Predictors of serious infections in the phase 3 safety population
| Variable* | Patients† | Serious infections | Adjusted results | |
|---|---|---|---|---|
| HR (95% CI) | p Value | |||
| UC phase 3 population | n=1114 | n=59 | ||
| Age, mean years±SD | 40.4±13.4 | 42.1±15.1 | 1.00 (0.98 to 1.02) | 0.98 |
| Sex, female, n (%) | 462 (42) | 28 (48) | 1.10 (0.65 to 1.85) | 0.72 |
| Disease duration ≥7 years, n (%) | 404 (36) | 22 (37) | 0.94 (0.54 to 1.63) | 0.82 |
| Prior anti-TNF therapy failure, n (%) | 483 (45) | 33 (56) | 1.99 (1.16 to 3.42) | 0.0122 |
| Baseline disease activity, mean Mayo score±SD | 5.9±1.8 | 5.9±1.6 | 0.96 (0.82 to 1.12) | 0.56 |
| On-study narcotic use, n (%) | 323 (29) | 34 (58) | 2.68 (1.57 to 4.58) | 0.0003 |
| On-study corticosteroid use, n (%) | 430 (39) | 22 (37) | 1.58 (0.92 to 2.71) | 0.10 |
| Baseline immunosuppressive use, n (%) | 359 (32) | 24 (41) | 1.68 (0.98 to 2.87) | 0.06 |
| Vedolizumab treatment, n (%)‡ | 1077 (97) | 56 (95) | N/A | N/A |
| CD phase 3 population | n=1770 | n=148 | ||
| Age, mean years±SD | 36.8±12.5 | 34.6±11.8 | 0.97 (0.95 to 0.98) | <0.0001 |
| Sex, female, n (%) | 974 (55) | 88 (60) | 1.30 (0.93 to 1.82) | 0.12 |
| Disease duration ≥7 years, n (%) | 929 (53) | 84 (57) | 1.18 (0.82 to 1.68) | 0.37 |
| Prior anti-TNF therapy failure, n (%) | 1127 (64) | 95 (65) | 0.82 (0.57 to 1.19) | 0.30 |
| Baseline disease activity, mean HBI score±SD | 11.0±3.6 | 10.9±3.4 | 1.01 (0.96 to 1.06) | 0.70 |
| On-study narcotic use, n (%) | 731 (41) | 96 (65) | 2.72 (1.90 to 3.89) | <0.0001 |
| On-study corticosteroid use, n (%) | 708 (40) | 66 (45) | 1.88 (1.35 to 2.63) | 0.0002 |
| Baseline immunosuppressive use, n (%) | 558 (32) | 41 (28) | 0.78 (0.54 to 1.13) | 0.19 |
| Vedolizumab treatment, n (%)‡ | 1712 (97) | 144 (97) | N/A | N/A |
| Combined phase 3 population | N=2884 | n=207 | ||
| Age, mean years±SD | 38.2±13.0 | 36.8±13.2 | 0.98 (0.97 to 1.00) | 0.0003 |
| Sex, female, n (%) | 1436 (50) | 116 (56) | 1.28 (0.97 to 1.69) | 0.09 |
| Disease duration ≥7 years, n (%) | 1333 (46) | 106 (51) | 1.12 (0.84 to 1.50) | 0.44 |
| Prior anti-TNF therapy failure, n (%) | 1610 (57) | 128 (62) | 1.19 (0.88 to 1.62) | 0.26 |
| Baseline disease activity, mean score±SD§ | 5.7±1.8 | 5.6±1.7 | 0.98 (0.91 to 1.07) | 0.68 |
| On-study narcotic use, n (%) | 1054 (37) | 130 (63) | 2.76 (2.06 to 3.72) | <0.0001 |
| On-study corticosteroid use, n (%) | 1138 (40) | 88 (43) | 1.72 (1.30 to 2.28) | 0.0002 |
| Baseline immunosuppressive use, n (%) | 917 (32) | 65 (31) | 0.97 (0.72 to 1.31) | 0.86 |
| Vedolizumab treatment, n (%)‡ | 2789 (97) | 200 (97) | N/A | N/A |
*Baseline values are reported for the combined placebo-treated and vedolizumab-treated population with the exception of corticosteroid use. On-study corticosteroid use was defined by corticosteroid use within 30 days before infection date.
†Includes placebo-exposed and vedolizumab-exposed patients.
‡Vedolizumab was not included as a covariate in the model because nearly all patients in the study population (97%) were exposed to vedolizumab.
§The baseline disease activity common index ranges from 0 to 9 and allows for pooling UC and CD disease activity markers.
anti-TNF, tumour necrosis factor α antagonist; CD, Crohn's disease; HBI, Harvey-Bradshaw index; N/A, not applicable; SD, standard deviation; UC, ulcerative colitis.