Summary of adverse events.
| Biologic-naive | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Events | Blinded, Weeks 0–16 | OLE, Weeks 16–64 | ||||||
| Placebo | Combined Dose Groups | All Patients | All Patients | |||||
| n = 54 | PY = 15.8 | n = 206 | PY = 61.9 | n = 260 | PY = 77.7 | n = 232 | PY = 235.6 | |
| % | IR | % | IR | % | IR | % | IR | |
| SAE | 1.9 | 0.06 | 3.4 | 0.11 | 3.1 | 0.10 | 7.3 | 0.07 |
| Serious infections | 0 | 0 | 0.5 | 0.02 | 0.4 | 0.01 | 2.2 | 0.02 |
| Neoplasms, benign, and malignant* | 1.9 | 0.06 | 0 | 0 | 0.4 | 0.01 | 0.3 | 0.01 |
| Deaths | 0 | NA | 0 | NA | 0 | NA | 0.9 | NA |
| TEAE | 55.6 | 1.90 | 59.2 | 1.97 | 58.5 | 1.96 | 72.4 | 0.71 |
| Discontinuations because of TEAE | 3.7 | NA | 1.5 | NA | 1.9 | NA | 1.3 | NA |
| Infections | 20.4 | 0.70 | 28.6 | 0.95 | 26.9 | 0.90 | 40.5 | 0.40 |
| TNF-IR | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Events | Blinded, Weeks 0–16 | OLE, Weeks 16–64 | ||||||
| Placebo | Combined Dose Groups | All Patients | All Patients | |||||
| n = 64 | PY = 18.4 | n = 124 | PY = 37.0 | n = 188 | PY = 55.4 | n = 158 | PY = 140.1 | |
| % | IR | % | IR | % | IR | % | IR | |
| SAE | 1.6 | 0.05 | 8.9 | 0.30 | 6.4 | 0.22 | 11.4 | 0.13 |
| Serious infections | 0 | 0 | 4.0 | 0.14 | 2.7 | 0.09 | 2.5 | 0.03 |
| Neoplasms, benign, and malignant* | 0 | 0 | 4.0 | 0.14 | 2.7 | 0.09 | 3.2 | 0.04 |
| Deaths | 0 | NA | 0 | NA | 0 | NA | 0.6 | NA |
| TEAE | 65.6 | 2.28 | 65.3 | 2.19 | 65.4 | 2.22 | 72.8 | 0.82 |
| Discontinuations because of TEAE | 0 | NA | 4.8 | NA | 3.2 | NA | 5.7 | NA |
| Infections | 29.7 | 1.03 | 31.5 | 1.05 | 30.9 | 1.05 | 40.5 | 0.46 |
↵* In the biologic-naive subpopulation, 1 malignancy (breast cancer) presented after the patient discontinued from the double-blind period of the study. In the TNF-IR subpopulation, 2 malignancies (bladder transitional cell carcinoma and breast cancer) occurred during the double-blind period, and 5 malignancies (2 basal cell carcinomas in the same patient, 1 metastatic lung adenocarcinoma, and 1 endometrial and 1 ovarian cancer in the same patient) occurred during the OLE. OLE: open-label extension; PY: patient year; IR: exposure-adjusted incidence rate; SAE: serious adverse event; TEAE: treatment-emergent adverse event; TNF-IR: tumor necrosis factor– inadequate responder; NA: IR not available for deaths and discontinuations due to TEAE.