Evidence map›Paper›PMID 40388086›Full record

Trial reportAdvances in therapy2025

Effectiveness and Safety of Tezepelumab in a Diverse Population of US Patients with Severe Asthma: Initial Results of the PASSAGE Study.

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

Erratum issued Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Early and Sustained Asthma Control and Remission in Real-World Patients With Severe Eosinophilic Asthma Treated With Benralizumab: XALOC-2.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026
    Observational
  6. Observational
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
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, USA.
Praveen AkuthotaDivision of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, La Jolla, CA, USA.
Kaharu SuminoDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Sameer K MathurDivision of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, University of Wisconsin, Madison, WI, USA.
Autumn F BurnetteDivision of Allergy and Immunology, Howard University, Washington, DC, USA.
Andrew W LindsleyUS Medical Affairs, Amgen, Thousand Oaks, CA, USA.
Jean-Pierre LlanosGlobal Medical Affairs, Amgen, Thousand Oaks, CA, USA.
Claudio MarcheseLate-Stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Christopher S AmbroseRespiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA.
Benjamin EmmanuelRespiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA. benjamin.emmanuel@astrazeneca.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionClinical trials for severe uncontrolled asthma (SUA) often underrepresent or exclude key patient populations. The phase 4 PASSAGE study assesses the effectiveness and safety of tezepelumab in a diverse, real-world US population of patients with SUA.

methodsPASSAGE is an ongoing, multicenter, single-arm, open-label study of patients (≥ 12 years) with SUA. The study enrolled participants across asthma phenotypes, based on blood eosinophil counts (BECs) (≥/< 300 cells/µL) and perennial aeroallergen sensitization, and underrepresented subgroups (Black/African Americans, adolescents, participants with comorbid mild to moderate chronic obstructive pulmonary disease (COPD) and smokers [≥ 10 pack-years]). Participants receive tezepelumab 210 mg subcutaneously every 4 weeks for 52 weeks. This interim analysis assessed annualized asthma exacerbation rates (AAERs) in the 12-month baseline period (before starting tezepelumab) and the treatment period, and changes from baseline to week 24 in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV

resultsOf 208 participants in this analysis, 41% had BEC ≥ 300 cells/µL, 56% had confirmed allergy, 17% were Black/African American, 5% were adolescents, 13% had comorbid COPD, and 23% were smokers. The AAER decreased by 76% (95% CI (confidence interval): 69, 81) from baseline to the treatment period; comparable reductions were observed across asthma phenotypes and underrepresented subgroups. The least squares mean change from baseline to week 24 in pre-BD FEV

conclusionThe PASSAGE study of US patients with SUA treated with tezepelumab demonstrates substantial reductions in AAERs across asthma phenotypes and underrepresented subgroups, with clinically meaningful improvements in lung function, asthma control and HRQoL.

trial registrationClinicalTrials.gov identifier, NCT05329194.

Indexed as

Anti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedAsthmaAdolescentAdultAgedBlack or African AmericanChildFemaleForced Expiratory VolumeHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveQuality of LifeSeverity of Illness IndexAnti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedtezepelumabAsthmaBiologicPhenotypeReal-worldSevere asthmaTezepelumabThymic stromal lymphopoietinUnderrepresented populations

Identifiers

PMID40388086
PMCPMC12182456

What Socratic 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 Socratic graph.