Selected adverse events and disease flares by gender, total events (exposure-adjusted event rate per 100 patient-years of exposure)
| Women | Men | |||||
|---|---|---|---|---|---|---|
| Placebo (n=54) | SSZ (n=47) | ETN (n=225) | Placebo (n=175) | SSZ (n=140) | ETN (n=642) | |
| Adverse events | ||||||
| Serious infections | 0 (0) | 0 (0) | 0 (0) | 1 (1.00) | 0 (0) | 4 (2.19) |
| Opportunistic infections* | 1 (3.18) | 0 (0) | 0 (0) | 2 (2.00) | 0 (0) | 3 (1.64) |
| Malignancies | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Disease-related events and flares | ||||||
| Inflammatory bowel disease | 0 (0) | 0 (0) | 0 (0) | 1 (1.00) | 0 (0) | 2 (1.10) |
| Uveitis | 5 (27.37) | 1 (7.59) | 4 (6.42) | 11 (18.65) | 6 (14.58) | 15 (8.22) |
*Such as tuberculosis.25 ,26
ETN, etanercept; SSZ, sulfasalazine.