Outcome Of Childhood Asthma Observational Follow-up Study In First 4 Years In Japan

Abstract

M O N D A Y 553 Omalizumab Improves Patient-Reported Outcomes In Patients With Allergic (IgE-mediated) Asthma W.H. Yang, P. Georgiou, J. Canvin, C. Chen, G. Peachey; Allergy & Asthma Research Centre, Ottawa, ON, CANADA, Novartis Horsham Research Centre, Horsham, UNITED KINGDOM, Novartis Pharmaceuticals, East Hanover, NJ. RATIONALE: Goals of asthma management are to optimise asthma control and improve health-related quality of life (QoL). Patient-reported outcomes (PROs) such as the asthma control test (ACT), the asthma control questionnaire (ACQ), and the asthma quality of life questionnaire (AQLQ) are important in evaluating the impact of asthma treatment. Omalizumab has demonstrated QoL improvements in clinical trials, but real-world evaluation is desirable. METHODS: eXpeRience is a multicenter, non-interventional, singlearm, observational registry evaluating the efficacy and safety of omalizumab in patients with allergic asthma. Interim data are available forWeek 16 and Month 8 of this 2-year registry. Data are presented for the ACT, ACQ, AQLQ and mini-AQLQ. Values are means6SDs. RESULTS: This analysis included 876 patients (age 44.9615.12 years). The ACToverall score at baselinewas 12.964.49. Omalizumab resulted in clinically meaningful changes from baseline (>_3 point increase) at Week 16 (5.264.70) and Month 8 (6.165.30). Omalizumab recipients also had clinically relevant changes (>_0.5 point decrease) in ACQ overall scores at Week 16 (-0.9860.989) and Month 8 (-0.7461.174) compared with baseline (overall score at baseline 2.760.954). Asthma-related QoL also improved. Overall AQLQ and mini-AQLQ scores at baseline were 4.2261.281 and 3.8161.180, respectively. Clinically meaningful improvements (>_0.5 point increase) in QoL scores were observed following both 16 weeks (AQLQ, 0.8960.932 and; mini-AQLQ 1.1061.139) and 8 months of omalizumab treatment (AQLQ 1.0461.341; mini-AQLQ 1.2461.323). CONCLUSIONS: Treatment with omalizumab was associated with clinically meaningful and sustained improvements in patient reported outcomemeasures of asthma control and asthma-related QoL in real-world management of severe allergic asthma.