Efficacy at Steroid Stable Phase (16 Weeks)

Add XOLAIR to Inhaled Corticosteroids (ICS) to Reduce Asthma Exacerbations*2

Significantly fewer asthma exacerbations in the steroid-stable phase at 16 weeks*2

XOLAIR, inhaled corticosteroids and asthma exacerbations

See the study designs

Patients treated with XOLAIR and inhaled corticosteroids experienced significantly fewer asthma exacerbations, even as ICS dose is lowered2

Percentage of patients with asthma exacerbations

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In Studies 1 and 2, reductions in asthma exacerbations were not seen in patients who had FEV1 >80% at the time of randomization or in patients who required oral steroids as maintenance therapy.2

The primary efficacy end point of Study 3 was to demonstrate a reduction in ICS use in subjects with severe IgE-mediated asthma receiving high-dose ICS therapy and no oral corticosteroid therapy following treatment with XOLAIR compared with placebo.8

  • In the steroid-stable phase of Study 3, the number of exacerbations in patients treated with XOLAIR was similar to that in placebo-treated patients2
    • 15.9% of patients receiving ICS experienced >1 exacerbation with XOLAIR versus 15.0% with placebo (difference of 0.9% with 95% confidence interval [–9.7, 13.7])
    • 32.0% of patients receiving ICS + oral steroids experienced >1 exacerbation with XOLAIR versus 22.2% with placebo (difference of 9.8% with 95% confidence interval [–10.5, 31.4])
  • In the steroid-reduction phase of this study, the number of exacerbations in patients treated with XOLAIR was similar to that in placebo-treated patients2
    • 22.2% of patients receiving ICS experienced >1 exacerbation with XOLAIR versus 26.7% with placebo (difference of –4.4% with 95% confidence interval [–17.6, 7.4])
    • 42.0% of patients receiving ICS + oral steroids experienced >1 exacerbation with XOLAIR versus 42.2% with placebo (difference of –0.2% with 95% confidence interval [–22.4, 20.1])

*An asthma exacerbation was defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of the subject's baseline BDP dose.
†Beclomethasone dipropionate.

INDICATION
XOLAIR® (omalizumab) for subcutaneous use IS INDICATED FOR adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients.

Important Limitations of Use
XOLAIR is not indicated for treatment of other allergic conditions
XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus
XOLAIR is not indicated for use in pediatric patients less than 12 years of age

IMPORTANT SAFETY INFORMATION

WARNING: Anaphylaxis

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after XOLAIR administration. Healthcare providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur (see Warnings and Precautions: Anaphylaxis).

XOLAIR should only be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening.
XOLAIR should not be administered to patients who have experienced a severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR (see Warnings and Precautions). XOLAIR should be discontinued in patients who experience a severe hypersensitivity reaction.
Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other allergic disorders.
XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus.
Patients should be given and instructed to read the accompanying Medication Guide before starting treatment and before each subsequent treatment.
Do not abruptly discontinue corticosteroid use upon initiation of XOLAIR therapy. Decrease corticosteroids gradually under the direct supervision of a physician.
In patients >12 years of age, the most commonly observed adverse reactions (>1% more frequent in XOLAIR-treated patients) from 4 placebo-controlled asthma studies were arthralgia (8%), pain (general) (7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%).
The adverse events most frequently resulting in clinical intervention (eg, discontinuation of XOLAIR, or the need for concomitant medication to treat an adverse event), in either placebo-controlled or other controlled asthma studies, were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in XOLAIR-treated patients and control patients.

 
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Allergic Asthma Facts
How many exacerbations requiring oral corticosteroid bursts per year may be a sign of uncontrolled asthma?
>1
>2
>3