the placebo group, yielding a Hodges-Lehmann estimate of the difference between the groups of 40.8 m. Eight of nine secondary end points were significantly improved with sotatercept versus placebo, but the cognitive-emotional impacts domain of the Pulmonary Arterial Hypertension-Symptoms and Impact Physical Impacts, Cardiopulmonary Symptoms score was not different between the groups. Adverse events, including epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure, occurred more frequently with sotatercept than placebo.
"This is the most impressive reduction in the pulmonary arterial pressure that we've ever seen in pretreated patients with PAH," Hoeper said in a statement. "For me, it's one of the strongest signals suggesting that we truly achieved some regression of the disease's adverse changes in the pulmonary vessels."
Acceleron Pharma supported the study. Acceleron is owned by Merck, the manufacturer of sotatercept.
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