|
Variable
|
Study 3.1
|
Study 3.5
|
|---|
|
Reference IFX IV (n = 304)
|
CT-P13 IV (n = 302)
|
All (n = 606)
|
CT-P13 IV (n = 176)
|
CT-P13 SC (n = 167)
|
All (n = 343)
|
|---|
|
Demographics
|
|
Sex
|
Male, n (%)
|
48 (15.8%)
|
57 (18.9%)
|
105 (17.3%)
|
37 (21.0%)
|
37 (22.2%)
|
74 (21.6%)
|
|
Female, n (%)
|
256 (84.2%)
|
245 (81.1%)
|
501 (82.7%)
|
139 (79.0%)
|
130 (77.8%)
|
269 (78.4%)
|
|
Race
|
White, n (%)
|
222 (73.0%)
|
220 (72.8%)
|
442 (72.9%)
|
151 (85.8%)
|
145 (86.8%)
|
296 (86.3%)
|
|
Asian, n (%)
|
37 (12.2%)
|
34 (11.3%)
|
71 (11.7%)
|
2 (1.1%)
|
1 (0.6%)
|
3 (0.9%)
|
|
Black, n (%)
|
1 (0.3%)
|
2 (0.7%)
|
3 (0.5%)
|
–
|
–
|
–
|
|
Other, n (%)
|
44 (14.5%)
|
46 (15.2%)
|
90 (14.9%)
|
23 (13.1%)
|
21 (12.6%)
|
44 (12.8%)
|
|
Region
|
European, n (%)
|
199 (65.5%)
|
196 (64.9%)
|
395 (65.2%)
|
147 (83.5%)
|
141 (84.4%)
|
288 (84.0%)
|
|
Non-European, n (%)
|
105 (34.5%)
|
106 (35.1%)
|
211 (34.8%)
|
29 (16.5%)
|
26 (15.6%)
|
55 (16.0%)
|
|
Age, years
|
Mean ± SD
|
48.6 ± 11.5
|
49.0 ± 12.2
|
48.8 ± 11.8
|
51.9 ± 12.4
|
50.9 ± 12.2
|
51.4 ± 12.3
|
|
Baseline weight, kg
|
Mean ± SD
|
69.9 ± 15.8
|
70.7 ± 16.3
|
70.3 ± 16.0
|
72.7 ± 14.4
|
73.0 ± 15.1
|
72.9 ± 14.7
|
|
Baseline BMI, kg/m2
|
Mean ± SD
|
26.3 ± 5.3
|
26.5 ± 5.3
|
26.4 ± 5.3
|
26.8 ± 4.1
|
26.8 ± 4.4
|
26.8 ± 4.3
|
|
Clinical characteristics
|
|
CRP, mg/L
|
Mean ± SD
|
18.9 ± 21.8
|
19.0 ± 25.1
|
18.9 ± 23.5
|
22.4 ± 35.4
|
18.3 ± 23.7
|
20.4 ± 30.2
|
|
ESR, mm/h
|
Mean ± SD
|
48.5 ± 22.6
|
46.5 ± 22.3
|
47.5 ± 22.4
|
44.6 ± 23.5
|
41.8 ± 19.1
|
43.2 ± 21.5
|
|
DAS28-CRP
|
Mean ± SD
|
5.8 ± 0.9
|
5.9 ± 0.8
|
5.8 ± 0.9
|
5.9 ± 0.8
|
6.0 ± 0.8
|
5.9 ± 0.8
|
|
DAS28-ESR
|
Mean ± SD
|
6.6 ± 0.8
|
6.7 ± 0.8
|
6.6 ± 0.8
|
6.6 ± 0.8
|
6.7 ± 0.8
|
6.6 ± 0.8
|
|
CDAI
|
Mean ± SD
|
39.4 ± 11.0
|
40.9 ± 11.4
|
40.2 ± 11.2
|
39.6 ± 10.0
|
42.7 ± 10.2
|
41.1 ± 10.2
|
|
SDAI
|
Mean ± SD
|
41.3 ± 11.6
|
42.8 ± 11.9
|
42.1 ± 11.8
|
41.9 ± 11.1
|
44.5 ± 10.7
|
43.1 ± 11.0
|
|
SF-36 Mental
|
Mean ± SD
|
37.8 ± 11.1
|
36.8 ± 10.7
|
37.3 ± 10.9
|
39.6 ± 10.5
|
39.9 ± 10.3
|
39.8 ± 10.4
|
|
SF-36 Physical
|
Mean ± SD
|
31.9 ± 7.2
|
31.1 ± 6.1
|
31.5 ± 6.7
|
33.3 ± 6.3
|
33.6 ± 5.6
|
33.5 ± 6.0
|
|
Patient assessment of global disease activity
|
Mean ± SD
|
65.4 ± 17.0
|
65.8 ± 17.2
|
65.6 ± 17.1
|
69.0 ± 17.5
|
70.5 ± 15.8
|
69.7 ± 16.7
|
|
Physician assessment of global disease activity
|
Mean ± SD
|
65.0 ± 13.5
|
64.9 ± 14.2
|
64.9 ± 13.8
|
68.9 ± 15.2
|
70.5 ± 14.1
|
69.7 ± 14.7
|
|
HAQ-DI
|
Mean ± SD
|
1.6 ± 0.6
|
1.6 ± 0.5
|
1.6 ± 0.6
|
1.6 ± 0.6
|
1.6 ± 0.5
|
1.6 ± 0.6
|
- BMI body mass index, CDAI Clinical Disease Activity Index, CRP C-reactive protein, DAS28-CRP 28-joint Disease Activity Score based on C-reactive protein, DAS28-ESR 28-joint Disease Activity Score based on erythrocyte sedimentation rate, ESR erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire–Disability Index, IFX infliximab, IV intravenous, SC subcutaneous, SDAI Simplified Disease Activity Index, SD standard deviation
