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Prescribing Information

For Patients and Caregivers

Contact a Rep Contact a Rep INSTRUCTIONS FOR USE Instructions for Use
Prescribing Information Prescribing Information Safety Safety

MENU

   
 * Allergic Asthma
    * When to Consider XOLAIR
    * Efficacy & Safety for XOLAIR
    * Pregnancy Registry Data

 * Chronic Spontaneous Urticaria
    * When to Consider XOLAIR
    * Efficacy & Safety for XOLAIR

 * Nasal Polyps
 * Dosing and Administration
    * Dosing
    * Preparation & Administration

 * Access and Resources
    * Patient Support & Resources
    * Financial Assistance

   

CONTACT A REP Instructions for Use Safety
For Patients and Caregivers


ALLERGIC ASTHMA TRIALS—XOLAIR EFFICACY & SAFETY PROFILE

XOLAIR has been shown to significantly reduce exacerbations in appropriate
allergic asthma patients uncontrolled on inhaled corticosteroids (ICS).1

Multiple clinical studies were done to analyze the efficacy and safety of XOLAIR
in 2 patient populations:

 1. Adolescent and adult patients aged ≥12 years. See data.
 2. Pediatric patients aged 6 to <12 years. See data.

See additional information for patient baseline characteristics. Please see full
safety information. 

Adolescent & Adult Study Results (≥12 Years) Pediatric Study Results (6 to <12
Years) Patient Baseline Characteristics
Adolescent & Adult Study Results (≥12 Years)


XOLAIR CLINICAL STUDIES IN ADOLESCENT AND ADULT PATIENTS AGED ≥12 YEARS


RESULTS FOR STUDIES 1 AND 2

TWO PIVOTAL STUDIES IN MODERATE TO SEVERE ASTHMA CONFIRMED XOLAIR SIGNIFICANTLY
REDUCED EXACERBATIONS



Study design for Studies 1 and 2: Identical 28-week, randomized, double-blind,
placebo-controlled studies evaluating the number of exacerbations in a total of
1071 patients aged 12 to 76 years with moderate to severe persistent allergic
asthma who were symptomatic despite ICS treatment.1,6,7

Patients received XOLAIR or placebo every 2 or 4 weeks for 16 weeks with an
unchanged BDP dose unless an acute exacerbation necessitated an increase.
Patients then entered a 12-week ICS-reduction phase during which ICS dose
reduction was attempted in a stepwise manner.1,6

Primary endpoint: number of exacerbations.1,6

 

MORE XOLAIR PATIENTS HAD ZERO EXACERBATIONS1*




XOLAIR REDUCED EXACERBATIONS TO ZERO IN THE MAJORITY OF ALLERGIC ASTHMA PATIENTS
STUDIED. WHAT COULD IT DO FOR YOURS?

 

SIGNIFICANTLY FEWER PATIENTS HAD ≥1 EXACERBATION(S) WITH XOLAIR1§






RESULTS FROM STUDY 3:

Study design for Study 3: A 32-week, randomized, double-blind,
placebo-controlled study designed to evaluate ICS reduction in 341 patients aged
12 to 76 years with severe allergic asthma. Exacerbation reduction was also
evaluated as a secondary endpoint; however, this study was not powered to show
statistical differences in exacerbation reduction.1

 * Unlike in Studies 1 and 2, there was no restriction on screening FEV1, and
   LABAs were allowed1
 * Patients were receiving ≥1000 μg/d ICS (fluticasone), and a subset was also
   receiving OCS1  
   * No reductions in exacerbations were seen in patients who required oral
     steroids as maintenance therapy1

 

Exacerbation was defined as a worsening of asthma that required treatment with
systemic corticosteroids or a doubling of the patient’s baseline ICS dose.

Patients were stratified by use of ICS only or ICS with concomitant OCS.
Patients received XOLAIR for 16 weeks with an unchanged corticosteroid dose
unless an acute exacerbation necessitated an increase. Patients then entered a
16-week ICS-reduction phase during which ICS dose reduction was attempted in a
stepwise manner.1,5

PERCENTAGE OF PATIENTS WITH ≥1 EXACERBATION IN STUDY 31

--------------------------------------------------------------------------------

In the ICS-stable phase:

 * 15.9% of patients taking XOLAIR + ICS (n=126) experienced ≥1 exacerbation vs
   15% of those taking placebo + ICS (n=120)
   * Difference of 0.9 (95% CI: -97, 13.7)
 * 32% of patients taking XOLAIR + ICS + OCS (n=50) experienced ≥1 exacerbation
   vs 22.2% of those taking placebo + ICS + OCS (n=45)
   * Difference of 9.8 (95% CI: -10.5, 31.4)

In the ICS-reduction phase:

 * 22.2% of patients taking XOLAIR + ICS (n=126) experienced ≥1 exacerbation vs
   26.7% of those taking placebo + ICS (n=120)
   * Difference of -4.4 (95% CI: -17.6, 7.4)
 * 42% of patients taking XOLAIR + ICS + OCS (n=50) experienced ≥1 exacerbation
   vs 42.2% of those taking placebo + ICS + OCS (n=45)
   * Difference of -0.2 (95% CI: -22.4, 20.1)
 * The number of exacerbations in the XOLAIR group was similar to that in the
   control group
 * The absence of an observed treatment effect may be related to differences in
   patient population compared with Studies 1 and 2, study sample size, or other
   factors
 * A reduction in exacerbations was not observed in XOLAIR-treated patients who
   had a FEV1 >80% predicted at the time of randomization or in patients who
   required OCS as maintenance therapy

--------------------------------------------------------------------------------

CI=confidence interval; FEV1=forced expiratory volume in 1 second;
LABA=long-acting beta2-agonist; OCS=oral corticosteroids.


