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Refractory Asthma: The Role of Omalizumab

Reviewed By Allergy, Immunology & Inflammation Assembly

Submitted by

David R. Stukus, MD

Section of Allergy and Immunology

Nationwide Children’s Hospital

The Ohio State University College of Medicine

Columbus, Ohio

Submit your comments to the author(s).


A 45-year-old Caucasian woman was referred by her primary care physician for evaluation and treatment recommendations for poorly controlled asthma. She was initially diagnosed with asthma as an adolescent and has a history of recurrent severe exacerbations requiring ten hospitalizations and greater than twenty emergency department visits throughout her life. Her last hospitalization occurred three months ago. Triggers for severe exacerbations include changes in the weather pattern, exposure to chemical irritants such as cigarette smoke and perfumes, and indoor and outdoor allergens. Despite her history of severe exacerbations, she denies chronic daytime symptoms, with albuterol use less than twice a week, nocturnal awakenings no more than once a month, and no exercise restrictions.

This patient also has a history of seasonal and perennial allergic rhinitis with symptoms including chronic nasal congestion, rhinorrhea, postnasal drip and intermittent itchy, watery eyes. She previously had pets, including dogs and cats, but no longer has exposure to these animals. Additional co-morbidities include intermittent atopic dermatitis affecting her hands and face, and gastroesophageal reflux disease.

Current medications include fluticasone/salmeterol 230/45 mcg 2 inhalations twice daily, montelukast 10 mg once daily, fluticasone nasal spray 2 sprays each nostril once daily, fexofenadine 180 mg once daily, topical pimecrolimus twice daily as needed for atopic dermatitis, and ranitidine 150 mg once daily.  She initiated treatment with allergen specific immunotherapy twice in the past, but failed to achieve maintenance dosing on either attempt due to intolerable adverse effects, including anaphylaxis on one occasion.

Physical Exam

On physical examination, vital signs are normal with Spo2 on room air of 98%. Her weight is 58 kg, BMI = 34 kg/cm. Nasal exam reveals significantly enlarged inferior turbinates with pale, bluish, edematous nasal mucosa. Posterior pharynx is mildly erythematous with cobblestoning. Lung exam reveals good aeration throughout all lung fields with clear breath sounds and absence of wheezing. Skin exam reveals erythematous macular eczematous plaques on the dorsum of hands bilaterally with mild lichenification.


Pulmonary Function Tests

  • Spirometry: FEV1- 1.98 L (58% predicted); FVC- 3.13 L (77% predicted); FEV1/FVC- 63.3%; post-bronchodilator studies FEV1- 2.27 L (increase of 13%); FVC- 3.43 L (increase of 10%)
  • Fractional Excretion of Exhaled Nitric Oxide (FeNO): 77 ppb

Asthma Control Test = 21

Skin Prick Testing

  • Mean wheal diameter > 6 mm observed towards dust mites, cat dander, dog dander, birch, maple, oak, cedar, mulberry, timothy grass, ragweed, alternaria
  • Mean wheal diameter < 1 mm observed towards cockroach, mouse, rabbit, guinea pig, horse, cladosporium, penicillium, aspergillus

Total Serum Immunoglobulin E (IgE) Level = 245 IU/mL, complete blood count was normal except for peripheral eosinophil count 625/mm3 (7%).

Question 1

Which of the following are criteria to initiate omalizumab for treatment of asthma?


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