Table 5. Summary of mortality through week 54 by treatment (all IBD studies) and immunomodulator use status (pivotal phase 3 IBD trials).
|
Crohn's diseasea |
Ulcerative colitisa |
All inflammatory bowel diseasea |
||||
|---|---|---|---|---|---|---|
| Placebob | Infliximab | Placebob | Infliximab | Placebob | Infliximab | |
| Pts. treated | 217 | 1,427 | 248 | 493 | 465 | 1,920 |
| Total/median pt-yrs of follow-up | 124/0.5 | 1,230/1.0 | 210/0.6 | 833/1.0 | 334/0.6 | 2,063/1.0 |
| Deaths | ||||||
| No. (%) of pts. | 1 (0.5%) | 3 (0.2%) | 0 (0.0%) | 1 (0.2%) | 1 (0.2%) | 4 (0.2%) |
| P-valuec | 0.433 | 1 | 1 | |||
| Incidence/100 pt-yrs | 0.8 | 0.24 | 0 | 0.12 | 0.3 | 0.19 |
| 95% CId | (0.02, 4.48) | (0.05, 0.71) | (0.00, 1.43) | (0.00, 0.67) | (0.01, 1.67) | (0.05, 0.50) |
| Infection-related deaths | ||||||
| No. (%) of pts. | 1 (0.5%) | 2 (0.1%) | 0 (0.0%) | 1 (0.2%) | 1 (0.2%) | 3 (0.2%) |
| P-value | 0.346 | 1 | 0.58 | |||
| Incidence/100 pt-yrs | 0.8 | 0.16 | 0 | 0.12 | 0.3 | 0.15 |
| 95% CI |
(0.02, 4.48) |
(0.02, 0.59) |
(0.00, 1.43) |
(0.00, 0.67) |
(0.01, 1.67) |
(0.03, 0.43) |
| |
No immunomodulatore |
Immunomodulatorf |
No immunomodulatore |
Immunomodulatorf |
No immunomodulatore |
Immunomodulatorf |
| Pts. treated | 776 | 613 | 394 | 334 | 1,170 | 947 |
| Total/median pt-yrs of follow-up | 715/1.0 | 520/1.0 | 541/0.8 | 500/1.0 | 1,256/1.0 | 1,020/1.0 |
| Deaths | ||||||
| No. (%) of pts. | 2 (0.3%) | 2 (0.3%) | 0 (0.0%) | 1 (0.3%) | 2 (0.2%) | 3 (0.3%) |
| P-value | 1 | 0.459 | 0.662 | |||
| Incidence/100 pt-yrs | 0.28 | 0.38 | 0 | 0.2 | 0.16 | 0.29 |
| 95% CI | (0.03, 1.01) | (0.05, 1.39) | (0.00, 0.55) | (0.01, 1.11) | (0.02, 0.58) | (0.06, 0.86) |
AZA, azathioprine; CI, confidence interval; IBD, inflammatory bowel disease; 6-MP, 6-mercaptopurine; MTX, methotrexate; pts., patients; pt-yrs, patient-years.
a
Includes 7 Crohn's disease and 3 ulcerative colitis, or a total of 10, IBD studies when summarized by treatment and 3 Crohn's disease and 2 ulcerative colitis, or a total of 5, pivotal phase 3 IBD studies when summarized by baseline immunomodulator use.
b
With or without concomitant conventional therapy.
c
P-values comparing treatment or immunomodulator use subgroups were calculated with the use of Fisher's exact test.
d
95% CIs based on an exact method.
e
No receipt of AZA, 6-MP, or MTX at baseline.
f
Receipt of AZA, 6-MP, or MTX at baseline.