ADVERSE REACTIONS FROM PLACEBO CONTROLLED TRIALS


ADVERSE REACTIONS FROM PLACEBO CONTROLLED TRIALS


ADVERSE REACTIONS ≥1% MORE FREQUENT IN XOLAIR-TREATED ADULT OR ADOLESCENT
PATIENTS 12 YEARS OF AGE AND OLDER IN PLACEBO-CONTROLLED ASTHMA TRIALS1



There were no differences in the incidence of adverse reactions based on age
(among patients under 65), gender or race.


POST HOC ANALYSES OF POOLED DATA FROM STUDIES 1 AND 2:


EXACERBATION DATA ACROSS PATIENT GROUPS

Limitations of these analyses of pooled data from Studies 1 and 2 include that
they are post hoc (ie, not prespecified) and that the 95% confidence intervals
were calculated within each investigated range of IgE levels, number of positive
allergens, or eosinophil counts, which does not afford the ability to compare
the subgroups to each other directly. These analyses do not allow the inference
of any sort of trend with increasing IgE levels, number of positive allergens,
or eosinophil counts, as no trend tests were performed.5,22

IN ALLERGIC ASTHMA PATIENTS AGED ≥12 YEARS:



SELECT BASELINE CHARACTERISTICS22



In these post hoc analyses, an asthma exacerbation was defined as the worsening
of asthma requiring treatment with oral or intravenous corticosteroids for at
least 3 days (adapted from 2009 American Thoracic Society/European Respiratory
Society).24

BDP=beclomethasone dipropionate; SD=standard deviation; SE=standard error.

Pediatric Study Results (6 to <12 Years)


CLINICAL STUDIES IN PEDIATRIC PATIENTS AGED 6 TO <12 YEARS

XOLAIR IS THE FIRST BIOLOGIC PROVEN TO REDUCE EXACERBATIONS IN PEDIATRIC
PATIENTS WITH ALLERGIC ASTHMA1,25



Study design: A 52-week, multicenter, randomized, double-blind,
placebo-controlled study of 628 patients aged 6 to <12 years with moderate to
severe allergic asthma evaluated XOLAIR as add-on therapy to ICS with or without
additional controller medications. Patients received XOLAIR or placebo every 2
or 4 weeks for 24 weeks during the fixed-steroid treatment phase. Steroid doses
remained constant from baseline unless an acute exacerbation necessitated an
increase. Patients then entered a 28-week period during which steroid adjustment
was allowed.1,25,26

Throughout the study, both groups were allowed to use additional controller
medications, including inhaled and nebulized beta2-agonists and LTRA.25

Primary measure: rate of asthma exacerbations during the 24-week period.1

Exacerbation was defined as a worsening of asthma symptoms requiring doubling of
baseline ICS dose for at least 3 days and/or treatment with rescue systemic
corticosteroids for at least 3 days.1

XOLAIR HAS AN ESTABLISHED SAFETY PROFILE IN OVER 900 PEDIATRIC PATIENTS AGED 6
TO <12 YEARS WITH ALLERGIC ASTHMA IN CLINICAL STUDIES1


Safety data described reflect XOLAIR exposure for 926 patients aged 6 to <12
years, including 583 patients exposed for 6 months and 292 exposed for 1 year or
more, in either placebo-controlled or other controlled studies.1

Patient Baseline Characteristics


SELECT BASELINE CHARACTERISTICS IN ALLERGIC ASTHMA PATIENTS AGED ≥12

BROAD RANGE OF PATIENTS INCLUDED1,5-7




CLINICAL STUDIES IN PEDIATRIC PATIENTS AGED 6 TO <12 YEARS

A BROAD RANGE OF PATIENTS WAS INCLUDED1,5,25




ADD-ON ANTI-IGE (OMALIZUMAB) TREATMENT FOR PATIENTS AGED ≥6 WITH MODERATE TO
SEVERE ALLERGIC ASTHMA THAT IS UNCONTROLLED ON STEP 4-5 TREATMENT.27,28

—Global Initiative for Asthma (GINA), 2021 Guideline Update

IMPORTANT SAFETY INFORMATION

Back to Top

INDICATIONS
XOLAIR® (OMALIZUMAB) IS INDICATED FOR:



 * Adults and pediatric patients 6 years of age and older 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.
   
   Limitations of Use: XOLAIR is not indicated for the relief of acute
   bronchospasm, status asthmaticus, or for treatment of other allergic
   conditions.
   
   
 * Add-on maintenance treatment of nasal polyps in adult patients 18 years of
   age and older with inadequate response to nasal corticosteroids.
   
   
 * Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age
   and older who remain symptomatic despite H1 antihistamine treatment.
   
   Limitations of Use: XOLAIR is not indicated for treatment of other forms of
   urticaria.

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, initiate XOLAIR
therapy in a healthcare setting and closely observe patients for an appropriate
period of time after XOLAIR administration. Health care providers administering
XOLAIR should be prepared to manage anaphylaxis which can be life-threatening.
Inform patients of the signs and symptoms of anaphylaxis and instruct them to
seek immediate medical care should symptoms occur. Selection of patients for
self-administration of XOLAIR should be based on criteria to mitigate risk from
anaphylaxis.

