Background A previous retrospective study of UK clinical practice demonstrated that omalizumab was associated with reduced exacerbations and healthcare utilisation in severe allergic asthmatics.
Aim This multicentre observational study was conducted to confirm the observed retrospective findings prospectively in UK clinical practice.
Methods Retrospective data were collected in the 12 months prior to and prospective data for up to 12 months following omalizumab initiation. The primary endpoint was the change in mean daily OCS dosage (reported previously). Secondary endpoints included changes in mean exacerbation frequency (defined as requiring hospital admission or Accident and Emergency (A&E) attendance and/or a course of OCS (dosage increase of at least 10 mg/day for at least 3 days)), healthcare utilisation and missed days in education or at work.
Results 235 patients were enrolled in the study at end December 2013 in 22 UK centres. Data for interim analysis were examined from patients with 12 months of assessment at database lock (n = 85, females, 54%, mean (±SD) age 44 yr (±13.2), mean (±SD) duration of asthma 26 yr (±14.0)). At the 16 weeks assessment 74/85 (87%) patients were classified as responders to omalizumab treatment. Comparing the 12 month periods prior to and following initiation of omalizumab, mean total exacerbations decreased by 51% from (mean, ±SD) 4.25 ± 2.73 to 2.07 ± 2.01 (mean difference 2.18, p < 0.001), while mean exacerbations involving hospital visits decreased by 61% from 1.52 ± 2.00 to 0.59 ± 1.25 (difference 0.93, p < 0.001). A&E attendances were reduced from 54 to 19 (p < 0.01) and inpatient hospitalisations from 85 to 36 (p < 0.001). The percentage of average days absent from work or education due to sickness was more than halved in the 12 months pre and post omalizumab initiation reducing from 19.6% to 7.72% (n = 27, p < 0.05).
Conclusions The data prospectively confirms that omalizumab is associated with significant reduction in exacerbations, healthcare utilisation and societal burden in severe allergic asthma patients as was reported in the retrospective study.
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