Table 2.
Incidence of AEs and ADRs to CT-P13 by disease and prior treatment status
| Total | RA | CD | UC | PS | Naïve to biologics | Switched from IFX | Switched from other biologics | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n = 1816 | n = 987 | n = 342 | n = 322 | n = 165 | n = 725 | n = 894 | n = 197 | |||||||||
| AEs | 634 | 34.9% | 318 | 32.2% | 132 | 38.6% | 140 | 43.5% | 44 | 26.7% | 293 | 40.4% | 258 | 28.9% | 83 | 42.1% |
| Serious AEs | 138 | 7.6% | 69 | 7.0% | 37 | 10.8% | 24 | 7.5% | 8 | 4.8% | 60 | 8.3% | 55 | 6.2% | 23 | 11.7% |
| AEs leading to discontinuation | 184 | 10.1% | 93 | 9.4% | 30 | 8.8% | 46 | 14.3% | 15 | 9.1% | 88 | 12.1% | 62 | 6.9% | 34 | 17.3% |
| AEs leading to death | 8 | 0.4% | 3 | 0.3% | 2 | 0.6% | 2 | 0.6% | 1 | 0.6% | 3 | 0.4% | 4 | 0.4% | 1 | 0.5% |
| ADRs | 439 | 24.2% | 224 | 22.7% | 82 | 24.0% | 104 | 32.3% | 29 | 17.6% | 221 | 30.5% | 152 | 17.0% | 66 | 33.5% |
| Serious ADRs | 84 | 4.6% | 51 | 5.2% | 14 | 4.1% | 17 | 5.3% | 2 | 1.2% | 41 | 5.7% | 26 | 2.9% | 17 | 8.6% |
| ADRs leading to discontinuation | 169 | 9.3% | 89 | 9.0% | 24 | 7.0% | 45 | 14.0% | 11 | 6.7% | 87 | 12.0% | 49 | 5.5% | 33 | 16.8% |
| ADRs leading to deatha | 4 | 0.2% | 1 | 0.1% | 1 | 0.3% | 1 | 0.3% | 1 | 0.6% | 1 | 0.1% | 3 | 0.3% | 0 | 0.0% |
| ADRs of special interest | ||||||||||||||||
| Infusion reactions | 149 | 8.2% | 60 | 6.1% | 32 | 9.4% | 46 | 14.3% | 11 | 6.7% | 70 | 9.7% | 47 | 5.3% | 32 | 16.2% |
| Infections | 110 | 6.1% | 73 | 7.4% | 12 | 3.5% | 24 | 7.5% | 1 | 0.6% | 56 | 7.7% | 40 | 4.5% | 14 | 7.1% |
| Serious infections | 32 | 1.8% | 23 | 2.3% | 1 | 0.3% | 8 | 2.5% | 0 | 0.0% | 16 | 2.2% | 9 | 1.0% | 7 | 3.6% |
| Tuberculosis | 4 | 0.2% | 2 | 0.2% | 1 | 0.3% | 1 | 0.3% | 0 | 0.0% | 3 | 0.4% | 0 | 0.0% | 1 | 0.5% |
| Interstitial lung disease | 16 | 0.9% | 11 | 1.1% | 1 | 0.3% | 1 | 0.3% | 3 | 1.8% | 7 | 1.0% | 6 | 0.7% | 3 | 1.5% |
| Neoplasmsb | 6 | 0.3% | 4 | 0.4% | 0 | 0.0% | 2 | 0.6% | 0 | 0.0% | 2 | 0.3% | 3 | 0.3% | 1 | 0.5% |
ADR adverse drug reaction, AE adverse event, CD Crohn’s disease, IFX infliximab, PS psoriasis, RA rheumatoid arthritis, UC ulcerative colitis
aTwo patients with interstitial pneumonia, one patient with pancytopenia followed by mesenteric hemorrhage and pneumonia, and one patient with an unknown cause of death
bGastric cancer in two patients, gastric carcinoid, hepatocellular carcinoma, lymphoproliferative disorder, and cutaneous T-cell lymphoma