Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma

Jason K. Lee; Stephen J. Pollard; Mark C. Liu; Florence Schleich; Girolamo Pelaia; Carlos Almonacid; Liam G. Heaney; Rekha Chaudhuri; Rafael Alfonso-Cristancho; Lingjiao Zhang; Aoife Maxwell; Peter Howarth

doi:10.1016/j.anai.2025.01.002

Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma

Jason K. Lee
, Stephen J. Pollard
, Mark C. Liu
, Florence Schleich
, Girolamo Pelaia
, Carlos Almonacid
, Liam G. Heaney
, Rekha Chaudhuri
, Rafael Alfonso-Cristancho
, Lingjiao Zhang
, Aoife Maxwell
, Peter Howarth

Research output: Contribution to journal › Article › peer-review

6 Citations (Scopus)

24 Downloads (Pure)

Abstract

Background
Some patients with severe asthma have overlapping allergic and eosinophilic phenotypes and may be eligible for anti-eosinophilic or anti-IgE biologics.

Objective
This post hoc sub-analysis assessed real-world mepolizumab effectiveness in patients with overlapping allergic and eosinophilic phenotypes, using 1-year data from the international, prospective REALITI-A study.

Methods
The clinically significant asthma exacerbation (CSE) rate was assessed 1 year prior to (pre-treatment) and following (follow-up) mepolizumab treatment, stratified by baseline total IgE levels (tIgE; <60, 60–<190, 190–<550, and ≥550 kU/L), atopic status (yes/no/unknown), prior omalizumab use (yes/no), geographic baseline omalizumab eligibility (eligible/non-eligible), and baseline tIgE level and blood eosinophil count (BEC) threshold combinations (<81 or ≥81 kU/L and <300 or ≥300 cells/µL).

Results
Overall, 822 patients were included. CSEs occurred in 760 (93%) patients pre-treatment and 398 (49%) during follow-up. CSE rate (RR[95% CI]) was reduced in follow-up across all tIgE subgroups (<60 [n=173]: 0.31[0.25, 0.37]; 60–<190 [n=176]: 0.30[0.25, 0.36]; 190–<550 [n=170]: 0.26[0.20, 0.33]; ≥550 kU/L [n=155]: 0.28[0.23, 0.35]) and irrespective of atopic status (yes [n=422]: 0.29[0.26, 0.33]; no [n=52]: 0.33[0.23, 0.47]; unknown [n=348]: 0.28[0.24, 0.32]), prior omalizumab use (yes [n=151]: 0.37[0.30, 0.45]; no [n=671]: 0.27[0.24, 0.30]) or eligibility (eligible (n=349): 0.29[0.25, 0.34]; non-eligible [n=191]: 0.32[0.27, 0.38]). Furthermore, the CSE rate was reduced across all tIgE (kU/L) and BEC (cells/µL) combinations (<81/<300 [n=53]: 0.34[0.24, 0.47], <81/≥300 [n=103]: 0.33[0.26, 0.41], ≥81/<300 [n=98]: 0.36[0.28, 0.47], ≥81/≥300 [n=249]: 0.26[0.22, 0.31]).

Conclusion
Mepolizumab demonstrates real-world effectiveness in reducing exacerbations in patients with severe asthma and an eosinophilic phenotype, regardless of any overlapping allergic phenotype.

Original language	English
Pages (from-to)	37-46
Journal	Annals of Allergy, Asthma and Immunology
Volume	135
Issue number	1
Early online date	26 Jun 2025
DOIs	https://doi.org/10.1016/j.anai.2025.01.002
Publication status	Published - Jul 2025

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Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma
Copyright 2025 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
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Lee, J. K., Pollard, S. J., Liu, M. C., Schleich, F., Pelaia, G., Almonacid, C., Heaney, L. G., Chaudhuri, R., Alfonso-Cristancho, R., Zhang, L., Maxwell, A., & Howarth, P. (2025). Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma. Annals of Allergy, Asthma and Immunology, 135(1), 37-46. https://doi.org/10.1016/j.anai.2025.01.002

