Evidence map›Paper›PMID 40526255›Full record

ArticleAdvances in therapy2025

Long-Term Mortality and Morbidity Impact on Patients with Pulmonary Arterial Hypertension (PAH) If Access to Sotatercept Is Delayed: A Simulation Model.

Adnan Alsumali, Vallerie McLaughlin, Jestinah Chevure, Rogier Klok, Wenjie Zhang, Eliana C Martinez, Christine Pausch, Janethe De Oliveira Pena, Gijs van de Wetering, Murvin Jootun and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Advances in therapy, 2025. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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

1 citing paper in PubMed.

  1. Review
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.

Adnan AlsumaliBARDS-Health Economics and Decision Science, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, NJ, 07065, USA. adnan.alsumali@merck.com.ORCID http://orcid.org/0000-0002-5139-3583
Vallerie McLaughlinDivision of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, MI, USA.
Jestinah ChevureMerck Sharp & Dohme (UK) Ltd., London, UK.
Rogier KlokBARDS-Health Economics and Decision Science, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, NJ, 07065, USA.ORCID http://orcid.org/0000-0001-6584-4886
Wenjie ZhangOPEN Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0001-8301-2821
Eliana C MartinezBARDS-Health Economics and Decision Science, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, NJ, 07065, USA.
Christine PauschInnovation Center Real-World Evidence, GWT-TUD GmbH, Dresden, Germany.ORCID http://orcid.org/0000-0002-1866-9015
Janethe De Oliveira PenaBARDS-Health Economics and Decision Science, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, NJ, 07065, USA.
Gijs van de WeteringOPEN Health, Rotterdam, The Netherlands.
Murvin JootunMerck Sharp & Dohme (UK) Ltd., London, UK.
Dominik LautschBARDS-Health Economics and Decision Science, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, NJ, 07065, USA.ORCID http://orcid.org/0000-0003-3803-1817
Marius M HoeperDepartment for Respiratory Medicine and Infectious Diseases, German Centre of Lung Research (DZL), Hannover Medical School, Hannover, Germany.ORCID http://orcid.org/0000-0001-9086-2293

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, where BGT included mono-, double-, or triple-PAH targeted therapy. Building on the trial's findings, a population health model was recently published assessing the long-term clinical impact of sotatercept. This analysis expands on this model and compares the clinical outcomes of immediate treatment initiation with sotatercept plus BGT against delayed treatment initiation with sotatercept plus BGT using a six-state Markov-type model and over a lifetime horizon.

methodsState-transition probabilities were obtained from STELLAR, while mortality rates adjusted for risk strata and probabilities of lung/heart-lung transplants were derived from COMPERA PAH registry data and literature.

resultsIn the base case, a 2-year delay in treatment with sotatercept plus BGT resulted in an average of 12.4 years life expectancy, whereas immediate initiation of sotatercept led to an average of 16.5 years, a difference of 4.1 years. Immediate treatment with sotatercept plus BGT was also associated with a gain in infused prostacyclin-free life-years and resulted in 210 PAH hospitalizations avoided and 5 lung/heart-lung transplant avoided per 1000 patients.

conclusionsThis research suggests that early addition of sotatercept to BGT has the potential to increase life expectancy among patients with PAH and to reduce PAH hospitalizations, prostacyclin-use, and lung/heart-lung transplants needs. Real-world data are needed to confirm these findings, guiding clinicians and healthcare decision-makers in optimizing PAH treatment strategies.

trial registrationClinicalTrials.gov identifier, NCT04576988 (STELLAR).

Indexed as

Antihypertensive AgentsHypertension, PulmonaryPulmonary Arterial HypertensionRecombinant Fusion ProteinsTime-to-TreatmentAdultFemaleHumansMaleMarkov ChainsMiddle AgedAntihypertensive AgentsRecombinant Fusion ProteinsPulmonary arterial hypertensionRisk strataSotaterceptSTELLARTreatment delay

Identifiers

PMID40526255
PMCPMC12313736

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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.