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. 2025 Sep;80(9):2557-2571.
doi: 10.1111/all.16618. Epub 2025 Jul 1.

Mepolizumab Effectiveness in Severe Asthma With/Without Chronic Rhinosinusitis With Nasal Polyps: Real-World Pooled Analysis

Florence Schleich  1 , Stelios Loukides  2 , Rekha Chaudhuri  3 , Joerg D Leuppi  4 , Enrico Heffler  5   6 , Cristian Domingo  7 , Claudio Micheletto  8 , Thomas Paulsson  9 , Nina Gaw  9 , Konstantina Kallinikou  10 , Carla Vossen  11 , Florent Guelfucci  12 , Jyothi Menon  13 , Armel Ngami  12 , Ines Palomares  14
Affiliations

Mepolizumab Effectiveness in Severe Asthma With/Without Chronic Rhinosinusitis With Nasal Polyps: Real-World Pooled Analysis

Florence Schleich et al. Allergy. 2025 Sep.

Abstract

Background: Severe asthma with an eosinophilic phenotype (SAEP) and chronic rhinosinusitis with nasal polyps (CRSwNP) are predominantly type 2-driven diseases, characterised by eosinophilic inflammation and substantial disease burden. Mepolizumab, a humanised monoclonal antibody that targets interleukin-5, a key cytokine in type 2 inflammation, is an effective, approved treatment both in SAEP and CRSwNP. We aimed to analyse real-world evidence of mepolizumab effectiveness in patients with comorbid SAEP and CRSwNP.

Methods: This study pooled five existing, predominantly European cohorts to describe the impact of mepolizumab on the rate of clinically significant exacerbations (CSEs) and other outcomes in adults with SAEP without and with comorbid CRSwNP (SAEP[-]CRSwNP and SAEP[+]CRSwNP, respectively).

Results: Overall, 1037 patients were included. Baseline characteristics were similar in both cohorts. Mepolizumab was associated with a reduction from baseline in the annual rate of CSEs at 12-months post-initiation (SAEP[-]CRSwNP: 72.7%; SAEP[+]CRSwNP: 79.7%), irrespective of baseline blood eosinophil count (BEC). When patients with SAEP[+]CRSwNP were compared with patients with SAEP[-]CRSwNP, a 30.0% incremental benefit in the reduction of CSEs was observed. At 12-months post-initiation, mepolizumab was also associated with a reduction in oral corticosteroid use and BEC, and an improvement in lung function and Asthma Control Test (ACT) scores in both cohorts. Post-mepolizumab initiation, ≥ 3 clinical remission criteria were fulfilled by 47.2% and 52.3% of patients with SAEP[-]CRSwNP and SAEP[+]CRSwNP, respectively.

Conclusions: The results provide a greater understanding of mepolizumab's effectiveness, demonstrating a substantial improvement in asthma outcomes, irrespective of baseline BEC and the presence of comorbid CRSwNP.

Keywords: asthma; biologics.

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Conflict of interest statement

Some material discussed herein has been presented at ERS 2024, Vienna, Austria: Palomares I, Loukides S, Schleich F, et al. Eur Resp J 2024; 64 (suppl 68): PA3929: doi.org/10.1183/13993003.congress‐2024.PA3929. F. Schleich reports consulting fees from AstraZeneca, Chiesi, GSK and TEVA; and payment or honoraria from AstraZeneca, Chiesi and GSK; and support for attending meetings/travel from AstraZeneca and Chiesi. S. Loukides reports consulting fees from GSK; payment or honoraria from AstraZeneca and GSK; participation on a Drug Safety Monitoring Board or Advisory Board for GSK; and holding of an unpaid position as President of the Hellenic Thoracic Society. R. Chaudhuri reports receiving grants or contracts from AstraZeneca for an investigator‐led study; payment or honoraria from AstraZeneca, Chiesi, GSK, Sanofi and TEVA; support for attending meetings/travel from Chiesei, GSK and Sanofi; and participation on a Drug Safety Monitoring Board or Advisory Board for AstraZeneca, Celltrion Healthcare and GSK. J. D. Leuppi reports unrestricted grants from AstraZeneca, GSK, OM Pharma and Sanofi; and payment or honoraria for lectures from AstraZeneca, GSK, OM Pharma and Sanofi. E. Heffler reports a research grant from Chiesi; consulting fees from Almirall, Apogee Therapeutics, AstraZeneca, Bosch, Celltrion Healthcare, Chiesi, GSK, Lofarma, Novartis, Regeneron and Sanofi; and support for attending meetings or travel from AstraZeneca, GSK and Sanofi. C. Domingo reports consulting fees, payment or honoraria, payment for expert testimony, and support for attending meetings or travel from ALK, GSK, Novartis, Sanofi, not on the original submitted file AstraZeneca, Asac Pharmaceutical Immunology, Immunotek and MSD. C. Micheletto has received payment or honoraria from AstraZeneca, Berlin Chemie, Boehringer Ingelheim, Chiesi, GSK, Guidotti, Lusofarmaco, Menarini, Roche, Sanofi and Zambon; support for attending meetings or travel from AstraZeneca, Menarini and Sanofi; and is President of the Italian Thoracic Society and member of the Regional Drug Commission. T. Paulsson, N. Gaw, K. Kallinikou and I. Palomares are employees of GSK and hold financial equities in GSK. C. Vossen, F. Guelfucci, J. Menon and A. Ngami are employees of Syneos Health, which received funding from GSK to conduct this study.

