Clinical experience with Omalizumab in a Portuguese severe asthma unit

Alfarroba, Sara; Videira, Wanda; Galvão‐Lucas, C.; Carvalho, Fernandes de; Bárbara, Cristina

doi:10.1016/j.rppnen.2014.01.001

Cited by 10 publications

(16 citation statements)

References 8 publications

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“…Korn et al (41) identified an age-related reduction in daytime symptoms of À67.8% in patients over age 50 and À79.3% in patients under age of 50. Similarly, the proportion of patients suffering night-time symptoms on a weekly basis decreased by up to À72% over the first 16 weeks (29), between À84% (29) and À51.1% (45) over the first six months of treatment, extending to À72.9% over 1 year and to À90.3% over 2 years (45). Also, Korn et al (41) identified age-related reduction in night-time symptoms of À66% in patients over age of 50 and À77% in patients under age 50.…”

Section: Effectiveness: Clinical Outcomesmentioning

confidence: 94%

“…There was a trend to focus on 16 weeks (28, 29, 34, 35, 37, 39-42, 44, 50) and 1 year (28,31,34,35,39,40,44,45,50), yet several studies followed patients up to two (35,40,44,45) and 4 years (34) after start of omalizumab therapy.…”

Section: Study Designsmentioning

confidence: 99%

“…Other anti-asthmatic treatments, both prior to and after start of omalizumab treatment, were included in twelve of these studies (28, 30-33, 35, 37, 42, 44, 45, 48, 49). The most common clinical outcome, included in 14 studies, was FEV1 (28,32,34,35,37,39,42,43,(45)(46)(47)(48)(49)(50). Fewer studies reported on other objective (32,34,39,46,49,50) and subjective (29,41) (37,42,50)), and work or school days lost due to asthma (29,32,37,44).…”

Section: Study Designsmentioning

confidence: 99%

“…Hence, the majority of patients can be estimated to have ranged from about 25 to 70 years of age -covering the predominant adult population. There was a slight preponderance of female patients: there were proportionately more women in 20 of the 23 studies reporting gender distribution (27)(28)(29)(30)(31)(32)(33)(34)(35)(37)(38)(39)(40)(41)(42)(43)(44)(45)(46)(47)(48)(49)(50). The majority of patients weighed between 66 kg (44) and 81 kg (45) Omalizumab candidates presented with marked one-year histories of severe exacerbations.…”

Section: Patientsmentioning

confidence: 99%

“…The majority of patients weighed between 66 kg (44) and 81 kg (45) Omalizumab candidates presented with marked one-year histories of severe exacerbations. Proportions of patients having experienced at least one exacerbation ranged from 88.5% (31) to all patients (42,45), averaging between 0.9 and 7.5 exacerbations per patient in the year prior to omalizumab treatment. As many as 96.1% and 86.4% of patients experienced, respectively, daytime symptoms on a daily-and night-time symptoms on a weekly basis (29), confirmed also by the elevated ACT scores reported in several other studies (34, 35, 44-46, 48, 49) The proportion of patients who lost at least 1 day of school or work in the preceding year reached as high as 76.4% (41).…”

Section: Patientsmentioning

confidence: 99%

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‘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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