Prescribing information

 

Summary of the key efficacy, quality of life and safety data for Xolair in SAA.

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There’s more to Xolair than you think

 


 

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

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

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Works regardless of eosinophil levels4

 


Quality of life

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Xolair demonstrates a 49% improvement in QoL vs placebo¶2

(absolute difference in overall AQLQ score=0.45)

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Xolair doubles the number of symptom-free days vs placebo (ARR=23.2%)**5

 

 


Confidence

 

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Xolair has been on the market for 15 years in the EU6

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1.3 million patient years of experience globally7

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An established safety profile including data in pregnancy regardless6

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 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

A multicentre, mixed methodology study assessing the real-life effectiveness of Xolair in 258 patients (aged ≥16 years) with severe persistent allergic asthma.3

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.8
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.
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.
**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).

Indication6: 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; ARR, absolute rate reduction; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; IgE, immunoglobulin E; LABA, long-acting beta2-agonist; OCS, oral corticosteroids; PEF, peak expiratory flow; 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. Humbert M et al. Allergy 2008;63(5):592–596.
  6. Xolair® (omalizumab) Summary of Product Characteristics.
  7. Novartis data on file. Periodic Safety Update Report (PSUR) 2019.
  8. Braunstahl GJ et al. Resp Med 2013;107(8):1141–1151.
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XSA20-C012 July 2020.
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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