Trial reportThe European respiratory journal2023
Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension.
Trial report in The European respiratory journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 73 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
RECOMPENSE: Right vEntricular COMPENsation With SotatercEpt: a Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension
Who cites it
73 citing papers in PubMed, 3 syntheses or guidelines pooled it, 140 citations in OpenAlex.
- Management of pulmonary arterial hypertension in systemic sclerosis: from classical treatments to new horizons.European respiratory review : an official journal of the European Respiratory Society · 2026Pooled it
- Exploring the Economic Burden of Pulmonary Arterial Hypertension and Its Relation to Disease Severity and Treatment Escalation: A Systematic Literature Review.PharmacoEconomics · 2025Pooled it
- A Systematic Review of Novel Therapies of Pulmonary Arterial Hypertension.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024Pooled it
- Positioning Imatinib for Pulmonary Arterial Hypertension: A Dose-Finding Phase 2 Study.American journal of respiratory and critical care medicine · 2025Trial
- Efficacy and safety of the activin signalling inhibitor, sotatercept, in a pooled analysis of PULSAR and STELLAR studies.The European respiratory journal · 2025Trial
- Pulmonary arterial hypertension from a translational perspective: Bridging pathophysiology and treatment.Chinese medical journal · 2026Review
- Activin Signaling Inhibitors in Pulmonary Hypertension: A State-of-the-Art Review.Pulmonary circulation · 2026Review
- Challenges and Strategies in Managing Pulmonary Arterial Hypertension Within the Indian Healthcare System: A Consensus Statement From the Pulmonary Vascular Research Institute India Taskforce.Pulmonary circulation · 2026Article
- Paradigm shift: from pulmonary vasodilation to cardiopulmonary dual-track therapy-a comprehensive review of pathophysiology and advances in pulmonary hypertension-associated right heart failure.Respiratory research · 2026Review
- Article
- Clinical relevance of the TAPSE/SPAP ratio in pulmonary arterial hypertension: a single-center retrospective study.BMC cardiovascular disorders · 2026Article
- The Vascular-Immune Cells Crosstalk and Microenvironment in Pulmonary Hypertension.Comprehensive physiology · 2026Review
- Advances in Novel Therapeutic Strategies for Pulmonary Arterial Hypertension.Canadian respiratory journal · 2026Review
- Use of Sotatercept to Facilitate Transition From Intravenous to Oral Prostacyclin Therapy.The clinical respiratory journal · 2025Article
- The activin pathway in chronic thromboembolic pulmonary hypertension: a potential biomarker for residual pulmonary hypertension after endarterectomy.ERJ open research · 2025Article
- Pathophysiology of Pulmonary Arterial Hypertension: Focus on Vascular Endothelium as a Potential Therapeutic Target.International journal of molecular sciences · 2025Review
- Sotatercept in pulmonary arterial hypertension: revolution, risk and the road ahead.The European respiratory journal · 2025Article
- Targeted delivery ofActa pharmaceutica Sinica. B · 2025Article
- Article
- Sotatercept: A novel therapeutic approach for pulmonary arterial hypertension through transforming growth factor-β signaling modulation.World journal of methodology · 2025Review
13 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
17 authors at 14 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn participants with pulmonary arterial hypertension, 24 weeks of sotatercept resulted in a significantly greater reduction from baseline in pulmonary vascular resistance than placebo. This report characterises the longer-term safety and efficacy of sotatercept in the PULSAR open-label extension. We report cumulative safety, and efficacy at months 18-24, for all participants treated with sotatercept.
methodsPULSAR was a phase 2, randomised, double-blind, placebo-controlled study followed by an open-label extension, which evaluated sotatercept on top of background pulmonary arterial hypertension therapy in adults. Participants originally randomised to placebo were re-randomised 1:1 to sotatercept 0.3 or 0.7 mg·kg
resultsOf 106 participants enrolled in the PULSAR study, 97 continued into the extension period. Serious treatment-emergent adverse events were reported in 32 (30.8%) participants; 10 (9.6%) reported treatment-emergent adverse events leading to study discontinuation. Three (2.9%) participants died, none considered related to study drug. The placebo-crossed group demonstrated significant improvement across primary and secondary endpoints and clinical efficacy was maintained in the continued-sotatercept group.
conclusionThese results support the longer-term safety and durability of clinical benefit of sotatercept for pulmonary arterial hypertension.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.