CONTRAINDICATIONS

XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to
XOLAIR or to any ingredient of XOLAIR.

WARNINGS AND PRECAUTIONS

Anaphylaxis
Anaphylaxis has been reported to occur after administration of XOLAIR in
premarketing clinical trials and in postmarketing spontaneous reports. In
premarketing clinical trials in patients with asthma, anaphylaxis was reported
in 3 of 3507 (0.1%) patients. Anaphylaxis occurred with the first dose of XOLAIR
in two patients and with the fourth dose in one patient. The time to onset of
anaphylaxis was 90 minutes after administration in two patients and 2 hours
after administration in one patient.

A case-control study showed that, among XOLAIR users, patients with a history of
anaphylaxis to foods, medications, or other causes were at increased risk of
anaphylaxis associated with XOLAIR, compared to those with no prior history of
anaphylaxis.

In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to
XOLAIR use was estimated to be at least 0.2% of patients based on an estimated
exposure of about 57,300 patients from June 2003 through December 2006.
Approximately 60% to 70% of anaphylaxis cases have been reported to occur within
the first three doses of XOLAIR, with additional cases occurring sporadically
beyond the third dose.

Initiate XOLAIR only in a healthcare setting equipped to manage anaphylaxis
which can be life-threatening. Observe patients closely for an appropriate
period of time after administration of XOLAIR, taking into account the time to
onset of anaphylaxis seen in premarketing clinical trials and postmarketing
spontaneous reports. Inform patients of the signs and symptoms of anaphylaxis,
and instruct them to seek immediate medical care should signs or symptoms occur.

Once XOLAIR therapy has been established, administration of XOLAIR Prefilled
Syringe outside of a healthcare setting by a patient or a caregiver may be
appropriate for selected patients. Patient selection, determined by the
healthcare provider in consultation with the patient, should take into account
the pattern of anaphylaxis events seen in premarketing clinical trials and
postmarketing spontaneous reports, as well as individual patient risk factors
(e.g. prior history of anaphylaxis), ability to recognize signs and symptoms of
anaphylaxis, and ability to perform subcutaneous injections with XOLAIR
Prefilled Syringe with proper technique according to the prescribed dosing
regimen and Instructions for Use.

Discontinue XOLAIR in patients who experience a severe hypersensitivity
reaction.

Malignancy
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 adults
and adolescents (≥12 years of age) with asthma and other allergic disorders. The
observed malignancies in XOLAIR-treated patients were a variety of types, with
breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than
once, and five other types occurring once each. The majority of patients were
observed for less than 1 year. The impact of longer exposure to XOLAIR or use in
patients at higher risk for malignancy (e.g., elderly, current smokers) is not
known.

A subsequent 5-year observational study of 5007 XOLAIR-treated and 2829
non-XOLAIR-treated adolescent and adult patients with moderate to severe
persistent asthma and a positive skin test reaction or in vitro reactivity to a
perennial aeroallergen found that the incidence rates of primary malignancies
(per 1000 patient years) were similar in both groups (12.3 vs 13.0,
respectively). Study limitations which include the observational study design,
the bias introduced by allowing enrollment of patients previously exposed to
XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a
premalignant condition were study exclusion criteria, and the high study
discontinuation rate (44%) preclude definitively ruling out a malignancy risk
with XOLAIR.

Acute Asthma Symptoms and Deteriorating Disease
XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use
XOLAIR to treat acute bronchospasm or status asthmaticus. Patients should seek
medical advice if their asthma remains uncontrolled or worsens after initiation
of treatment with XOLAIR.

Corticosteroid Reduction
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation
of XOLAIR therapy for asthma or nasal polyps. Decrease corticosteroids gradually
under the direct supervision of a physician. In CSU patients, the use of XOLAIR
in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions
In rare cases, patients with asthma on therapy with XOLAIR may present with
serious systemic eosinophilia, sometimes presenting with clinical features of
vasculitis consistent with Churg-Strauss syndrome. These events usually, but not
always, have been associated with the reduction of oral corticosteroid therapy.
Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary
symptoms, cardiac complications, and/or neuropathy presenting in their patients.
A causal association between XOLAIR and these underlying conditions has not been
established.

Fever, Arthralgia, and Rash
In post-approval use, some patients have experienced a constellation of signs
and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy
with an onset 1 to 5 days after the first or subsequent injections of XOLAIR.
These signs and symptoms have recurred after additional doses in some patients.
Physicians should stop XOLAIR if a patient develops this constellation of signs
and symptoms.

Parasitic (Helminth) Infection
Monitor patients at high risk of geohelminth infection while on XOLAIR therapy.
Insufficient data are available to determine the length of monitoring required
for geohelminth infections after stopping XOLAIR treatment.

Laboratory Tests
Due to formation of XOLAIR:IgE complexes, serum total IgE levels increase
following administration of XOLAIR and may remain elevated for up to 1 year
following discontinuation of XOLAIR. Do not use serum total IgE levels obtained
less than 1 year following discontinuation to reassess the dosing regimen for
asthma or nasal polyps patients, because these levels may not reflect steady
state free IgE levels.

ADVERSE REACTIONS

Asthma
In patients ≥12 years of age, the most common adverse reactions (≥1% more
frequent in XOLAIR-treated patients) 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%). In pediatric patients 6 to <12
years of age, the most commonly observed adverse reactions (≥3% more frequent in
XOLAIR-treated pediatric patients) were: nasopharyngitis, headache, pyrexia,
upper abdominal pain, pharyngitis streptococcal, otitis media, viral
gastroenteritis, arthropod bite, and epistaxis.

