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