@article{84b1d6b974f54b838b16e745acded1e8,

title = "Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma",

abstract = "Background Some patients with severe asthma have overlapping allergic and eosinophilic phenotypes and may be eligible for anti-eosinophilic or anti-IgE biologics. Objective This post hoc sub-analysis assessed real-world mepolizumab effectiveness in patients with overlapping allergic and eosinophilic phenotypes, using 1-year data from the international, prospective REALITI-A study. Methods The clinically significant asthma exacerbation (CSE) rate was assessed 1 year prior to (pre-treatment) and following (follow-up) mepolizumab treatment, stratified by baseline total IgE levels (tIgE; <60, 60–<190, 190–<550, and ≥550 kU/L), atopic status (yes/no/unknown), prior omalizumab use (yes/no), geographic baseline omalizumab eligibility (eligible/non-eligible), and baseline tIgE level and blood eosinophil count (BEC) threshold combinations (<81 or ≥81 kU/L and <300 or ≥300 cells/µL). Results Overall, 822 patients were included. CSEs occurred in 760 (93\%) patients pre-treatment and 398 (49\%) during follow-up. CSE rate (RR[95\% CI]) was reduced in follow-up across all tIgE subgroups (<60 [n=173]: 0.31[0.25, 0.37]; 60–<190 [n=176]: 0.30[0.25, 0.36]; 190–<550 [n=170]: 0.26[0.20, 0.33]; ≥550 kU/L [n=155]: 0.28[0.23, 0.35]) and irrespective of atopic status (yes [n=422]: 0.29[0.26, 0.33]; no [n=52]: 0.33[0.23, 0.47]; unknown [n=348]: 0.28[0.24, 0.32]), prior omalizumab use (yes [n=151]: 0.37[0.30, 0.45]; no [n=671]: 0.27[0.24, 0.30]) or eligibility (eligible (n=349): 0.29[0.25, 0.34]; non-eligible [n=191]: 0.32[0.27, 0.38]). Furthermore, the CSE rate was reduced across all tIgE (kU/L) and BEC (cells/µL) combinations (<81/<300 [n=53]: 0.34[0.24, 0.47], <81/≥300 [n=103]: 0.33[0.26, 0.41], ≥81/<300 [n=98]: 0.36[0.28, 0.47], ≥81/≥300 [n=249]: 0.26[0.22, 0.31]). Conclusion Mepolizumab demonstrates real-world effectiveness in reducing exacerbations in patients with severe asthma and an eosinophilic phenotype, regardless of any overlapping allergic phenotype. ",

author = "Lee, \{Jason K.\} and Pollard, \{Stephen J.\} and Liu, \{Mark C.\} and Florence Schleich and Girolamo Pelaia and Carlos Almonacid and Heaney, \{Liam G.\} and Rekha Chaudhuri and Rafael Alfonso-Cristancho and Lingjiao Zhang and Aoife Maxwell and Peter Howarth",

year = "2025",

month = jul,

doi = "10.1016/j.anai.2025.01.002",

language = "English",

volume = "135",

pages = "37--46",

journal = "Annals of Allergy, Asthma and Immunology",

issn = "1081-1206",

publisher = "American College of Allergy, Asthma and Immunology",

number = "1",

}

Lee, JK, Pollard, SJ, Liu, MC, Schleich, F, Pelaia, G, Almonacid, C, Heaney, LG, Chaudhuri, R, Alfonso-Cristancho, R, Zhang, L, Maxwell, A & Howarth, P 2025, 'Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma', Annals of Allergy, Asthma and Immunology, vol. 135, no. 1, pp. 37-46. https://doi.org/10.1016/j.anai.2025.01.002

TY - JOUR

T1 - Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma

AU - Lee, Jason K.

AU - Pollard, Stephen J.

AU - Liu, Mark C.

AU - Schleich, Florence

AU - Pelaia, Girolamo

AU - Almonacid, Carlos

AU - Heaney, Liam G.

