Xolair in SAA: summary

There’s more to Xolair than you think

Efficacy

 

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

Quality of life

 

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

(absolute difference in overall AQLQ score=0.45)

 

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

Confidence

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

1.3 million patient years of experience globally⁷

An established safety profile including data in pregnancy regardless⁶

*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.