No New Erosions 46.2 62.9 16.7 0.001 ≤ (% of Patients) JSN Score 1.0 0.1 0.9 (0.3, 1.4) 0.002 40 mg administered fortnightly a Based on rank analysis b MTX: Methotrexate *95% confidence intervals for the differences in change scores between MTX and adalimumab In RA Study V, adalimumab-treated patients had a mean duration of rheumatoid arthritis of less than 9 months and had not previously received methotrexate. Structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score. The Week 52 results are shown in Table 7. A statistically significant difference for change in modified Total Sharp Score and the erosion score was observed at Week 52 and maintained at Week 104. Table 7. Change in Modified Total Sharp Score From Baseline at Weeks 52 and 104 (All Randomised Subjects) in RA Study V MTX Adalimumab Adalimumab + MTX n = 257 n = 274 n = 268 p-valuea p-valueb Week 52 Baseline (mean) 21.8 ± 22.2 18.8 ± 19.0 18.1 ± 20.1 Week 52 (mean) 27.6 ± 24.6 21.8 ± 19.7 19.4 ± 19.9 Change at week 52 5.7 ± 12.7 3.0 ± 11.2 1.3 ± 6.5 < 0.001 < 0.002 (mean ± SD) Week 104 Baseline (mean) 21.8 ± 22.2 18.8 ± 19.0 18.1 ± 20.1 Week 104 (mean) 32.3 ± 30.0 24.3 ± 23.2 20.0 ± 20.5 Change at week 10.4 ± 21.7 5.5 ± 15.8 1.9 ± 8.3 < 0.001 < 0.001 104 (mean ± SD)
No New Erosions (% of Patients) 46.2 62.9 16.7 ≤ 0.001 JSN Score 1.0 0.1 0.9 (0.3, 1.4) 0.002 a 40 mg administered fortnightly b Based on rank analysis MTX: Methotrexate *95% confidence intervals for the differences in change scores between MTX and adalimumab In RA Study V, adalimumab-treated patients had a mean duration of rheumatoid arthritis of less than 9 months and had not previously received methotrexate. Structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score. The Week 52 results are shown in Table 7. A statistically significant difference for change in modified Total Sharp Score and the erosion score was observed at Week 52 and maintained at Week 104. Table 7. Change in Modified Total Sharp Score From Baseline at Weeks 52 and 104 (All Randomised Subjects) in RA Study V MTX n = 257 Adalimumab n = 274 Adalimumab + MTX n = 268 p-valuea p-valueb Week 52 Baseline (mean) 21.8 ± 22.2 18.8 ± 19.0 18.1 ± 20.1 Week 52 (mean) 27.6 ± 24.6 21.8 ± 19.7 19.4 ± 19.9 Change at week 52 (mean ± SD) 5.7 ± 12.7 3.0 ± 11.2 1.3 ± 6.5 < 0.001 < 0.002 Week 104 Baseline (mean) 21.8 ± 22.2 18.8 ± 19.0 18.1 ± 20.1 Week 104 (mean) 32.3 ± 30.0 24.3 ± 23.2 20.0 ± 20.5 Change at week 104 (mean ± SD) 10.4 ± 21.7 5.5 ± 15.8 1.9 ± 8.3 < 0.001 < 0.001
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