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Table 1 Demographics and baseline characteristics in patients with baseline DSS > 0 or DSS = 0

From: Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies

 

DSS > 0

DSS = 0

(N1 = 337)

Hands only

(N1 = 251)

Feet only

(N1 = 275)

Hands and feet

(N1 = 153)

Hands or feet

(N1 = 373)

Tofacitinib 5 mg BID

N = 84a

N = 97

N = 54

N = 127a

N = 111b

Tofacitinib 10 mg BID

N = 87

N = 91

N = 53

N = 125

N = 111

Placebo

N = 80

N = 87

N = 46

N = 121

N = 115

Men, n (%)

44 (52.4)

57 (58.8)

31 (57.4)

70 (55.1)

47 (42.3)

42 (48.3)

42 (46.2)

24 (45.3)

60 (48.0)

40 (36.0)

42 (52.5)

46 (52.9)

30 (65.2)

58 (47.9)

42 (36.5)

Age, mean (SD), years

50.3 (12.0)

47.6 (12.5)

48.8 (12.4)

48.9 (12.3)

50.2 (12.5)

48.8 (11.5)

47.9 (12.0)

48.1 (11.3)

48.5 (12.0)

50.4 (11.4)

48.1 (13.8)

48.2 (12.7)

47.0 (14.5)

48.6 (12.7)

48.3 (12.3)

Race, n (%)

 White

80 (95.2)

90 (92.8)

51 (94.4)

119 (93.7)

107 (96.4)

80 (92.0)

80 (87.9)

49 (92.5)

111 (88.8)

110 (99.1)

77 (96.3)

83 (95.4)

45 (97.8)

115 (95.0)

107 (93.0)

 Other

4 (4.8)

7 (7.2)

3 (5.6)

8 (6.3)

4 (3.6)

7 (8.0)

11 (12.1)

4 (7.5)

14 (11.2)

1 (0.9)

3 (3.8)

4 (4.6)

1 (2.2)

6 (5.0)

8 (7.0)

BMI, mean (SD), kg/m2

29.8 (6.8)

29.7 (6.2)

29.2 (6.4)

30.0 (6.5)

29.6 (6.2)

29.9 (6.5)

30.1 (6.7)

29.6 (6.9)

30.2 (6.5)

30.3 (6.1)

29.5 (5.9)

29.5 (5.4)

29.9 (5.4)

29.3 (5.7)

29.1 (5.6)

PsA duration, mean (SD), years

9.3 (9.3)

7.7 (6.8)

8.2 (8.0)

8.5 (8.2)

8.7 (7.6)

7.8 (6.2)

8.1 (7.0)

8.1 (6.7)

7.9 (6.5)

7.0 (6.7)

7.8 (6.9)

8.2 (8.8)

7.3 (7.4)

8.3 (8.1)

7.8 (6.9)

DSS,c median (range)

7.0 (1.0–52.0)

6.0 (1.0–52.0)

11.0 (3.0–52.0)

6.0 (1.0–52.0)

NA

10.0 (1.0–40.0)

8.0 (1.0–40.0)

11.0 (2.0–40.0)

6.0 (1.0–40.0)

NA

8.0 (1.0–31.0)

8.0 (1.0–31.0)

12.5 (4.0–31.0)

6.0 (1.0–31.0)

NA

Dactylitic digits count,c median (range)

2.0 (1–10)

2.0 (1–10)

5.0 (2–20)

3.0 (1–20)

NA

2.0 (1–10)

2.0 (1–10)

5.0 (2–20)

4.0 (1–20)

NA

3.0 (1–10)

2.0 (1–10)

7.0 (2–17)

3.0 (1–17)

NA

PASDAS, mean (SD)d,e

6.7 (1.1)

6.6 (1.2)

6.9 (1.1)

6.5 (1.2)

5.5 (1.0)

6.8 (1.1)

6.8 (1.2)

7.1 (1.1)

6.7 (1.1)

5.7 (0.9)

6.7 (1.0)

6.7 (1.0)

7.0 (1.0)

6.6 (1.0)

5.4 (1.1)

HAQ-DI, mean (SD)

1.3 (0.6)

1.2 (0.7)

1.3 (0.7)

1.2 (0.7)

1.2 (0.7)b

1.3 (0.6)

1.3 (0.6)

1.3 (0.6)

1.3 (0.6)

1.2 (0.6)

1.3 (0.7)

1.2 (0.6)

1.2 (0.6)

1.3 (0.7)

1.1 (0.7)

FACIT-F total score, mean (SD)

25.7 (11.4)

27.5 (11.2)

25.7 (11.4)

27.1 (11.2)

26.8 (11.7)b

26.0 (10.1)

26.3 (10.1)

25.2 (8.8)

26.5 (10.6)

27.5 (10.4)

26.5 (11.1)

27.6 (10.1)

28.1 (10.3)

26.7 (10.7)

29.3 (10.6)

SF-36, mean (SD)

 PCS score

34.4 (8.1)a

34.0 (8.7)

33.9 (8.7)

34.3 (8.3)a

34.5 (8.2)f

33.1 (8.4)

33.1 (7.8)

32.1 (7.1)

33.5 (8.5)

34.1 (8.9)

