Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial
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Date
2018
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Abstract
Background: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. Methods: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV1, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. Results: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. Conclusion: Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good. © 2018 S. Karger AG, Basel. Copyright: All rights reserved.
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Adolescent , Adult , Aged , Aged, 80 and over , Anti-Asthmatic Agents , Asthma , Female , Forced Expiratory Volume , Humans , Male , Middle Aged , Omalizumab , Retrospective Studies , Young Adult , beta 2 adrenergic receptor stimulating agent , corticosteroid , leukotriene receptor blocking agent , neuroleptic agent , omalizumab , antiasthmatic agent , omalizumab , adult , aged , allergic asthma , Article , Asthma Control Test , chronopharmacology , clinical decision making , clinical evaluation , clinical outcome , comparative study , corticosteroid therapy , disease exacerbation , drug efficacy , drug safety , drug tolerability , drug withdrawal , female , forced expiratory volume , hospital patient , hospitalization , human , long term care , major clinical study , male , medical documentation , medical record review , medication compliance , myopathy , outcome variable , patient compliance , patient dropout , personal experience , pneumonia , pregnancy , priority journal , prostate carcinoma , retrospective study , self report , side effect , systemic therapy , traffic accident , treatment duration , treatment refusal , adolescent , asthma , clinical trial , middle aged , multicenter study , pathophysiology , very elderly , young adult