Table 4.
Adverse events
| Patients, n (%) | Overall | Prior exposure to systemic therapies | Lack of response to systemic therapies | |||
|---|---|---|---|---|---|---|
| Placebo (n = 503) | Adalimumab (n = 966) | Placebo (n = 269) | Adalimumab (n = 511) | Placebo (n = 69) | Adalimumab (n = 160) | |
| AE | 297 (59) | 615 (64) | 162 (60) | 311 (65) | 47 (68) | 96 (60) |
| Serious AE | 8 (2) | 18 (2) | 1 (<1) | 10 (2) | 0 | 4 (3) |
| AE leading to discontinuation | 11 (2) | 18 (2) | 5 (2) | 8 (2) | 5 (7) | 5 (3) |
| Severe AE | 15 (3) | 27 (3) | 5 (2) | 12 (2) | 2 (3) | 6 (4) |
| Drug-related AE | 87 (17) | 221 (23) | 55 (20) | 122 (24) | 14 (20) | 31 (19) |
| AE leading to death | 0 | 0 | 0 | 0 | 0 | 0 |
| Infection | 118 (23) | 287 (30) | 63 (23) | 154 (30) | 20 (29) | 42 (26) |
| Serious infection | 4 (1) | 5 (1) | 0 | 3 (1) | 0 | 1 (1) |
| Legionella infection | 0 | 0 | 0 | 0 | 0 | 0 |
| Diverticulitis | 0 | 1 (<1) | 0 | 0 | 0 | 0 |
| Opportunistic infection (excluding oral candidiasis and TB) | 0 | 0 | 0 | 0 | 0 | 0 |
| Oral candidiasis | 0 | 0 | 0 | 0 | 0 | 0 |
| TB | 0 | 0 | 0 | 0 | 0 | 0 |
| Parasitic infection | 0 | 0 | 0 | 0 | 0 | 0 |
| Reactivation of hepatitis B | 0 | 0 | 0 | 0 | 0 | 0 |
| PML | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignancy | 2 (<1) | 6 (1) | 0 | 2 (<1) | 0 | 1 (1) |
| Lymphoma | 0 | 0 | 0 | 0 | 0 | 0 |
| HSTCL | 0 | 0 | 0 | 0 | 0 | 0 |
| NMSC | 1 (<1) | 4 (<1) | 0 | 2 (<1) | 0 | 1 (1) |
| Melanoma | 0 | 1 (<1) | 0 | 0 | 0 | 0 |
| Leukemia | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignancy other than lymphoma, HSTCL, leukemia, NMSC, or melanoma | 1 (<1) | 1 (<1) | 0 | 0 | 0 | 0 |
| Allergic reaction (including angioedema and anaphylaxis) | 3 (1) | 13 (1) | 3 (1) | 7 (1) | 0 | 1 (1) |
| Lupus-like reactions and SLE | 0 | 0 | 0 | 0 | 0 | 0 |
| Vasculitis | 0 | 0 | 0 | 0 | 0 | 0 |
| Sarcoidosis | 0 | 1 (<1) | 0 | 1 (<1) | 0 | 1 (1) |
| Autoimmune hepatitis | 0 | 0 | 0 | 0 | 0 | 0 |
| Myocardial infarction | 1 (<1) | 1 (<1) | 1 (<1) | 0 | 0 | 0 |
| Cerebrovascular accident | 0 | 0 | 0 | 0 | 0 | 0 |
| CHF | 0 | 1 (<1) | 0 | 0 | 0 | 0 |
| Pulmonary embolism | 0 | 0 | 0 | 0 | 0 | 0 |
| Interstitial lung disease | 0 | 0 | 0 | 0 | 0 | 0 |
| Intestinal perforation | 0 | 0 | 0 | 0 | 0 | 0 |
| Pancreatitis | 0 | 2 (<1) | 0 | 1 (<1) | 0 | 0 |
| Stevens–Johnson syndrome | 0 | 0 | 0 | 0 | 0 | 0 |
| Erythema multiforme | 0 | 0 | 0 | 0 | 0 | 0 |
| Psoriasis worsening or new onset | 11 (2) | 10 (1) | 5 (2) | 4 (1) | 3 (4) | 3 (2) |
| Demyelinating disorder | 0 | 0 | 0 | 0 | 0 | 0 |
| Amyotrophic lateral sclerosis | 0 | 0 | 0 | 0 | 0 | 0 |
| Reversible posterior leukoencephalopathy | 0 | 0 | 0 | 0 | 0 | 0 |
| Hematologic disorders (including pancytopenia) | 1 (<1) | 2 (<1) | 1 (<1) | 1 (<1) | 1 (1) | 0 |
| Liver failure/event | 2 (<1) | 2 (<1) | 0 | 1 (<1) | 0 | 0 |
| Administration-related medication error | 0 | 0 | 0 | 0 | 0 | 0 |
| Injection-site reaction | 26 (5) | 69 (7) | 16 (6) | 40 (8) | 1 (1) | 10 (6) |
AE adverse event, CHF congestive heart failure, HSTCL hepatosplenic T-cell lymphoma, NMSC non-melanoma skin cancer, PML progressive multifocal leukoencephalopathy, SLE systemic lupus erythematosus, TB tuberculosis