Effect of Omalizumab as Add-On Therapy on Asthma-Related Quality of Life in Severe Allergic Asthma: A Brazilian Study (QUALITX)

Abstract

Objective. To assess the impact of omalizumab as an add-on therapy to standard treatment with inhaled corticosteroids (ICS) and long-acting beta-2 agonists (LABA) on asthma-related quality of life (QoL) in patients with severe allergic asthma. 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. Results. 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). Conclusion. Omalizumab was well tolerated and significantly improved the overall AQLQ score. Hence, it is a potential add-on therapy for severe persistent allergic asthma not controlled by standard prescribed treatment in Brazilian patients.

• AQLQ score
• Brazilian patients
• omalizumab
• severe persistent allergic asthma

Acknowledgments

The authors thank the patients who took part in the study and the staff at the participating clinical centers (Cukier A, Godoy AL, Pereira CA, Sole D, Sarinho E, Castro F, Ribeiro JD, Fiterman J, Stirbulov R, Rubini N, Jacob C, Pizzichini E, and Lundgren F). QUALITX Group: Castro F, Cukier A, Fiterman J, Godoy AL, Jacob CM, Lundgren F, Pereira CA, Pizzichini E, Ribeiro JD, Rubini N, Sarinho E, Sole D, and Stirbulov R.

Declaration of Interest

The authors thank Dr. Bhumika Gurnani (Novartis) for medical writing assistance in the preparation of the manuscript and PGS medical statistics for the assistance in the statistical section of the manuscript.

Adalberto Rubin has been consulting, participated in trials, and received lecture fees from AstraZeneca, Chiesi Pharmaceuticals, Pfizer, Novartis, Nycomed, MSD, GSK, and Boehringer Ingelheim. He holds no stock or other equities in pharmaceutical companies. Souza-Machado A and Andradre-Lima M are currently conducting clinical studies sponsored by Novartis. Ferreira F, Honda A, and Matozo TM are employees of Novartis.