Table 1 Patient demographics and baseline characteristics of the AMBITION cohort, according to treatment group. Differences between treatment groups are presented by one-way ANOVA t test
Characteristics | Tocilizumab, N = 164 | Methotrexate, N = 161 | Placebo, N = 62 | P value |
|---|---|---|---|---|
Age (years), mean (SD) | 50.7 (12.9) | 51.3 (13.3) | 50.5 (11.8) | ns |
Female, n (%) | 131 (80) | 122 (76) | 47 (76) | ns |
Male, n (%) | 33 (20) | 39 (24) | 15 (24) | ns |
DAS28, mean (SD) | 6.8 (0.9) | 6.8 (0.9) | 6.9 (0.9) | ns |
BMI (SD) | 28.1 (6.4) | 27.4 (6.0) | 29.1 (7.4) | ns |
TJC, mean (SD) | 32.6 (14.8) | 32.1 (14.1) | 35.4 (16.3) | ns |
SJC, mean (SD) | 19.4 (10.9) | 19.9 (10.6) | 23.5 (12.2) | P = 0.04 |
RADUR (SD) | 6.7 (8.1) | 6.6 (8.0) | 7.4 (9.0) | ns |
CRP (mg/dL), mean (SD) | 3.2 (3.6) | 3.1 (3.5) | 2.5 (2.7) | ns |
ESR (mm/h), mean (SD) | 46.9 (26.1) | 47.9 (24.1) | 48.2 (22.4) | ns |
HAQ-DI, mean (SD) | 1.6 (0.6) | 1.6 (0.6) | 1.4 (0.5) | ns |
Pain VAS 100 mm, mean (SD) | 59.0 (22.4) | 61.3 (20.7) | 59.5 (24.4) | ns |
Patient VAS 100 mm, mean (SD) | 64.6 (22.0) | 64.9 (19.4) | 64.3 (22.5) | ns |
Physician VAS 100 mm, mean (SD) | 63.5 (16.1) | 64.6 (16.3) | 69.1 (17.9) | ns |
Baseline C1M (ng/mL), mean (95% CI) | 42.7 (37.5–47.8) | 45.2 (39.4–50.9) | 40.5 (34.5–46.5) | ns |
Baseline C2M (ng/mL), mean (95% CI) | 0.4 (0.4–0.5) | 0.4 (0.4–0.5) | 0.3 (0.3–0.4) | ns |
Baseline C3M (ng/mL), mean (95% CI) | 17.8 (16.5–19.2) | 18.3 (17.1–19.5) | 15.9 (13.8–17.9) | ns |
Baseline C4M (ng/mL), mean (95% CI) | 53.9 (49.3–58.4) | 51 (47.2–54.8) | 42.3 (36.5–48.1) | P = 0.02 |
Baseline CRPM (ng/mL), mean (95% CI) | 21.9 (19.6–24.2) | 20.8 (18.9–22.8) | 18.5 (15.0–21.9) | ns |
Baseline CRP (ng/mL), mean (95% CI) | 3.2 (2.6–3.8) | 3.1 (2.6–3.7) | 2.5 (1.8–3.2) | ns |