Changes from baseline in erosion and joint space narrowing scores of the hands and feet at week 102 in patients with early RA
Assessment variable | MTX-only | 3 mg/kg Infliximab+MTX | 10 mg/kg Infliximab+MTX | Total infliximab | ||
---|---|---|---|---|---|---|
q 8 Weeks | q 4 Weeks | q 8 Weeks | q 4 Weeks | |||
SD, standard deviation; IQR, interquartile range. | ||||||
Patients randomised | 88 | 86 | 86 | 87 | 81 | 340 |
Patients with early RA | 17 | 19 | 19 | 20 | 7 | 65 |
Patients evaluated | 12 | 10 | 16 | 17 | 6 | 49 |
Erosion scores | ||||||
Total | ||||||
Mean (SD) | 12.21 (13.32) | −1.02 (2.49) | −1.07 (6.05) | 0.46 (1.90) | −0.78 (2.81) | −0.49 (3.89) |
Median | 8.71 | −1.63 | 0.00 | 0.50 | −0.85 | 0.00 |
IQR | (1.50, 19.77) | (−2.00, −0.50) | (−1.25, 1.25) | (0.00, 1.00) | (−1.98, 1.00) | (−1.70, 1.00) |
p Value v placebo | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |
Hands | ||||||
Mean (SD) | 5.67 (6.17) | −0.67 (1.71) | −0.78 (4.70) | 0.22 (1.82) | −1.13 (2.73) | −0.45 (3.10) |
Median | 4.21 | −0.38 | 0.00 | 0.00 | −0.99 | 0.00 |
IQR | (0.00, 9.81) | (−2.41, 0.50) | (−1.25, 0.27) | (−0.50, 1.00) | (−2.20, 1.00) | (−1.50, 0.50) |
p Value v placebo | <0.001 | 0.001 | 0.005 | 0.003 | <0.001 | |
Feet | ||||||
Mean (SD) | 6.54 (7.87) | −0.35 (2.43) | −0.28 (1.56) | 0.24 (1.12) | 0.35 (0.44) | −0.04 (1.55) |
Median) | 4.50 | −0.25 | 0.00 | 0.00 | 0.25 | 0.00 |
IQR | (1.25, 7.75) | (−1.50, 0.50) | (−0.25, 0.50) | (0.00, 0.50) | (0.00, 0.50) | (−0.50, 0.50) |
p Value v placebo | <0.001 | <0.001 | <0.001 | 0.008 | <0.001 | |
Total joint space narrowing scores | ||||||
Mean (SD) | 12.82 (15.73) | 0.39 (6.24) | −1.44 (4.21) | 1.21 (3.42) | −0.61 (2.09) | −0.05 (4.30) |
Median | 5.77 | 0.21 | 0.00 | 0.00 | −1.38 | 0.00 |
IQR | (1.25, 26.58) | (−2.00, 2.00) | (−3.20, 0.69) | (0.00, 2.50) | (−1.93, −0.50) | (−1.93, 1.00) |
p Value v placebo | 0.002 | <0.001 | 0.010 | 0.002 | <0.001 | |
Hands | ||||||
Mean (SD) | 7.71 (11.71) | 0.94 (5.53) | −0.75 (3.47) | 0.65 (2.78) | −0.43 (2.09) | 0.12 (3.61) |
Median | 3.25 | 0.25 | 0.00 | 0.00 | −1.07 | 0.00 |
IQR | (0.00, 9.83) | (−1.50, 2.00) | (−1.70, 0.69) | (0.00, 0.50) | (−1.93, 0.00) | (−0.50, 0.50) |
p Value v placebo | 0.051 | 0.008 | 0.031 | 0.009 | 0.003 | |
Feet | ||||||
Mean (SD) | 5.11 (7.63) | −0.55 (2.31) | −0.69 (1.82) | 0.56 (1.09) | −0.19 (0.45) | −0.17 (1.66) |
Median | 4.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
IQR | (0.00, 6.00) | (0.00, 0.00) | (0.00, 0.00) | (0.00, 0.50) | (0.00, 0.00) | (0.00, 0.00) |
p Value v placebo | <0.001 | <0.001 | 0.012 | 0.003 | <0.001 |