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Table 1 Baseline values and changes from baseline at months 3 and 6 for patient-reported outcome measures

From: Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs

 

Baseline mean (SD)

Month 3 LSM change from baseline (SE)

Month 6 LSM change from baseline (SE)

 

Placebo (n = 122)

Tofacitinib 5 mg BID (n = 243)

Tofacitinib 10 mg BID (n = 245)

Placebo (n = 122)

Tofacitinib 5 mg BID (n = 243)

Tofacitinib 10 mg BID (n = 245)

Placebo → Tofacitinib 5 mg BID (n = 61)

Placebo → Tofacitinib 10 mg BID (n = 61)

Tofacitinib 5 mg BID (n = 243)

Tofacitinib 10 mg BID (n = 245)

PtGA

62.63 (21.91)

61.66 (22.00)

63.46 (23.23)

−11.19 (2.10)

−26.99 (1.45)***

−30.94 (1.47)***

−28.07 (2.97)

−29.62 (3.05)

−30.25 (1.47)

−33.99 (1.50)

Pain

61.79 (21.27)

61.35 (22.27)

62.03 (23.63)

−10.71 (2.14)

−26.94 (1.47)***

−31.06 (1.50)***

−26.01 (3.02)

−29.48 (3.10)

−29.19 (1.49)

−34.11 (1.52)

HAQ-DI

1.53 (0.65)

1.53 (0.66)

1.50 (0.64)

−0.19 (0.05)

−0.50 (0.03)***

−0.57 (0.03)***

−0.43 (0.07)

−0.59 (0.07)

−0.62 (0.03)

−0.67 (0.04)

SF-36 component summary scores

          

SF-36 PCS score

32.21 (8.35)

31.23 (8.03)

31.37 (7.39)

2.63 (0.78)

6.79 (0.53)***

8.55 (0.55)***

5.18 (1.09)

6.14 (1.11)

8.01 (0.53)

9.66 (0.55)

SF-36 MCS score

39.87 (11.62)

41.36 (11.68)

42.19 (12.44)

1.09 (0.89)

4.11 (0.61)*

5.39 (0.62)***

3.83 (1.23)

8.01 (1.26)

4.62 (0.60)

4.80 (0.62)

SF-36 domain scores

          

Physical functioning

31.41 (9.66)

30.09 (9.31)

30.51 (8.76)

2.17 (0.88)

6.15 (0.60)**

6.97 (0.62)***

4.02 (1.22)

5.15 (1.26)

6.95 (0.60)

8.17 (0.62)

Role physical

33.33 (8.97)

32.84 (8.87)

33.45 (8.69)

1.88 (0.83)

5.89 (0.57)***

7.53 (0.58)***

4.33 (1.16)

6.31 (1.20)

7.01 (0.57)

7.85 (0.59)

Bodily pain

32.77 (7.67)

32.41 (7.57)

32.74 (7.55)

3.91 (0.86)

8.26 (0.58)***

10.84 (0.60)***

7.88 (1.21)

10.28 (1.25)

9.44 (0.59)

11.30 (0.61)

General health

34.70 (9.00)

34.86 (8.72)

35.71 (8.86)

2.44 (0.75)

4.76 (0.51)*

6.34 (0.53)***

5.26 (1.06)

5.37 (1.10)

6.51 (0.52)

7.49 (0.54)

Vitality

40.13 (9.82)

41.22 (10.06)

41.04 (10.27)

2.03 (0.81)

6.56 (0.55)***

8.49 (0.57)***

4.67 (1.15)

8.27 (1.18)

6.87 (0.56)

8.30 (0.58)

Social functioning

35.16 (10.34)

36.78 (11.04)

36.07 (11.27)

0.62 (0.91)

5.29 (0.62)***

7.51 (0.64)***

3.54 (1.29)

8.21 (1.34)

6.05 (0.63)

6.83 (0.65)

Role emotional

35.17 (13.11)

34.26 (12.63)

36.70 (13.03)

1.20 (1.05)

4.07 (0.72)*

5.50 (0.74)**

4.54 (1.43)

6.96 (1.47)

5.95 (0.70)

5.56 (0.72)

Mental health

38.43 (12.36)

40.05 (11.49)

40.50 (12.57)

2.19 (0.88)

4.71 (0.60)*

5.52 (0.62)*

4.09 (1.23)

8.02 (1.27)

4.52 (0.60)

5.35 (0.62)

FACIT-F

27.17 (10.88)

27.90 (10.70)

27.72 (11.15)

2.84 (0.82)

6.70 (0.56)***

8.01 (0.58)***

6.57 (1.16)

9.11 (1.20)

6.98 (0.57)

8.63 (0.58)

MOS Sleep Scale

47.32 (21.24)

42.45 (18.38)

43.09 (20.41)

−4.81 (1.48)

−7.13 (1.02)

−10.18 (1.04)*

−8.43 (2.06)

−10.50 (2.14)

−7.48 (1.02)

−9.98 (1.05)

  1. Co-primary endpoint at month 3. *p < 0.05; **p < 0.001; *** p < 0.0001 vs placebo. BID twice daily, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue, HAQ-DI Health Assessment Questionnaire-Disability Index, LSM least squares mean, MCS Mental Component Summary, MOS Medical Outcomes Study, Pain Patient Global Assessment of Pain, PCS Physical Component Summary, PtGA Patient Global Assessment of Disease Activity, SD standard deviation, SE standard error, SF-36 Short Form-36