Evidence map›Paper›PMID 33971856›Full record

Trial reportRespiratory research2021

Benefit of switching to mepolizumab from omalizumab in severe eosinophilic asthma based on patient characteristics.

Mark C Liu, Bradley Chipps, Xavier Munoz, Gilles Devouassoux, Miguel Bergna, Steven G Smith, Robert G Price, Dmitry V Galkin, Jay Azmi, Dalal Mouneimne and 2 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Respiratory research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02654145 (A Multi-centre, Open Label, Single Arm, 32-week Treatment Study in Subjects With Severe Eosinophilic Asthma Not Optimally Controlled With Current Omalizumab Treatment Who Are Switched From Omalizumab to Mepolizumab 100mg Subcutaneous), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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.

NCT02654145 phase4completednot on this map

A Multi-centre, Open Label, Single Arm, 32-week Treatment Study in Subjects With Severe Eosinophilic Asthma Not Optimally Controlled With Current Omalizumab Treatment Who Are Switched From Omalizumab to Mepolizumab 100mg Subcutaneous (Study Number 204471- the OSMO Study)

TypeinterventionalSponsorGlaxoSmithKlineRan2016 to 2017Enrolled145ConditionsAsthmaArmsMepolizumab 100mg SC, Albuterol/salbutamol MDIs, Omalizumab
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Switching Biological Therapies in Severe Asthma.International journal of molecular sciences · 2023
    Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. 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.

Mark C LiuDivisions of Allergy and Clinical Immunology, Pulmonary and Critical Care Medicine, Johns Hopkins Asthma and Allergy Center, Baltimore, MD, USA.
Bradley ChippsCapital Allergy and Respiratory Disease Center, Sacramento, CA, USA.
Xavier MunozPulmonology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Gilles DevouassouxService de Pneumologie, Hôpital de la Croix Rousse, Hospices Civils de Lyon, UCB Lyon, Lyon, France.
Miguel BergnaRespiratory Research, CEMER, Vicente Lopez, Buenos Aires, Argentina.
Steven G SmithRespiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.
Robert G PriceBiostatistics, GSK, Stevenage, Hertfordshire, UK.
Dmitry V GalkinGlobal Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USA.
Jay AzmiRespiratory TAU, GSK, Uxbridge, Middlesex, UK.
Dalal MouneimneGlobal Medical Affairs, GSK House, Brentford, Middlesex, UK.
Frank C AlbersGlobal Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USA.
Kenneth R ChapmanAsthma and Airway Centre, University Health Network, University of Toronto, Toronto, ON, Canada. ken.chapman.airways@gmail.com.ORCID http://orcid.org/0000-0002-2498-9859

Funding

GlaxoSmithKline foundation 204471
6 · The paper itself

Abstract

backgroundThe OSMO study assessed the efficacy of switching to mepolizumab in patients with severe eosinophilic asthma that was uncontrolled whilst receiving omalizumab. The objective of this analysis was to assess the proportion of patients achieving pre-defined improvements in up to four efficacy outcomes and the relationship between patient baseline characteristics and treatment response.

methodsThis was a post hoc analysis of OSMO study data (GSK ID:204471; ClinicalTrials.gov No. NCT02654145). Patients with severe eosinophilic asthma uncontrolled by high-dose inhaled corticosteroids, other controller(s) and omalizumab subcutaneously (≥ 4 months) were switched to mepolizumab 100 mg administered subcutaneously. Endpoints included the proportion of responders-i.e. patients achieving a pre-defined clinical improvement in ≥ 1 of the following outcomes: (1) Asthma Control Questionnaire (ACQ)-5 score (≥ 0.5-points), (2) St George's Respiratory Questionnaire (SGRQ) total score (≥ 4-points), (3) pre-bronchodilator forced expiratory volume in 1s (FEV

resultsOf the 145 patients included, 94%, 83%, 63% and 31% were responders for ≥ 1, ≥ 2, ≥ 3 and 4 outcomes, respectively; 75% and 78% were ACQ-5 and SGRQ score responders, and 50% and 69% were FEV

conclusionsAfter switching to mepolizumab, almost all patients with uncontrolled severe eosinophilic asthma on omalizumab achieved a beneficial response in ≥ 1 clinical outcome. Improvements were observed regardless of baseline characteristics. Trial registration This manuscript is a post hoc analysis of data from the OSMO study. ClinicalTrials.gov, NCT02654145. Registered January 13, 2016.

Indexed as

Drug SubstitutionAdultAgedAnti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedAsthmaDisease ProgressionFemaleForced Expiratory VolumeHumansLungMaleMiddle AgedOmalizumabPulmonary EosinophiliaQuality of LifeAnti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedmepolizumabOmalizumabAsthmaAsthma treatmentBiologicsEosinophils

Identifiers

PMID33971856
PMCPMC8111733

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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.