Table 2 |
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|
Improvements in health-related quality of life at weeks 12, 24 and 52 (ITT population, LOCF)* |
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|
Week 12 |
Week 24 |
Week 52 |
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|
|
|
|
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|
CZP 200 mg + MTX (n = 393) |
CZP 400 mg + MTX (n = 390) |
PBO + MTX (n = 199) |
CZP 200 mg + MTX (n = 393) |
CZP 400 mg + MTX (n = 390) |
PBO + MTX (n = 199) |
CZP 200 mg + MTX (n = 393) |
CZP 400 mg + MTX (n = 390) |
PBO + MTX (n = 199) |
|
|
|
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|
PCS |
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|
Mean score (SD) |
36.1 (8.9) |
36.8 (8.4) |
30.7 (7.1) |
37.8 (9.5) |
38.4 (8.8) |
31.4 (7.3) |
38.1 (9.5) |
38.9 (8.9) |
31.5 (7.4) |
|
Mean change from BL |
5.8 (0.5)† |
6.4 (0.6)† |
0.7 (0.6) |
7.7 (0.4)† |
8.3 (0.4)† |
1.8 (0.6) |
7.8 (0.4)† |
8.6 (0.4)† |
1.7 (0.6) |
|
% MCID |
38.2† |
36.5† |
21.4 |
46.6† |
51.7† |
10.9 |
42.2† |
46.1† |
11.5 |
|
MCS |
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|
Mean score (SD) |
45.5 (11.5) |
45.7 (11.6) |
41.4 (10.8) |
45.6 (11.5) |
45.6 (11.6) |
41.3 (10.7) |
45.8 (11.4) |
45.4 (11.5) |
41.1 (10.8) |
|
Mean change from BL |
5.6 (0.7)† |
5.5 (0.7)† |
2.0 (0.8) |
6.3 (0.6)† |
6.5 (0.6)† |
2.3 (0.8) |
6.4 (0.6)† |
6.4 (0.6)† |
2.1 (0.8) |
|
% MCID |
36.0‡ |
33.3 |
28.1 |
41.1† |
41.9† |
13.0 |
39.2† |
38.1† |
9.9 |
|
Physical Functioning |
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|
Mean score (SD) |
45.1 (25.8) |
46.1 (24.6) |
31.2 (21.0) |
47.6 (26.5) |
48.8 (24.7) |
33.3 (22.2) |
49.3 (26.9) |
50.3 (24.9) |
33.1 (22.3) |
|
Mean change from BL |
11.4 (1.4)† |
12.2 (1.4)† |
-1.0 (1.7) |
15.6 (1.2)† |
16.5 (1.2)† |
1.9 (1.6) |
16.7 (1.2)† |
17.9 (1.2)† |
1.7 (1.6) |
|
% MCID |
32.1† |
33.6† |
18.4 |
42.0† |
46.6† |
10.7 |
38.0† |
44.3† |
9.7 |
|
Role Physical |
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|
Mean score (SD) |
34.1 (38.3) |
33.9 (38.5) |
15.0 (28.0) |
37.2 (40.4) |
38.6 (40.2) |
18.0 (30.2) |
37.7 (40.3) |
39.2 (41.8) |
17.3 (30.2) |
|
Mean change from BL |
24.8 (2.4)† |
24.2 (2.5)† |
6.4 (2.9) |
27.8 (2.0)† |
29.1 (2.0)† |
9.4 (2.8) |
26.9 (2.1)† |
29.1 (2.0)† |
8.1 (2.9) |
|
% MCID |
24.9† |
24.5‡ |
13.9 |
33.0† |
36.8† |
10.3 |
32.2† |
31.1† |
8.2 |
|
Bodily Pain |
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|
Mean score (SD) |
47.8 (20.1) |
49.6 (20.4) |
33.1 (18.5) |
51.4 (22.3) |
53.4 (20.8) |
33.2 (19.4) |
52.0 (22.8) |
53.9 (22.2) |
34.0 (20.1) |
|
Mean change from BL |
18.0 (1.3)† |
20.2 (1.4)† |
4.5 (1.6) |
23.3 (1.1)† |
25.8 (1.1)† |
6.3 (1.5) |
23.5 (1.1)† |
26.2 (1.1)† |
6.8 (1.6) |
|
% MCID |
45.9‡ |
43.3‡ |
33.3 |
52.5† |
58.2† |
15.9 |
48.8† |
50.7† |
14.9 |
|
General Health |
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|
