Table 4.
Summary of adverse events in placebo-controlled analysis populations from studies of adalimumab for adults with hidradenitis suppurativa
| Events (E/100 PY) | Phase II, 16-week placebo-controlled study | Phase III pooled 24-week placebo-controlled period Ba | ||||
|---|---|---|---|---|---|---|
| PBO (n = 51) PY 14.5 |
EOW (n = 52) PY 16.2 |
EW (n = 51) PY 15.0 |
EW/PBO (n = 100) PY 31.8 |
EW/EOW (n = 101) PY 33.1 |
EW/EW (n = 99) PY 35.4 |
|
| Any AE | 105 (723.1) | 126 (783.6) | 124 (827.2) | 188 (591.2) | 163 (492.4) | 167 (471.8) |
| Serious AE | 2 (13.8) | 3 (18.5) | 4 (26.7) | 2 (6.3) | 7 (21.1) | 5 (14.1) |
| Any AE leading to discontinuation | 0 | 2 (12.4) | 2 (13.3) | 2 (6.3) | 2 (6.0) | 2 (5.6) |
| Death | 0 | 0 | 0 | 0 | 1 (3.0) | 0 |
| AEs of special interest | ||||||
| Infections | 36 (247.9) | 32 (199.0) | 30 (200.1) | 55 (173.0) | 46 (139.0) | 45 (127.1) |
| Opportunistic infectionsb | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious infections | 0 | 1 (6.2) | 2 (13.3) | 0 | 0 | 1 (2.8) |
| Tuberculosis (active or latent) | 0 | 0 | 0 | 0 | 0 | 0 |
| Injection-site reactions | 1 (6.9) | 1 (6.2) | 11 (73.4) | 1 (3.1) | 1 (3.0) | 1 (2.8) |
| Lupus-like syndrome | 0 | 0 | 0 | 1 (3.1) | 0 | 0 |
| Lymphoma | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignancyc | 0 | 0 | 1 (6.7) | 0 | 0 | 0 |
| NMSC | 0 | 0 | 0 | 0 | 1 (3.0) | 0 |
| Worsening/new onset psoriasis | 2 (13.8) | 0 | 0 | 1 (3.1) | 1 (3.0) | 3 (8.5) |
| CHF | 0 | 0 | 0 | 0 | 1 (3.0) | 0 |
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
aPeriod B double-blind, placebo-controlled phase. EW/PBO indicates an initial period of EW treatment followed by PBO treatment; EW/EOW indicates an initial period of EW treatment followed by EOW treatment; EW/EW indicates an initial period of EW treatment followed by continued EW treatment
bExcluding oral candidiasis and tuberculosis
cExcluding lymphoma and NMSC in the phase II study and lymphoma, NMSC, melanoma, leukemia, and hepatosplenic T-cell lymphoma in the phase III pooled data