Nasal Polyps
The most common adverse reactions (≥3% incidence in XOLAIR-treated patients and
more frequent than placebo) included: headache (8.1%), injection site reaction
(5.2%), arthralgia (3.0%), upper abdominal pain (3.0%), and dizziness (3.0%).

Chronic Spontaneous Urticaria
The most common adverse reactions (≥2% XOLAIR-treated patients and more frequent
than in placebo) for XOLAIR 150 mg and 300 mg, respectively, included: headache
(12%, 6%), nasopharyngitis (9%, 7%), arthralgia (3%, 3%), viral upper
respiratory infection (2%, 1%), nausea (1%, 3%), sinusitis (1%, 5%), upper
respiratory tract infection (1%, 3%), and cough (1%, 2%).

Injection Site Reactions

Asthma
In adults and adolescents with asthma, injection site reactions of any severity
occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in
placebo-treated patients. Severe injection site reactions occurred more
frequently in XOLAIR‑treated patients compared with patients in the placebo
group (12% vs 9%, respectively). The types of injection site reactions in asthma
studies included: bruising, redness, warmth, burning, stinging, itching, hive
formation, pain, indurations, mass, and inflammation.

Nasal Polyps
Injection site reactions occurred at a rate of 5.2% in XOLAIR-treated patients
compared with 1.5% in placebo-treated patients. Injection site reactions were
mild to moderate severity and none resulted in study discontinuation.

Chronic Spontaneous Urticaria
Injection site reactions of any severity occurred in more XOLAIR-treated
patients (11 patients [2.7%] at 300 mg, 1 patient [0.6%] at 150 mg) compared
with 2 placebo-treated patients (0.8%). The types of injection site reactions
included: swelling, erythema, pain, bruising, itching, bleeding, and urticaria.
None of the events resulted in study discontinuation or treatment interruption.

Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with
Asthma
A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829
non-XOLAIR-treated patients ≥12 years of age with moderate to severe persistent
asthma and a positive skin test reaction to a perennial aeroallergen to evaluate
the long term safety of XOLAIR, including the risk of malignancy. Similar
percentages of patients in both cohorts were current (5%) or former smokers
(29%). Patients had a mean age of 45 years and were followed for a mean of 3.7
years. More XOLAIR-treated patients were diagnosed with severe asthma (50%)
compared to the non-XOLAIR-treated patients (23%). A higher incidence rate (per
1000 patient-years) of overall cardiovascular and cerebrovascular serious
adverse events (SAEs) was observed in XOLAIR-treated patients (13.4) compared to
non-XOLAIR-treated patients (8.1). Increases in rates were observed for
transient ischemic attack (0.7 vs 0.1), myocardial infarction (2.1 vs 0.8),
pulmonary hypertension (0.5 vs 0), pulmonary embolism/venous thrombosis (3.2 vs
1.5), and unstable angina (2.2 vs 1.4), while the rates observed for ischemic
stroke and cardiovascular death were similar among both study cohorts. The
results suggest a potential increased risk of serious cardiovascular and
cerebrovascular events in patients treated with XOLAIR, however the
observational study design, the inclusion of patients previously exposed to
XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk
factors between the treatment groups, an inability to adjust for unmeasured risk
factors, and the high study discontinuation rate (44%) limit the ability to
quantify the magnitude of the risk.

Pregnancy
Data with XOLAIR use in pregnant women are insufficient to inform on drug
associated risk.

You may report side effects to the FDA at (800) FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to Genentech at (888)
835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Boxed WARNING and Medication
Guide, for additional Important Safety Information.





References

 * * XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis
     Pharmaceuticals Corporation; 2021.
     
     XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis
     Pharmaceuticals Corporation; 2021.
   
   * Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and
     TH2-high asthma phenotypes in a general population with current asthma. Ann
     Allergy Asthma Immunol. 2016;116(1):37-42.
     
     Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and
     TH2-high asthma phenotypes in a general population with current asthma. Ann
     Allergy Asthma Immunol. 2016;116(1):37-42.
   
   * Allergens and allergic asthma. Asthma and Allergy Foundation of America.
     Accessed August 11, 2021. https://www.aafa.org/allergic-asthma/
     
     Allergens and allergic asthma. Asthma and Allergy Foundation of America.
     Accessed August 11, 2021. https://www.aafa.org/allergic-asthma/
   
   * World Health Organization. Prevention of allergy and allergic asthma. Based
     on the WHO/WAO meeting on the prevention of allergy and allergic asthma;
     January 8-9, 2002; Geneva, Switzerland.
     
     World Health Organization. Prevention of allergy and allergic asthma. Based
     on the WHO/WAO meeting on the prevention of allergy and allergic asthma;
     January 8-9, 2002; Geneva, Switzerland.
   
   * Data on file. Genentech USA, Inc. South San Francisco, CA.
     
     Data on file. Genentech USA, Inc. South San Francisco, CA.
   
   * Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-lgE recombinant
     humanized monoclonal antibody, for the treatment of severe allergic asthma.
     J Allergy Clin Immunol. 2001;108(2):184-190.
     
     Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-lgE recombinant
     humanized monoclonal antibody, for the treatment of severe allergic asthma.
     J Allergy Clin Immunol. 2001;108(2):184-190.
   
   * Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces
     exacerbations and steroid requirement in allergic asthmatics. Eur Respir J.
     2001;18(2):254-261.
     
     Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces
     exacerbations and steroid requirement in allergic asthmatics. Eur Respir J.
     2001;18(2):254-261.
   
   * Chipps BE, Zeiger RS, Luskin AT, et al. Baseline asthma burden,
     comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO.
     Ann Allergy Asthma Immunol. 2017;119(6):524-532.e2.
     
     Chipps BE, Zeiger RS, Luskin AT, et al. Baseline asthma burden,
     comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO.
     Ann Allergy Asthma Immunol. 2017;119(6):524-532.e2.
   
   * Ledford DK, Lockey RF. Asthma and comorbidities. Curr Opin Allergy Clin
     Immunol. 2013;13(1):78-86.
     
     Ledford DK, Lockey RF. Asthma and comorbidities. Curr Opin Allergy Clin
     Immunol. 2013;13(1):78-86.
   
   * Comberiati P, McCormack K, Malka-Rais J, Spahn JD. Proportion of severe
     asthma patients eligible for mepolizumab therapy by age and age of onset of
     asthma. J Allergy Clin Immunol Pract. 2019;7(8):2689-2696.e2.
     
     Comberiati P, McCormack K, Malka-Rais J, Spahn JD. Proportion of severe
     asthma patients eligible for mepolizumab therapy by age and age of onset of
     asthma. J Allergy Clin Immunol Pract. 2019;7(8):2689-2696.e2.
   
   * Castillo JR, Peters SP, Busse WW. Asthma exacerbations: pathogenesis,
     prevention, and treatment. J Allergy Clin Immunol Pract. 2017;5(4):918-927.
     
     Castillo JR, Peters SP, Busse WW. Asthma exacerbations: pathogenesis,
     prevention, and treatment. J Allergy Clin Immunol Pract. 2017;5(4):918-927.
   
   * Eguiluz-Gracia I, Layhadi JA, Rondon C, Shamji MH. Mucosal IgE immune
     responses in respiratory diseases. Curr Opin Pharmacol. 2019;46:100-107.
     
     Eguiluz-Gracia I, Layhadi JA, Rondon C, Shamji MH. Mucosal IgE immune
     responses in respiratory diseases. Curr Opin Pharmacol. 2019;46:100-107.
   
   * Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol.
     2008;8(3):205-217.
     
     Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol.
     2008;8(3):205-217.
   
   * Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med.
     2012;18(5):693-704.
     
     Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med.
     2012;18(5):693-704.
   
   * Akdis CA, Arkwright PD, Brüggen M-C, et al. Type 2 immunity in the skin and
     lungs. Allergy. 2020;75(7):1582-1605.
     
     Akdis CA, Arkwright PD, Brüggen M-C, et al. Type 2 immunity in the skin and
     lungs. Allergy. 2020;75(7):1582-1605.
   
   * Siles RI, Hsieh FH. Allergy blood testing: a practical guide for
     clinicians. Cleve Clin J Med. 2011;78(9):585-592.
     doi:10.3949/ccjm.78a.11023.
     
     Siles RI, Hsieh FH. Allergy blood testing: a practical guide for
     clinicians. Cleve Clin J Med. 2011;78(9):585-592.
     doi:10.3949/ccjm.78a.11023.
   
   * National Heart, Lung, and Blood Institute of Health; 2007. NIG publication
     07-4051.
     
     National Heart, Lung, and Blood Institute of Health; 2007. NIG publication
     07-4051.
   
   * Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an
     updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3)(Suppl
     3):S1-S148.
     
     Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an
     updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3)(Suppl
     3):S1-S148.
   
   * Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Clinical management
     review: allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol
     Pract. 2020;8:429-440.
     
     Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Clinical management
     review: allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol
     Pract. 2020;8:429-440.
   
   * Sonora Quest Laboratories. Test Interpretation and Management
     Options—Utilizing ImmunoCAP®’ KU/L Results.
     https://www.sonoraquest.com/media/2315/immunocap-ref-range_test-menu_0318.pdf.
     Accessed March 19, 2020.
     
     Sonora Quest Laboratories. Test Interpretation and Management
     Options—Utilizing ImmunoCAP®’ KU/L Results.
     https://www.sonoraquest.com/media/2315/immunocap-ref-range_test-menu_0318.pdf.
     Accessed March 19, 2020.
   
   * Kerkhof M, Dubois AE, Postma DS, et al. Role and interpretation of total
     serum IgE measurements in the diagnosis of allergic airway disease in
     adults. Allergy. 2003;58(9):905-911.
     
     Kerkhof M, Dubois AE, Postma DS, et al. Role and interpretation of total
     serum IgE measurements in the diagnosis of allergic airway disease in
     adults. Allergy. 2003;58(9):905-911.
   
   * Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient
     enrichment criteria from trials of novel biologics in asthma. Allergy.
     2018;73(2):490-497.
     
     Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient
     enrichment criteria from trials of novel biologics in asthma. Allergy.
     2018;73(2):490-497.
   
   * Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab
     pregnancy registry and a disease-matched comparator cohort. J All Clin
     Immunol. 2020;145(2):528-536.e1.
     
     Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab
     pregnancy registry and a disease-matched comparator cohort. J All Clin
     Immunol. 2020;145(2):528-536.e1.
   
   * Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day
     [press release]. Washington, DC: U.S. Census Bureau; December 30, 2013.
     
     Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day
     [press release]. Washington, DC: U.S. Census Bureau; December 30, 2013.
   
   * Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in
     chronic spontaneous urticaria. A GA2LEN task force report [published online
     November 17, 2010]. Allergy. 2011;66(3):317-330.
     doi:10.1111/j.1398-9995.2010.02496.x.
     
     Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in
     chronic spontaneous urticaria. A GA2LEN task force report [published online
     November 17, 2010]. Allergy. 2011;66(3):317-330.
     doi:10.1111/j.1398-9995.2010.02496.x.
   
   * Grattan CEH. Urticaria and angioedema. In: Bolognia JL, Jorizzo JL,
     Schaffer JV, eds. Dermatology. 3rd ed. Philadelphia, PA: Elsevier Saunders;
     2012:291-306.
     
     Grattan CEH. Urticaria and angioedema. In: Bolognia JL, Jorizzo JL,
     Schaffer JV, eds. Dermatology. 3rd ed. Philadelphia, PA: Elsevier Saunders;
     2012:291-306.
   
   * Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of
     refractory and non-refractory chronic idiopathic urticaria in the USA:
     clinical burden and healthcare resource use. Curr Med Res Opin.
     2019;35(8):1387-1395.
     
     Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of
     refractory and non-refractory chronic idiopathic urticaria in the USA:
     clinical burden and healthcare resource use. Curr Med Res Opin.
     2019;35(8):1387-1395.
   
   * Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic
     urticaria, a form of chronic hives.
     https://www.roche.com/media/releases/med-cor-2014-03-24.htm. March 2014.
     Accessed January 14, 2021.
     
     Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic
     urticaria, a form of chronic hives.
     https://www.roche.com/media/releases/med-cor-2014-03-24.htm. March 2014.
     Accessed January 14, 2021.
   
   * Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of
     omalizumab in patients with chronic idiopathic/spontaneous urticaria who
     remain symptomatic on H1 antihistamines: a randomized, placebo-controlled
     study [published correction appears in J Invest Dermatol. 2015;135(3):925.
     doi:10.1038/jid.2014.512]. J Invest Dermatol. 2015;135(1):67-75.
     doi:10.1038/jid.2014.306.
     
     Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of
     omalizumab in patients with chronic idiopathic/spontaneous urticaria who
     remain symptomatic on H1 antihistamines: a randomized, placebo-controlled
     study [published correction appears in J Invest Dermatol. 2015;135(3):925.
     doi:10.1038/jid.2014.512]. J Invest Dermatol. 2015;135(1):67-75.
     doi:10.1038/jid.2014.306.
   
   * US Department of Health and Human Services. Determination that astemizole
     10-milligram tablets were withdrawn from sale for safety reasons. Federal
     Register. 1999;64(162):45973-45974.
     
     US Department of Health and Human Services. Determination that astemizole
     10-milligram tablets were withdrawn from sale for safety reasons. Federal
     Register. 1999;64(162):45973-45974.

 * * Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to
     atopy: results from the Third National Health and Nutrition Examination
     Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.
     
     Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to
     atopy: results from the Third National Health and Nutrition Examination
     Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.
   
   * Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European
     Respiratory Society Task Force on Asthma Control and Exacerbations. An
     official American Thoracic Society/European Respiratory Society statement:
     asthma control and exacerbations: standardizing endpoints for clinical
     asthma trials and clinical practice. Am J Respir Crit Care Med.
     2009;180(1):59-99.
     
     Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European
     Respiratory Society Task Force on Asthma Control and Exacerbations. An
     official American Thoracic Society/European Respiratory Society statement:
     asthma control and exacerbations: standardizing endpoints for clinical
     asthma trials and clinical practice. Am J Respir Crit Care Med.
     2009;180(1):59-99.
   
   * Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of
     exacerbations in children with inadequately controlled allergic
     (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.
     
     Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of
     exacerbations in children with inadequately controlled allergic
     (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.
   
   * Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and
     tolerability of omalizumab in children with allergic (IgE-mediated) asthma.
     Curr Med Res Opin. 2011;27(1):163-169.
     
     Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and
     tolerability of omalizumab in children with allergic (IgE-mediated) asthma.
     Curr Med Res Opin. 2011;27(1):163-169.
   
   * Global Initiative for Asthma (GINA). What’s new in GINA 2021? GINA global
     strategy for asthma management and prevention.
     
     Global Initiative for Asthma (GINA). What’s new in GINA 2021? GINA global
     strategy for asthma management and prevention.
   
   * Global Initiative for Asthma. Global strategy for asthma management and
     prevention, 2021.
     
     Global Initiative for Asthma. Global strategy for asthma management and
     prevention, 2021.

References

 * * XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis
     Pharmaceuticals Corporation; 2021.
     
     XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis
     Pharmaceuticals Corporation; 2021.
   
   * Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and
     TH2-high asthma phenotypes in a general population with current asthma. Ann
     Allergy Asthma Immunol. 2016;116(1):37-42.
     
     Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and
     TH2-high asthma phenotypes in a general population with current asthma. Ann
     Allergy Asthma Immunol. 2016;116(1):37-42.
   
   * Allergens and allergic asthma. Asthma and Allergy Foundation of America.
     Accessed August 11, 2021. https://www.aafa.org/allergic-asthma/
     
     Allergens and allergic asthma. Asthma and Allergy Foundation of America.
     Accessed August 11, 2021. https://www.aafa.org/allergic-asthma/
   
   * World Health Organization. Prevention of allergy and allergic asthma. Based
     on the WHO/WAO meeting on the prevention of allergy and allergic asthma;
     January 8-9, 2002; Geneva, Switzerland.
     
