Prescribing information

 

Key efficacy, quality of life and safety data for Xolair in SAA.

Think sustained exacerbation reduction

Xolair can result in a 70% reduction in exacerbations, even at 4 years.1

 

Efficacy

 

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Xolair can result in a 70% reduction in exacerbations, even at 4 years†1

(Real-world data. In the INNOVATE RCT, 83.2% of patients were free from severe exacerbations over 28 weeks vs 73.8% of placebo patients [n=419, p=0.002]. In the same trial, a 26% reduction in clinically significant asthma exacerbations was achieved with Xolair vs placebo during the 28-week treatment phase p=0.042; ARR = 0.23 events per treatment period)2

 

 

 

Xolair has a response rate of up to 82.4%§3

 

Works regardless of eosinophil levels4

 

 

Timeline showing exacerbation reduction data with Xolair at 16 weeks, 28 weeks, 52 weeks and 4 years

of patients were free from severe exacerbations

Results over 16 weeks of treatment in a real-world study (n=132)5

of patients were free from severe exacerbations over 28 weeks

vs 73.8% of placebo patients (n=419, p=0.002)2

reduction in the rate of asthma exacerbations during the 12 months post Xolair initiation

Reduction in the rate of asthma exacerbations (ARR=1.0 events/year, n=258)3

reduction in severe asthma exacerbations

Reduction from 2.27 at baseline to 0.66 at 4 years (n=60, p<0.0001)1

In INNOVATE, the primary endpoint was the rate of clinically significant asthma exacerbations** during the 28-week double-blind treatment phase. The primary endpoint was met in the PITT population after adjustment for baseline exacerbation history (0.68 with Xolair and 0.91 with placebo; rate ratio 0.738 [95% CI: 0.552–0.998]; p=0.042). In the primary analysis not accounting for previous exacerbations, the treatment group difference was of a similar magnitude but failed to reached statistical significance (rate ratio 0.806; p=0.153).2

 

Think rapid response rates in your patients

Xolair showed response rates of up to 82.4% as early as week 16 in a real-world study.5

 

 

REAL-WORLD PERSIST, a prospective, open-label, observational study (n=153)5

 

At week 16, 82.4% of patients had good or excellent GETE ratings. 5
 

 

RCT INNOVATE, a randomised, placebo-controlled, double-blind study (n=419)2

 

At week 28, 60.5% of patients had good or excellent GETE ratings vs 42.8% of placebo patients (p<0.001) 2
 
 

Think effectiveness regardless of patient eosinophil levels

Xolair is effective in IgE-mediated asthma regardless of eosinophil levels.4
 

The retrospective STELLAIR study demonstrates Xolair’s effectiveness for severe persistent allergic asthma regardless of blood eosinophil count, which exceeded 300 cells/μl in a large proportion of patients.4

 

Combined responders of Xolair in adults according to the distribution of blood eosinophil count in the whole population. 4

Adapted from Humbert M et al. 2018.4

 

Think oral corticosteroid reduction

In a real-world study, Xolair reduced the burden of OCS on patients. Within a year of Xolair initiation, patients requiring continuous OCS treatment were able to3:

  • Stop OCS use completely (15.8% of patients)
  • Reduce their OCS use by 20% (42.1% of patients)

A 4-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.1

Endpoints1:

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 emergency room visit, or was hospitalised for the exacerbation)

•    Level of asthma control

•    Daily dose of ICS

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 LABA5.

Primary objectives5:

  • 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 required2.

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

A multicentre, mixed methodology study assessing the real-life effectiveness of Xolair in 258 patients (aged ≥16 years) with severe persistent allergic asthma3.

Primary endpoint3:

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

Secondary endpoints included3:

  • 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

 

*Xolair provides clinically meaningful improvements in quality of life for patients with severe allergic asthma.6
Data from a non-interventional, observational study of 60 patients with severe persistent asthma receiving treatment with Xolair.
Severe exacerbations were defined as: PEF or FEV1 <60% of personal best, requiring treatment with systemic corticosteroid.
§Data from APEX II, a non-interventional, mixed methodology study of 258 patients aged 16 years with severe persistent allergic asthma, combining retrospective and prospective data collection for 12 months pre- and post-Xolair initiation, respectively.
Severe exacerbations were defined as: exacerbations during which the patient required a systemic corticosteroid, or an emergency room visit or hospitalisation for the exacerbation.
**Clinically significant exacerbations were defined as a worsening of asthma symptoms requiring treatment with systemic corticosteroids.

Indication7: 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.

A&E, accident and emergency; AQLQ, Asthma Quality of Life Questionnaire; ARR, absolute rate reduction; EQ-5D, European quality of life questionnaire 5 dimensions; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GETE, physician-rated global evaluation of treatment effectiveness; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; IgE, immunoglobulin E; ITT, intent-to-treat; LABA, long-acting beta2-agonist; OCS, oral corticosteroids; PEF, peak expiratory flow; PITT, primary intent-to-treat; QoL, quality of life; RCT, randomised controlled trial; SAA, severe allergic asthma.

References

  1. Tzortzaki E et al. Pulm Pharmacol Ther 2012;25(1):77–82.
  2. Humbert M et al. Allergy 2005;60(3):309–316.
  3. Niven RM et al. BMJ Open 2016;6:e011857.
  4. Humbert M et al. Eur Respir J 2018;51(5):1702523.
  5. Brusselle G et al. Respir Med 2009;103(11):1633–1642.
  6. Braunstahl GJ et al. Resp Med 2013;107(8):1141–1151.
  7. Xolair® (omalizumab) Summary of Product Characteristics.
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XSA20-C014 July 2020.
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