Mean score (SD) |
44.0 (18.9) |
48.4 (19.6) |
36.9 (18.0) |
47.4 (19.6) |
48.5 (19.7) |
37.2 (17.1) |
47.5 (20.3) |
47.6 (19.2) |
36.9 (16.6) |
|
Mean change from BL |
8.9 (1.1)† |
11.1 (1.1)† |
2.4 (1.3) |
13.2 (0.9)† |
14.0 (0.9)† |
3.7 (1.2) |
13.0 (0.9)† |
13.0 (0.9)† |
3.1 (1.3) |
|
% MCID |
31.1 |
32.7‡ |
24.2 |
44.3† |
45.7† |
11.3 |
40.3† |
40.6† |
10.3 |
|
Vitality |
|||||||||
|
Mean score (SD) |
48.2 (21.4) |
50.0 (21.3) |
37.0 (19.1) |
50.9 (21.6) |
51.4 (21.3) |
38.3 (19.9) |
50.7 (21.7) |
51.1 (20.9) |
38.4 (20.0) |
|
Mean change from BL |
12.9 (1.3)† |
14.4 (1.4)† |
2.8 (1.6) |
15.5 (1.1)† |
16.2 (1.1)† |
4.7 (1.5) |
15.1 (1.0)† |
15.6 (1.0)† |
4.5 (1.5) |
|
% MCID |
35.5‡ |
35.3‡ |
27.0 |
45.1† |
45.7† |
12.2 |
40.8† |
42.8† |
11.2 |
|
Social Functioning |
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|
Mean score (SD) |
64.8 (25.2) |
64.0 (24.4) |
50.6 (25.1) |
66.6 (25.7) |
65.7 (24.4) |
50.8 (25.7) |
67.2 (25.9) |
66.2 (25.3) |
50.6 (25.4) |
|
Mean change from BL |
15.6 (1.6)† |
14.7 (1.6)† |
2.6 (1.9) |
18.3 (1.3)† |
18.1 (1.3)† |
3.4 (1.8) |
18.5 (1.3)† |
18.6 (1.3)† |
3.2 (1.8) |
|
% MCID |
39.5‡ |
36.8 |
30.1 |
45.3† |
48.3† |
11.7 |
43.5† |
44.4† |
11.2 |
|
Role Emotional |
|||||||||
|
Mean score (SD) |
50.4 (43.0) |
50.8 (43.9) |
37.4 (41.2) |
50.2 (42.9) |
54.1 (43.4) |
36.3 (40.9) |
52.8 (43.0) |
53.9 (43.5) |
35.7 (40.6) |
|
Mean change from BL |
19.2 (2.8)‡ |
19.3 (2.9)‡ |
6.6 (3.3) |
22.2 (2.2)† |
26.4 (2.2)† |
7.8 (3.1) |
23.9 (2.3)† |
26.1 (2.2)† |
7.1 (3.1) |
|
% MCID |
25.5‡ |
22.4 |
17.4 |
31.7† |
33.2† |
10.8 |
29.0† |
29.7† |
9.2 |
|
Mental Health |
|||||||||
|
Mean score (SD) |
64.1 (19.4) |
64.5 (20.2) |
56.1 (19.7) |
64.3 (20.1) |
63.8 (20.2) |
56.3 (21.1) |
64.3 (20.4) |
63.3 (19.9) |
55.8 (21.1) |
|
Mean change from BL |
9.3 (1.2)† |
8.9 (1.2)† |
2.1 (1.4) |
11.0 (1.0)† |
10.5 (1.0)† |
3.7 (1.3) |
10.7 (1.0)† |
9.9 (1.0)† |
3.0 (1.4) |
|
% MCID |
33.3‡ |
27.4 |
27.0 |
40.8† |
37.1† |
14.3 |
37.3† |
33.9† |
11.2 |
|
|
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|
*SF-36 PCS, MCS and domain scores, adjusted mean change from baseline, and percentage of patients reporting improvements meeting or exceeding MCID. Changes from baseline were analyzed using ANCOVA with region and treatment as factors, and baseline as covariate (using LOCF imputation of missing data). †P < 0.001; ‡P < 0.05. BL = baseline; CZP = certolizumab pegol; ITT = intent to treat; LOCF = last observation carried forward; MCID = minimal clinically important difference; MCS = mental component summary; MTX = methotrexate; PBO = placebo; PCS = physical component summary; SD = standard deviation; SF-36 = short-form 36-item health survey. |
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|
Strand et al. Arthritis Research & Therapy 2009 11:R170 doi:10.1186/ar2859 |
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