Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients

Siergiejko, Zenon; Świebocka, Ewa; Smith, Nicola J.; Peckitt, Clare; Leo, Jo; Peachey, Guy; Maykut, Robert

doi:10.1185/03007995.2011.620950

Cited by 72 publications

(57 citation statements)

References 16 publications

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“…As an add-on treatment, omalizumab has been shown to improve long-term asthma control and lung function, and reduce the use of corticosteroids, rescue medication and frequency of exacerbations in patients with persistent allergic asthma [6][7][8]. Supporting the results from clinical studies, real-world studies conducted in various European countries also reported improvement in asthma control and quality of life of patients after treatment with omalizumab [9][10][11][12].…”

Section: Introductionsupporting

confidence: 64%

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Kirchnerová¹,

Valena²,

Novosad³

et al. 2019

pdia

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A b s t r a c tIntroduction: This was a sub-group analysis of patients with uncontrolled persistent allergic asthma (AA) in the healthcare setting of the Czech Republic, from a global non-interventional, 2-year post-marketing, observational eXpeRience registry. Aim: To evaluate the real-life effectiveness and safety of omalizumab. Material and methods: Patients with uncontrolled persistent AA (currently defined by the Global Initiative for Asthma (GINA) as uncontrolled severe AA) who started omalizumab treatment 15 weeks before inclusion in the registry were analysed for physicians' global evaluation of treatment effectiveness (GETE), asthma symptoms, corticosteroid use, exacerbation rate, asthma control, quality of life, healthcare utilisation and safety during a 24-month observation period. Results: One hundred and fourteen patients from the Czech Republic were enrolled in the eXpeRience registry. A total of 88.9% of the patients were evaluated as responders to omalizumab according to the GETE assessment at week 16. From baseline to month 24: mean change in forced expiratory volume in 1 s (FEV 1 ) was 137 ml and the daily dose of OCS decreased (11.6 mg to 6.4 mg prednisolone equivalent); the percentage of patients with no severe clinically significant exacerbations increased (29.5% to 95.1%); Asthma Control Test scores improved (12.4 to 17.3) and mean total number of days of asthma-related medical healthcare use decreased (6.8 days to 0.4 days). Conclusions: The results of this subgroup analysis support the evidence that add-on omalizumab therapy is effective and well tolerated for management of patients with uncontrolled persistent AA in the Czech Republic. Global evaluation of treatment effectiveness assessment is a reliable predictor of long-term response to omalizumab treatment.

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Section: Introductionsupporting

confidence: 64%

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Kirchnerová¹,

Valena²,

Novosad³

et al. 2019

pdia

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“…However, such use is associated with serious long-term adverse effects such as hypothalamic-pituitary-adrenal axis suppression, impaired glucose tolerance and diabetes, osteoporosis, hypertension, and cataract formation. There is therefore a need for therapies that improve outcomes, have acceptable safety and tolerability profiles, while allowing reductions in OCS use [12]. …”

Section: Discussionmentioning

confidence: 99%

“…Omalizumab has been shown to reduce asthma exacerbations and hospital visits, as well as corticosteroid use, in patients with allergic asthma [9-11]. Omalizumab has also been shown to have a direct OCS-sparing effect in a 32-week randomized, open-label study in adolescents and adults (12–75 years) with severe asthma [12], as well as in a 16-week uncontrolled therapeutic trial in children (median age 12 years) [13]. …”

Section: Introductionmentioning

confidence: 99%

Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting

Braunstahl

Chlumský

Peachey

et al. 2013

All Asth Clin Immun

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BackgroundOral corticosteroids (OCS) are commonly administered in patients with severe persistent allergic asthma. Despite their efficacy, they are associated with a wide variety of adverse events. The eXpeRience registry was set up to investigate real-world outcomes among patients receiving omalizumab for the treatment of uncontrolled allergic asthma. Here, we present the effect of omalizumab treatment on OCS use.MethodseXpeRience was a 2-year, multinational, non-interventional, observational registry of patients receiving omalizumab for uncontrolled allergic asthma. OCS use (proportion of patients on maintenance OCS, mean total daily OCS dose and change in status of OCS therapy) was assessed at baseline, 16 weeks, and 8, 12, 18, and 24 months after the initiation of omalizumab. Response to omalizumab was assessed using the physician’s Global Evaluation of Treatment Effectiveness (GETE) at approximately Week 16. Safety data were also recorded.ResultsA total of 943 patients (mean age, 45 years; female, 64.9%) were enrolled in the registry, 263 of whom were receiving maintenance OCS at baseline. The proportion of patients taking maintenance OCS was markedly lower at Months 12 (16.1%) and 24 (14.2%) than at baseline (28.6%; intent-to-treat population). GETE status was determined in 915 patients receiving omalizumab: 64.2% were responders (excellent or good response), 30.7% were non-responders (moderate, poor or worsening response); 5.1% had no assessment. The frequency of serious adverse events was comparable to that seen in controlled trials of omalizumab.ConclusionsOmalizumab use is associated with an OCS-sparing effect in patients with uncontrolled persistent allergic asthma in the real-world setting.

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“…In inner-city US children, adolescents, and young adults with persistent allergic asthma the presence of sensitization and exposure to cockroach allergen predicted a very good response to omalizumab 36. It has been reported that patients receiving long-term oral corticosteroids or frequent courses of oral corticosteroids respond poorly to omalizumab,34 although there is some limited evidence to support an oral corticosteroid sparing effect of omalizumab 65. An open-label study of 82 patients with severe allergic asthma, found the addition of omalizumab therapy resulted in lower mean (SD) percent maintenance oral corticosteroid use after 32 weeks of treatment (−45.0%) compared with that in 23 patients who received usual care (18.3%) 65…”

Section: Assessment Of Therapeutic Responsementioning

confidence: 99%

Omalizumab: Clinical Use for the Management of Asthma

Thomson

Chaudhuri

2012

Clin Med Insights Circ Respir Pulm Med

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Omalizumab, a humanized monoclonal antibody that binds circulating IgE antibody, is a treatment option for patients with moderate to severe allergic asthma whose asthma is poorly controlled with inhaled corticosteroids and inhaled long-acting β2 agonist bronchodilators. This review considers the mechanism of action, pharmacokinetics, efficacy, safety and place in management of omalizumab in asthma and focuses particularly on key articles published over the last three years. Omalizumab reduces IgE mediated airway inflammation and its effect on airway remodeling is under investigation. Recent long-term clinical trials confirm the benefits of omalizumab in reducing exacerbations and symptoms in adults and in children with moderate to severe allergic asthma. No clinical or immunological factor consistently predicts a good therapeutic response to omalizumab in allergic asthma. In responders, the duration of treatment is unclear. The main adverse effect of omalizumab is anaphylaxis, although this occurs infrequently. Preliminary data from a five-year safety study has raised concerns about increased cardiovascular events and a final report is awaited. Clinical trials are in progress to determine whether omalizumab has efficacy in the treatment of non-allergic asthma.

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Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients

Abstract: In this open-label study of patients with severe allergic asthma, OMA/OAT therapy reduced maintenance OCS use, compared with OAT alone. Improvements in efficacy measures were observed in the OMA/OAT group, irrespective of OCS change. CLINICALTRIALS.GOV IDENTIFIER: NCT00264849.

Cited by 72 publications

References 16 publications

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting

Omalizumab: Clinical Use for the Management of Asthma

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