Evidence map›Paper›PMID 37851297›Full record

ArticleAdvances in therapy2024

Population Health Model Predicting the Long-Term Impact of Sotatercept on Morbidity and Mortality in Patients with Pulmonary Arterial Hypertension (PAH).

Vallerie McLaughlin, Adnan Alsumali, Rongzhe Liu, Rogier Klok, Eliana C Martinez, Iman Nourhussein, David Bernotas, Jestinah Chevure, Christine Pausch, Janethe De Oliveira Pena and 2 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04576988 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension), which is not on this 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
5.4field-weighted citation impact, top 4% of its field
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.

NCT04576988 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

TypeinterventionalSponsorAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USARan2021 to 2022Enrolled324ConditionsPulmonary Arterial HypertensionArmsSotatercept, Placebo, Background PAH Therapy
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Journal of preventive medicine and hygiene · 2026
    Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Sotatercept: A First-In-Class Activin Signaling Inhibitor for Pulmonary Arterial Hypertension.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2025
    Review
  11. Article
  12. A new day has come: Sotatercept for the treatment of pulmonary arterial hypertension.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2025
    Review
  13. Article
  14. Article
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 3 countries.

Vallerie McLaughlinDivision of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, MI, USA. vmclaugh@umich.edu.
Adnan AlsumaliMerck & Co., Inc., Rahway, NJ, USA.ORCID 0000-0002-5139-3583
Rongzhe LiuOPEN Health, Bethesda, MD, USA.ORCID 0000-0001-8316-6089
Rogier KlokMerck & Co., Inc., Rahway, NJ, USA.ORCID 0000-0001-6584-4886
Eliana C MartinezMerck & Co., Inc., Rahway, NJ, USA.
Iman NourhusseinOPEN Health, Bethesda, MD, USA.ORCID 0000-0003-3271-7439
David BernotasOPEN Health, Bethesda, MD, USA.
Jestinah ChevureMerck Sharp & Dohme (UK) Ltd., London, UK.
Christine PauschInnovation Center Real-World Evidence, GWT-TUD GmbH, Dresden, Germany.ORCID 0000-0002-1866-9015
Janethe De Oliveira PenaMerck & Co., Inc., Rahway, NJ, USA.
Dominik LautschMerck & Co., Inc., Rahway, NJ, USA.ORCID 0000-0003-3803-1817
Marius M HoeperDepartment for Respiratory Medicine and Infectious Diseases and German Centre of Lung Research (DZL), Hannover Medical School, Hannover, Germany.ORCID 0000-0001-9086-2293
Merck & Co., Inc., Rahway, NJ, USA (United States) · USOpen Health Systems Laboratory · USGWT-TUD (Germany) · DEMedizinische Hochschule Hannover · DEMSD (UK) Limited (United Kingdom) · GBUniversity of Michigan · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPulmonary arterial hypertension (PAH) is a rare, progressive disease associated with significant morbidity and mortality. The phase 3 STELLAR trial tested sotatercept plus background therapy (BGT) versus placebo plus BGT. BGT was comprised of mono-, double-, or triple-PAH targeted therapy. Building on STELLAR findings, we employed a population health model to assess the potential long-term clinical impact of sotatercept.

methodsBased on the well-established ESC/ERS 4-strata risk assessment approach, we developed a six-state Markov-type model (low risk, intermediate-low risk, intermediate-high risk, high risk, lung/heart-lung transplant, and death) to compare the clinical outcomes of sotatercept plus BGT versus BGT alone over a lifetime horizon. State-transition probabilities were obtained from STELLAR. Risk stratum-adjusted mortality and lung/heart-lung transplant probabilities were based on COMPERA PAH registry data, and the post-transplant mortality probability was obtained from existing literature. Model outcomes were discounted at 3% annually. Sensitivity analyses were conducted to examine model robustness.

resultsIn the base case, sotatercept plus BGT was associated with longer life expectancy from model baseline (16.5 vs 5.1 years) versus BGT alone, leading to 11.5 years gained per patient. Compared with BGT alone, sotatercept plus BGT was further associated with a gain in infused prostacyclin-free life years per patient, along with 683 PAH hospitalizations and 4 lung/heart-lung transplant avoided per 1000 patients.

conclusionsAccording to this model, adding sotatercept to BGT increased life expectancy by roughly threefold among patients with PAH while reducing utilization of infused prostacyclin, PAH hospitalizations, and lung/heart-lung transplants. Real-world data are needed to confirm these findings.

trial registrationClinicalTrials.gov identifier, NCT04576988 (STELLAR).

Indexed as

Pulmonary Arterial HypertensionHumansMorbidityRecombinant Fusion ProteinsRisk AssessmentRecombinant Fusion ProteinssotaterceptPulmonary arterial hypertensionRisk strataSotaterceptSTELLAR

Identifiers

PMID37851297
PMCPMC10796519
OpenAlexW4387729695

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.