AU - Chaudhuri, Rekha

AU - Alfonso-Cristancho, Rafael

AU - Zhang, Lingjiao

AU - Maxwell, Aoife

AU - Howarth, Peter

PY - 2025/7

Y1 - 2025/7

N2 - Background Some patients with severe asthma have overlapping allergic and eosinophilic phenotypes and may be eligible for anti-eosinophilic or anti-IgE biologics. Objective This post hoc sub-analysis assessed real-world mepolizumab effectiveness in patients with overlapping allergic and eosinophilic phenotypes, using 1-year data from the international, prospective REALITI-A study. Methods The clinically significant asthma exacerbation (CSE) rate was assessed 1 year prior to (pre-treatment) and following (follow-up) mepolizumab treatment, stratified by baseline total IgE levels (tIgE; <60, 60–<190, 190–<550, and ≥550 kU/L), atopic status (yes/no/unknown), prior omalizumab use (yes/no), geographic baseline omalizumab eligibility (eligible/non-eligible), and baseline tIgE level and blood eosinophil count (BEC) threshold combinations (<81 or ≥81 kU/L and <300 or ≥300 cells/µL). Results Overall, 822 patients were included. CSEs occurred in 760 (93%) patients pre-treatment and 398 (49%) during follow-up. CSE rate (RR[95% CI]) was reduced in follow-up across all tIgE subgroups (<60 [n=173]: 0.31[0.25, 0.37]; 60–<190 [n=176]: 0.30[0.25, 0.36]; 190–<550 [n=170]: 0.26[0.20, 0.33]; ≥550 kU/L [n=155]: 0.28[0.23, 0.35]) and irrespective of atopic status (yes [n=422]: 0.29[0.26, 0.33]; no [n=52]: 0.33[0.23, 0.47]; unknown [n=348]: 0.28[0.24, 0.32]), prior omalizumab use (yes [n=151]: 0.37[0.30, 0.45]; no [n=671]: 0.27[0.24, 0.30]) or eligibility (eligible (n=349): 0.29[0.25, 0.34]; non-eligible [n=191]: 0.32[0.27, 0.38]). Furthermore, the CSE rate was reduced across all tIgE (kU/L) and BEC (cells/µL) combinations (<81/<300 [n=53]: 0.34[0.24, 0.47], <81/≥300 [n=103]: 0.33[0.26, 0.41], ≥81/<300 [n=98]: 0.36[0.28, 0.47], ≥81/≥300 [n=249]: 0.26[0.22, 0.31]). Conclusion Mepolizumab demonstrates real-world effectiveness in reducing exacerbations in patients with severe asthma and an eosinophilic phenotype, regardless of any overlapping allergic phenotype.

AB - Background Some patients with severe asthma have overlapping allergic and eosinophilic phenotypes and may be eligible for anti-eosinophilic or anti-IgE biologics. Objective This post hoc sub-analysis assessed real-world mepolizumab effectiveness in patients with overlapping allergic and eosinophilic phenotypes, using 1-year data from the international, prospective REALITI-A study. Methods The clinically significant asthma exacerbation (CSE) rate was assessed 1 year prior to (pre-treatment) and following (follow-up) mepolizumab treatment, stratified by baseline total IgE levels (tIgE; <60, 60–<190, 190–<550, and ≥550 kU/L), atopic status (yes/no/unknown), prior omalizumab use (yes/no), geographic baseline omalizumab eligibility (eligible/non-eligible), and baseline tIgE level and blood eosinophil count (BEC) threshold combinations (<81 or ≥81 kU/L and <300 or ≥300 cells/µL). Results Overall, 822 patients were included. CSEs occurred in 760 (93%) patients pre-treatment and 398 (49%) during follow-up. CSE rate (RR[95% CI]) was reduced in follow-up across all tIgE subgroups (<60 [n=173]: 0.31[0.25, 0.37]; 60–<190 [n=176]: 0.30[0.25, 0.36]; 190–<550 [n=170]: 0.26[0.20, 0.33]; ≥550 kU/L [n=155]: 0.28[0.23, 0.35]) and irrespective of atopic status (yes [n=422]: 0.29[0.26, 0.33]; no [n=52]: 0.33[0.23, 0.47]; unknown [n=348]: 0.28[0.24, 0.32]), prior omalizumab use (yes [n=151]: 0.37[0.30, 0.45]; no [n=671]: 0.27[0.24, 0.30]) or eligibility (eligible (n=349): 0.29[0.25, 0.34]; non-eligible [n=191]: 0.32[0.27, 0.38]). Furthermore, the CSE rate was reduced across all tIgE (kU/L) and BEC (cells/µL) combinations (<81/<300 [n=53]: 0.34[0.24, 0.47], <81/≥300 [n=103]: 0.33[0.26, 0.41], ≥81/<300 [n=98]: 0.36[0.28, 0.47], ≥81/≥300 [n=249]: 0.26[0.22, 0.31]). Conclusion Mepolizumab demonstrates real-world effectiveness in reducing exacerbations in patients with severe asthma and an eosinophilic phenotype, regardless of any overlapping allergic phenotype.

U2 - 10.1016/j.anai.2025.01.002

DO - 10.1016/j.anai.2025.01.002

M3 - Article

C2 - 39805551

SN - 1081-1206

VL - 135

SP - 37

EP - 46

JO - Annals of Allergy, Asthma and Immunology

JF - Annals of Allergy, Asthma and Immunology

IS - 1

ER -

Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma

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