MI analysis of radiographic changes at weeks 26, 50 and 78; results were adjusted for baseline values and study site
| Radiographic outcome | Intravenous steroid n=57 | IFX n=55 | Unadjusted difference (95% CI) | Adjusted difference (95% CI) | p Value |
|---|---|---|---|---|---|
| Change at week 26 | |||||
| ERO | |||||
| mean (SD) | 0.74 (1.94) | 0.35 (0.89) | −0.39 (−1.03 to 0.26) | −0.26 (−0.82 to 0.30) | 0.357 |
| Median (IQR) | 0.00 (0.00, 0.65) | 0.00 (0.00, 0.38) | 0.00 (−0.13 to 0.13) | 0.00 (−0.12 to 0.12) | 1.000 |
| JSN | |||||
| mean (SD) | 0.78 (2.63) | 0.48 (1.02) | −0.31 (−1.09 to 0.48) | −0.29 (−0.99 to 0.42) | 0.420 |
| median (IQR) | 0.00 (0.00, 0.57) | 0.00 (0.00, 0.64) | 0.00 (−0.17 to 0.17) | 0.00 (−0.12 to 0.12) | 1.000 |
| mTSS | |||||
| mean (SD) | 1.52 (4.25) | 0.83 (1.69) | −0.69 (−1.99 to 0.60) | −0.59 (−1.70 to 0.52) | 0.291 |
| median (IQR) | 0.04 (0.00, 1.18) | 0.00 (0.00, 1.02) | −0.04 (−0.34 to 0.42) | −0.20 (−0.29 to 0.25) | 0.880 |
| Change<SDC | 82.5% | 85.1% | OR 1.23 (0.35 to 4.31) | OR 1.18 (0.31 to 4.51)* | 0.806 |
| Change≤0.5 | 63.5% | 68.5% | OR 1.25 (0.52 to 3.04) | OR 1.35 (0.46 to 3.95) | 0.579 |
| Change at week 50 | |||||
| ERO | |||||
| mean (SD) | 1.28 (3.26) | 0.49 (1.21) | −0.79 (−1.83 to 0.26) | −0.58 (−1.53 to 0.37) | 0.224 |
| median (IQR) | 0.14 (0.00, 0.87) | 0.00 (0.00, 0.64) | −0.14 (−0.68 to 0.40) | 0.00 (−0.21 to 0.21) | 1.000 |
| JSN | |||||
| mean (SD) | 1.53 (3.95) | 0.71 (1.31) | −0.82 (−1.99 to 0.34) | −0.80 (−1.87 to 0.27) | 0.141 |
| median (IQR) | 0.07 (0.00, 1.51) | 0.00 (0.00, 0.97) | −0.07 (−0.55 to 0.40) | −0.03 (−0.38 to 0.32) | 0.878 |
| mTSS | |||||
| mean (SD) | 2.81 (6.88) | 1.20 (2.27) | −1.61 (−3.69 to 0.47) | −1.45 (−3.35 to 0.45) | 0.132 |
| median (IQR) | 0.65 (0.00, 2.37) | 0.11 (0.00, 1.55) | −0.53 (−1.36 to 0.29) | −0.16 (−0.85 to 0.54) | 0.651 |
| Change<SDC | 71.0% | 80.6% | OR 1.68 (0.57 to 4.95) | OR 1.77 (0.56 to 5.61)* | 0.328 |
| Change≤0.5 | 46.7% | 61.9% | OR 1.96 (0.77 to 4.47) | OR 2.13 (0.83 to 5.46)* | 0.116 |
| Change at week 78 | |||||
| ERO | |||||
| Mean (SD) | 1.32 (3.46) | 0.75 (2.03) | −0.57 (−1.83 to 0.70) | −0.33 (−1.46 to 0.81) | 0.564 |
| median (IQR) | 0.07 (0.00, 0.80) | 0.01 (0.00, 1.07) | −0.06 (−0.49 to 0.38) | 0.00 (−0.28 to 0.28) | 1.000 |
| JSN | |||||
| mean (SD) | 1.87 (4.58) | 0.94 (1.69) | −0.93 (−2.35 to 0.48) | −0.90 (−2.22 to 0.42) | 0.178 |
| median (IQR) | 0.31 (0.00, 1.90) | 0.03 (0.00, 1.26) | −0.28 (−0.93 to 0.36) | −0.04 (−0.48 to 0.40) | 0.856 |
| mTSS | |||||
| mean (SD) | 3.19 (7.75) | 1.69 (3.28) | −1.50 (−4.01 to 1.01) | −1.31 (−3.59 to 0.96) | 0.253 |
| median (IQR) | 0.66 (0.00, 2.59) | 0.43 (0.00, 2.17) | −0.23 (−1.16 to 0.71) | −0.11 (−0.85 to 0.63) | 0.769 |
| Change<SDC | 66.4% | 74.4% | OR 1.50 (0.50 to 4.55) | OR 1.53 (0.45 to 5.14)* | 0.492 |
| Change≤0.5 | 51.1% | 54.5% | OR 1.15 (0.46 to 2.89) | OR 1.22 (0.45 to 3.32)* | 0.699 |
*Not adjusted for site because for at least one site the outcome was the same for all patients, therefore OR could not be calculated.
ERO, erosion; IFX, infliximab + methotrexate; intravenous steroid, intravenous methylprednisolone/placebo + methotrexate; JSN, joint space narrowing; MI, multiple imputation; mTSS, van der Heijde modified total Sharpe score; SDC, smallest detectable change in mTSS (2 units).