Table 5.
Summary of adverse events in studies of adalimumab for adults with psoriasis
| Events (E/100 PY) | Phase II, 12-week placebo-controlled study | Open-label extension study | |||
|---|---|---|---|---|---|
| PBO (n = 52) PY 11.9 |
EOW (n = 45) PY 10.2 |
EW (n = 50) PY 11.1 |
EOW (n = 1256) PY 2787.2 |
EW (n = 349) PY 222.4 |
|
| Any AE | 84 (705.9) | 62 (607.8) | 110 (991.0) | 6623 (237.6) | 517 (232.5) |
| Serious AE | 0 | 1 (9.8) | 3 (27.0) | 181 (6.5) | 17 (7.6) |
| Any AE leading to discontinuation | 1 (8.4) | 2 (19.6) | 3 (27.0) | 80 (2.9) | 22 (9.9) |
| Death | 0 | 0 | 0 | 4 (0.1) | 1 (0.4) |
| AEs of special interest | |||||
| Infections | 8 (67.2) | 8 (78.4) | 14 (126.1) | 2029 (72.8) | 144 (64.8) |
| Opportunistic infectionsa | 0 | 0 | 0 | 6 (0.2) | 1 (0.4) |
| Serious infectionb | 0 | 0 | 1 (9.0) | 33 (1.2) | 2 (0.9) |
| Tuberculosis (active or latent) | 0 | 0 | 0 | 5 (0.2) | 0 |
| Injection-site reaction | 13 (109.2) | 8 (78.4) | 20 (180.2) | 174 (6.2) | 3 (1.3) |
| Lupus-like syndrome | 0 | 0 | 0 | 0 | 0 |
| Lymphoma | 0 | 0 | 0 | 0 | 0 |
| Malignancyc | 0 | 0 | 1 (9.0) | 14 (0.5) | 3 (1.3) |
| NMSC | 0 | 1 (9.8) | 0 | 19 (0.7) | 1 (0.4) |
| Worsening/new onset psoriasis | 4 (33.6) | 0 | 1 (9.0) | 43 (1.5) | 8 (3.6) |
| CHF | 0 | 0 | 0 | 5 (0.2) | 3 (1.3) |
AE adverse event, CHF congestive heart failure, E events, EOW every-other-week dosing of adalimumab, EW every-week dosing of adalimumab, NMSC non-melanoma skin cancer, PBO placebo, PY patient-year
aExcluding oral candidiasis and tuberculosis
bExcluding tuberculosis in the placebo-controlled study, but including tuberculosis in the open-label study
cExcluding lymphoma and NMSC in the placebo-controlled study and excluding lymphoma, NMSC, melanoma, leukemia, and hepatosplenic T-cell lymphoma in the open-label study