Rubin AS et al. – Omalizumab was well tolerated and significantly improved the overall Asthma–related Quality of Life Questionnaire score. Hence, it is a potential add–on therapy for severe persistent allergic asthma not controlled by standard prescribed treatment in Brazilian patients.Methods
- This was a 20–week, randomized, open–label, study involving Brazilian patients (>12 years) with severe persistent allergic asthma inadequately controlled despite regular treatment with, at least, ICS (≥500 μg/day fluticasone or equivalent) ++ LABA.
- The primary objective was to assess the mean change from baseline in overall Asthma–related Quality of Life Questionnaire (AQLQ) score in omalizumab–treated patients compared with the control group.
- Secondary outcome measures included rescue medication use, incidence of asthma exacerbations, perception of treatment efficacy among patients, mean change from baseline in AQLQ score, and >1.5–point increase in overall AQLQ score.
- In the omalizumab group, overall AQLQ score was 3.2 (0.9) (mean [SD]) at baseline and 4.4 (1.3) at week 20 versus 3.0 (1.0) at baseline and 3.0 (1.1) at week 20 in the control group.
- Mean change from baseline on overall AQLQ score at week 20 in the omalizumab group was 1.2 (0.2) versus 0 (0.1) in the control group, showing a significant increase in scores from baseline in the omalizumab group (p < .001).
- There was also a statistically significant difference (p < .001) in the number of patients who showed a >1.5–point increase from baseline in overall AQLQ score after 20 weeks, thus indicating a better QoL in the omalizumab group.
- There was no significant difference with respect to the use of rescue medication, incidence of asthma exacerbation, and adverse events between treatment groups.
- The global evaluation of treatment effectiveness was significantly better for omalizumab (p < .001).