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In patients with severe asthma with eosinophilia in reslizumab clinical trials, high peripheral blood eosinophil levels are associated with low FEV1 reversibility.

ABSTRACT: Background:A post hoc analysis of two randomized, placebo-controlled, Phase 3 trials of intravenous reslizumab, an anti-interleukin-5 (IL-5) biologic for severe eosinophilic asthma. Methods:Relationships between baseline blood eosinophil levels (EOS), forced expiratory volume in 1 s (FEV1) reversibility to ?2-agonists and treatment outcomes were assessed. Results:Mean baseline FEV1 reversibility was numerically lower among patients with high (??400 cells/µL) versus low baseline EOS. Reslizumab produced clinically significant improvement in FEV1, exacerbation rates and patient-reported outcomes after 52 weeks, including in patients with high EOS and low FEV1 reversibility (??14%) to ?2-agonists at baseline. Conclusions:Clinical trial eligibility criteria stipulating minimum FEV1 reversibility to ?2-agonists of???12% might exclude patients who would benefit from treatment with anti-IL-5 biologics.

SUBMITTER: Virchow JC

PROVIDER: S-EPMC7168990 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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In patients with severe asthma with eosinophilia in reslizumab clinical trials, high peripheral blood eosinophil levels are associated with low FEV<sub>1</sub> reversibility.

Virchow J Christian JC Hickey Lisa L Du Evelyn E Garin Margaret M

Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology 20200419

<h4>Background</h4>A post hoc analysis of two randomized, placebo-controlled, Phase 3 trials of intravenous reslizumab, an anti-interleukin-5 (IL-5) biologic for severe eosinophilic asthma.<h4>Methods</h4>Relationships between baseline blood eosinophil levels (EOS), forced expiratory volume in 1 s (FEV<sub>1</sub>) reversibility to β<sub>2</sub>-agonists and treatment outcomes were assessed.<h4>Results</h4>Mean baseline FEV<sub>1</sub> reversibility was numerically lower among patients with high ...[more]

PMID: 32328116

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Project description:ObjectiveTo evaluate the potential determinants of forced expiratory volume in 1 s (FEV1) decline in workers with occupational asthma (OA) still exposed to the causative agent. We hypothesised that sputum eosinophilia might be a predictor of poor asthma outcome after diagnosis.Setting, design and participantsIn a specialistic clinical centre of the University Hospital of Pisa, we studied 39 participants (28 M, 11 F) diagnosed as having OA, routinely followed up between 1990 and 2009. They were a subgroup of 94 participants diagnosed as affected by OA in that period: 9 had been removed from work at the diagnosis, 21 were excluded for having ceased occupational exposure after few months from diagnosis, and 25 were lost at the follow-up or had no acceptable sputum measurements at the diagnosis. Estimates of the decline in FEV1 were obtained by means of simple regression analysis during the period of occupational exposure after diagnosis. Logistic regression was used to analyse the effects of factors (baseline FEV1 and sputum inflammatory cells, duration and type of exposure) that may potentially influence FEV1 decline.ResultsAt follow-up (5.7+3.7 years), most participants were still symptomatic despite inhaled corticosteroids (ICS) treatment and had their occupational exposure reduced. Participants with higher sputum eosinophils (>3%) at baseline had a significantly greater decline of FEV1 (-52.5 vs -18.6 mL/year, p=0.012). Logistic regression showed that persistent exposure and sputum eosinophilia were significantly associated with a greater decline in FEV1 (OR 11.5, 95% CI 1.8 to 71.4, p=0.009 and OR 6.7, 95% CI 1.1 to 41.7, p= 0.042, respectively).ConclusionsSputum eosinophilia at diagnosis, together with the persistence of occupational exposure during follow-up, may contribute to a greater decline in FEV1 in patients with OA still at work. Further long-term studies are required as to whether intensive ICS treatment may be beneficial for patients with OA and increase ad eosinophilic inflammation.

Dataset Information

In patients with severe asthma with eosinophilia in reslizumab clinical trials, high peripheral blood eosinophil levels are associated with low FEV1 reversibility.

Publications

In patients with severe asthma with eosinophilia in reslizumab clinical trials, high peripheral blood eosinophil levels are associated with low FEV<sub>1</sub> reversibility.

Similar Datasets

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