Table 1

Baseline disease activity and PRO scores (ITT population)

Characteristic, mean (SD)

CZP 200 mg + MTX

(n = 393)

CZP 400 mg + MTX

(n = 390)

PBO + MTX

(n = 199)

DAS28, range 0-10

6.9 (0.8)

6.9 (0.8)

7.0 (0.9)

PtGA VAS, range 0-100 mm

63.1 (20.3)

64.1 (18.3)

64.2 (19.6)

Pain VAS, range 0-100 mm

62.1 (20.0)

63.8 (17.2)

63.6 (19.9)

HAQ-DI, range 0-3

1.7 (0.6)

1.7 (0.6)

1.7 (0.6)

Fatigue NRS, range 0-10

6.4 (2.0)

6.5 (1.9)

6.7 (2.0)

SF-36

PCS, range 0-100*

30.9 (6.5)

30.8 (6.8)

30.5 (5.8)

MCS, range 0-100*

40.0 (11.2)

39.3 (11.1)

38.6 (11.4)

Domains, range 0-100

Physical Functioning

33.4 (21.4)

32.9 (21.2)

32.0 (20.1)

Role Physical

13.3 (23.7)

12.9 (25.4)

11.2 (20.8)

Bodily Pain

30.6 (15.3)

28.9 (15.9)

28.5 (14.7)

General Health

35.3 (16.5)

35.9 (17.5)

34.9 (15.6)

Vitality

35.8 (18.0)

36.1 (18.6)

32.9 (17.4)

Social Functioning

50.9 (23.8)

48.1 (24.0)

46.6 (25.2)

Role Emotional

32.4 (39.1)

28.9 (38.1)

30.9 (38.7)

Mental Health

53.8 (20.1)

53.5 (20.7)

52.2 (21.2)

* mean US population normative value equals 50

CZP = certolizumab pegol; DAS28 = disease activity score; HAQ-DI = health assessment questionnaire-disability index; ITT = intent to treat; MCS = mental component summary; MTX = methotrexate; NRS = numeric rating scale; PBO = placebo; PCS = physical component summary; PRO = patient-reported outcomes; PtGA = patient's global assessment of disease activity; SD = standard deviation; SF-36 = short-form 36-item health survey; VAS = visual analog scale.

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