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Wise et al.

Page 106

no additional benefit over subcutaneous immunotherapy (SCIT) alone in suppressing the allergen-induced skin late-phase response. 1405

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Although there is consistent evidence that omalizumab monotherapy is superior to placebo in symptom reduction and QOL improvement in AR, the benefits are relatively small over pharmacotherapy. Omalizumab is superior in combination with AIT vs AIT alone and reduces the risk of anaphylaxis associated with AIT, but the costs of the treatment preclude a widespread use. The combination therapy might be indicated in selected patients who are polysensitized and highly sensitive. • Aggregate Grade of Evidence: A (Level 1a: 1 study; Level 1b: 5 studies; Table IX.B.7). • Benefit: Consistent reduction in symptoms and rescue medication as well as improvement in QOL in RCTs and systematic review of RCTs compared to placebo. • Harm: Injection site reactions, possibility of anaphylactic reaction. • Costs: High. Annual incurred drug costs estimated to be above $18,000 per year in the United States. • Benefits-Harm Assessment: No therapy option as omalizumab is not registered for treatment of AR alone. This review was limited to evaluation of AR only; comorbid asthma was not evaluated. • Value Judgments: Omalizumab monotherapy is superior to placebo, but effects are small over pharmacotherapy. May be evaluated in exceptional cases of highly sensitive polysensitized individuals in combination with AIT. • Policy Level: No indication for the treatment of AR alone. • Intervention: Omalizumab should not be used as monotherapy in the treatment of AR but may be considered in combination with AIT for highly sensitive polyallergic rhinitis patients with increased risk of anaphylaxis. As omalizumab is not currently approved by the FDA for AR treatment, in the US this treatment approach would likely not be performed in routine clinical practice presently. IX.B.8. Nasal saline— Nasal saline is frequently utilized in the treatment of AR. However, the term “nasal saline” encompasses a wide variety of therapeutic regimens. These can include hypertonic saline, isotonic/normal saline, seawater, buffered or nonbuffered solutions, and volumes varying from 300 μ L to 500 mL per administration. Irrigation regimens are also used with varying frequency. This review included only level 1 evidence published in the English language. The search identified 5 RCTs in adults 151,1406-1409 (Table IX.B.8-1), 6 RCTs in children 1410-1415 (Table IX.B.8-2), and 1 systematic review 1416 encompassing all ages (included in both tables), which evaluated the efficacy of nasal saline in the treatment of AR.

Int Forum Allergy Rhinol . Author manuscript; available in PMC 2020 June 10.

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