ArticleThe European respiratory journal2025
A long-term follow-up study of sotatercept for treatment of pulmonary arterial hypertension: interim results of SOTERIA.
Article in The European respiratory journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 32 papers, 3 of them syntheses that pooled it.
What it found
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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.
An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)
Withdrawal of Background Prostacyclin Pathway Therapy in Patients With Pulmonary Arterial Hypertension Receiving Sotatercept: an Open Label Non-inferiority Trial
Who cites it
32 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Management of inflammatory cardiopulmonary manifestations in systemic lupus erythematosus: a systematic review.Advances in rheumatology (London, England) · 2026Pooled it
- Efficacy and safety of sotatercept in pulmonary arterial hypertension: A systematic review and meta-analysis of randomized controlled trials.Indian heart journalPooled it
- Clinical, hemodynamic, and safety outcomes of sotatercept in pulmonary arterial hypertension: a meta-analysis of randomized trials with time-to-event data.Therapeutic advances in respiratory diseasePooled it
- Haemoptysis in chronic pulmonary vascular disease: a narrative review.European respiratory review : an official journal of the European Respiratory Society · 2026Review
- Review
- Beyond Vasodilation: Sotatercept and the Dawn of Disease Modification in Connective Tissue Disease-Associated Pulmonary Arterial Hypertension.International journal of rheumatic diseases · 2026Article
- Activin Signaling Inhibitors in Pulmonary Hypertension: A State-of-the-Art Review.Pulmonary circulation · 2026Review
- Observed Weight Gain in Patients With Pulmonary Arterial Hypertension Treated With Sotatercept.Pulmonary circulation · 2026Article
- Clinical Updates in Pulmonary Hypertension.Reviews in cardiovascular medicine · 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
- Sotatercept as an Add-On to Background Therapy in Idiopathic Pulmonary Arterial Hypertension: Insights from a Real-World Cohort.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Sotatercept in Children with Pulmonary Hypertension-A Narrative Review.Children (Basel, Switzerland) · 2026Review
- Update on pulmonary hypertension.Respiratory research · 2026Review
- 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
- Phase 3, Open-Label Multicenter Study of Sotatercept in Japanese Participants With Pulmonary Arterial Hypertension.JACC. Asia · 2026Article
- Sotatercept for the treatment of portopulmonary hypertension: a case report.Communications medicine · 2026Article
- Sotatercept in Pulmonary Arterial Hypertension: Molecular Mechanisms, Clinical Evidence, and Emerging Role in Reverse Remodelling.International journal of molecular sciences · 2026Review
- Sotatercept for Decompensated Pulmonary Arterial Hypertension Requiring VA ECMO: First Canadian ICU Experience.Pulmonary circulation · 2026Article
- Advances in Novel Therapeutic Strategies for Pulmonary Arterial Hypertension.Canadian respiratory journal · 2026Review
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSOTERIA (ClinicalTrials.gov: NCT04796337) is an ongoing open-label study evaluating long-term safety, tolerability and efficacy of sotatercept in participants with pulmonary arterial hypertension (PAH).
methodsEligible adults with PAH on stable background therapy who completed a prior sotatercept study without early discontinuation were enrolled. Participants received subcutaneous sotatercept (≤0.7 mg·kg
resultsAltogether, 426 participants were included in the analyses. Mean±sd duration of exposure to sotatercept and follow-up in SOTERIA was 448.6±172.93 days (range 21-923 days; 523 patient-years). Of 426 participants, 387 (90.8%) experienced AEs, 15 (3.5%) discontinued treatment, 129 (30.3%) had serious AEs and 11 (2.6%) had serious AEs related to treatment. There were 12 deaths (2.8%). Among AEs of interest, epistaxis (22.1%) and telangiectasia (16.9%) were the most frequently reported individual events. 22 (5.2%) participants had serious bleeding events, including two (0.5%) with serious bleeding leading to death (not related to treatment by investigator judgement). Improvements in 6MWD, NT-proBNP, WHO Functional Class and SFRS achieved from baseline of SOTERIA were largely maintained at 1 year, including in the placebo-crossed group.
conclusionInterim results of SOTERIA support the favourable benefit-risk of add-on sotatercept treatment in adults with PAH. Follow-up reports from this study will provide additional information on benefit-risk.
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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 OpenQuestion graph.