|
ACTEMRA(tocilizumab) injection, solution, concentrate(二十一)
sp;
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
ACR70
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
Table 4 Proportion of Patients with DAS28-ESR Less Than 2.6 with Number of Residual Active Joints 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 joints (n) 33% (4) 27% (19) 21% (27)
Of responders, proportion with 1 active joint (n) 8% (1) 19% (13) 13% (16)
Of responders, proportion with 2 active joints (n) 25% (3) 13% (9) 20% (25)
Of responders, proportion with 3 or more active joints (n) 33% (4) 41% (29) 47% (59)
The results of the components of the ACR response criteria for Studies III and V are shown in Table 5. Similar results to Study III were observed in Studies I, II and IV.
Table 5 Components of ACR Response at Week 24 Study III Study V
ACTEMRA
4 mg per kg + MTX ACTEMRA
8 mg per kg + MTX Placebo + MTX ACTEMRA
4 mg per kg + MTX ACTEMRA
8 mg per kg + MTX Placebo + MTX
N=213 N=205 N=204 N=161 N=170 N=158
Component (mean) Baseline Week 24* Baseline Week 24 * Baseline Week 24 Baseline Week 24 * Baseline Week 24 * Baseline Week 24
*
Data shown is mean at week 24, difference in adjusted mean change from baseline compared with placebo + MTX at week 24 and 95% confidence interval for that difference
†
Visual analog scale: 0 = best, 100 = worst
‡
Health Assessment Questionnaire: 0 = best, 3 = worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities
Number of tender joints (0-68) 33 19
-7.0
(-10.0, -4.1) 32 14.5
-9.6
(-12.6, -6.7) 33 25 31 21
-10.8
(-14.6, -7.1) 32 17
-15.1
(-18.8, -11.4) 30 30
Number of swollen joints (0-66) 20 10
-4.2
(-6.1, -2.3) 19.5 8
-6.2
(-8.1, -4.2) 21 15 19.5 13
-6.2
(-9.0, -3.5) 19 11
-7.2
(-9.9, -4.5) 19 18
Pain† 61 33
-11.0
(-17.0, -5.0) 60 30
-15.8
(-21.7, -9.9) 57 43 63.5 43
-12.4
(-22.1, -2.1) 65 33
-23.9
(-33.7, -14.1) 64 48
Patient global assessment† 66 34
-10.9
(-17.1, -4.8) 65 31
-14.9
(-20.9, -8.9) 64 45 70 46
-10.0
(-20.3, 0.3) 70 36
-17.4
(-27.8, -7.0) 71 51
Physician global assessment† 64 26
-5.6
(-10.5, -0.8) 64 23
-9.0
(-13.8, -4.2) 64 32 66.5 39
-10.5
(-18.6, -2.5) 66 28
-18.2
(-26.3, - |
|
