Table 2.
Summary of changes from baseline to weeks 12 and 24 in RAMRIS scores
| Group 1 | Group 2 | Golimumab+MTX | |||
|---|---|---|---|---|---|
| Characteristic | Placebo+MTX | Golimumab 100 mg+placebo | Group 3 50 mg | Group 4 100 mg | Groups 3 and 4 combined |
| Randomised MRI substudy patients | 72 | 72 | 47 | 49 | 96 |
| RAMRIS synovitis (wrist plus MCP) score (n=223)* | |||||
| N=64 | N=67 | N=45 | N=47 | N=92 | |
| Change from baseline to week 12 | |||||
| Mean±SD | −0.15±2.75 | −0.78±2.58 | −2.04±2.43 | −1.54±2.63 | −1.77±2.54 |
| Median (IQ range) | −0.45 (−1.50 to 1.50) | −0.31 (−2.00 to 0.50) | −2.00 (−3.00 to −0.50) | −2.00 (−3.20 to 0.50) | −2.00 (−3.20 to 0.00) |
| p Value† | 0.30 | <0.001 | 0.014 | <0.001 | |
| Change from baseline to week 24 | |||||
| Mean±SD | −0.38±2.66 | −0.96±2.53 | −1.85±2.28 | −1.96±2.63 | −1.91±2.45 |
| Median (IQ range) | −0.50 (−1.45 to 1.00) | −1.00 (−1.50 to 0.00) | −1.75 (−3.00 to −0.50) | −1.00 (−4.50 to 2.00) | −1.00 (−3.13 to −0.33) |
| p Value | 0.20 | <0.001 | 0.003 | <0.001 | |
| RAMRIS synovitis (wrist) score (n=240)* | |||||
| Change from baseline to week 12 | |||||
| Mean±SD | 0.08±1.51 | −0.46±1.36 | −1.13±1.61 | −0.85±1.42 | −0.98±1.51 |
| Median (IQ range) | 0.00 (−1.00 to 1.00) | 0.00 (−1.00 to 0.00) | 1.00 (−2.00 to 0.00) | −1.00 (−2.00 to 0.00) | −1.00 (−2.00 to 0.00) |
| p Value | 0.07 | <0.001 | 0.002 | <0.001 | |
| Change from baseline to week 24 | |||||
| Mean±SD | 0.05±1.64 | −0.56±1.46 | −1.11±1.57 | −1.16±1.70 | −1.14±1.63 |
| Median (IQ range) | 0.00 (−1.00 to 0.50) | −0.50 (−1.00 to 0.00) | −0.50 (−2.00 to 0.00) | −0.50 (−4.50 to 2.00) | −0.50 (−2.00 to 0.00) |
| p Value | 0.029 | <0.001 | <0.001 | <0.001 | |
| Sensitivity analysis for week 24 data (available data only/no imputation for missing data‡) | |||||
| N=49 | N=44 | N=28 | N=30 | N=58 | |
| Mean±SD | 0.16±1.78 | −0.56±1.59 | −1.19±1.49 | −1.48±1.89 | −1.34±1.70 |
| Median (IQ range) | 0.00 (−0.75 to 1.00) | −0.50 (−1.25 to 0.50) | −1.00 (−2.00 to 0.00) | −1.50 (−3.00 to 0.00) | −1.00 (−3.00 to 0.00) |
| p Value | 0.037 | <0.001 | <0.001 | <0.001 | |
| RAMRIS bone oedema (osteitis) score | |||||
| Change from baseline to week 12 | |||||
| Mean±SD | 0.19±7.52 | −2.11±4.99 | −2.81±5.12 | −1.31±3.49 | −2.00±4.36 |
| Median (IQ range) | 0.00 (−1.00 to 1.50) | 0.00 (−2.07 to 0.00) | −0.50 (−4.50 to 0.00) | −0.03 (−1.50 to 0.00) | −0.50 (−2.09 to 0.00) |
| p Value | 0.007 | 0.002 | 0.07 | 0.003 | |
| Change from baseline to week 24 | |||||
| Mean±SD | 0.71±7.54 | −1.28±3.94 | −2.58±4.75 | −0.92±3.38 | −1.74±4.17 |
| Median (IQ range) | 0.00 (−0.50 to 0.50) | 0.00 (−1.50 to 0.00) | −0.50 (−4.09 to 0.00) | 0.00 (−1.60 to 0.00) | 0.00 (−2.19 to 0.00) |
