Table 1 Baseline demographics and clinical characteristics
CharacteristicsAll patients (n  =  854)Patients with fistulas at baseline
Placebo (n  =  47)Adalimumab (n  =  70)All patients with fistulas (n  =  117)
Male, no (%)326 (38.2)15 (31.9)34 (48.6)49 (41.9)
Age in years, mean (SD)37.1 (11.9)36.5 (10.1)35.9 (12.2)36.1 (11.4)
Baseline CDAI score, mean (SD)313.1 (62.0)308.0 (59.3)318.4 (55.8)314.3 (57.2)
CRP (mg/dl)
    Mean (SD)2.3 (3.4)3.6 (4.7)2.8 (3.0)3.1 (3.8)
    Median (range)0.9 (0.02–35.0)2.3 (0.12–28.7)1.8 (0.06–12.3)1.9 (0.06–28.7)
CRP concentration ⩾1.0 mg/dl (10 mg/l), n (%)407 (47.7)32 (68.1)42 (60.0)74 (63.2)
Previous TNF antagonist exposure, n (%)424 (49.6)31 (66.0)41 (58.6)72 (61.5)
Concomitant medication, n (%)
    Any glucocorticoid*376 (44.0)20 (42.6)29 (41.4)49 (41.9)
        Prednisone244 (28.6)14 (29.8)18 (25.7)32 (27.4)
        Budesonide100 (11.7)9 (19.1)2 (2.9)11 (9.4)
    Any immunosuppressive agent399 (46.7)26 (55.3)31 (44.3)57 (48.7)
        Azathioprine275 (32.2)21 (44.7)24 (34.3)45 (38.5)
        6-Mercaptopurine81 (9.5)4 (8.5)3 (4.3)7 (6.0)
        Methotrexate90 (10.5)3 (6.4)7 (10.0)10 (8.5)
    5-Aminosalicylates†334 (39.1)13 (27.7)24 (34.3)37 (31.6)
Current smoker, no (%)303 (35.5)18 (38.3)20 (28.6)38 (32.5)
  • *Includes betamethasone, budesonide, dexamethasone, deflazacort, cortisone, cloprednol, fluocortolone, glucocorticoids, hydrocortisone, methylprednisolone, prednisolone, prednisone, paramethasone and prednylidene. †Aminosalicylic acid, balsalazide, mesalazine, olsalazine, sulfasalazine. CDAI, Crohn’s disease activity index; CRP, C-reactive protein; TNF, tumour necrosis factor.