Baseline demographics and disease characteristics (ITT population)
| Tocilizumab + DMARD | Placebo + DMARD | |
|---|---|---|
| (N=409) | (N=205) | |
| Women, n (%) | 325 (79.5) | 172 (83.9) |
| Age, years | 55.2 (12.06) | 55.8 (12.42) |
| Race, n (%) | ||
| White | 328 (80.2) | 170 (82.9) |
| Black | 53 (13.0) | 17 (8.3) |
| Hispanic | 12 (2.9) | 9 (4.4) |
| Asian | 7 (1.7) | 4 (2.0) |
| American Indian/Alaska native | 4 (1.0) | 3 (1.5) |
| Other | 5 (1.2) | 2 (1.0) |
| Ethnicity, n (%) | ||
| Hispanic | 69 (17) | 42 (20) |
| Non-Hispanic | 340 (83) | 163 (80) |
| Selected major comorbid diagnoses, n (%) | ||
| Hypertension | 153 (37.4) | 84 (41.0) |
| Coronary artery disease | 14 (3.4) | 10 (4.9) |
| Chronic obstructive pulmonary disease | 10 (2.4) | 11 (5.4) |
| Diabetes mellitus | 50 (12.2) | 24 (11.7) |
| Duration of RA, years | 8.62 (8.93) | 8.52 (9.05) |
| DAS28 | 6.53 (1.03) | 6.55 (1.01) |
| No of previous DMARD/anti-TNF | 1.35 (1.41) | 1.31 (1.23) |
| Past use of anti-TNF, n (%) | 155 (37.9) | 78 (38.0) |
| No of past anti-TNF, n (%) | ||
| 1 | 110 (26.9) | 55 (26.8) |
| 2 | 35 (8.6) | 21 (10.2) |
| 3 | 10 (2.4) | 2 (1.0) |
| Reasons for anti-TNF discontinuation, n (%) | n=155 | n=78 |
| Discomfort | 19 (12.3) | 9 (11.5) |
| Lack of efficacy | 19 (12.3) | 9 (11.5) |
| Safety | 7 (4.5) | 3 (3.8) |
| Other | 127 (81.9) | 65 (83.3) |
| Unknown | 2 (1.3) | 2 (2.6) |
| Past use of DMARD, n (%) | 278 (68.0) | 144 (70.2) |
| No of past DMARD, n (%) | ||
| 1 | 130 (31.8) | 69 (33.7) |
| 2 | 75 (18.3) | 44 (21.5) |
| 3 | 42 (10.3) | 18 (8.8) |
| 4 | 18 (4.4) | 8 (3.9) |
| 5 | 7 (1.7) | 5 (2.4) |
| >5 | 6 (1.5) | 0 |
| Reasons for DMARD discontinuation (antimetabolite)*, n (%) | n=134 | n=62 |
| Discomfort | 16 (11.9) | 5 (8.1) |
| Lack of efficacy | 40 (29.9) | 14 (22.6) |
| Safety | 6 (4.5) | 5 (8.1) |
| Other | 38 (28.4) | 11 (17.7) |
| Unknown | 45 (33.6) | 30 (48.4) |
| No of background DMARD, n (%) | ||
| 1 | 354 (86.6) | 175 (85.4) |
| 2 | 48 (11.7) | 27 (13.2) |
| 3 or more | 6 (1.5) | 2 (1.0) |
| None | 1 (0.2) | 1 (0.5) |
| Methotrexate dose, mg/week | n=353 | n=178 |
| Mean (SD) | 17.0 (4.68) | 17.2 (10.71) |
| Oral steroid use, n (%) | 176 (43) | 80 (39) |
| SJC | 19.7 (12.4) | 19.9 (12.1) |
| TJC | 29.7 (16.5) | 30.4 (16.9) |
| ESR, mm/h† | 46.0 (23.64) | 47.3 (22.42) |
| CRP, nmol/l‡ | 174.3 (218.4) | 171.4 (212.0) |
| MDHAQ-PF† | 4.07 (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.