The real world effect of omalizumab add on therapy for patients with moderate to severe allergic asthma: The ASTERIX Observational study.

Omalizumab is a non-steroidal medication indicated for the treatment of poorly controlled moderate-to-severe allergic asthmatics. This observational study examines the "real world" effectiveness of omalizumab in this population.This is a one year open-label observational study that compared clinical outcomes including total oral corticosteroid use, exacerbation history, measures of quality of life and inflammation in patients with moderate-to-severe allergic asthma, who were prescribed omalizumab as part of their treatment with the year prior to therapy.A total of 99 patients were enrolled at 25 sites in Canada. During the study period, the mean total annual OCS dose was reduced from 2301.5 mg (prednisone equivalents) in the year prior to omalizumab to 1130.0 mg (p<0.0001). There was a 71% reduction in asthma exacerbations and 56% of patients on omalizumab remained exacerbation free when compared to the year prior to study entry. Associated with this was reduced health care utilization. There were significant improvements in the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life questionnaire (AQLQ) Patients with an elevated FeNO at baseline showed a better response to treatment. No new safety issues were identified during the study period.Our study demonstrates that in "real world" clinical practice, after initiating omalizumab, there is a reduction in total OCS use and exacerbation frequency in patients with moderate-to-severe allergic asthma. Patients on treatment reported improved asthma control and quality of life. FeNO may be a useful biomarker to identify patients who may benefit with omalizumab treatment

Mean change in total annual oral corticosteroid (OCS) dose [¹] (ITT population).

<p>Mean change in total annual oral corticosteroid (OCS) dose [^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0183869#t002fn001" target="_blank">1</a>}] (ITT population).</p

Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) total scores during treatment with omalizumab (ITT population).

<p>Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) total scores during treatment with omalizumab (ITT population).</p

Percent change in total annual OCS dose and number of severe asthma exacerbations in Low/High FeNO baseline subgroups from baseline to end of prospective period (ITT population).

<p>Percent change in total annual OCS dose and number of severe asthma exacerbations in Low/High FeNO baseline subgroups from baseline to end of prospective period (ITT population).</p

Change from baseline in Asthma Control Questionnaire (ACQ) total score [¹] during the prospective period (ITT population).

<p>Change from baseline in Asthma Control Questionnaire (ACQ) total score [^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0183869#t004fn001" target="_blank">1</a>}] during the prospective period (ITT population).</p

Change from baseline in Forced Exhaled Nitric Oxide (FeNO) mean values [¹] during the prospective period (ITT / FeNO population).

<p>Change from baseline in Forced Exhaled Nitric Oxide (FeNO) mean values [^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0183869#t006fn001" target="_blank">1</a>}] during the prospective period (ITT / FeNO population).</p

Number (%) of subjects experiencing severe asthma exacerbations [¹] and change from baseline health resource utilization (ITT population).

<p>Number (%) of subjects experiencing severe asthma exacerbations [^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0183869#t003fn001" target="_blank">1</a>}] and change from baseline health resource utilization (ITT population).</p

Demographics and baseline characteristics.

<p>Demographics and baseline characteristics.</p

All Serious adverse events.

<p>All Serious adverse events.</p