Abstract
Objective: SAA is frequently inadequately controlled despite intensive guideline-based therapy. Disease control can be improved by targeting allergic inflammatory processes underlying its pathogenesis.
Methods: SMILE was a prospective, multicenter, observational, study designed to assess the clinical effects of omalizumab over a period of 18 months of treatment in everyday clinical practice. Clinical variables including quality of life (QoL), asthma symptoms, exacerbations, hospitalizations, visits to ER and lung function were evaluated at baseline and at pre-specified time points. Work productivity and activity impairment was measured through the WPAI-AA questionnaire. Safety data were also recorded.
Results: Overall 169 SAA patients were recruited. Omalizumab therapy resulted in significant improvements in QoL; mean AQLQ score increase of 2.41; (p<0.001). The QoL improvement was also depicted at the reduction of asthma symptoms such as cough, phlegm, dyspnea and wheezing (p<0.001). Mean number of exacerbations, hospitalizations and ER visits was reduced from 5.7, 0.9 and 3.4 visits/year before initiation of omalizumab treatment to 0.2, 0.0 and 0.0 at month 18, respectively (p<0.001). Lung function was significantly improved while the overall work and activity impairment was significantly decreased (p<0.001). Most frequent adverse events reported were dyspnea and cough.
Conclusions: The results of the SMILE study (albeit being single-arm) suggest therapeutic benefits recorded in a “real-world” setting are consistent with the ones demonstrated in omalizumab's randomized controlled trials, with a similar safety and tolerability profile.
The study was sponsored by Novartis.
- Copyright ©the authors 2016