Omalizumab, the first available antibody for biological treatment of
severe asthma: more than a decade of real-life effectiveness

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Abstract

Omalizumab was the first, and for a long time the only available monoclonal antibody for the add-on treatment of severe allergic asthma. In particular, omalizumab selectively targets human immunoglobulin (Ig)E, forming small-size immune complexes that inhibit IgE binding to its high- and low-affinity receptors. Therefore, omalizumab effectively blunts the immune response in atopic asthmatic patients, thus significantly improving the control of asthma symptoms and successfully preventing disease exacerbations. These very positive effects of omalizumab make it possible to drastically decrease both referrals to the emergency room and hospitalizations for asthma exacerbations. Such important therapeutic actions of omalizumab have been documented by several randomized clinical trials, and especially by more than 10 years of real-life experience in daily clinical practice. Omalizumab can also interfere with airway remodelling by inhibiting the activation of IgE receptors located on structural cells such as bronchial epithelial cells and airway smooth muscle cells. Moreover, omalizumab is characterized by a very good safety and tolerability profile. Hence, omalizumab represents a valuable therapeutic option for the add-on biological treatment of severe allergic asthma.

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Most cited references 129

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Asthma

Alberto Papi, Christopher Brightling, Søren Pedersen … (2018)

Asthma-one of the most common chronic, non-communicable diseases in children and adults-is characterised by variable respiratory symptoms and variable airflow limitation. Asthma is a consequence of complex gene-environment interactions, with heterogeneity in clinical presentation and the type and intensity of airway inflammation and remodelling. The goal of asthma treatment is to achieve good asthma control-ie, to minimise symptom burden and risk of exacerbations. Anti-inflammatory and bronchodilator treatments are the mainstay of asthma therapy and are used in a stepwise approach. Pharmacological treatment is based on a cycle of assessment and re-evaluation of symptom control, risk factors, comorbidities, side-effects, and patient satisfaction by means of shared decisions. Asthma is classed as severe when requiring high-intensity treatment to keep it under control, or if it remains uncontrolled despite treatment. New biological therapies for treatment of severe asthma, together with developments in biomarkers, present opportunities for phenotype-specific interventions and realisation of more personalised treatment. In this Seminar, we provide a clinically focused overview of asthma, including epidemiology, pathophysiology, clinical diagnosis, asthma phenotypes, severe asthma, acute exacerbations, and clinical management of disease in adults and children older than 5 years. Emerging therapies, controversies, and uncertainties in asthma management are also discussed.

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Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study.

Jean Bousquet, Søren Pedersen, Romain Pauwels … (2004)

For most patients, asthma is not controlled as defined by guidelines; whether this is achievable has not been prospectively studied. A 1-year, randomized, stratified, double-blind, parallel-group study of 3,421 patients with uncontrolled asthma compared fluticasone propionate and salmeterol/fluticasone in achieving two rigorous, composite, guideline-based measures of control: totally and well-controlled asthma. Treatment was stepped-up until total control was achieved (or maximum 500 microg corticosteroid twice a day). Significantly more patients in each stratum (previously corticosteroid-free, low- and moderate-dose corticosteroid users) achieved control with salmeterol/fluticasone than fluticasone. Total control was achieved across all strata: 520 (31%) versus 326 (19%) patients after dose escalation (p < 0.001) and 690 (41%) versus 468 (28%) at 1 year for salmeterol/fluticasone and fluticasone, respectively. Asthma became well controlled in 1,071 (63%) versus 846 (50%) after dose escalation (p < 0.001) and 1,204 (71%) versus 988 (59%) at 1 year. Control was achieved more rapidly and at a lower corticosteroid dose with salmeterol/fluticasone versus fluticasone. Across all strata, 68% and 76% of the patients receiving salmeterol/fluticasone and fluticasone, respectively, were on the highest dose at the end of treatment. Exacerbation rates (0.07-0.27 per patient per year) and improvement in health status were significantly better with salmeterol/fluticasone. This study confirms that the goal of guideline-derived asthma control was achieved in a majority of the patients.

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Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE.

M. Humbert, R. Beasley, J. AYRES … (2005)

Patients with severe persistent asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Following a run-in phase, patients (12-75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting beta(2)-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. A total of 419 patients were included in the efficacy analyses. The clinically significant asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced severe asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved asthma-related quality of life, morning peak expiratory flow and asthma symptom scores. The incidence of adverse events was similar between treatment groups. In patients with inadequately controlled severe persistent asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant asthma exacerbations, severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled severe persistent asthma who have a significant unmet need despite best available therapy.

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Author and article information

Contributors

Corrado Pelaia

Cecilia Calabrese

Rosa Terracciano

Francesco de Blasio

Alessandro Vatrella

Girolamo Pelaia:

ORCID: https://orcid.org/0000-0001-9288-8913

Journal

Journal ID (nlm-ta): Ther Adv Respir Dis

Journal ID (iso-abbrev): Ther Adv Respir Dis

Journal ID (publisher-id): TAR

Journal ID (hwp): sptar

Title: Therapeutic Advances in Respiratory Disease

Publisher: SAGE Publications (Sage UK: London, England )

ISSN (Print): 1753-4658

ISSN (Electronic): 1753-4666

Publication date (Electronic): 07 November 2018

Publication date Collection: Jan-Dec 2018

Volume: 12

Electronic Location Identifier: 1753466618810192

Affiliations

[1-1753466618810192]Department of Medical and Surgical Sciences, University ‘Magna Græcia’ of Catanzaro, Catanzaro, Italy

[2-1753466618810192]Department of Cardio-Thoracic and Respiratory Sciences, University of Campania ‘Luigi Vanvitelli’, Naples, Italy

[3-1753466618810192]Department of Health Sciences, University ‘Magna Græcia’ of Catanzaro, Catanzaro, Italy

[4-1753466618810192]Respiratory Medicine and Pulmonary Rehabilitation Section, Clinic Center Private Hospital, Naples, Italy

[5-1753466618810192]Department of Medicine and Health Sciences ‘V. Tiberio’, University of Molise, Campobasso, Italy

[6-1753466618810192]Department of Medicine, Surgery and Dentistry, University of Salerno, Salerno, Italy

[7-1753466618810192]Department of Medical and Surgical Sciences, University ‘Magna Græcia’ of Catanzaro, Catanzaro, Italy; Campus Universitario ‘Salvatore Venuta’, Viale Europa – Località Germaneto, Catanzaro, 88100, Italy

Author notes

[*] pelaia@ 123456unicz.it

Author information

Girolamo Pelaia https://orcid.org/0000-0001-9288-8913

Article

Publisher ID: 10.1177_1753466618810192

DOI: 10.1177/1753466618810192

PMC ID: 6236630

PubMed ID: 30400762

SO-VID: cb884d2c-321c-42d3-b050-e716d23d3291

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This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

History

Date received : 21 August 2018

Date accepted : 10 October 2018

Custom metadata

cover-date January-December 2018

Keywords: ige,omalizumab,severe allergic asthma

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Keywords: ige, omalizumab, severe allergic asthma

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Omalizumab, the first available antibody for biological treatment of severe asthma: more than a decade of real-life effectiveness

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Most cited references 129

Asthma

Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study.

Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE.

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