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. 2025 Mar 24;11(2):00625-2024.
doi: 10.1183/23120541.00625-2024. eCollection 2025 Mar.

Effectiveness of anti-IL-5/5Rα biologics in severe asthma in real-world studies: a systematic review and meta-analysis

Christos Kyriakopoulos  1 , Efthymia Papadopoulou  2 , Dimitrios Potonos  1 , Konstantinos Exarchos  1 , Evangelos Beris  1 , Christina Aggelopoulou  1 , Stavros Tryfon  2 , Athena Gogali  1 , Konstantinos Kostikas  1
Affiliations

Effectiveness of anti-IL-5/5Rα biologics in severe asthma in real-world studies: a systematic review and meta-analysis

Christos Kyriakopoulos et al. ERJ Open Res. .

Abstract

Background: Three biologics targeting interleukin 5 (anti-IL-5) or its receptor-α (anti-IL-5Rα) are approved for patients with severe asthma.

Methods: We systematically searched the literature published in Medline and Embase up to 1 May 2023 to identify observational studies and nonrandomised trials that assess the response to anti-IL-5/5Rα in real-life patients with severe eosinophilic asthma. We also performed random-effects meta-analyses.

Results: We identified 6401 studies, of which 92 with 9546 patients were analysed. Biologics use was associated with a 62% reduction in severe exacerbations (risk ratio 0.38, 95% CI 0.29-0.50) and a 54% reduction in hospitalisations (risk ratio 0.46, 95% CI 0.35-0.61) at 12 months of treatment, compared to pre-treatment. Biologics improved asthma control (decrease in asthma control questionnaire score by 1.11 points (95% CI -1.29--0.94) and increase in asthma control test score by 6.41 points (95% CI 5.66-7.16)) and increased the asthma quality of life questionnaire score by 1.08 points (95% CI 0.88-1.28) and forced expiratory volume in 1 s by 0.21 L (95% CI 0.15-0.27) at 12 months. There was a significant reduction in oral corticosteroids use of 51% (risk ratio 0.49, 95% CI 0.42-0.56), with a mean dose reduction of 6.01 mg·day-1 (95% CI -7.55--4.48) at 12 months of treatment. Similar findings were observed at 3-4, 6 and 24 months. A biomarker-related response to treatment was also noted.

Conclusions: This comprehensive meta-analysis summarises the significant clinical response to anti-IL-5/5Rα biologics in real-life studies, providing important insights for their use in clinical practice.

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Conflict of interest statement

Conflict of interest: S. Tryfon has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from GSK, AstraZeneca, ELPEN and Chiesi, and support for attending meetings and/or travel from AstraZenecca, ELPEN and Menarini. Conflict of interest: A. Gogali has received consulting fees from Boehringer Ingelheim and Chiesi, and payment or honoraria for lectures, presentations or educational events from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK and Novartis. Conflict of interest: K. Kostikas has received grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Innovis, ELPEN, GSK, Menarini, Novartis and NuvoAir; consulting fees from AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, ELPEN, GSK, Menarini, Novartis, Pfizer and Sanofi Genzyme; payment or honoraria for lectures, presentations or educational events from Alector Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, ELPEN, Gilead, GSK, Menarini, MSD, Novartis, Pfizer, Sanofi Genzyme and WebMD; and a leadership role with GOLD Assembly. Conflict of interest: The other authors declare no competing interests.