Figures

FIGURE 1
FIGURE 1
Existing cohorts of patients with SAEP describing real‐world effectiveness of mepolizumab included in the MEPOLYP analysis. Abbreviations: CRSwNP, chronic rhinosinusitis with nasal polyps; IPD, individual patient data; Liège‐BSAR: Belgium Severe Asthma Registry (Liège); MEPOLYP, Real‐world effectiveness of MEpolizumab in patients with severe eosinophilic asthma and comorbid chronic rhinosinusitis with or without nasal POLYPs; REALITI‐A, REAL world effectiveness of mepolizumab in paTIent care—Asthma study; REDES, REal worlD Effectiveness and Safety of Mepolizumab; RELIght, A two‐year REal‐LIfe study of mepolizumab in patients with severe eosinophilic asTHma in Greece; REDES, REal worlD Effectiveness and Safety of Mepolizumab; SAEP, severe asthma with an eosinophilic phenotype; SSAR: Swiss Severe Asthma Registry.
FIGURE 2
FIGURE 2
Change in rate of CSEs by baseline peripheral BEC for patients with (A) SAEP[−]CRSwNP and (B) SAEP[+]CRSwNP. Abbreviations: BEC, blood eosinophil count; CI, confidence interval; CRSwNP, chronic rhinosinusitis with nasal polyps; CSE, clinically significant exacerbation; SAEP, severe asthma with an eosinophilic phenotype.
FIGURE 3
FIGURE 3
Between‐cohort statistical comparison of reduction in CSEs from 12‐months pre‐initiation to 12‐months post‐mepolizumab initiation in patients with SAEP[−]CRSwNP versus patients with SAEP[+]CRSwNP. Abbreviations: aRR, annual rate ratio; CI, confidence interval; CRSwNP, chronic rhinosinusitis with nasal polyps; CSE, clinically significant exacerbation; Liège‐BSAR, Belgium Severe Asthma Registry (Liège); IPD, individual patient data; REALITI‐A, REAL world effectiveness of mepolizumab In paTIent care —Asthma study; REDES, REal worlD Effectiveness and Safety of Mepolizumab; RELIght, a two‐year REal‐LIfe study of mepolizumab in patients with severe eosinophilic asTHma in Greece; SAEP, severe asthma with an eosinophilic phenotype; SSAR, Swiss Severe Asthma Registry. a: Cohort‐specific annual rate ratio.
FIGURE 4
FIGURE 4
Clinical remission criteria in patients with (A) SAEP[−]CRSwNP and (B) SAEP[+]CRSwNP who achieved a reduction in CSEs. Abbreviations: ACQ‐5, Asthma Control Questionnaire‐5; ACT, Asthma Control Test; CI, confidence interval; CRSwNP, chronic rhinosinusitis with nasal polyps; CSE, clinically significant exacerbation; FEV1 , forced expiratory volume in 1 s; I 2 , heterogeneity index; OCS, oral corticosteroids; SAEP, severe asthma with an eosinophilic phenotype. a: Total number of patients who achieved a reduction in CSEs in each cohort; bDuring the 12‐month post‐mepolizumab initiation period; aAt 12‐months post‐mepolizumab initiation.
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