The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma

Kenneth R. Chapman, Frank C. Albers, Bradley Chipps, Xavier Muñoz, Gilles Devouassoux, Miguel Bergna, Dmitry Galkin, Jay Azmi, Dalal Mouneimne, Robert G. Price, Mark C. Liu

Research output: Contribution to journalArticle

Abstract

Background: Mepolizumab and omalizumab are treatments for distinct but overlapping severe asthma phenotypes. Objective: To assess if patients eligible for both biologics but not optimally controlled with omalizumab experience improved asthma control when switched directly to mepolizumab. Methods: OSMO was a multicenter, open-label, single-arm, 32-week trial in patients with ≥2 asthma exacerbations in the year prior to enrollment, despite receiving high-dose inhaled corticosteroids and other controller(s), plus omalizumab (≥4 months). At baseline, patients with blood eosinophil counts ≥150 cells/µL (or ≥300 cells/µL in the prior year) and an Asthma Control Questionnaire (ACQ)-5 score ≥1.5 discontinued omalizumab and immediately commenced mepolizumab 100 mg subcutaneously every 4 weeks. Endpoints included change from baseline in ACQ-5 score (primary), St George's Respiratory Questionnaire (SGRQ) score and the proportions of ACQ-5 and SGRQ responders, all at Week 32, and the annualized exacerbation rate over the study period. Results: At Week 32 (intent-to-treat population [n = 145]), the least squares (LS) mean changes (standard error [SE]) in ACQ-5 and SGRQ total scores were −1.45 (0.107) and −19.0 (1.64) points; with 77% and 79% of patients achieving the minimum clinically important differences (ACQ-5: ≥0.5 points; SGRQ: ≥4 points), respectively. The annualized rate of clinically significant exacerbations was 1.18 events/year, a 64% reduction from 3.26 events/year during the previous year. Safety and immunogenicity profiles were consistent with previous trials. Conclusion: After directly switching from omalizumab to mepolizumab, patients with uncontrolled severe eosinophilic asthma experienced clinically significant improvements in asthma control, health status, and exacerbation rate, with no tolerability issues reported.

Original languageEnglish (US)
Pages (from-to)1716-1726
Number of pages11
JournalAllergy: European Journal of Allergy and Clinical Immunology
Volume74
Issue number9
DOIs
StatePublished - Sep 1 2019

Fingerprint

Asthma
mepolizumab
Omalizumab
Surveys and Questionnaires
Biological Products
Least-Squares Analysis
Eosinophils
Health Status
Adrenal Cortex Hormones
Phenotype
Safety
Population

Keywords

  • ACQ-5
  • asthma control
  • mepolizumab
  • omalizumab
  • severe eosinophilic asthma

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma. / Chapman, Kenneth R.; Albers, Frank C.; Chipps, Bradley; Muñoz, Xavier; Devouassoux, Gilles; Bergna, Miguel; Galkin, Dmitry; Azmi, Jay; Mouneimne, Dalal; Price, Robert G.; Liu, Mark C.

In: Allergy: European Journal of Allergy and Clinical Immunology, Vol. 74, No. 9, 01.09.2019, p. 1716-1726.

Research output: Contribution to journalArticle

Chapman, KR, Albers, FC, Chipps, B, Muñoz, X, Devouassoux, G, Bergna, M, Galkin, D, Azmi, J, Mouneimne, D, Price, RG & Liu, MC 2019, 'The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma', Allergy: European Journal of Allergy and Clinical Immunology, vol. 74, no. 9, pp. 1716-1726. https://doi.org/10.1111/all.13850
Chapman, Kenneth R. ; Albers, Frank C. ; Chipps, Bradley ; Muñoz, Xavier ; Devouassoux, Gilles ; Bergna, Miguel ; Galkin, Dmitry ; Azmi, Jay ; Mouneimne, Dalal ; Price, Robert G. ; Liu, Mark C. / The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma. In: Allergy: European Journal of Allergy and Clinical Immunology. 2019 ; Vol. 74, No. 9. pp. 1716-1726.
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AU - Albers, Frank C.

