Prescribing information

 

Key quality of life data for Xolair in SAA.

 

Quality of life

 

 

Xolair demonstrates a 49% improvement in QoL vs placebo†1

(absolute difference in overall AQLQ score=0.45)

 

Xolair doubles the number of symptom-free days vs placebo (ARR=23.2%)‡2

 

 

Think improved quality of life for your patients

Xolair has demonstrated1:

  • 49% overall improvement in quality of life vs placebo     
    • LSM AQLQ score for overall quality of life at week 28: 0.91 with Xolair, 0.46 with placebo (p<0.001)
  • 56% increase in AQLQ symptom domain score vs placebo     
    • LSM AQLQ score for symptoms domain at week 28: 0.90 with Xolair, 0.40 with placebo (p<0.001)

Think double the number of symptom-free days

Xolair responders experience double the number of symptom-free days vs patients on placebo.‡2

 

Graph showing the number of symptom-free days in patients who received Xolair, Xolair responders and patients who received placebo in a post hoc analysis of INNOVATE

Adapted from Humbert M et al. 2008.2

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.2

Primary endpoint2:

  • 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 included2:

  • 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

 

*Xolair provides clinically meaningful improvements in quality of life for patients with severe allergic asthma.3

Data from INNOVATE, 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. Chart shows effect of treatment (change from baseline) at endpoint (week 28 or discontinuation) in the PITT population.

During the last observed interval, weeks 26–28. Data from a post hoc analysis of INNOVATE in the Xolair responder group n=118 vs placebo group n=210 (responses assessed at week 28). INNOVATE was 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.

Indication4: Xolair should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma. In adults and adolescents (12 years of age and older): Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. In children (6 to <12 years of age): Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

AQLQ, Asthma Quality of Life Questionnaire; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroids; IgE, immunoglobulin E; LABA, long-acting beta2-agonist; LSM, least squares mean; PEF, peak expiratory flow; PITT, primary intent-to-treat; SAA, severe allergic asthma.

References

  1. Humbert M et al. Allergy 2005;60(3):309–316.
  2. Humbert M et al. Allergy 2008;63(5):592–596.
  3. Braunstahl GJ et al. Resp Med 2013;107(8):1141–1151.
  4. Xolair® (omalizumab) Summary of Product Characteristics.
XSA20-C015 July 2020.
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