Evidence map›Paper›PMID 39884760›Full record

Trial reportThe European respiratory journal2025

Efficacy and safety of the activin signalling inhibitor, sotatercept, in a pooled analysis of PULSAR and STELLAR studies.

Marius M Hoeper, Mardi Gomberg-Maitland, David B Badesch, J Simon R Gibbs, Ekkehard Grünig, Grzegorz Kopeć, Vallerie V McLaughlin, Gisela Meyer, Karen M Olsson, Ioana R Preston and 13 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in The European respiratory journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. 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 · 2026
    Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Clinical Applications of Ligand Traps Targeting Activin Type II Receptors.Anti-inflammatory & anti-allergy agents in medicinal chemistry · 2026
    Review
  11. Article
  12. Article
  13. Article
  14. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Marius M HoeperHannover Medical School and the German Center for Lung Research, Hannover, Germany hoeper.marius@mh-hannover.de.ORCID https://orcid.org/0000-0001-9086-2293
Mardi Gomberg-MaitlandGeorge Washington University, Washington, DC, USA.
David B BadeschUniversity of Colorado, Anschutz Medical Campus, Aurora, CO, USA.
J Simon R GibbsNational Heart and Lung Institute, Imperial College London, London, UK.
Ekkehard GrünigThoraxklinik-Heidelberg and the German Center for Lung Research, Heidelberg, Germany.
Grzegorz KopećThe Pulmonary Circulation Center, Department of Cardiac and Vascular Diseases, Jagiellonian University Medical College, St. John Paul II Hospital in Krakow, Krakow, Poland.
Vallerie V McLaughlinUniversity of Michigan, Ann Arbor, MI, USA.
Gisela MeyerIrmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil.
Karen M OlssonHannover Medical School and the German Center for Lung Research, Hannover, Germany.
Ioana R PrestonTufts Medical Center, Boston, MA, USA.ORCID https://orcid.org/0000-0002-1378-7362
Stephan RosenkranzDepartment of Cardiology, Heart Center, University Hospital Cologne, and Cologne Cardiovascular Research Center (CCRC), Medical Faculty, University of Cologne, Cologne, Germany.
Rogerio SouzaInstituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, Brazil.ORCID https://orcid.org/0000-0003-2789-9143
Aaron B WaxmanBrigham and Women's Hospital, Boston, MA, USA.ORCID https://orcid.org/0000-0001-7797-0361
Loïc PerchenetMerck & Co., Inc., Rahway, NJ, USA.
James StraitMerck & Co., Inc., Rahway, NJ, USA.
Aiwen XingMerck & Co., Inc., Rahway, NJ, USA.
Solaiappan ManimaranMerck & Co., Inc., Rahway, NJ, USA.
Xuelong WangMerck & Co., Inc., Rahway, NJ, USA.
Barry MillerMerck & Co., Inc., Rahway, NJ, USA.
Alexandra G CornellMerck & Co., Inc., Rahway, NJ, USA.
Janethe de Oliveira PenaMerck & Co., Inc., Rahway, NJ, USA.
H Ardeschir GhofraniDepartment of Internal Medicine, Justus-Liebig-University Giessen, Universities of Giessen and Marburg Lung Center (UGMLC), Member of the German Center for Lung Research (DZL), Giessen, Germany.ORCID https://orcid.org/0000-0002-2029-4419
Marc HumbertUniversité Paris-Saclay, INSERM Unité Mixte de Recherche en Santé 999 (HPPIT), Service de Pneumologie et Soins Intensifs Respiratoires, Hôpital Bicêtre (Assistance Publique-Hôpitaux de Paris), Le Kremlin-Bicêtre, France.ORCID https://orcid.org/0000-0003-0703-2892

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPulmonary arterial hypertension is a progressive disease associated with significant morbidity and mortality. Sotatercept is a first-in-class activin signalling inhibitor that acts to restore the balance between the growth-promoting and growth-inhibiting signalling pathways.

methodsThis

resultsA total of 429 patients were randomised and treated; 237 received sotatercept and 192 received placebo. Adding sotatercept to background pulmonary arterial hypertension therapy for 24 weeks improved exercise capacity (as assessed by 6-min walk distance), pulmonary vascular resistance and World Health Organization functional class, and delayed time to first occurrence of death or clinical worsening event. There were clinically important reductions in both pulmonary and right heart pressures; improvements in right ventricle size during both systole and diastole; and enhancements in right ventricle contractility and right ventricular-pulmonary artery coupling. The number of patients who experienced at least one adverse event of interest or special interest (increased haemoglobin, thrombocytopenia, bleeding events (mostly epistaxis), increased blood pressure and telangiectasia) was higher in the sotatercept group than the placebo group.

conclusionThis pooled analysis confirms that sotatercept delivers therapeutic benefit across a range of efficacy end-points and has favourable safety in patients with pulmonary arterial hypertension. Increased duration of follow-up will provide further insight into long-term outcomes of sotatercept in patients with pulmonary arterial hypertension.

Indexed as

ActivinsHypertension, PulmonaryRecombinant Fusion ProteinsAdultAgedDouble-Blind MethodExercise ToleranceFemaleHumansMaleMiddle AgedSignal TransductionTreatment OutcomeVascular ResistanceActivinsRecombinant Fusion Proteins

Identifiers

PMID39884760
PMCPMC12056246

What OpenQuestion holds

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Registered trials

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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.