Evidence map›Paper›PMID 42148905›Full record

Trial reportAmerican journal of respiratory and critical care medicine2026

Tezepelumab in real-world US patients with severe asthma across phenotypes and underrepresented populations: the phase 4 PASSAGE study.

Njira L Lugogo, Praveen Akuthota, Kaharu Sumino, Autumn F Burnette, Sameer K Mathur, Andrew W Lindsley, Jean-Pierre Llanos, Claudio Marchese, Christopher S Ambrose, Benjamin Emmanuel

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of respiratory and critical care medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05329194 (A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants With Severe Asthma Including Several Under-Studied Populations in the United States), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05329194 phase4completednot on this map

A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants With Severe Asthma Including Several Under-Studied Populations in the United States (PASSAGE)

TypeinterventionalSponsorAstraZenecaRan2022 to 2025Enrolled286ConditionsAsthmaArmsTezepelumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Njira L LugogoDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Michigan, Ann Arbor, MI, United States.
Praveen AkuthotaDivision of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, La Jolla, CA, United States.
Kaharu SuminoDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Washington University School of Medicine, St Louis, MO, United States.
Autumn F BurnetteDivision of Allergy and Immunology, Howard University, Washington, DC, United States.
Sameer K MathurDivision of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, University of Wisconsin-Madison, Madison, WI, United States.
Andrew W LindsleyUS Medical Affairs, Amgen, Thousand Oaks, CA, United States.
Jean-Pierre LlanosGlobal Medical Affairs, Amgen, Thousand Oaks, CA, United States.
Claudio MarcheseRespiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.
Christopher S AmbroseRespiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, United States.
Benjamin EmmanuelRespiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, United States.

Funding

Amgen IncAstraZenecaThousand Oaks
6 · The paper itself

Abstract

rationaleClinical trials of severe asthma therapies often exclude or underrepresent key patient populations.

objectivesTo evaluate the effectiveness and safety of tezepelumab in a diverse, real-world US population with severe, uncontrolled asthma (SUA).

methodsPASSAGE was a phase 4, multicenter, single-arm, open-label, 12-month study enrolling patients with SUA (≥12 years old), including different phenotypes (blood eosinophil count ≥300 or <300 cells/µL, with or without allergy) and underrepresented populations (Black/African American patients, adolescents, those with SUA with comorbid mild-to-moderate chronic obstructive pulmonary disease, people with a significant smoking history [≥10 pack-years]). The primary outcome was the annualized asthma exacerbation rate (AAER) in the 12 months before (baseline period) and after (treatment period) tezepelumab initiation. MEASUREMENTS AND MAIN

resultsAmong 286 participants, AAER decreased by 70% (95% CI, 63%-75%) from 2.88 (baseline period) to 0.87 (treatment period) and by 54% to 77% across phenotypes and underrepresented populations. At week 52, least-squares mean pre-bronchodilator FEV1 increased from baseline by 0.122 L (95% CI, 0.07-0.17) overall and by 0.212 L (95% CI, 0.15-0.28) among participants with percent predicted pre-bronchodilator FEV1 ≤80% at baseline. Clinically meaningful improvements in Asthma Control Questionnaire-6, Asthma Impairment and Risk Questionnaire, and St George's Respiratory Questionnaire scores were observed in 51% to 91% of participants across phenotypes and underrepresented populations at week 52. No new safety signals were identified.

conclusionsThe PASSAGE study of a diverse, real-world US population with SUA treated with tezepelumab demonstrated substantial reductions in asthma exacerbations across phenotypes and underrepresented populations as well as clinically meaningful improvements in lung function, asthma control, and health-related quality of life. CLINICAL

trial registrationwww.clinicaltrials.gov (NCT05329194).

Indexed as

Anti-Asthmatic AgentsAsthmaAdolescentAdultAgedFemaleHumansMaleMiddle AgedPhenotypeSeverity of Illness IndexTreatment OutcomeUnited StatesAnti-Asthmatic Agentsphenotypereal-worldsevere asthmatezepelumabunderrepresented populations

Identifiers

PMID42148905
PMCPMC13519350

What OpenQuestion holds

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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.