Treating severe allergic asthma with anti-IgE monoclonal antibody (omalizumab): a review

D’Amato, Gennaro; Stanziola, Anna Agnese; Sanduzzi, Alessandro; Liccardi, Gennaro; Salzillo, Antonello; Vitale, Carolina; Molino, Antonio; Vatrella, Alessandro; D’Amato, Maria

doi:10.1186/2049-6958-9-23

Cited by 67 publications

(38 citation statements)

References 54 publications

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“…Omalizumab treatment significantly improves symptoms and disease control, reduces asthma exacerbations, and increases patients’ quality of life [22]. Our study corroborates these findings, but also shows that omalizumab is helpful for severe chronic asthma caused by seasonal allergens.…”

Section: Discussionsupporting

confidence: 85%

Omalizumab Is Equally Effective in Persistent Allergic Oral Corticosteroid-Dependent Asthma Caused by Either Seasonal or Perennial Allergens: A Pilot Study

Domingo

Pomares

Navarro

et al. 2017

IJMS

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Omalizumab is marketed for chronic severe asthma patients who are allergic to perennial allergens. Our purpose was to investigate whether omalizumab is also effective in persistent severe asthma due to seasonal allergens. Thirty patients with oral corticosteroid-dependent asthma were treated with Omalizumab according to the dosing table. For each patient with asthma due to seasonal allergens, we recruited the next two consecutive patients with asthma due to perennial allergens. The dose of oral methyl prednisolone (MP) was tapered at a rate of 2 mg every two weeks after the start of treatment with omalizumab depending on tolerance. At each monthly visit, a forced spirometry and fractional exhaled nitric oxide (FeNO) measurement were performed and the accumulated monthly MP dose was calculated. At entry, there were no differences between groups in terms of gender, body mass index or obesity, year exacerbation rate, monthly dose of MP, FeNO and blood immunoglobuline E (IgE) values, or spirometry (perennial: FVC: 76%; FEV1: 62%; seasonal: FVC: 79%; FEV1: 70%). The follow-up lasted 76 weeks. One patient in each group was considered a non-responder. Spirometry did not worsen in either group. There was a significant intragroup reduction in annual exacerbation rate and MP consumption but no differences were detected in the intergroup comparison. Omalizumab offered the same clinical benefits in the two cohorts regardless of whether the asthma was caused by a seasonal or a perennial allergen. These results strongly suggest that allergens are the trigger in chronic asthma but that it is the persistent exposure to IgE that causes the chronicity.

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Section: Discussionsupporting

confidence: 85%

Omalizumab Is Equally Effective in Persistent Allergic Oral Corticosteroid-Dependent Asthma Caused by Either Seasonal or Perennial Allergens: A Pilot Study

Domingo

Pomares

Navarro

et al. 2017

IJMS

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“…Phase III trials with study periods up to 12 months have shown omalizumab to reduce the frequency of asthma exacerbations and concomitant medication burden and improve symptom severity and quality of life, while also being safe (12)(13)(14)(15). Efficacy and safety data from these and subsequent studies have been reviewed elsewhere (16)(17)(18)(19)(20)(21)(22)(23)(24)(25) A meta-analysis of eight randomized trials (n = 3429) showed that omalizumab therapy was associated with a greater likelihood of withdrawal from corticosteroid therapy (relative risk [RR] = 1.80, 95% CI = 1.42-2.28, P < 0.0001) and a lower risk of exacerbations at the end of the stable (RR = 0.57, 95% CI = 0.48-0.66, P = 0.0001) and the adjustable-steroid phases (RR = 0.55, 95% CI = 0.47-0.64, P = 0.0001) (26).…”

Section: Introductionmentioning

confidence: 99%

‘Real-life’ effectiveness studies of omalizumab in adult patients with severe allergic asthma: systematic review