34.4 (8.7)

34.3 (8.0)

35.1 (8.4)

34.0 (8.3)

36.6 (8.9)

 MCS, score

38.8 (10.9)a

40.9 (12.2)

39.2 (11.1)

40.2 (11.9)a

40.2 (11.7)f

39.8 (12.5)

39.3 (11.5)

39.6 (12.2)

39.5 (12.0)

40.7 (12.3)

39.0 (10.9)

39.7 (11.1)

40.1 (10.5)

39.1 (11.3)

41.2 (12.2)

 PF domain scoreg

33.4 (10.2)

34.1 (10.7)

32.8 (11.1)

34.2 (10.1)

33.6 (10.4)

34.2 (9.7)

33.8 (9.0)

33.2 (7.7)

34.3 (9.9)

33.8 (10.0)

33.4 (11.2)

34.2 (9.8)

34.3 (10.6)

33.6 (10.4)

36.7 (9.8)

Arthritis pain, mean (SD)h

59.0 (23.4)

55.2 (23.6)

56.5 (25.1)

57.1 (22.9)

54.8 (24.3)

58.8 (21.7)

59.2 (21.2)

58.3 (19.8)

59.3 (22.1)

54.9 (22.0)

59.8 (23.4)

56.5 (22.9)

57.8 (23.6)

58.2 (23.0)

49.8 (25.2)

WLQ dimension sub-scores, mean (SD)i,j

 Time management

36.4 (24.1)

37.0 (23.8)

38.8 (24.6)

35.9 (23.6)

41.5 (27.9)

39.1 (24.9)

35.1 (24.7)

37.3 (23.5)

36.7 (25.4)

43.3 (26.8)

49.0 (28.2)

46.3 (26.8)

48.4 (28.6)

47.2 (27.0)

35.3 (24.0)

 Physical demands

43.4 (23.2)

49.0 (25.5)

46.0 (23.9)

46.7 (25.0)

53.8 (26.7)

51.9 (24.2)

49.3 (23.6)

49.9 (22.1)

50.7 (24.7)

48.1 (27.0)

46.2 (27.9)

48.3 (26.1)

50.9 (28.4)

45.7 (26.2)

49.1 (27.0)

 Mental/interpersonal demands

27.6 (22.0)

26.4 (24.2)

28.2 (23.5)

26.4 (23.1)

28.5 (26.9)

25.5 (20.1)

24.5 (21.3)

24.6 (18.7)

25.1 (21.6)

29.7 (25.3)

29.0 (20.5)

28.7 (19.9)

28.2 (20.9)

29.1 (19.9)

25.5 (20.2)

 Output demands

30.5 (23.2)

32.2 (24.7)

34.5 (25.3)

30.2 (23.4)

34.2 (27.6)

33.4 (24.4)

29.9 (23.4)

32.8 (24.2)

30.9 (23.8)

33.3 (28.0)

41.1 (28.4)

39.5 (25.9)

41.3 (27.4)

39.8 (27.0)

29.2 (20.5)

  1. BID twice daily, BMI body mass index, DSS Dactylitis Severity Score, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue, HAQ-DI Health Assessment Questionnaire-Disability Index, MCS Mental Component Summary, n number of patients applicable for each category, N total number of patients, N1 number of patients in a dactylitis group at baseline receiving a particular treatment, NA not applicable, PASDAS Psoriatic Arthritis Disease Activity Score, PCS Physical Component Summary, PF physical functioning, PsA psoriatic arthritis, SD standard deviation, SF-36 Short Form-36 Health Survey, WLQ Work Limitations Questionnaire
  2. Italics indicate the placebo group throughout the table
  3. aSF-36 PCS/MCS included 83 (hands only) and 126 patients (hands or feet)
  4. bHAQ-DI, FACIT-F, and arthritis pain (patients with baseline DSS = 0) included 110 patients
  5. cDactylitis was defined as swelling of an entire digit; dactylitis digit counts were evaluated by a blinded, qualified assessor, and severity ranged from 0 to 3 (0 = no tenderness; 3 = extreme tenderness); DSS (sum of scores) ranged from 0 to 60 (60 = highest dactylitis severity) [20]
  6. dPASDAS (patients with baseline DSS > 0) included 78–86 patients for hands only, 86–97 patients for feet only, 46–54 patients for hands and feet, and 118–126 patients for hands or feet, across groups
  7. ePASDAS (patients with baseline DSS = 0) included 103–113 patients across groups
  8. fSF-36 PCS/MCS (patients with baseline DSS = 0) included 108 patients
  9. gSF-36 PF (patients with baseline DSS = 0) included 109, 110, and 114 patients receiving tofacitinib 5 mg BID, 10 mg BID, and placebo, respectively
  10. hArthritis pain was measured by 0–100 mm VAS; patients with baseline DSS = 0 included 110 patients receiving tofacitinib 5 mg BID
  11. iWLQ dimension sub-scores (patients with baseline DSS > 0) included 44–52 patients for hands only, 51–64 patients for feet only, 29–34 patients for hands and feet, and 68–82 patients for hands or feet, across groups
  12. jWLQ dimension sub-scores (patients with baseline DSS = 0) included 63–72 patients across groups
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