Noelle M. Griffin

Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO

BACKGROUND Patients included in clinical trials do not necessarily reflect the real-world population. OBJECTIVE To understand the characteristics, including disease and comorbidity burden, of patients with asthma receiving omalizumab in a real-world setting. METHODS The Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab (PROSPERO) was a US-based, multicenter, single-arm, and prospective study. Patients (≥12 years of age) with allergic asthma initiating omalizumab treatment based on physician-assessed need were included and followed for 12 months. Exacerbations, health care use, adverse events, and Asthma Control Test (ACT) scores were assessed monthly. Biomarkers (blood eosinophils, fractional exhaled nitric oxide, and periostin) were evaluated and patient-reported outcomes (Asthma Quality of Life Questionnaire for 12 Years and Older [AQLQ+12] and Work Productivity and Activity Impairment: Asthma questionnaire [WPAI:Asthma]) were completed at baseline and months 6 and 12. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) was completed at baseline and 12 months. RESULTS Most of the 806 enrollees (91.4%) were adults (mean age 47.3 years, SD 17.4), white (70.3%), and female (63.5%). Allergic comorbidity was frequently reported (84.2%), as were hypertension (35.5%) and depression (22.1%). In the 12 months before study entry, 22.1% of patients reported at least 1 asthma-related hospitalization, 60.7% reported at least 2 exacerbations, and 83.3% reported ACT scores no higher than 19 (uncontrolled asthma). Most patients had low biomarker levels based on prespecified cut-points. Baseline mean patient-reported outcome scores were 4.0 (SD 1.4) for AQLQ+12, 2.7 (SD 1.4) for MiniRQLQ, and 47.7 (SD 28.9) for WPAI:Asthma percentage of activity impairment and 33.5 (SD 28.7) for percentage of overall work impairment. CONCLUSION The population initiating omalizumab in PROSPERO reported poorly controlled asthma and a substantial disease burden. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01922037.

Cost and health care utilization in patients with asthma and high oral corticosteroid use

Disclosures: Ms Raimundo and Dr Griffin are employed by Genentech. Drs Chang and Broder are employees of the Partnership for Health Analytic Research, LLC, a health services research company paid by Genentech to conduct this research. Dr Ngai is a consultant for Partnership for Health Analytic Research, LLC. Funding Sources: This research was funded by Genentech, Inc. [3] Khoo J, Shek LP, Khor ES, Wang DY, Lee BW. Pattern of sensitization to common environmental allergens amongst atopic Singapore children in the first 3 years of life. Asian Pac J Allergy Immunol. 2001;19:225e229. [4] Maitra A, Sherriff A, Strachan D, Henderson J. Mode of delivery is not associated with asthma or atopy in childhood. Clin Exp Allergy. 2004;34:1349e1355. [5] Leung JY, Li AM, Leung GM, Schooling CM. Mode of delivery and childhood hospitalizations for asthma and other wheezing disorders. Clin Exp Allergy. 2015;45:1109e1117. [6] Magnus MC, Håberg SE, Stigum H, et al. Delivery by cesarean section and early childhood respiratory symptoms and disorders: the Norwegian Mother and Child Cohort Study. Am J Epidemiol. 2011;174:1275e1285. [7] Tollånes MC, Moster D, Daltveit AK, Irgens LM. Cesarean section and risk of severe childhood asthma: a population-based cohort study. J Pediatr. 2008; 153:112e116.e1. [8] Spahr JE, Krawiec ME. The early origins of asthma: nature, nurture, or parturition? Ann Allergy Asthma Immunol. 2005;94:211e212. [9] Almqvist C, Cnattingius S, Lichtenstein P, Lundholm C. The impact of birth mode of delivery on childhood asthma and allergic diseases: a sibling study. Clin Exp Allergy. 2012;42:1369e1376. [10] Sausenthaler S, Koletzko S, Schaaf B, et al. Maternal diet during pregnancy in relation to eczema and allergic sensitization in the offspring at 2 y of age. Am J Clin Nutr. 2007;85:530e537.