Figures

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ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AQLQ: Asthma Quality of Life Questionnaire; FEV1: forced expiratory volume in 1 s; FENO: exhaled nitric oxide fraction; IL: interleukin; MD: mean difference; OCS: oral corticosteroid; R: receptor.
FIGURE 1
FIGURE 1
Systematic review and meta-analysis flow-diagram illustrating the systematic search and screening strategy, including number of studies meeting eligibility criteria and number of excluded studies.
FIGURE 2
FIGURE 2
a) Forest plot of the mean change in the annual rate of asthma severe exacerbations after 12 months of anti-interleukin (IL)-5/5Rα treatment compared to pre-treatment. b) Forest plot of asthma severe exacerbations relative risk after 12 months of anti-IL-5/5Rα treatment compared to pre-treatment. c) Forest plot of the mean change in the annual rate of asthma severe exacerbations after 24 months of anti-IL-5/5Rα treatment compared to pre-treatment. d) Forest plot of asthma severe exacerbations relative risk after 24 months of anti-IL-5/5Rα treatment compared to pre-treatment. In all panels, sample sizes are given for the total number of participants included in the study. Summary estimates presented separately for each biologic agent category. IV: inverse variance.
FIGURE 3
FIGURE 3
a) Forest plot of the mean change in the annual rate of hospitalisations due to asthma exacerbation after 12 months of anti-interleukin (IL)-5/5Rα treatment compared to pre-treatment. b) Forest plot of hospitalisations due to asthma exacerbation relative risk after 12 months of anti-IL-5/5Rα treatment compared to pre-treatment. c) Forest plot of the mean change in the annual rate of hospitalisations due to asthma exacerbation after 24 months of anti-IL-5/5Rα treatment compared to pre-treatment. In all panels, sample sizes are given for the total number of participants included in the study. Summary estimates presented separately for each biologic agent category. IV: inverse variance.
FIGURE 4
FIGURE 4
a) Forest plot of the mean change in asthma control questionnaire (ACQ) score after 12 months of anti-interleukin (IL)5/5Rα treatment compared to pre-treatment. Sample sizes are given for the total number of participants included in the study. Summary estimates presented separately for each biologic agent category. b) Variation over time of the mean change in ACQ score after anti-IL-5/5Rα treatment compared to pre-treatment. Interval plots display 95% confidence intervals for the mean difference. c) Forest plot of the mean change in asthma control test (ACT) score after 12 months of anti-IL-5/5Rα treatment compared to pre-treatment. Sample sizes are given for the total number of participants included in the study. Summary estimates presented separately for each biologic agent category. d) Variation over time of the mean change in ACT score after anti-IL-5/5Rα treatment compared to pre-treatment. Interval plots display 95% confidence intervals for the mean difference. IV: inverse variance.
FIGURE 5
FIGURE 5
a) Forest plot of the mean change in forced expiratory volume in 1 s (FEV1) in litres after 12 months of anti-interleukin (IL)5/5Rα treatment compared to pre-treatment. Sample sizes are given for the total number of participants included in the study. Summary estimates presented separately for each biologic agent category. b) Variation over time of the mean change in FEV1 in litres after anti-IL-5/5Rα treatment compared to pre-treatment. Interval plots display 95% confidence intervals for the mean difference. c) Forest plot of the mean change in FEV1 % predicted after 12 months of anti-IL-5/5Rα treatment compared to pre-treatment. Sample sizes are given for the total number of participants included in the study. Summary estimates presented separately for each biologic agent category. d) Variation over time of the mean change in FEV1 % predicted after anti-IL-5/5Rα treatment compared to pre-treatment. Interval plots display 95% confidence intervals for the mean difference. IV: inverse variance.
FIGURE 6
FIGURE 6
a) Forest plot of oral corticosteroids use relative risk after 12 months of anti-interleukin (IL)5/5Rα treatment compared to pre-treatment. Sample sizes are given for the total number of participants included in the study. Summary estimates presented separately for each biologic agent category. b) Variation over time of the oral corticosteroids use relative risk after anti-IL-5/5Rα treatment compared to pre-treatment. Interval plots display 95% confidence intervals for the relative risk. c) Forest plot of the mean change in oral corticosteroids dose (mg) after 12 months of anti-IL-5/5Rα treatment compared to pre-treatment. Sample sizes are given for the total number of participants included in the study. Summary estimates presented separately for each biologic agent category. d) Variation over time of the mean change in oral corticosteroids dose (mg) after anti-IL-5/5Rα treatment compared to pre-treatment. Interval plots display 95% confidence intervals for the mean difference. IV: inverse variance.
FIGURE 7
FIGURE 7
a) Forest plot of the mean change in the number of blood eosinophils·μL−1 after 12 months of anti-interleukin (IL)5/5Rα treatment compared to pre-treatment. Sample sizes are given for the total number of participants included in the study. Summary estimates presented separately for each biologic agent category. b) Variation over time of the mean change in the number of blood eosinophils·μL−1 after anti-IL-5/5Rα treatment compared to pre-treatment. Interval plots display 95% confidence intervals for the mean difference. c) Forest plot of the mean change in fractional exhaled nitric oxide (FENO) ppb after 12 months of anti-IL-5/5Rα treatment compared to pre-treatment. Sample sizes are given for the total number of participants included in the study. Summary estimates presented separately for each biologic agent category. d) Variation over time of the mean change in FENO ppb after anti-IL-5/5Rα treatment compared to pre-treatment. Interval plots display 95% confidence intervals for the mean difference.
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References

    1. Global Initiative for Asthma . 2023 GINA main report. Date last accessed: 10 July 2023. Date last updated: 10 July 2023. https://ginasthma.org/2023-gina-main-report/
    1. Hekking PW, Wener RR, Amelink M, et al. . The prevalence of severe refractory asthma. J Allergy Clin Immunol 2015; 135: 896–902. doi:10.1016/j.jaci.2014.08.042 - DOI - PubMed
    1. Chung KF, Wenzel SE, Brozek JL, et al. . International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43: 343–373. doi:10.1183/09031936.00202013 - DOI - PubMed
    1. Pavord ID, Korn S, Howarth P, et al. . Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 2012; 380: 651–659. doi:10.1016/S0140-6736(12)60988-X - DOI - PubMed
    1. Ortega HG, Liu MC, Pavord ID, et al. . Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371: 1198–1207. doi:10.1056/NEJMoa1403290 - DOI - PubMed

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