Abraham

Alhossan

Lee

et al. 2016

Allergy

112

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We reviewed 24 'real-life' effectiveness studies of omalizumab in the treatment of severe allergic asthma that included 4117 unique patients from 32 countries with significant heterogeneity in patients, clinicians and settings. The evidence underscores the short-and long-term benefit of anti-IgE therapy in terms of the following: improving lung function; achieving asthma control and reducing symptomatology, severe exacerbations and associated work/school days lost; reducing healthcare resource utilizations, in particular hospitalizations, hospital lengths of stay and accident specialist or emergency department visits; reducing or discontinuing other asthma medications; and improving quality of life -thus confirming, complementing and extending evidence from randomized trials. Thus, omalizumab therapy is associated with signal improvements across the full objective and subjective burden of illness chain of severe allergic asthma. Benefits of omalizumab may extend up to 2-4 years, and the majority of omalizumab-treated patients may benefit for many years. Omalizumab has positive short-and longterm safety profiles similar to what is known from randomized clinical trials. Initiated patients should be monitored for treatment response at 16 weeks. Those showing positive response at that time are highly likely to show sustained treatment response and benefit in terms of clinical, quality of life and health resource utilization outcomes.Over the past four decades, the prevalence, morbidity and mortality of asthma have increased significantly (1-4). In particular, severe asthma, which affects about 10% of all patients with asthma, presents with significant morbidity, high healthcare resource utilization and impaired quality of life (5). As there is no cure for asthma, the objective of treatment is to control the clinical aspects of the disease (6). Despite guidelines for the evaluation, classification and management of asthma, most patients and certainly those with severe asthma are controlled suboptimally (7-10).Immunoglobulin E (IgE) is an antibody class associated with hypersensitivity and allergic reactions (11). IgE elicits an immune response by binding mainly to the high-affinity receptor (FceRI) found on the surface of mast cells and basophils. In the mast cell, activation of these receptors through cross-linking with IgE causes the cell to release inflammatory mediators (11).Omalizumab (Xolair Ò , Novartis basel, Switzerland) is a recombinant humanized monoclonal anti-IgE antibody that inhibits the binding of IgE to high-affinity receptors. It is indicated as add-on treatment to inhaled corticosteroids (ICS) and long-acting b2-agonists (LABA). Initial treatment response is evaluated at 16 weeks, and treatment is continued in patients showing a response at that time. Phase III trials with study periods up to 12 months have shown omalizumab to reduce the frequency of asthma exacerbations and concomitant medication burden and improve symptom severity and quality of life, while also being safe (12-15). Effica...

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“…Airway allergies are largely type 1 hypersensitivity reactions, and they are characterized by elevated levels of systemic allergen-specific IgE antibodies and hyperreactivity of the airway tract [3]. Medications such as anti-IgE therapy, and anti-histamines, which can be administered orally or systemically via injections are available for short term relief [4, 5]. However, allergen specific immunotherapy (ASI) is the only approach to treat allergies permanently [6].…”

Section: Introductionmentioning

confidence: 99%

Cutaneous vaccination with coated microneedles prevents development of airway allergy

Shakya

Lee

Gill

2017

Journal of Controlled Release

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Allergy cases are increasing worldwide. Currently allergies are treated after their appearance in patients. However, now there is effort to make a preventive vaccine against allergies. The rationale is to target patient populations that are already sensitized to allergens but have yet to develop severe forms of the allergic disease, or who are susceptible to allergy development but have not yet developed them. Subcutaneous injections and the sublingual route have been used as the primary mode of preventive vaccine delivery. However, injections are painful, especially considering that they have to be given repeatedly to infants or young children. The sublingual route is hard to use since infants can’t be trained to hold the vaccine under their tongue. In the present study, we demonstrate a microneedle (MN)-based cutaneous preventive allergy treatment against ovalbumin (Ova)-induced airway allergy in mice. Insertion of MNs coated with Ova as a model allergen and CpG oligonucleotide as an adjuvant (MNs-CIT) into the skin significantly induced Ova specific systemic immune response. This response was similar to that induced by hypodermic-needle-based delivery of Ova using the clinically-approved subcutaneous immunotherapy (SCIT) route. MNs-CIT upregulated Ova-specific Th2 cytokines (IL-4, IL-5 & IL-13) and anti-inflammatory cytokines (IL-10) in the bronchoalveolar fluid, and IL-2 and IFN-γ cytokines in restimulated splenocyte cultures. Absence of mucus deposition inside the bronchiole wall and low stiffness around the lung bronchioles after Ova-allergen challenge further confirmed the protective role of MNs-CIT. Overall, MNs-CIT represents a novel minimally invasive cutaneous immunotherapy to prevent the progression of Ova induced airway allergy in mice.

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Treating severe allergic asthma with anti-IgE monoclonal antibody (omalizumab): a review

Cited by 67 publications

References 54 publications

Omalizumab Is Equally Effective in Persistent Allergic Oral Corticosteroid-Dependent Asthma Caused by Either Seasonal or Perennial Allergens: A Pilot Study

Omalizumab Is Equally Effective in Persistent Allergic Oral Corticosteroid-Dependent Asthma Caused by Either Seasonal or Perennial Allergens: A Pilot Study

‘Real-life’ effectiveness studies of omalizumab in adult patients with severe allergic asthma: systematic review

Cutaneous vaccination with coated microneedles prevents development of airway allergy

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