Table 1

Demographic and baseline disease characteristics

Characteristic*Placebo (n = 70)AdalimumabAll patients (n = 284)
20 mg (n = 72)40 mg (n = 70)80 mg (n = 72)All doses (n = 214)
RA, rheumatoid arthritis; RF, rheumatoid factor; AE, adverse event; DMARD, disease modifying antirheumatic drug; NSAID, non-steroidal anti-inflammatory drug; RF, rheumatoid factor; TJC, tender joint count; SJC, swollen joint count; VAS, visual analogue scale; CRP, C reactive protein; ESR, erythrocyte sedimentation rate; DAS28, disease activity score 28.
*Values are mean (SD) unless indicated otherwise; †mean; ‡includes total hip replacement, total knee replacement, synovectomy (hand, wrist, and knee), and radiotherapeutic procedure; §0 = no pain; 100 = severe pain; ¶0 = no disease activity; 100 = extreme disease activity; **0 = no difficulty; 3 = unable to perform activity; ††higher score indicates greater disease activity.
Age, years50.2 (11.9)53.7 (13.3)52.6 (11.6)53.2 (12.3)53.2 (12.4)52.4 (12.3)
Female, No (%)57 (81)61 (85)57 (81)50 (69)168 (78)225 (79)
RA duration, years9.4 (6.6)10.4 (7.3)10.0 (7.0)10.1 (7.9)10.2 (7.4)10.0 (7.2)
RF positivity, No (%)59 (84)61 (85)64 (91)54 (75.0)179 (84)238 (84)
Pretreatment AEs, No (%)38 (54)47 (65)44 (63)47 (65)138 (65)176 (62)
Prior DMARDs, n†3.544.073.673.713.823.75
Patients undergoing previous joint procedure, No (%)‡28 (40)42 (58)31 (44)38 (53)111 (52)139 (49)
Patients receiving NSAIDs at baseline, No (%)56 (80)55 (76)57 (81)56 (78)168 (79)224 (79)
Corticosteroids, No (%)54 (77)55 (76)9 (70)54 (75)158 (74)212 (75)
TJC (0–68), n30.9 (13.1)31.7 (13.2)31.0 (12.3)32.5 (12.8)31.7 (12.7)31.5 (12.8)
SJC (0–66), n20.2 (7.4)19.6 (9.0)18.7 (7.7)19.6 (8.3)19.3 (8.3)19.5 (8.1)
Patient assessment of pain (scale, 0–100 mm on VAS)§72.4 (18.6)73.1 (18.0)73.4 (19.4)67.9 (23.1)71.5 (20.4)71.7 (19.9)
Patient global assessment of disease activity (scale 0–100 mm on VAS)¶73.5 (19.3)74.0 (19.9)75.7 (19.5)69.3 (24.2)73.0 (21.4)73.1 (20.8)
Doctor global assessment of disease activity (scale 0–100 mm on VAS)¶65.4 (17.8)65.6 (17.6)64.8 (18.2)63.9 (20.6)64.8 (18.8)64.9 (18.5)
Disability index of the HAQ (scale 0 to 3)**1.63 (0.67)1.79 (0.64)1.74 (0.66)1.66 (0.73)1.73 (0.68)1.71 (0.67)
CRP, mg/l63 (44)57 (40)56 (39)60 (55)58 (45)59 (45)
ESR, mm/1st h53.6 (27.9)52.9 (31.0)51.7 (27.4)50.7 (24.8)51.8 (27.7)52.2 (27.7)
DAS28 (scale 2–10)††7.1 (0.8)7.0 (1.0)7.1 (0.8)7.0 (1.0)7.0 (0.9)7.0 (0.9)