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Wise et al.

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Author Manuscript Author Manuscript Author Manuscript Author Manuscript TABLE IX.D.8. Study

design Study groups Clinical endpoint Conclusion Massanari et al. 1736 2010 1b RCT Adults with poorly controlled moderate persistent allergic asthma: 1 Omalizumab pretreatment + cluster AIT; 2 Placebo + cluster AIT Incidence of systemic allergic reactions Omalizumab pretreatment is associated with a lower incidence of systemic allergic reactions and higher likelihood of reaching maintenance AIT dose. 1 AIT-ragweed + omalizumab; 2 AIT-ragweed alone; 3 Omalizumab alone; 4 Placebo Ragweed hypersensitivity via IgE-FAB assay, allergen specific IgG4 Combination therapy enhanced the inhibition of sIgE binding for 42 weeks after discontinuation. 1 Omalizumab pretreatment + RIT; Daily symptom severity, incidence of adverse events

Pretreatment with omalizumab resulted in a 5 fold decrease in risk of RIT associated

anaphylaxis. Combination therapy is associated with significant reduction in symptom severity versus AIT alone.

Combination therapy is associated with reduced symptom severity and rescue medication scores.

Combination therapy is associated with reduced leukotriene release following antigen stimulation.

Combination therapy is clinically superior to either component monotherapy, with reduced

symptom severity and rescue medication scores.

Rolinck-Werninghaus et al. 1401 , b 2004 1b RCT Subgroup analysis of Kuehr et al. 1400 study Daily symptom severity, rescue medication use 1 AIT-birch + omalizumab; 2 AIT-birch + placebo; 3 AIT-grass + omalizumab; 4 AIT-grass + placebo Daily symptom severity, rescue medication use

Kopp et al. 1735 , b 2002 1b RCT Subgroup analysis of Kuehr et al. 1400 study In vitro leukotriene release following antigen stimulation

2 Omalizumab pretreatment + placebo [IT]; 3 Placebo [omalizumab] + RIT; 4 Placebo for both interventions

Evidence for the combination of omalizumab and subcutaneous immunotherapy in the treatment of allergic rhinitis Study Year LOE Klunker et al. 1734 , a 2007 1b RCT Adults with ragweed induced AR: Casale et al. 1402 , a 2006 1b RCT Adults with ragweed induced AR: Kuehr et al. 1400 , b

2002 1b RCT Children and adolescents with SAR and:

Omalizumab Rhinitis Study Group.

a Immune Tolerance Network Group. b

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