Effects of Omalizumab in Non-Atopic Asthma: Results from a Spanish Multicenter Registry

Llano, Luís Pérez de; Vennera, María del Carmen; Álvarez, Francisco; Medina, Juan F.; Borderías, Luis; Pellicer, C.; González, Héctor; Blanco, José Antonio Gullón; Martínez‐Moragón, Eva; Sabadell, Carles; Zamarro, Soledad; Picado, César

doi:10.3109/02770903.2012.757780

Cited by 101 publications

(91 citation statements)

References 18 publications

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“…There was an improvement in symptoms, as measured by an increase in the ACT score, and a non-significant decrease in severe exacerbations. 101 Thus the data is limited at this time to recommend omalizumab in this group.…”

Section: Efficacy In Special Populationsmentioning

confidence: 99%

Recognition and management of severe asthma: A Canadian Thoracic Society position statement

FitzGerald

Lemière

Lougheed

et al. 2017

Canadian Journal of Respiratory, Critical Care, and Sleep Medic

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RATIONALE: While severe asthma affects approximately 5% of all individuals with asthma, this small minority of individuals accounts for a large proportion of the asthma-related costs. Greater understanding of the pathophysiology of asthma combined with the emergence of novel biologic therapies for severe asthma supported the need for a thorough review of the diagnosis, investigation, phenotyping, and management of severe asthma. OBJECTIVES: We aimed to propose a practical approach to distinguish uncontrolled asthma due to inadequate asthma management from severe asthma despite optimal asthma management. Moreover, based on emerging scientific evidence, we sought to provide guidance for characterizing individuals with severe asthma and considering a phenotype-specific management. We also aimed to review other novel new potential therapeutic approaches. METHODS: We systematically reviewed the relevant literature focusing on randomized controlled trials and when available, systematic reviews of randomized controlled trials. The proposed key messages, based on scientific evidence and expert opinion, were agreed upon by unanimous consensus. MAIN RESULTS: We defined severe asthma and outlined its significant impact from the societal and patient perspectives. We outlined a practical approach to distinguish severe from uncontrolled but not severe asthma, based on stepwise investigation and management of potential reasons for uncontrolled asthma. After reviewing the current evidence we concluded that: 1) Several biomarkers (e.g. sputum or blood eosinophil count, total IgE, or FeNO) can help identify potential responders to new therapeutic options; 2) Tiotropium may be considered as an add-on therapy for individuals 12 years of age and over with severe asthma uncontrolled despite combination ICS/LABA therapy; 3) The chronic use of macrolides may decrease asthma exacerbations in individuals 18 years of age and over with severe asthma independent of their inflammatory profile; 4) Children aged 6 years and older and adults who are sensitized to at least one relevant perennial allergen and who remain poorly controlled asthmatics despite high dose ICS and a second controller can benefit from the addition of anti-IgE therapy to reduce asthma exacerbations; due to the known risk of side effects associated with high-dose ICS in children, omalizumab should also be considered in children and adolescents who repeatedly exacerbate or have poor control when therapy is stepped down from high-dose to moderate-dose ICS and at least one other controller; 5) Anti-IL5 therapies may be considered for adults 18 years of age and over with severe eosinophilic asthma who experience recurrent asthma exacerbations in spite of high doses of ICS in addition to at least one other controller; and 6) Although bronchial thermoplasty has shown a decrease in asthma exacerbations in one study, its role in the treatment of severe asthma remains uncertain. CONCLUSIONS: After reviewing existing and emerging therapies for severe asthma, we developed ke...

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Section: Efficacy In Special Populationsmentioning

confidence: 99%

Recognition and management of severe asthma: A Canadian Thoracic Society position statement

FitzGerald

Lemière

Lougheed

et al. 2017

Canadian Journal of Respiratory, Critical Care, and Sleep Medic

View full text Add to dashboard Cite

show abstract

“…The Spanish registry study of Llana et al showed that during a 2 year period, omalizumab also significantly improved the ACTs of non-allergic asthma patients at the 1 st and 2 nd years. However, it had no effect on FEV 1 and exacerbations (15). In the present study, the step 5-treated nonallergic group, who were not treated with omalizumab, also exhibited significantly increased ACTs at all time points.…”

Section: Discussionmentioning

confidence: 50%

“…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.…”

Section: Introductionmentioning

confidence: 99%

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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“…Currently, no studies have been performed to compare the effect difference of these two antibodies on severe asthma. It is conceivable that in nonallergic eosinophilic asthma, there is no place for anti-IgE treatment although occasionally omalizumab has been administered in non-allergic asthmatics based on local production of IgE (70,71).…”

Section: Discussionmentioning

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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Effects of Omalizumab in Non-Atopic Asthma: Results from a Spanish Multicenter Registry

Cited by 101 publications

References 18 publications

Recognition and management of severe asthma: A Canadian Thoracic Society position statement

Recognition and management of severe asthma: A Canadian Thoracic Society position statement

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: Anti-IgE or Anti-IL-5?

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