| p Value | 0.11 | <0.001 | 0.177 | 0.004 | |
| Sensitivity analysis for week 24 data (available data only/no imputation for missing data‡) | |||||
| N=49 | N=44 | N=29 | N=30 | N=59 | |
| Mean±SD | 0.68±5.35 | −1.66±4.64 | −3.20±5.52 | −1.14±3.84 | −2.15±4.81 |
| Median (IQ range) | 0.00 (−0.50 to 0.55) | 0.00 (−2.00 to 0.00) | −1.00 (−3.64 to 0.00) | 0.00 (−2.00 to 0.00) | −0.50 (−3.07 to 0.00) |
| p Value | 0.05 | <0.001 | 0.10 | 0.002 | |
| RAMRIS bone erosion score | |||||
| Change from baseline to week 12 | |||||
| Mean±SD | −0.76±3.54 | 0.50±2.93 | −1.28±4.80 | −0.80±6.67 | −1.02±5.85 |
| Median (IQ range) | 0.00 (−0.50 to 0.07) | 0.00 (0.00 to 0.50) | 0.00 (−0.50 to 0.00) | 0.00 (−0.10 to 0.41) | 0.00 (−0.50 to 0.00) |
| p Value | 0.038 | 0.36 | 0.32 | 0.90 | |
| Change from baseline to week 24 | |||||
| Mean±SD | −0.47±3.40 | 0.40±2.62 | −1.08±4.35 | −0.78±6.48 | −0.92±5.51 |
| Median (IQ range) | 0.00 (−0.50 to 0.00) | 0.00 (0.00 to 0.02) | 0.00 (−0.50 to 0.00) | 0.00 (−0.09 to 0.18) | 0.00 (−0.19 to 0.00) |
| p Value | 0.14 | 0.21 | 0.68 | 0.62 | |
| Sensitivity analysis for week 24 data (available data only/no imputation for missing data‡) | |||||
| N=50 | N=44 | N=29 | N=30 | N=59 | |
| Mean±SD | −0.56±4.01 | 0.22±2.43 | −1.46±5.38 | −1.53±8.18 | −1.50±6.89 |
| Median (IQ range) | 0.00 (−0.50 to 0.39) | 0.00 (0.00 to 0.45) | 0.00 (−0.50 to 0.00) | 0.00 (−0.50 to 0.32) | 0.00 (−0.50 to 0.00) |
| p Value | 0.42 | 0.16 | 0.62 | 0.26 | |
| Linear extrapolation§ | |||||
| Mean±SD | −0.90±5.23 | 0.55±3.96 | −1.54±5.03 | −0.65±6.63 | −1.09±5.89 |
| Median (IQ range) | 0.00 (−0.50 to 0.32) | 0.00 (0.00 to 0.27) | 0.00 (−0.83 to 0.00) | 0.00 (−0.09 to 0.32) | 0.00 (−0.40 to 0.00) |
| p Value | 0.33 | 0.22 | 0.60 | 0.68 | |
All analyses are based on the 240 randomised substudy patients unless otherwise noted in the table.
Due to an inability to obtain postgadolinium images of both the wrist and the metacarpophalangeal joints at the study site, 223 patients have RAMRIS synovitis scores of the wrist plus MCP joints and 240 patients have RAMRIS synovitis scores for the wrist joint only.
All p values derive from statistical comparisons versus group 1.
The sensitivity analysis employing no imputation rules included the 153/240 (64%) substudy patients who received subcutaneous study agent through week 24 with no missed doses and no missing baseline or week 24 data.
Evaluation of the RAMRIS bone erosion score with linear extrapolation was implemented for less than 36% of all substudy patients.
MCP, metacarpophalangeal; MTX, methotrexate; RAMRIS, Rheumatoid Arthritis MRI Scoring system.