Table 2

Improvements in health-related quality of life at weeks 12, 24 and 52 (ITT population, LOCF)*

Week 12

Week 24

Week 52




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)


PCS

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

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

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

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

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

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

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


*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.

Strand et al. Arthritis Research & Therapy 2009 11:R170   doi:10.1186/ar2859

Open Data