     World Health Organization. Prevention of allergy and allergic asthma. Based
     on the WHO/WAO meeting on the prevention of allergy and allergic asthma;
     January 8-9, 2002; Geneva, Switzerland.
   
   * Data on file. Genentech USA, Inc. South San Francisco, CA.
     
     Data on file. Genentech USA, Inc. South San Francisco, CA.
   
   * Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-lgE recombinant
     humanized monoclonal antibody, for the treatment of severe allergic asthma.
     J Allergy Clin Immunol. 2001;108(2):184-190.
     
     Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-lgE recombinant
     humanized monoclonal antibody, for the treatment of severe allergic asthma.
     J Allergy Clin Immunol. 2001;108(2):184-190.
   
   * Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces
     exacerbations and steroid requirement in allergic asthmatics. Eur Respir J.
     2001;18(2):254-261.
     
     Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces
     exacerbations and steroid requirement in allergic asthmatics. Eur Respir J.
     2001;18(2):254-261.
   
   * Chipps BE, Zeiger RS, Luskin AT, et al. Baseline asthma burden,
     comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO.
     Ann Allergy Asthma Immunol. 2017;119(6):524-532.e2.
     
     Chipps BE, Zeiger RS, Luskin AT, et al. Baseline asthma burden,
     comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO.
     Ann Allergy Asthma Immunol. 2017;119(6):524-532.e2.
   
   * Ledford DK, Lockey RF. Asthma and comorbidities. Curr Opin Allergy Clin
     Immunol. 2013;13(1):78-86.
     
     Ledford DK, Lockey RF. Asthma and comorbidities. Curr Opin Allergy Clin
     Immunol. 2013;13(1):78-86.
   
   * Comberiati P, McCormack K, Malka-Rais J, Spahn JD. Proportion of severe
     asthma patients eligible for mepolizumab therapy by age and age of onset of
     asthma. J Allergy Clin Immunol Pract. 2019;7(8):2689-2696.e2.
     
     Comberiati P, McCormack K, Malka-Rais J, Spahn JD. Proportion of severe
     asthma patients eligible for mepolizumab therapy by age and age of onset of
     asthma. J Allergy Clin Immunol Pract. 2019;7(8):2689-2696.e2.
   
   * Castillo JR, Peters SP, Busse WW. Asthma exacerbations: pathogenesis,
     prevention, and treatment. J Allergy Clin Immunol Pract. 2017;5(4):918-927.
     
     Castillo JR, Peters SP, Busse WW. Asthma exacerbations: pathogenesis,
     prevention, and treatment. J Allergy Clin Immunol Pract. 2017;5(4):918-927.
   
   * Eguiluz-Gracia I, Layhadi JA, Rondon C, Shamji MH. Mucosal IgE immune
     responses in respiratory diseases. Curr Opin Pharmacol. 2019;46:100-107.
     
     Eguiluz-Gracia I, Layhadi JA, Rondon C, Shamji MH. Mucosal IgE immune
     responses in respiratory diseases. Curr Opin Pharmacol. 2019;46:100-107.
   
   * Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol.
     2008;8(3):205-217.
     
     Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol.
     2008;8(3):205-217.
   
   * Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med.
     2012;18(5):693-704.
     
     Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med.
     2012;18(5):693-704.
   
   * Akdis CA, Arkwright PD, Brüggen M-C, et al. Type 2 immunity in the skin and
     lungs. Allergy. 2020;75(7):1582-1605.
     
     Akdis CA, Arkwright PD, Brüggen M-C, et al. Type 2 immunity in the skin and
     lungs. Allergy. 2020;75(7):1582-1605.
   
   * Siles RI, Hsieh FH. Allergy blood testing: a practical guide for
     clinicians. Cleve Clin J Med. 2011;78(9):585-592.
     doi:10.3949/ccjm.78a.11023.
     
     Siles RI, Hsieh FH. Allergy blood testing: a practical guide for
     clinicians. Cleve Clin J Med. 2011;78(9):585-592.
     doi:10.3949/ccjm.78a.11023.
   
   * National Heart, Lung, and Blood Institute of Health; 2007. NIG publication
     07-4051.
     
     National Heart, Lung, and Blood Institute of Health; 2007. NIG publication
     07-4051.
   
   * Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an
     updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3)(Suppl
     3):S1-S148.
     
     Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an
     updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3)(Suppl
     3):S1-S148.
   
   * Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Clinical management
     review: allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol
     Pract. 2020;8:429-440.
     
     Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Clinical management
     review: allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol
     Pract. 2020;8:429-440.
   
   * Sonora Quest Laboratories. Test Interpretation and Management
     Options—Utilizing ImmunoCAP®’ KU/L Results.
     https://www.sonoraquest.com/media/
     2315/immunocap-ref-range_test-menu_0318.pdf.
     Accessed March 19, 2020.
     
     Sonora Quest Laboratories. Test Interpretation and Management
     Options—Utilizing ImmunoCAP®’ KU/L Results.
     https://www.sonoraquest.com/media/
     2315/immunocap-ref-range_test-menu_0318.pdf.
     Accessed March 19, 2020.
   
   * Kerkhof M, Dubois AE, Postma DS, et al. Role and interpretation of total
     serum IgE measurements in the diagnosis of allergic airway disease in
     adults. Allergy. 2003;58(9):905-911.
     
