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 in Trials of Intravenous ACTEMRA
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, -10.0) 67.5 43
Disability index (HAQ)‡ 1.64 1.01
-0.18
(-0.34, -0.02) 1.55 0.96
-0.21
(-0.37, -0.05) 1.55 1.21 1.67 1.39
-0.25
(-0.42, -0.09) 1.75 1.34
-0.34
(-0.51, -0.17) 1.70 1.58
CRP (mg per dL) 2.79 1.17
-1.30
(-2.0, -0.59) 2.61 0.25
-2.156
(-2.86, -1.46) 2.36 1.89 3.11 1.77
-1.34
(-2.5, -0.15) 2.80 0.28
-2.52
(-3.72, -1.32) 3.705 3.06
The percent of ACR 20 responders by visit for Study III is shown in FIGURE 1. Similar response curves were observed in studies I, II, IV, and V.
Figure 1 Percent of ACR 20 Responders by Visit for Study III (Inadequate |
