
	XOLAIR^® Co-Pay Card Program

	Learn more about the program


	Physician Locator

	Help connect your patients to local physicians

Clinical Study Design

Clinical Study Design²^,6^,7

A large, multicenter, double-blind trial enrolled patients who were symptomatic despite treatment with inhaled corticosteroids (ICS). Eligible patients were randomly allocated to receive subcutaneous omalizumab or matching placebo every 2 or 4 weeks (at least 0.016 mg/kg/IgE [IU/mL] every 4 weeks), and during the first 16 weeks of the study, they were switched to the equivalent doses of inhaled Beclomethasone dipropionate (BDP) (via metered-dose inhaler) to maintain asthma control. The dose of BDP was kept constant during this period (steroid-stable phase), after which patients entered a 12-week steroid-reduction phase whereupon the dose of BDP was reduced by 25% of the baseline dose every 2 weeks for 8 weeks. The lowest dose of BDP required for asthma control was subsequently maintained for the final 4 weeks of the study. Treatment with omalizumab or placebo continued throughout the steroid-reduction phase. With the exception of BDP and inhaled beta-agonist rescue medication (albuterol,100 μg/puff), no other asthma medication was allowed.

Patients completing the core study were eligible to enter a 24-week, double-blind extension phase in which they were maintained on randomized treatment (omalizumab or placebo) and the lowest effective dose of BDP.⁶^,7 The use of concomitant medication was liberalized during the extension phase so that investigators could treat patients with any asthma medication they considered necessary, including switching to other ICS.

An asthma exacerbation was defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline BDP dose.

The safety and efficacy of XOLAIR were evaluated in 3 randomized, double-blind, placebo-controlled, multicenter trials.

XOLAIR was compared with placebo in 1071 patients aged 12 to 75 years

After a 4-week to 6-week run-in period to establish a stable baseline BDP dose, patients were randomized to receive XOLAIR or placebo in 2 study phases.⁷

Steroid-stable phase (16 weeks)
Patients received XOLAIR or placebo via subcutaneous injection every 2 or 4 weeks. Baseline BDP dose remained unchanged except for treatment of acute exacerbations.^2,⁶

Steroid-reduction phase (12 weeks)
Patients continued to receive XOLAIR or placebo and a BDP dose reduction was attempted over 8 weeks (forced reduction of 25% every 2 weeks) until discontinuation or worsening of asthma symptoms. If worsening of asthma symptoms occurred, BDP dose was increased. The minimum effective BDP dose that did not result in worsening of asthma symptoms was maintained for the remaining 4 weeks of the study.^2,^6,⁷

Extension phase (24 weeks)
During the extension phase, patients were maintained on randomized treatment (XOLAIR or placebo) and the lowest sustainable dose of BDP. The use of other asthma medications was permitted during the extension phase. Investigators were also allowed to switch patients from BDP to other ICS medications if considered necessary.^6,⁷

Dosage and dropout information⁵

The following chart provides a summary of baseline and end-of-study BDP as well as dropout rates for Studies 1, 2, and the extension phase.

Clinical Study 3

XOLAIR was compared with placebo in 341 patients aged 12 to 75 years^5,⁸

The protocol was similar to the protocols in Studies 1 and 2, except for the following:

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

Number of exacerbations was a secondary end point
Patients were not excluded based on FEV₁ at baseline²
Total asthma symptom score <4 out of a possible 9⁵
Long-acting beta-agonists were allowed
Patients received >1000 μg of fluticasone propionate per day instead of BDP
A subset of patients also received oral corticosteroids
The steroid-reduction phase lasted for 16 weeks instead of 12 weeks; in the oral corticosteroid subset, oral corticosteroid reduction was attempted during this phase^5,⁸
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])

Study 3 differed from Studies 1 and 2 in that patients received fluticasone propionate instead of BDP, long-acting beta-agonists were allowed, and a subset of patients also received oral corticosteroids⁸
The absence of an observed treatment effect in Study 3 may be related to differences in the patient population compared with Studies 1 and 2, study sample size, or other factors⁸

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. Health care 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.

		A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of XOLAIR in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.

		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 (e.g. 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.

Please see accompanying full Prescribing Information, including Boxed WARNING and Medication Guide, for additional important safety information.
Important Safety Information | Prescribing Information | Contact Us | Site Map | For Patients

| | Copyright Language

© 2013 Genentech USA, Inc. and Novartis Pharmaceuticals Corporation. All rights reserved.
Terms and Conditions | Privacy Policy | Free Adobe Reader | References

This Web site is a service of Genentech USA, Inc. and Novartis Pharmaceuticals Corporation
and is intended for U.S. Healthcare Professionals only. XOL0001012903

	E-mail This Page

	Share this information with colleagues
	To send this link to another healthcare professional, please fill out the form below.

	*Fields marked with an asterisk are required.

	*Recipient's e-mail:

	*Recipient's name:

	*Your e-mail:

	*Your name:

Clinical Study Design

Clinical Study Design²^,6^,7

XOLAIR was compared with placebo in 1071 patients aged 12 to 75 years

Dosage and dropout information⁵

Clinical Study 3

XOLAIR was compared with placebo in 341 patients aged 12 to 75 years^5,⁸

IMPORTANT SAFETY INFORMATION

Disclaimer

E-mail This Page

Share this information with colleagues

E-mail Thank-You Page

Thank you for sharing with a colleague

Copyright

Forgot Your Password?

We’ve got you covered.

Forgot Your Password?

We've got you covered.

Forgot Which E-Mail
Address We Have On File?

Forgot Which E-Mail
Address We Have On File?

Your e-mail address on file is:

E-Mail This Page

Share this information with colleagues.

Thank you for sharing with a colleague

DEACTIVATE YOUR ACCOUNT

TERMS AND CONDITIONS


	Copyright

	Genentech USA, Inc., hereby authorizes you to copy documents or pages published by Genentech USA, Inc., on this Web site for your non-commercial use only, provided any copy of these documents that you make retains all copyright or other proprietary notices and any disclaimer contained thereon. This publication is provided "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO THAT ABOVE EXCLUSION MAY NOT APPLY TO YOU.

Clinical Study Design

Clinical Study Design2,6,7

XOLAIR was compared with placebo in 1071 patients aged 12 to 75 years

Dosage and dropout information5

Clinical Study 3

XOLAIR was compared with placebo in 341 patients aged 12 to 75 years5,8

IMPORTANT SAFETY INFORMATION

Disclaimer

E-mail This Page

Share this information with colleagues

E-mail Thank-You Page

Thank you for sharing with a colleague

Copyright

Log In

Forgot Your Password?

We’ve got you covered.

Forgot Your Password?

We've got you covered.

Forgot Which E-Mail Address We Have On File?

Forgot Which E-Mail Address We Have On File?

Your e-mail address on file is:

E-Mail This Page

Share this information with colleagues.

Thank you for sharing with a colleague

DEACTIVATE YOUR ACCOUNT

TERMS AND CONDITIONS

Clinical Study Design²^,6^,7

Dosage and dropout information⁵

XOLAIR was compared with placebo in 341 patients aged 12 to 75 years^5,⁸

Forgot Which E-Mail
Address We Have On File?

Forgot Which E-Mail
Address We Have On File?