6/28/23, 10:10 PM EXTRA Pathway Feedback Search Clinical Topics Home Studies EXTRA EXTRA Disease Disease Asthma Severe asthma phenotypes Trial question What is the effect of omalizumab in patients with severe allergic asthma that is inadequately controlled with standard therapy? Study design Multi-center Double blinded RCT Population Characteristics of study participants 66.0% female N = 850 34.0% male 850 patients (557 female, 291 male) Inclusion criteria: patients with inadequately controlled severe asthma who are receiving high- dose ICS and long-acting -agonists, with or without additional controller therapy Key exclusion criteria: asthma exacerbation requiring intubation in the 12 months before screening or an exacerbation requiring treatment with systemic corticosteroids in the 30 days before screening, active lung disease other than asthma, treatment with omalizumab in the 12 months before screening, elevated serum IgE levels for reasons other than allergy, or smoking history of 10 pack-years Interventions N=427 omalizumab (minimum dose of 0.008 mg/kg of body weight per IgE (IU/mL) every 2 weeks or 0.016 mg/kg per IgE (IU/mL) every 4 weeks for 48 weeks) N=423 placebo (matching placebo for 48 weeks) P i t https://web.pathway.md/studies/recve9CmhhRxapBwR 1/2 6/28/23, 10:10 PM EXTRA Pathway Primary outcome Asthma exacerbations at 48 weeks 0.9/pt 0.88 0.7/pt 0.66 0.4/pt 0.2/pt Significant decrease 0.0/pt Omalizumab Placebo Significant decrease in asthma exacerbations at 48 weeks (0.66 per patient vs. 0.88 per patient; IRR 0.75, 95% CI 0.61 to 0.92) Secondary outcomes Significant increase in AQLQ[S] scores (1.15 vs. 0.92; MD 0.23, 95% CI 0.07 to 0.39) Significant decrease in Asthma Symptom Score (-1.56 points vs. -1.3 points; MD -0.26, 95% CI -0.49 to -0.1) No significant difference in daily albuterol puffs (-1.58 puffs vs. -1.31 puffs; MD -0.28, 95% CI -0.6 to 0.04) Safety outcomes No significant difference in adverse events (80.4% vs. 79.5%) and serious adverse events (9.3% vs. 10.5%). Conclusion In patients with inadequately controlled severe asthma who are receiving high-dose ICS and long-acting -agonists, with or without additional controller therapy, omalizumab was superior to placebo with respect to asthma exacerbations at 48 weeks. Reference Hanania NA, Alpan O, Hamilos DL et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011 May 3;154(9):573-82. Open reference URL https://web.pathway.md/studies/recve9CmhhRxapBwR 2/2