     Kerkhof M, Dubois AE, Postma DS, et al. Role and interpretation of total
     serum IgE measurements in the diagnosis of allergic airway disease in
     adults. Allergy. 2003;58(9):905-911.
   
   * Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient
     enrichment criteria from trials of novel biologics in asthma. Allergy.
     2018;73(2):490-497.
     
     Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient
     enrichment criteria from trials of novel biologics in asthma. Allergy.
     2018;73(2):490-497.
   
   * Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab
     pregnancy registry and a disease-matched comparator cohort. J All Clin
     Immunol. 2020;145(2):528-536.e1.
     
     Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab
     pregnancy registry and a disease-matched comparator cohort. J All Clin
     Immunol. 2020;145(2):528-536.e1.
   
   * Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day
     [press release]. Washington, DC: U.S. Census Bureau; December 30, 2013.
     
     Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day
     [press release]. Washington, DC: U.S. Census Bureau; December 30, 2013.
   
   * Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in
     chronic spontaneous urticaria. A GA2LEN task force report [published online
     November 17, 2010]. Allergy. 2011;66(3):317-330.
     doi:10.1111/j.1398-9995.2010.02496.x.
     
     Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in
     chronic spontaneous urticaria. A GA2LEN task force report [published online
     November 17, 2010]. Allergy. 2011;66(3):317-330.
     doi:10.1111/j.1398-9995.2010.02496.x.
   
   * Grattan CEH. Urticaria and angioedema. In: Bolognia JL, Jorizzo JL,
     Schaffer JV, eds. Dermatology. 3rd ed. Philadelphia, PA: Elsevier Saunders;
     2012:291-306.
     
     Grattan CEH. Urticaria and angioedema. In: Bolognia JL, Jorizzo JL,
     Schaffer JV, eds. Dermatology. 3rd ed. Philadelphia, PA: Elsevier Saunders;
     2012:291-306.
   
   * Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of
     refractory and non-refractory chronic idiopathic urticaria in the USA:
     clinical burden and healthcare resource use. Curr Med Res Opin.
     2019;35(8):1387-1395.
     
     Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of
     refractory and non-refractory chronic idiopathic urticaria in the USA:
     clinical burden and healthcare resource use. Curr Med Res Opin.
     2019;35(8):1387-1395.
   
   * Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic
     urticaria, a form of chronic hives.
     https://www.roche.com/media/releases/med-cor-2014-03-24.htm. March 2014.
     Accessed January 14, 2021.
     
     Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic
     urticaria, a form of chronic hives.
     https://www.roche.com/media/releases/med-cor-2014-03-24.htm. March 2014.
     Accessed January 14, 2021.
   
   * Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of
     omalizumab in patients with chronic idiopathic/spontaneous urticaria who
     remain symptomatic on H1 antihistamines: a randomized, placebo-controlled
     study [published correction appears in J Invest Dermatol. 2015;135(3):925.
     doi:10.1038/jid.2014.512]. J Invest Dermatol. 2015;135(1):67-75.
     doi:10.1038/jid.2014.306.
     
     Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of
     omalizumab in patients with chronic idiopathic/spontaneous urticaria who
     remain symptomatic on H1 antihistamines: a randomized, placebo-controlled
     study [published correction appears in J Invest Dermatol. 2015;135(3):925.
     doi:10.1038/jid.2014.512]. J Invest Dermatol. 2015;135(1):67-75.
     doi:10.1038/jid.2014.306.
   
   * US Department of Health and Human Services. Determination that astemizole
     10-milligram tablets were withdrawn from sale for safety reasons. Federal
     Register. 1999;64(162):45973-45974.
     
     US Department of Health and Human Services. Determination that astemizole
     10-milligram tablets were withdrawn from sale for safety reasons. Federal
     Register. 1999;64(162):45973-45974.

 * * Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to
     atopy: results from the Third National Health and Nutrition Examination
     Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.
     
     Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to
     atopy: results from the Third National Health and Nutrition Examination
     Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.
   
   * Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European
     Respiratory Society Task Force on Asthma Control and Exacerbations. An
     official American Thoracic Society/European Respiratory Society statement:
     asthma control and exacerbations: standardizing endpoints for clinical
     asthma trials and clinical practice. Am J Respir Crit Care Med.
     2009;180(1):59-99.
     
     Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European
     Respiratory Society Task Force on Asthma Control and Exacerbations. An
     official American Thoracic Society/European Respiratory Society statement:
     asthma control and exacerbations: standardizing endpoints for clinical
     asthma trials and clinical practice. Am J Respir Crit Care Med.
     2009;180(1):59-99.
   
   * Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of
     exacerbations in children with inadequately controlled allergic
     (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.
     
     Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of
     exacerbations in children with inadequately controlled allergic
     (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.
   
   * Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and
     tolerability of omalizumab in children with allergic (IgE-mediated) asthma.
     Curr Med Res Opin. 2011;27(1):163-169.
     
     Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and
     tolerability of omalizumab in children with allergic (IgE-mediated) asthma.
     Curr Med Res Opin. 2011;27(1):163-169.
   
   * Global Initiative for Asthma (GINA). What’s new in GINA 2021? GINA global
     strategy for asthma management and prevention.
     
     Global Initiative for Asthma (GINA). What’s new in GINA 2021? GINA global
     strategy for asthma management and prevention.
   
   * Global Initiative for Asthma. Global strategy for asthma management and
     prevention, 2021.
     
     Global Initiative for Asthma. Global strategy for asthma management and
     prevention, 2021.

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