Long term safety and efficacy of Sotatercept to treat pulmonary arterial hypertension

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Created On: 31/03/2023

This report elucidated Sotatercept's long-term safety and effectiveness in adults having pulmonary arterial hypertension from the phase 2 randomized PULSAR open-label extension period.

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Key take away

For the management of pulmonary arterial hypertension, Sotatercept is effective with a good safety profile.

Background

This report elucidated Sotatercept's long-term safety and effectiveness in adults having pulmonary arterial hypertension from the phase 2 randomized PULSAR open-label extension period.

Method

PULSAR was a placebo-controlled, double-blind study followed by an open-label extension. It assessed Sotatercept on top of background pulmonary arterial hypertension therapy. Participants who were initially randomly assigned to the placebo underwent a 1:1 re-randomization to the Sotatercept 0.3 or 0.7 mg kg-1 (placebo-crossed group).

On the other hand, those who were initially assigned to the Sotatercept dose remained to receive that dose (continued-Sotatercept group). All subjects who got ≥1 dose of Sotatercept had their safety assessed. Alteration in pulmonary vascular resistance between baseline and months 18–24 served as the primary effectiveness outcome. Functional class and six-minute walk distance were the secondary outcomes ascertained. In two predetermined analyses, delayed-start and placebo-crossed, efficacy was assessed regardless of dose.

Result

Out of 106 volunteers recruited in the PULSAR trial, ninety-seven continued into the extension period. In 32 subjects (30.8%), serious treatment-related adverse events were reported. Notably, 10 subjects (9.6%) experienced treatment-emergent adverse events resulting in study discontinuation.

Three (2.9%) individuals perished, however, none were thought to be due to the research medicine. Both primary and secondary endpoints illustrated a remarkable improvement in the placebo-crossed group. In the continued-Sotatercept group, clinical efficacy was maintained.

Conclusion

For the treatment of pulmonary arterial hypertension, the findings of the study favored Sotatercept's long-term safety and durability of clinical benefit.