Table 2. Efficacy End Points in the Intention-to-Treat Population*.
End Point | Mepolizumab (N = 68) |
Placebo (N = 68) |
Odds Ratio or Hazard Ratio (95% CI) | P Value |
---|---|---|---|---|
no. of participants (%) | ||||
Primary end points | ||||
Accrued weeks of remission over 52-wk period | 5.91 (2.68–13.03) | <0.001 | ||
0 wk | 32 (47) | 55 (81) | ||
>0 to <12 wk | 8 (12) | 8 (12) | ||
12 to <24 wk | 9 (13) | 3 (4) | ||
24 to <36 wk | 10 (15) | 0 | ||
≥36 wk | 9 (13) | 2 (3) | ||
Remission at wk 36 and wk 48 | 22 (32) | 2 (3) | 16.74 (3.61–77.56) | <0.001 |
Other end points | ||||
Remission within the first 24 wk that was sustained until wk 52 | 13 (19) | 1 (1) | 19.65 (2.30–167.93) | 0.007 |
First EGPA relapse | 38 (56) | 56 (82) | 0.32 (0.21–0.50) | <0.001 |
Odds ratios are shown for the analyses of the two primary end points and for the secondary analysis of remission within the first 24 weeks that was sustained until week 52. For the analysis of accrued weeks in remission, the odds ratio is for 24 or more weeks of accrued remission. Remission was defined as a BVAS of 0 (on a scale from 0 to 63, with higher scores indicating greater disease activity) and a prednisolone or prednisone dose of 4.0 mg or less per day. For the time-to-event analysis of the first relapse of EPGA, the hazard ratio is shown. Participants with a first EGPA relapse were those who had a relapse before the completion of the planned trial period or who withdrew prematurely from the trial.