Summary and predictors of gastrointestinal (GI) perforation estimated by univariate logistic regression analysisa.
| No. Patients with AE | No. Patients | (%) | OR | 95% CI | p | ||
|---|---|---|---|---|---|---|---|
| Total GI perforations | 36 | 5573 | (0.65) | ||||
| Sex | Female | 18 | 4542 | (0.40) | |||
| Male | 18 | 1031 | (1.75) | 4.467 | 2.316 to 8.615 | < 0.001 | |
| Age | < 65 yrs | 22 | 3552 | (0.62) | |||
| ≥ 65 yrs | 14 | 2019 | (0.69) | 1.120 | 0.572 to 2.195 | 0.740 | |
| Unknown | 0 | 2 | (0.00) | ||||
| Disease duration | < 10 yrs | 16 | 3146 | (0.51) | |||
| ≥ 10 yrs | 18 | 2149 | (0.84) | 1.652 | 0.841 to 3.248 | 0.145 | |
| Unknown | 2 | 278 | (0.72) | ||||
| Disease stage classified by Steinbrocker | Per 1 unit | 1.216 | 0.850 to 1.741 | 0.284 | |||
| Function classified by Steinbrocker | Per 1 unit | 2.309 | 1.362 to 3.913 | 0.002 | |||
| Unknown | 0 | 1 | (0.00) | ||||
| Complications or medical history | |||||||
| Diverticulum | No | 35 | 5554 | (0.63) | |||
| Yes | 1 | 19 | (5.26) | 8.760 | 1.138 to 67.434 | 0.037 | |
| Diverticulitis | No | 36 | 5564 | (0.65) | |||
| Yes | 0 | 9 | (0.00) | ||||
| Amyloidosis | No | 33 | 5467 | (0.60) | |||
| Yes | 3 | 106 | (2.83) | 4.799 | 1.449 to 15.894 | 0.010 | |
| GI ulcer | No | 30 | 5220 | (0.57) | |||
| Yes | 6 | 353 | (1.70) | 2.992 | 1.237 to 7.236 | 0.015 | |
| GI perforation | No | 36 | 5556 | (0.65) | |||
| Yes | 0 | 17 | (0.00) | ||||
| GI tract disturbance | No | 23 | 4244 | (0.54) | |||
| Yes | 13 | 1329 | (0.98) | 1.813 | 0.916 to 3.589 | 0.088 | |
| Astriction | No | 32 | 5283 | (0.61) | |||
| Yes | 4 | 290 | (1.38) | 2.295 | 0.806 to 6.534 | 0.120 | |
| Biologics (previous drug) | No | 12 | 2071 | (0.58) | |||
| Yes | 24 | 3502 | (0.69) | 1.184 | 0.591 to 2.373 | 0.634 | |
| NSAID (at the start of TCZ) | No | 16 | 1890 | (0.85) | |||
| Yes | 20 | 3683 | (0.54) | 0.640 | 0.331 to 1.237 | 0.184 | |
| Glucocorticoids (at the start of TCZ) | No | 7 | 1417 | (0.49) | |||
| Yes | 29 | 4156 | (0.70) | 1.415 | 0.618 to 3.236 | 0.411 | |
| Dose of glucocorticoids at baseline, mg/day | Per 1 mg/day | 1.022 | 1.004 to 1.041 | 0.017 | |||
| CRP at baseline | < 2.0 mg/dl | 14 | 2813 | (0.50) | |||
| ≥ 2.0 mg/dl | 20 | 2431 | (0.82) | 1.658 | 0.836 to 3.291 | 0.148 | |
| Unknown | 2 | 329 | (0.61) |
↵a Multiple classification analysis did not reveal that the number of GI perforations was too small for reliable analysis. Highlighted cells indicate covariates that were significant predictors of GI perforation. AE: adverse event; CRP: C-reactive protein; GI: gastrointestinal; NSAID: nonsteroidal antiinflammatory drugs; TCZ: tocilizumab.