MI analysis of secondary and exploratory clinical and patient-reported outcomes at weeks 2, 14, 26, 50 and 78; results were adjusted for baseline values and study site
| Week | Clinical outcome | Intravenous steroid (n=57) (%) | IFX (n=55) (%) | Unadjusted OR (95% CI) | Adjusted OR (95% CI) | p Value |
|---|---|---|---|---|---|---|
| 6 | DAS44 remission | 7.1 | 18.3 | 2.93 (0.86 to 10.00) | 5.02 (1.30 to 19.33)* | 0.019 |
| DAS44 LDAS | 30.4 | 46.0 | 1.95 (0.89 to 4.25) | 3.75 (1.46 to 9.62) | 0.006 | |
| DAS28 remission | 7.5 | 22.3 | 3.56 (1.07 to 11.80) | 6.16 (1.61 to 23.54)* | 0.008 | |
| DAS28 LDAS | 23.9 | 33.5 | 1.60 (0.69 to 3.69) | 2.63 (1.00 to 6.93)* | 0.051 | |
| SDAI remission | 3.6 | 4.4 | 1.19 (0.16 to 8.66) | 1.54 (0.21 to 11.48)* | 0.674 | |
| 14 | DAS44 remission | 31.0 | 34.8 | 1.19 (0.53 to 2.65) | 1.89 (0.78 to 4.62)* | 0.161 |
| DAS44 LDAS | 61.4 | 66.8 | 1.27 (0.58 to 2.77) | 3.44 (1.21 to 9.76) | 0.020 | |
| DAS28 remission | 40.0 | 42.3 | 1.10 (0.52 to 2.35) | 1.68 (0.70 to 4.05)* | 0.250 | |
| DAS28 LDAS | 54.1 | 55.4 | 1.061 (0.50 to 2.24) | 1.61 (0.670 to 3.83)* | 0.285 | |
| SDAI remission | 16.7 | 24.5 | 1.61 (0.58 to 4.44) | 2.04 (0.70 to 5.92)* | 0.191 | |
| 26 | DAS44 remission | 40.0 | 31.6 | 0.69 (0.31 to 1.54) | 0.82 (0.36 to 1.88) | 0.644 |
| DAS44 LDAS | 68.4 | 65.9 | 0.89 (0.40 to 2.00) | 1.48 (0.57 to 3.84) | 0.422 | |
| DAS28 remission | 50.8 | 40.6 | 0.66 (0.31 to 1.42) | 0.76 (0.34 to 1.70) | 0.510 | |
| DAS28 LDAS | 66.6 | 64.6 | 0.92 (0.41 to 2.04) | 1.32 (0.54 to 3.27)* | 0.545 | |
| SDAI remission | 24.1 | 29.6 | 1.32 (0.56 to 3.14) | 1.55 (0.63 to 3.79) | 0.340 | |
| ACR EULAR remission | 19.3 | 14.5 | 0.71 (0.26 to 1.93) | 0.75 (0.27 to 2.08) | 0.587 | |
| ACR20 | 75.2 | 71.0 | 0.81 (0.35 to 1.89) | 0.81 (0.35 to 1.89)* | 0.626 | |
| ACR50 | 55.1 | 54.0 | 0.96 (0.45 to 2.03) | 0.95 (0.45 to 2.03) | 0.898 | |
| ACR70 | 31.8 | 32.7 | 1.04 (0.47 to 2.32) | 1.04 (0.46 to 2.33) | 0.927 | |
| Change in HAQ-DI mean (SD) | −0.61 (0.47) | −0.70 (0.56) | −0.09 (−0.29 to 0.11) | −0.05 (−0.23 to 0.13) | 0.568 | |
| Change in RAQoL mean (SD) | −6.29 (5.83) | −7.87 (6.58) | −1.57 (−3.96 to 0.81) | −0.88 (−3.19 to 1.44) | 0.454 | |
| 50 | DAS44 remission | 36.1 | 48.5 | 1.67 (0.75 to 3.72) | 2.13 (0.91 to 5.00)* | 0.082 |
| DAS44 LDAS | 70.6 | 70.4 | 0.99 (0.42 to 2.32) | 1.26 (0.51 to 3.12) | 0.617 | |
| DAS28 remission | 49.6 | 55.7 | 1.28 (0.59 to 2.76) | 1.71 (0.73 to 3.99) | 0.218 | |
| DAS28 LDAS | 63.4 | 68.7 | 1.27 (0.55 to 2.91) | 1.68 (0.68 to 4.19) | 0.264 | |
| SDAI remission | 27.2 | 45.3 | 2.23 (0.96 to 5.18) | 2.98 (1.18 to 7.56) | 0.021 | |
| ACR EULAR remission | 19.4 | 16.5 | 0.82 (0.31 to 2.17) | 0.84 (0.31 to 2.25)* | 0.729 | |
| 78 | DAS44 remission | 50.0 | 47.7 | 0.91 (0.40 to 2.09) | 1.12 (0.47 to 2.68)* | 0.792 |
| DAS44 LDAS | 80.4 | 72.7 | 0.65 (0.23 to 1.87) | 0.92 (0.29 to 2.93)* | 0.888 | |
| DAS28 remission | 65.3 | 54.3 | 0.63 (0.27 to 1.46) | 0.74 (0.31 to 1.76)* | 0.488 | |
| DAS28 LDAS | 76.4 | 63.6 | 0.54 (0.22 to 1.35) | 0.60 (0.23 to 1.53)* | 0.282 | |
| SDAI remission | 49.4 | 37.6 | 0.62 (0.27 to 1.40) | 0.73 (0.30 to 1.76) | 0.480 | |
| ACR EULAR remission | 15.9 | 15.7 | 0.99 (0.34 to 2.87) | 1.04 (0.35 to 3.08)* | 0.950 | |
| ACR20 | 71.1 | 70.7 | 0.98 (0.39 to 2.46) | 0.98 (0.39 to 2.46)* | 0.973 | |
| ACR50 | 63.4 | 64.3 | 1.04 (0.44 to 2.45) | 1.03 (0.43 to 2.48) | 0.953 | |
| ACR70 | 50.1 | 46.2 | 0.85 (0.39 to 1.89) | 0.84 (0.37 to 1.88) | 0.669 | |
| Change in HAQ-DI mean (SD) | −0.79 (0.54) | −0.85 (0.60) | −0.06 (−0.31 to 0.19) | −0.03 (−0.26 to 0.21) | 0.826 | |
| Change in RAQoL mean (SD) | −7.96 (6.32) | −9.71 (7.80) | −1.75 (−4.77 to 1.28) | −0.62 (−3.34 to 2.09) | 0.650 |
ACR, American College of Rheumatology; DAS28, disease activity score based on 28-joint counts; DAS44, disease activity score based on RAI and SJC44; HAQ-DI, Rasch-transformed health assessment questionnaire disability index score; IFX, infliximab + methotrexate; intravenous steroid, intravenous methylprednisolone/placebo + methotrexate; MI, multiple imputation; LDAS, low disease activity score; RAQoL, Rasch-transformed rheumatoid arthritis quality of life score; SDAI, simplified disease activity index.