Efficacy and Safety of Subcutaneous Omalizumab vs Placebo as Add-on Therapy to Corticosteroids for Children and Adults With Asthma

Rodrigo, Gustavo J.; Neffen, Hugo; Castro-Rodriguez, José A.

doi:10.1378/chest.10-1194

Cited by 250 publications

(168 citation statements)

References 23 publications

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“…The systematic review of Norman et al also showed that in patients with allergic asthma, omalizumab decreased the exacerbations (24). A systematic metaanalysis evaluating the effectiveness of omalizumab versus placebo in 3429 patients with moderatesevere persistent allergic asthma found that omalizumab treatment (1883 patients) significantly improved asthma exacerbations, steroid dose requirement, and asthma symptom scores (25).…”

Section: Discussionmentioning

confidence: 98%

Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies

Gemicioğlu¹,

Öztürk²,

Duman³

2016

Tuberk Toraks

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SUMMARY Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies Introduction: To assess the long-term (5 year) efficacy of omalizumab and systemic corticosteroid therapy in allergic and non-allergic asthma that could not be controlled by step 4 therapy, respectively. Patients and Methods:This single-center study was based on all consecutive step 4 patients with severe persistent uncontrolled allergic and non-allergic asthma who were given omalizumab and systemic corticosteroid (minimum: 4 mg, maximum: 12 mg, median: 8 mg methyl prednisone), respectively, in 2006-2014 and were Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies INTRODUCTIONThe great majority of patients with severe asthma are step 4 asthmatics, meaning that their asthma can be controlled with high doses of inhaled corticosteroids and long acting β2 agonists. However, the remaining patients with severe asthma are candidates for step 5 treatment, as their condition cannot be controlled with step 4 medications (1-3). Since these patients have severe asthma, require many medications, frequently visit emergency rooms, and are often hospitalized, this condition places a significant burden on both the patients and the health care system (4,5).Around 5-10% of patients with asthma have severe asthma. IgE-mediated immune mechanisms are thought to play a role in over 50% of these patients (6). Omalizumab is a recombinant humanized monoclonal antibody that complexes with free IgE, thereby preventing it from adhering to specific receptors on mast cells and basophils (FcRI). Omalizumab therefore acts as a potent antiinflammatory agent in patients with severe perennial allergic asthma (7). Three studies with follow-up periods of 0.5, 4 and 7 years found that omalizumab effectively decreases asthma exacerbations, lowers steroid doses, and imposes better asthma control (8-10). Four randomized controlled studies of omalizumab also showed that it decreases asthmarelated symptoms, reduces corticosteroid use, and improves quality of life (11-14).In recent years, case reports and a Spanish multicenter registry study showed that omalizumab is also effective in non-allergic asthma (15). Thereafter, research efforts turned to assessing the usefulness of omalizumab in patients with non-allergic asthma.However, at present, the guidelines state that when non-allergic asthma is even unresponsive to macrolide or tiotropium medications and another diagnosis cannot be made, oral corticosteroid or anticytokine treatments should be administered (16,17). However, the long-term outcomes of patients with non-allergic step 5 asthma who do not accept treatment with continuous oral steroids remain unclear.The present cohort study was performed to determine the outcomes over a 5 year follow-up period of patients whose severe persistent asthma w...

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Section: Discussionmentioning

confidence: 98%

Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies

Gemicioğlu¹,

Öztürk²,

Duman³

2016

Tuberk Toraks

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“…This action reduces the release of mediators of allergic reactions. Omalizumab has been studied in patients with severe asthma, and it was shown that it is effective as a steroid-sparing drug and in decreasing the frequency of asthma exacerbations [34,35].…”

Section: Biological Treatmentsmentioning

confidence: 99%

Severe Asthma: Moving from Phenotype to Endotype Classification with Updates on Treatment

Noujeim¹,

Bou‐Khalil²

2016

J Nurs Care

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Asthma has classically been categorized into several phenotypes to address the complexities of this disease. However, phenotypes only cover the clinically relevant aspects of the disease, but do not address the relationship between the disease and its etiology and pathophysiology. This led to the development of the term "endotypes" which links key pathogenic mechanisms with asthma phenotypes, and ultimately leads to better selection of treatment resulting in improved response. Although the exact pathogenesis of asthma is still under investigation, targeted-therapy based on asthma phenotypes and endotypes has shown some success, and the future appears promising for patients suffering from severe asthma since treatment is being tailored according to individual biology. We review in this manuscript the best evidence and updates currently available in the classification and treatment recommendations for severe asthma.

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“…Adverse effects were generally of mild-to-moderate severity and of short duration. However, injection site reactions were more frequent in the omalizumab group (19.9% vs. 13.2%) (34). Based on previous observations from clinical trials, concern arose about the relationship between omalizumab treatment and malignancies' development.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Severe Asthma: Anti-IgE or Anti-IL-5?

Bakakos¹,

Loukides²

2015

J Allergy Ther

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Severe asthma is a discrete clinical entity characterised by recurrent exacerbations, reduced quality of life and poor asthma control as ordinary treatment regimens remain inadequate. Difficulty in managing severe asthma derives partly from the multiple existing phenotypes and our inability to recognise them. Though the exact pathogenetic pathway of severe allergic asthma remains unclear, it is known that numerous inflammatory cells and cytokines are involved, and eosinophils represent a key inflammatory cell mediator. Anti-IgE (omalizumab) and anti-IL-5 (mepolizumab) antibodies are biological agents that interfere in different steps of the Th2 inflammatory cascade and are licensed in severe asthma. Both exhibit a favourable clinical outcome as they reduce exacerbation rate and improve asthma control and quality of life, while mepolizumab also induces an oral steroid sparing effect. Nevertheless, it is still questionable which agent is more suitable in the management of severe allergic asthma since no comparable studies have been conducted. Omalizumab's established effectiveness in clinical practice over a long period is complemented by a beneficial effect on airway remodelling process mediated mainly through its impact on eosinophils and other parameters strongly related to eosinophilic inflammation. However, it is possible that mepolizumab through nearly depleting eosinophils could have a similar effect on airway remodelling. Moreover, to date, markers indicative of the patient population responding to each treatment are unavailable although baseline eosinophils and exacerbation rate in the previous year demonstrate a predictive value regarding anti-IL-5 therapy effectiveness. On the other hand, a better therapeutic response for omalizumab has been observed when low forced expiratory volume in 1 sec, high-dose inhaled corticosteroids and increased IgE concentrations are present. Consequently, conclusions are not yet safe to be drawn based on existing knowledge, and additional research is necessary to unravel the remaining issues for the severe asthmatic population.

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Efficacy and Safety of Subcutaneous Omalizumab vs Placebo as Add-on Therapy to Corticosteroids for Children and Adults With Asthma

Cited by 250 publications

References 23 publications

Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies

Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies

Severe Asthma: Moving from Phenotype to Endotype Classification with Updates on Treatment

Severe Asthma: Anti-IgE or Anti-IL-5?

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