What is the recommended dose of omalizumab (anti-IgE antibody) for the treatment of allergic rhinitis?

Omalizumab Dosing for Allergic Rhinitis

Omalizumab is not FDA-approved for allergic rhinitis and is not recommended as a treatment option due to its high cost and lack of superiority over standard treatments, despite showing some efficacy in symptom reduction. 1

Evidence on Omalizumab Use in Allergic Rhinitis

• Omalizumab has demonstrated efficacy in reducing nasal and ocular symptoms and improving quality of life in patients with seasonal and perennial allergic rhinitis 1, 2
• However, it has not shown superiority to currently approved rhinitis treatments, making its high cost unjustifiable for allergic rhinitis without concomitant asthma 1
• Omalizumab is only FDA-approved for allergic asthma, not for allergic rhinitis 1, 3

Dosing Used in Research Studies for Allergic Rhinitis

• In clinical trials examining allergic rhinitis, the following dosing regimens were used:
  • 300 mg subcutaneously every 3 weeks (for patients with baseline IgE levels of 151-700 IU/mL) or every 4 weeks (for patients with baseline IgE levels of 30-150 IU/mL) 2, 4
  • Dosage of 0.016 mg/kg per IU of total serum IgE/mL administered subcutaneously every 2-4 weeks 5, 6

Mechanism of Action

• Omalizumab is a recombinant humanized monoclonal anti-IgE antibody that selectively binds to free circulating IgE 1, 3
• This binding decreases the expression of IgE receptors on mast cells, basophils, and dendritic cells, interfering with their activation 1, 3
• By reducing free IgE levels, omalizumab attenuates the allergic inflammatory response 3, 6

Clinical Considerations

• If considering off-label use, the dosing should follow the same principles as for asthma, with dose and frequency determined by patient's body weight and baseline total serum IgE levels 3, 6
• Treatment duration in studies ranged from 12-16 weeks, typically covering the allergy season for seasonal allergic rhinitis 2, 4
• Side effects are generally similar to placebo, with the most common being injection site reactions and upper respiratory infections 4, 7
• There is a small risk of anaphylaxis (0.09-0.2% of patients) with omalizumab treatment 1

Alternative Recommended Treatments

• First-line treatments for allergic rhinitis include intranasal corticosteroids, which are more effective than the combination of antihistamines and leukotriene receptor antagonists 1
• Second-generation antihistamines, leukotriene receptor antagonists, and saline irrigation are other effective options with better cost-effectiveness profiles 1
• Allergen immunotherapy should be considered for patients with inadequate response to pharmacotherapy, as it can potentially modify disease progression and provide sustained benefits after discontinuation 1

Important Caveats

• The high cost of omalizumab treatment makes it impractical for allergic rhinitis without concomitant asthma to perennial allergens 1
• Unlike allergen immunotherapy, there is no evidence that omalizumab improves the natural course of allergic rhinitis after discontinuation 1
• Omalizumab may be considered in patients with both allergic rhinitis and allergic asthma, where its approved use for asthma may provide dual benefits 1, 7