ABSTRACT
Objective: To evaluate the long-term efficacy and safety of omalizumab in asthma in a real-life setting
Subjects and Methods: This 4-year observational study included 65 patients treated with omalizumab during clinic visits; treatment response was rated as excellent, good, and partial based on a modified physician's Global Evaluation of Treatment Effectiveness [mGETE] scale of emergency room visits [ERV], hospitalization, use of oral corticosteroids, inhaled corticosteroid [ICS]/long-acting Beta-agonist [LABA] dose, and short-acting Beta-agonist rescue. The following tests were done: forced expiratory volume in 1 s [FEV1] and the asthma control test [ACT]. Measurements were performed 1 month before therapy and at 16 weeks, 1 year, and 4 years of treatment. Statistical analyses were done using the Wilcoxon signed-rank test, Spearman rank correlation, and McNemar X[2] test
Results: The dropout rate was 15 [18.5%]: 8 nonresponders [10.0%]; 2 patients died [2.5%], and 5 were lost to follow-up [6.25%]. Treatment response was excellent in 35 [53.8%]; good in 23 [35.4%], and partial in 7 patients [10.8%]. The number of excellent responders increased from 35 [53.8%] at 16 weeks to 48 [73.8%] at the 4-year follow-up. The number of patients who did not require ERV improved from 0 to 59 [90.8%], and the lowest rate of hospitalization was 1 in year 4 [p < 0.001]; patients who did not require courses of oral corticosteroids improved from 0 to 54 [83%]. ICS/LABA dose significantly reduced from 65 [100%] to 25 [38.5%] after 4 years of treatment [p < 0.001]; ACT scores significantly increased from 15 +/- 3 at baseline to 23 +/- 3 [p < 0.001] and FEV[1] level from 55.6 +/- 10.6 to 76.63 +/- 10.34 at year 4
Conclusion: In this study, omalizumab therapy resulted in better asthma control, and was effective and well tolerated as an add-on therapy for patients with moderate-to-severe asthma