bsp;ACTEMRA 4 mg per kg + MTX ACTEMRA 8 mg per kg + MTX
N=284 N=286
(95% CI)* N=393 N=399
( 95% CI)* N=398
(95% CI)* N=204 N=213
( 95% CI)* N=205
(95% CI)* N=413 N=803
(95% CI)* N=158 N=161
( 95% CI)* N=170
(95% CI)*
* CI: 95% confidence interval of the weighted difference to placebo adjusted for site (and disease duration for Study I only) † Major clinical response is defined as achieving an ACR 70 response for a continuous 24 week period
ACR 20
Week 24 53% 70%
(0.11, 0.27) 27% 51%
(0.17, 0.29) 56%
(0.23, 0.35) 27% 48%
(0.15, 0.32) 59%
(0.23, 0.41) 24% 61%
(0.30, 0.40) 10% 30%
(0.15, 0.36) 50%
(0.36, 0.56)
Week 52 N/A N/A 25% 47%
(0.15, 0.28) 56%
(0.25, 0.38) N/A N/A N/A N/A N/A N/A N/A N/A
ACR 50
Week 24 34% 44%
(0.04, 0.20) 10% 25%
(0.09, 0.20) 32%
(0.16, 0.28) 11% 32%
(0.13, 0.29) 44%
(0.25, 0.41) 9% 38%
(0.23, 0.33) 4% 17%
(0.05, 0.25) 29%
(0.21, 0.41)
Week 52 N/A N/A 10% 29%
(0.14, 0.25) 36%
(0.21, 0.32) N/A N/A N/A N/A N/A N/A N/A N/A
ACR 70
Week 24 15% 28%
(0.07, 0.22) 2% 11%
(0.03, 0.13) 13%
(0.05, 0.15) 2% 12%
(0.04, 0.18) 22%
(0.12, 0.27) 3% 21%
(0.13, 0.21) 1% 5%
(-0.06, 0.14) 12%
(0.03, 0.22)
Week 52 N/A N/A 4% 16%
(0.08, 0.17) 20%
(0.12, 0.21) N/A N/A N/A N/A N/A N/A N/A N/A
Major Clinical Responses †
Week 52 N/A N/A 1% 4%
(0.01, 0.06) 7%
(0.03, 0.09) N/A N/A N/A N/A N/A N/A N/A N/A
In study II, a greater proportion of patients treated with 4 mg per kg and 8 mg per kg ACTEMRA + MTX achieved a low level of disease activity as measured by a DAS 28-ESR less than 2.6 compared with placebo +MTX treated patients at week 52. The proportion of ACTEMRA-treated patients achieving DAS 28-ESR less than 2.6, and the number of residual active joints in these responders in Study II are shown in TABLE 4.
Table 4 Proportion of Patients with DAS28-ESR Less Than 2.6 with Number of Residual Active Joints in Trials of Intravenous ACTEMRA
Study II
Placebo + MTX
N = 393 ACTEMRA 4 mg per kg + MTX
N = 399 ACTEMRA 8 mg per kg + MTX
N = 398
*n denotes numerator of all the percentage. Denominator is the intent-to-treat population. Not all patients received DAS28 assessments at Week 52.
DAS28-ESR less than 2.6
Proportion of responders at week 52 (n) 95% confidence interval 3% (12) 18% (70)
0.10, 0.19 32% (127)
0.24, 0.34
Of responders, proportion with 0 active |
