Chipps BE, et al. - This study offers a "real-world" characterization of asthmatics on omalizumab therapy, including disease and comorbidity burden. In the Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab (PROSPERO), poorly controlled asthma and a substantial disease burden was observed in patients initiating omalizumab.

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.
• Participants included were patients (≥12 years of age) with allergic asthma initiating omalizumab treatment based on physician-assessed need.
• Study participants were followed for 12 months.
• Monthly examination was also performed to assess exacerbations, health care use, adverse events, and Asthma Control Test (ACT) scores.
• Furthermore, an evaluation of biomarkers (blood eosinophils, fractional exhaled nitric oxide, and periostin) was undertaken 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.
• Additionally, the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) was completed at baseline and 12 months.

Results

• Data showed that most of the 806 enrollees (91.4%) were adults (mean age 47.3 years, SD 17.4), white (70.3%), and female (63.5%).
• In findings, allergic comorbidity was frequently reported (84.2%), as were hypertension (35.5%) and depression (22.1%).
• In the 12 months before study entry, at least 1 asthma-related hospitalization was reported by 22.1% of patients, at least 2 exacerbations by 60.7% , and ACT scores no higher than 19 (uncontrolled asthma) by 83.3%.
• Based on prespecified cut-points, most patients had low biomarker levels.
• In addition, it was noted that 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.