Abstract
Introduction: there are no studies in steroid-dependent allergic asthma patients that demonstrate the oral corticosteroid (OC) sparing capacity of omalizumab or its histological benefits.
Methodology: Open randomized study with two groups: OC + omalizumab (OMA G.) and OC alone (CG). At every monthly visit we recorded: accumulated and daily OC dose, exacerbations, spirometry, FeNO and adverse events. IgE measurement and bronchial biopsies were performed at baseline and after 12 months (immunohistochemical and EM).
Results: 31 patients (17 OMA; 14 CG) without baseline differences. OC dose was reduced by 83% in OMA G. and by 9.5% in CG (p=0.03). A reduction of 41% in exacerbation rate was observed in OMA G. compared to CG; (p=0.09); severe exacerbations and duration fell (p=0.02). FEV1 fell by 60 mL in OMA G. and by 320 mL in CG (p=ns). At month 12 between-group differences were observed in FeNO values (p=0.025). In OMA G IgE increased 3.4-fold, baseline membrane thickness and the intercellular spaces were reduced and the epithelial damage improved (and became focal); the presence of cilia improved(p<0.05). No differences were observed in the EGFR, galectin and e-cadherin immunostaining;the degree of epithelial detachment observed was elevated. There were no relevant secondary effects.
Conclusions: 1) OMA allowed a significant OC reduction. 2) OMA G. showed a clinical improvement which correlated with the improvement in bronchial pathology. 3) OMA allowed an improvement in bronchial remodeling. 4) The presence of e-cadherin in the biopsies may suggest that the lack of differences in the EGFR immunostaining was due to mucosal denudation. 5) Treatment with OMA was well-tolerated.
Footnotes
Cite this article as: European Respiratory Journal 2019; 54: Suppl. 63, OA5335.
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- Copyright ©the authors 2019