Table 2.
Treatment emergent adverse events in Period B
| For patients who received ADAew in Period A, n (%) | ADAew/pbo, (N = 100) | ADAew/eow, (N = 101) | ADAew/ew (N = 99) |
|---|---|---|---|
| Any adverse event | 65 (65) | 58 (57·4) | 59 (59·6) |
| Serious adverse eventsa | 2 (2) | 5 (5·0) | 3 (3·0) |
| Adverse event leading to study drug discontinuation | 2 (2) | 2 (2·0) | 2 (2·0) |
| Infection | 29 (29) | 31 (30·7) | 32 (32·3) |
| Serious infectionb | 0 | 0 | 1 (1·0) |
| Malignancy | 0 | 1 (1·0) | 0 |
| Nonmelanoma skin cancer | 0 | 1 (1·0) | 0 |
| Psoriasis‐related adverse eventsc | 1 (1) | 1 (1·0) | 3 (3·0) |
| Adverse events leading to deathd | 0 | 1 (1·0) | 0 |
| Adverse events in ≥ 10% of patients in any group | |||
| Nasopharyngitis | 10 (10) | 4 (4·0) | 6 (6·1) |
| Worsening of hidradenitis suppurativa (HS) | 20 (20) | 18 (17·8) | 5 (5·1) |
ADA, adalimumab; ew, every‐week dosing; eow, every‐other‐week dosing; pbo, placebo. aSerious adverse events included the following: lymphadenitis, acute myocardial infarction, cardiorespiratory arrest, abortion induced (ADAew/eow, n = 1 for each); pneumonia, ectopic pregnancy (ADAew/ew, n = 1 for each); HS (ADAew/pbo, n = 2; ADAew/eow, n = 3) and rash (ADAew/ew, n = 1). bSerious infections included pneumonia (ADAew/ew, n = 1). cEvents of worsening or new onset included dermatitis psoriasiform (ADAew/pbo, n = 1; ADAew/ew, n = 2); psoriasis (ADAew/eow, n = 1; ADAew/ew, n = 1). dOne death owing to cardiorespiratory arrest occurred 42 days after the last dose of ADA in a 35‐year‐old man with a history of diabetes mellitus, smoking and a family history of coronary heart disease. Events include worsening of underlying HS disease.