4. Corticosteroid use during steroid‐tapering phase.
Solèr 2001 | Busse 2001 | Milgrom 2001 | Holgate 2004 | Pooled estimates | |
Baseline mean ICS dose (omalizumab/placebo) | 766/777 | 564/522 | 284/267 | 1407/1376 | N/A |
Length of study (weeks) | 52 | 28 | 28 | 32 | N/A |
Length of tapering phase | 12 | 12 | 12 | 16 | N/A |
Mean daily ICS dose at end of tapering phase (omalizumab/placebo) | 213/378 Source: FDA website | 193/274 Source: FDA website | N/A | 506/690 Source: unpublished data (Acumed) | N/A |
Change in CS dose (omalizumab/placebo), mcg | Mean change (ICS): ‐553/‐399 Source: FDA website | Mean change (ICS): ‐371/‐278 Source: FDA website | N/A | Mean change (ICS): ‐782/‐596 Source: published paper | Busse 2001/Solèr 2001/Holgate 2004: WMD ‐119 mcg/d (95% CI ‐153.72 to ‐84.34) |
Median (95% CI) daily ICS dose at end of tapering (omalizumab/placebo) | 100 (0 to 400)/300 (100 to 600) | N/A | N/A | N/A | N/A |
Change (%) (omalizumab/placebo) | 72/51 | 66/50 | Median change (ICS): 100/67 P = 0.001 | Median change (ICS): 60/50 P = 0.003 Source: FDA website Median change (OCS): 69%/75% P = 0.7 |
N/A |
Number of participants achieving > 50% reduction in ICS dose (n/N) (omalizumab/placebo) | 216/274 150/272 | 194/268 141/257 | 174/216 68/101 | 94/126 61/120 | OR 2.5 (95% CI 2.02 to 3.10) NNTB five to seven |
Number of participants achieving complete ICS withdrawal (omalizumab/placebo) | 118/274 53/272 | 106/268 49/257 | 119/216 39/101 | 27/126 18/120 | OR 2.5 (95% CI 2.0 to 3.13) NNTB five to eight |