Table 1

Baseline demographics and disease characteristics (ITT population)

Tocilizumab + DMARDPlacebo + DMARD
(N=409)(N=205)
Women, n (%)325 (79.5)172 (83.9)
Age, years55.2 (12.06)55.8 (12.42)
Race, n (%)
 White328 (80.2)170 (82.9)
 Black53 (13.0)17 (8.3)
 Hispanic12 (2.9)9 (4.4)
 Asian7 (1.7)4 (2.0)
 American Indian/Alaska native4 (1.0)3 (1.5)
 Other5 (1.2)2 (1.0)
Ethnicity, n (%)
 Hispanic69 (17)42 (20)
 Non-Hispanic340 (83)163 (80)
Selected major comorbid diagnoses, n (%)
 Hypertension153 (37.4)84 (41.0)
 Coronary artery disease14 (3.4)10 (4.9)
 Chronic obstructive pulmonary disease10 (2.4)11 (5.4)
 Diabetes mellitus50 (12.2)24 (11.7)
Duration of RA, years8.62 (8.93)8.52 (9.05)
DAS286.53 (1.03)6.55 (1.01)
No of previous DMARD/anti-TNF1.35 (1.41)1.31 (1.23)
Past use of anti-TNF, n (%)155 (37.9)78 (38.0)
No of past anti-TNF, n (%)
 1110 (26.9)55 (26.8)
 235 (8.6)21 (10.2)
 310 (2.4)2 (1.0)
Reasons for anti-TNF discontinuation, n (%)n=155n=78
 Discomfort19 (12.3)9 (11.5)
 Lack of efficacy19 (12.3)9 (11.5)
 Safety7 (4.5)3 (3.8)
 Other127 (81.9)65 (83.3)
 Unknown2 (1.3)2 (2.6)
Past use of DMARD, n (%)278 (68.0)144 (70.2)
No of past DMARD, n (%)
 1130 (31.8)69 (33.7)
 275 (18.3)44 (21.5)
 342 (10.3)18 (8.8)
 418 (4.4)8 (3.9)
 57 (1.7)5 (2.4)
 >56 (1.5)0
Reasons for DMARD discontinuation (antimetabolite)*, n (%)n=134n=62
 Discomfort16 (11.9)5 (8.1)
 Lack of efficacy40 (29.9)14 (22.6)
 Safety6 (4.5)5 (8.1)
 Other38 (28.4)11 (17.7)
 Unknown45 (33.6)30 (48.4)
No of background DMARD, n (%)
 1354 (86.6)175 (85.4)
 248 (11.7)27 (13.2)
 3 or more6 (1.5)2 (1.0)
 None1 (0.2)1 (0.5)
Methotrexate dose, mg/weekn=353n=178
 Mean (SD)17.0 (4.68)17.2 (10.71)
Oral steroid use, n (%)176 (43)80 (39)
SJC19.7 (12.4)19.9 (12.1)
TJC29.7 (16.5)30.4 (16.9)
ESR, mm/h46.0 (23.64)47.3 (22.42)
CRP, nmol/l174.3 (218.4)171.4 (212.0)
MDHAQ-PF4.07 (1.73)4.00 (2.09)
Patient's global assessment of pain (VAS 0–100 mm)56.5 (22.6)55.9 (22.8)
Patient's global assessment of disease activity (VAS 0–100 mm)62.3 (22.5)61.7 (21.9)
Physician's global assessment of disease activity (VAS 0–100 mm)62.2 (18.25)62.8 (18.33)
  • Data are presented as mean (SD) unless otherwise indicated.

  • * Lack of efficacy was also the most common reason for discontinuation of antimalarial agents and gold.

  • Sample size differed from the ITT population for the following parameters: ESR (tocilizumab, n=408); MDHAQ-PF (tocilizumab, n=405; placebo, n=204); patient's global assessment of pain (tocilizumab, n=405; placebo, n=203); patient's global assessment of disease (tocilizumab n=405; placebo, n=203); physician's global assessment of disease (tocilizumab, n=408; placebo, n=203).

  • Conversion factor for SI to conventional units (mg/dl) is 1/9.524.

  • CRP, C-reactive protein; DAS28, disease activity score in 28 joints; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; ITT, intent-to-treat; MDHAQ-PF, multidimensional health assessment questionnaire for physical function; RA, rheumatoid arthritis; SJC, swollen joint count; TJC, tender joint count; TNF, tumour necrosis factor; VAS, visual analogue scale.