Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Apr 3:15:21.
doi: 10.1186/s13223-019-0337-2. eCollection 2019.

Omalizumab in patients with severe asthma and persistent sputum eosinophilia

Manali Mukherjee  1   2 , Melanie Kjarsgaard  1   2 , Katherine Radford  1   2 , Chynna Huang  1   2 , Richard Leigh  3 , Delbert R Dorscheid  4 , Catherine Lemiere  5 , Louis-Philippe Boulet  6 , Susan Waserman  1   2 , James Martin  7   8 , Parameswaran Nair  1   2
Affiliations

Omalizumab in patients with severe asthma and persistent sputum eosinophilia

Manali Mukherjee et al. Allergy Asthma Clin Immunol. .

Abstract

Omalizumab, a recombinant humanized monoclonal antibody targeting the IgE molecule, is the first biologic approved for moderate-to-severe allergic asthmatics, who remain uncontrolled despite high dose inhaled corticosteroid and bronchodilators. Steroid-sparing effect of omalizumab has not been demonstrated in asthmatics with persistent airway eosinophilia in a randomised controlled trial till date. From this double-blind, placebo-controlled, multi-centred, randomized parallel group design, we report that omalizumab is possibly inadequate to control sputum eosinophilia, and therefore may not have a steroid-sparing effect, especially in those maintained on oral corticosteroids daily. This needs to be confirmed or refuted in a larger trial, which may be a challenge with respect to recruitment, since there are currently three additional biologics available to prescribe. Trial registration Clinicaltrials.gov, NCT02049294, Registered 30th January 2014, https://clinicaltrials.gov/ct2/show/NCT02049294.

Keywords: IgE; Omalizumab; Severe asthma; Sputum eosinophils; TSLP.

PubMed Disclaimer

Conflict of interest statement

PN reports grants from AZ, Novartis (current submitted manuscript), Teva, Sanofi. He has received consultant fees from Roche, Teva, Novartis, Knopp, outside the submitted work. MM no conflicts of interest to declare. CL reports grants from AZ and TEVA Innovation. She has received consultant fees from AZ, GSK, Sanofi Genzyme, Teva Innovation, outside the submitted work. RL has received grant funding from AstraZeneca, MedImmune, Novartis and Sanofi (outside the submitted work and paid to his institution) and honoraria and speaker’s fees from AstraZeneca, the Canadian Thoracic Society and Teva Canada. SW has received grant funding from MedImmune, and honoraria from Novartis Astra Zeneca, and Teva Canada. MM, MK, KR, CH has nothing to declare.

Figures

Fig. 1
Fig. 1
Consort flow diagram of patient recruitment: details of patient recruitment process, study and analysis is provided in a schematic
Fig. 2
Fig. 2
Effect of omalizumab on eosinophilia and indices of asthma severity: no significant reduction in eosinophils in the a sputum or b circulation, nor in the measurements of c fractional exhaled nitric oxide (FeNO), d asthma control (ACQ-5), or e FEV1 %predicted, could be documented for patients in the drug arm compared to placebo. Bars within the plots indicate the mean value for each group, and the delta (∆) values reflecting the mean absolute change within the group is give. Changes from baseline were compared for each arm using Wilcoxon paired analysis. P values were > 0.05, and were deemed non-significant
See this image and copyright information in PMC

References

    1. Hanania NA, Alpan O, Hamilos DL, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154(9):573–582. doi: 10.7326/0003-4819-154-9-201105030-00002. - DOI - PubMed
    1. Normansell R, Walker S, Milan SJ, Walters EH, Nair P. Omalizumab for asthma in adults and children. Cochrane Database Syst Rev. 2014;1:CD003559. - PMC - PubMed
    1. Djukanović R, Wilson SJ, Kraft M, Jarjour NN, Steel M, Chung KF, et al. Effects of treatment with anti-immunoglobulin e antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med. 2004;170(6):583–593. doi: 10.1164/rccm.200312-1651OC. - DOI - PubMed
    1. Smith SG, Gugilla A, Mukherjee M, Merim K, Irshad A, Tang W, et al. Thymic stromal lymphopoietin and IL-33 modulate migration of hematopoietic progenitor cells in patients with allergic asthma. J Allergy Clin Immunol. 2015;135(6):1594–1602. doi: 10.1016/j.jaci.2014.12.1918. - DOI - PubMed
    1. Gauvreau GM, O’Byrne PM, Boulet L-P, Wang Y, Cockcroft D, Bigler J, et al. Effects of an anti-TSLP antibody on allergen-induced asthmatic responses. N Engl J Med. 2014;370(22):2102–2110. doi: 10.1056/NEJMoa1402895. - DOI - PubMed

Associated data