AU - Chipps, Bradley

AU - Muñoz, Xavier

AU - Devouassoux, Gilles

AU - Bergna, Miguel

AU - Galkin, Dmitry

AU - Azmi, Jay

AU - Mouneimne, Dalal

AU - Price, Robert G.

AU - Liu, Mark C.

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N2 - Background: Mepolizumab and omalizumab are treatments for distinct but overlapping severe asthma phenotypes. Objective: To assess if patients eligible for both biologics but not optimally controlled with omalizumab experience improved asthma control when switched directly to mepolizumab. Methods: OSMO was a multicenter, open-label, single-arm, 32-week trial in patients with ≥2 asthma exacerbations in the year prior to enrollment, despite receiving high-dose inhaled corticosteroids and other controller(s), plus omalizumab (≥4 months). At baseline, patients with blood eosinophil counts ≥150 cells/µL (or ≥300 cells/µL in the prior year) and an Asthma Control Questionnaire (ACQ)-5 score ≥1.5 discontinued omalizumab and immediately commenced mepolizumab 100 mg subcutaneously every 4 weeks. Endpoints included change from baseline in ACQ-5 score (primary), St George's Respiratory Questionnaire (SGRQ) score and the proportions of ACQ-5 and SGRQ responders, all at Week 32, and the annualized exacerbation rate over the study period. Results: At Week 32 (intent-to-treat population [n = 145]), the least squares (LS) mean changes (standard error [SE]) in ACQ-5 and SGRQ total scores were −1.45 (0.107) and −19.0 (1.64) points; with 77% and 79% of patients achieving the minimum clinically important differences (ACQ-5: ≥0.5 points; SGRQ: ≥4 points), respectively. The annualized rate of clinically significant exacerbations was 1.18 events/year, a 64% reduction from 3.26 events/year during the previous year. Safety and immunogenicity profiles were consistent with previous trials. Conclusion: After directly switching from omalizumab to mepolizumab, patients with uncontrolled severe eosinophilic asthma experienced clinically significant improvements in asthma control, health status, and exacerbation rate, with no tolerability issues reported.

AB - Background: Mepolizumab and omalizumab are treatments for distinct but overlapping severe asthma phenotypes. Objective: To assess if patients eligible for both biologics but not optimally controlled with omalizumab experience improved asthma control when switched directly to mepolizumab. Methods: OSMO was a multicenter, open-label, single-arm, 32-week trial in patients with ≥2 asthma exacerbations in the year prior to enrollment, despite receiving high-dose inhaled corticosteroids and other controller(s), plus omalizumab (≥4 months). At baseline, patients with blood eosinophil counts ≥150 cells/µL (or ≥300 cells/µL in the prior year) and an Asthma Control Questionnaire (ACQ)-5 score ≥1.5 discontinued omalizumab and immediately commenced mepolizumab 100 mg subcutaneously every 4 weeks. Endpoints included change from baseline in ACQ-5 score (primary), St George's Respiratory Questionnaire (SGRQ) score and the proportions of ACQ-5 and SGRQ responders, all at Week 32, and the annualized exacerbation rate over the study period. Results: At Week 32 (intent-to-treat population [n = 145]), the least squares (LS) mean changes (standard error [SE]) in ACQ-5 and SGRQ total scores were −1.45 (0.107) and −19.0 (1.64) points; with 77% and 79% of patients achieving the minimum clinically important differences (ACQ-5: ≥0.5 points; SGRQ: ≥4 points), respectively. The annualized rate of clinically significant exacerbations was 1.18 events/year, a 64% reduction from 3.26 events/year during the previous year. Safety and immunogenicity profiles were consistent with previous trials. Conclusion: After directly switching from omalizumab to mepolizumab, patients with uncontrolled severe eosinophilic asthma experienced clinically significant improvements in asthma control, health status, and exacerbation rate, with no tolerability issues reported.

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KW - asthma control

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