Table 3

Adverse events

Treatment groupAdalimumabPlaceboAll patients
N=34N=36N=70
Patients with adverse events
 ≥1 Adverse event24 (70.6%)35 (97.2%)59 (84.3%)
 ≥1 Serious adverse event5 (14.7%)17 (47.2%)22 (31.4%)
Patients with infection
 Patients with ≥1 infection20 (58.8%)11 (30.6%)31 (44.35%)
 Patients with ≥1 serious infection3 (8.8%)8 (22.2%)11 (15.7%)
Infections
 Upper respiratory tract infection156
 Ear nose and throat infection2810
 Lower respiratory tract infection358
 Urinary infection459
 Cutaneous infection044
 Ocular infection11
 Gastrointestinal tract infection077
 Pancreatitis or cholecystitis033
 Viral infection (herpes simplex virus, varicella zoster virus)314
 Fungal infection213
Injection-related reactions
 General reaction033
 Local reaction145
Steroid-related events
 Cataract202
 Glaucoma112
 Diabetes mellitus224
 Apparition or exacerbation of hypertension112
 Cardiac insufficiency055
 Coronary syndrome044
 Stroke213
Cancer112