Abstract
A retrospective study of UK practice demonstrated that omalizumab reduced oral corticosteroid (OCS) burden and exacerbations. The aim of this observational study was to confirm these findings prospectively. Retrospective data were collected in 12 months prior to omalizumab, prospective data were collated at 16 weeks, 8 and 12 months following initiation. Primary endpoint was the change in mean daily OCS dose in 12 months pre and post omalizumab initiation. Secondary endpoints included changes in mean exacerbation frequency. 257 patients were enrolled (mean 45yr, female 65%), 218 patients (85%) completed. At 16 weeks assessment 197/239 patients (82%) were classified as responders. At 12 months, mean daily OCS dose decreased by 15% (p<0.001, n=172). 49% of patients stopped OCS (n=84/172) and 63% patients (n=109/173) stopped or reduced OCS by ≥20%. Comparing the 12 month periods mean exacerbations decreased 44% from (mean, SD) 4.70 ±2.87 to 2.64±2.54 (n=172; difference -2.06, p<0.001) and mean exacerbations involving hospitalisations decreased 58% from 1.67±1.98 to 0.71±1.43 (n=215,difference -0.96, p<0.001).
Overall patients | |||
12 months pre | 12 months post | Difference, % difference, p-value | |
Mean number of exacerbations (SD) | 4.70 (2.87) | 2.64 (2.54) | -2.06, 44%, p<0.001 (n=172) |
Mean number exacerbations requiring hospitalisation (SD) | 1.67 (1.98) | 0.71 (1.43) | -0.96, 58%, p<0.001 (n=215) |
Mean total quantity OCS (g) per patient (SD) | 3.85 (2.69) | 3.29 (3.17) | -0.56, 15%, p<0.001 (n=173) |
Mean daily OCS dose (mg) (SD) | 10.55 (7.37) | 9.01 (8.69) | -1.5, 15%, p<0.001 (n=173) |
This study prospectively confirms omalizumab is associated with a significant reduction in OCS burden and exacerbations in severe allergic asthma.
- Copyright ©ERS 2015