Table 1.
Event | Monotherapy | Combination therapy | Source |
---|---|---|---|
Remission | 0.38 | 0.47 | SONIC week 50a,4 |
Responseb | 0.036 | 0.030 | SONIC week 50a,4 |
SAEc | 0.24 | 0.15 | SONIC week 544 |
Serious infectiond | 0.049 | 0.039 | SONIC week 544 |
Lymphomad | 0.0004 | 0.0006 | Kandiel et al,7 2005; Siegel et al,5 2009 |
Surgery for flare | 0.10 | 0.10 | Lewis et al,10 2000 |
Die of lymphoma (1 y) | 0.22 | 0.22 | SEER14 |
Die of serious infection | 0.05 | 0.05 | Siegel et al,e,8 2006 |
Die of surgery | 0.0008 | 0.0008 | Lewis et al,10 2000; Gregor et al,9 1997 |
Die of Crohn’s disease | 0.0018 | 0.0018 | Lewis et al,13 2008 |
Die all-cause mortality | 0.0012 | 0.0012 | US Life Table12 |
SONIC week 50 for all randomized patients, assuming that patients who did not enter trial extension did not achieve the end point through week 50.
Crohn’s disease activity index of 100 points drop.
SAE is an event other than serious infection.
Ranges for uniform sampling distributions used in probabilistic sensitivity analyses for outcomes of interest were serious infection with monotherapy, 0.03–0.07; serious infection with combination therapy, 0.02–0.06; lymphoma with monotherapy, 0.0001–0.0007; lymphoma with combination therapy, 0.0002–0.001.
Derived from Siegel et al, 2005 analysis.