Efficacy & Safety of Omalizumab in Indian Adult Patients with Severe Allergic Asthma: A Retrospective Observational Study

Abstract

Background: We designed the present study to understand the characteristics of patients who initiate Omalizumab in a real-world setting and understand the long-term outcomes of Omalizumab in India. Methods: This was a retrospective, observational, cohort study using the data from health records of a tertiary care center (June 2018 and May 2020) in north India. We included patients aged 18 years or over with IgE mediated asthma (IgE levels 30-1500 IU/ml) who were prescribed omalizumab therapy at MCRD Severe Asthma Clinic for a minimum duration of 16 weeks. Patients were evaluated at 16 weeks (±2 weeks) and 52 weeks(±4 weeks). Exacerbations, hospitalizations/emergency visits, medications, asthma control test (ACT) score, and lung function before/after initiation with omalizumab therapy were assessed. Results: A total of 101 patients were included in the study. The mean age of patients was 61.1 years, with only 24.8% patients aged less than 50 years The number of exacerbations per year significantly improved (p <0.001) from a mean baseline of 6.34±2.04 to 1.52±0.99 at 16 weeks, 2.81±1.63 at 52 weeks. We observed a significant improvement(p<0.001) in ACT score, frequency of OCS bursts, and FEV1 at 16 weeks and 52 weeks. There were statistically significant improvements(p<0.001) in hospitalizations/ER visits per year and reductions in mean ICS dosage and mean number of medications prescribed for asthma daily. Conclusion: Omalizumab led to improved asthma control, lung function, and QoL and allowed a reduction in the dosage of medications for asthma. The improvement was observed irrespective of age and biomarker levels.