Introduction: To assess the long-term (5 year) efficacy of omalizumab and systemic corticosteroid therapy in allergic and non-allergic asthma that could not be controlled by step 4 therapy, respectively.
Patients and methods: This single-center study was based on all consecutive step 4 patients with severe persistent uncontrolled allergic and non-allergic asthma who were given omalizumab and systemic corticosteroid (minimum: 4 mg, maximum: 12 mg, median: 8 mg methyl prednisone), respectively, in 2006-2014 and were followed up for at least 5 years. Asthma control test (ACT), FEV1 and exacerbation rates at initial presentation and 1, 2, and 5 years after step 5 treatment initiation were calculated for both groups.
Result: There were 17 and 16 allergic and non-allergic group patients, respectively. Both groups exhibited significant improvements in ACT at the 1st, 2nd, and 5th years relative to baseline (all p< 0.01). The allergic group had significantly better ACTs at 16 weeks, 1 year, and 2 years than the non-allergic group (all p< 0.01). By the 5th year, the exacerbations in the non-allergic group rose significantly by 39.6% (3.3 on average) compared to baseline (2.38 on average, p< 0.001). By contrast, the allergic group continued to have significantly fewer exacerbations at the 5th year (77.1% fewer relative to baseline, p< 0.001). However, 47% of the allergic group patients still presented with one exacerbation in the 5th year.
Conclusions: Adding omalizumab to step 5 therapy improved the control of severe persistent allergic asthma. However, nearly half of the patients in both groups presented at least one exacerbation in the 5th year.