A prospective, open-label, observational, multicentre 52-week study in 158 patients (aged ≥12 years) with severe persistent allergic asthma despite treatment with an ICS and a LABA.

Primary objectives:

• Describe the patients who, in the treating physician’s best clinical judgement, were being treated with Xolair

• Determine the 16- and 52-week effectiveness of Xolair as an add-on therapy by measuring the proportion of patients:

  • improving in 2005 GINA classification

  • with good/excellent GETE rating

  • achieving ≥0.5 point improvement in total AQLQ score

  • severe exacerbation-free (severe exacerbation defined as exacerbation during which the patient required a systemic corticosteroid, or emergency room visit or hospitalisation for the exacerbation

  • improving in EQ-5D utility (52 weeks only)

• Describe the treatment patterns involving add-on Xolair treatment

• Describe the safety and tolerability of treatment with Xolair when used in a pragmatic trial

A randomised, multicentre, placebo-controlled, double-blind, parallel-group study in 419 patients (aged 12–75 years) with severe persistent allergic asthma who were inadequately controlled despite treatment with a high-dose ICS plus LABA, and additional controller medication if required.

The primary efficacy variable analysis included a post-hoc adjustment for baseline exacerbation history. After adjustment for the primary ITT population, the clinically significant asthma exacerbation rate showed a statistically significant between-group difference (0.68 with Xolair vs 0.91 with placebo; p=0.042).

Primary endpoint:

• Rate of clinically significant asthma exacerbations (defined as a worsening of asthma symptoms requiring treatment with systemic corticosteroids) during the 28-week double-blind treatment phase

Secondary endpoints included:

• Severe exacerbation rate (severe exacerbation defined as PEF or FEV₁ <60% of personal best, requiring treatment with systemic corticosteroids)

• Rate of hospitalisation, emergency room visits, and unscheduled doctor’s visits for exacerbations

• Symptoms, morning PEF, rescue medication use and FEV₁

• Quality of life at weeks 0, 12 and 28 of the treatment phase (assessed using AQLQ)

• Treatment effectiveness at treatment end

Observational, retrospective, mixed-methodology study assessing the real-life effectiveness of Xolair in 258 patients (aged ≥16 years) with severe persistent allergic asthma.

Primary endpoint:

Change in mean daily dose of OCS prescribed per patient between the 12-month pre-Xolair and post-Xolair initiation periods

Secondary endpoints included:

• Proportion of patients stopping and/or reducing OCS by ≥20%

• Exacerbation rate (exacerbations requiring either hospitalisation or increase in OCS dose ≥10 mg at any point for at least 3 days)

• Hospital resource use

• Lung function

• Patient-reported outcomes

Four-year non-interventional, retrospective, observational, multicentre study in 60 patients (aged ≥12 years) with poorly controlled severe persistent allergic asthma despite treatment with a high-dose ICS and a LABA according to the GINA guidelines.

Endpoints:

Effectiveness of Xolair, at 4 months, 1 year and 4 years, as add-on therapy in relation to:

• Lung function (FEV₁ and FVC)

• Number of severe exacerbations (patient required a systemic corticosteroid, required an ER visit or was hospitalised for the exacerbation)

• Level of asthma control

• Daily dose of ICS

A multicentre, non-interventional, retrospective, observational study using data from medicinal records of of 872 patients with SAA treated with Xolair.

Primary endpoint:

• Response to Xolair at T4–6 compared with T–12 using GETE, ≥40% reduction in annual exacerbation rate and a combined response of both

• Response was analysed according to blood eosinophil count (cells/µL) measured in the year prior to Xolair initiation.