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Table 1 Demographics and baseline disease characteristics of patients with LEI > 0 at baseline

From: Efficacy of tofacitinib on enthesitis in patients with active psoriatic arthritis: analysis of pooled data from two phase 3 studies

 

Patients with LEI > 0 (N = 479)

Locationa

Severityb

Lateral epicondyle humerus

N = 331

Medial femoral condyle

N = 285

Achilles tendon insertion

N = 260

1 site

N = 105

2 sites

N = 127

3–6 sites

N = 246

Tofacitinib 5 mg BID

N = 102

N = 94

N = 87

N = 37

N = 47

N = 73

Tofacitinib 10 mg BID

N = 119

N = 100

N = 92

N = 31

N = 37

N = 95

Placebo

N = 110

N = 91

N = 81

N = 37

N = 43

N = 78

Female, n (%)

58 (56.9)

49 (52.1)

47 (54.0)

19 (51.4)

26 (55.3)

39 (53.4)

80 (67.2)

66 (66.0)

55 (59.8)

14 (45.2)

20 (54.1)

66 (69.5)

68 (61.8)

60 (65.9)

50 (61.7)

15 (40.5)

26 (60.5)

53 (67.9)

Age, years, mean (SD)

50.8 (11.8)

49.2 (11.6)

48.7 (12.2)

50.0 (11.6)

49.4 (11.5)

49.7 (12.1)

50.6 (11.6)

50.2 (11.5)

50.5 (11.6)

48.2 (13.5)

48.4 (11.5)

51.4 (11.3)

49.2 (13.0)

49.3 (12.3)

49.6 (12.4)

48.1 (13.2)

50.0 (13.0)

49.6 (12.7)

Race, White, n (%)

96 (94.1)

89 (94.7)

83 (95.4)

35 (94.6)

46 (97.9)

69 (94.5)

112 (94.1)

94 (94.0)

88 (95.7)

28 (90.3)

34 (91.9)

92 (96.8)

104 (94.5)

85 (93.4)

77 (95.1)

34 (91.9)

41 (95.3)

73 (93.6)

BMI, kg/m2, mean (SD)

30.2 (6.4)

31.0 (6.9)

30.8 (6.3)

29.1 (7.3)

30.7 (7.1)

30.4 (6.0)

30.7 (6.3)

31.0 (6.5)

30.6 (6.8)

29.3 (5.6)

29.3 (6.9)

31.1 (6.5)

29.7 (5.8)

29.5 (5.8)

30.4 (6.1)

29.9 (4.7)

29.3 (5.9)

30.0 (6.2)

PsA duration, years, mean (SD)

7.6 (6.6)

9.6 (8.5)

8.7 (7.7)

10.4 (9.4)

7.5 (7.1)

8.5 (7.2)

6.9 (5.9)

7.5 (5.8)

7.6 (6.3)

7.1 (5.2)

6.8 (6.9)

7.5 (5.9)

7.5 (6.0)

8.5 (7.8)

8.0 (6.8)

10.0 (8.9)

9.5 (7.1)

6.8 (5.9)

CRP, mg/L, mean (SD)

9.8 (16.1)

11.3 (18.0)

13.8 (22.5)

17.4 (26.9)

17.1 (29.4)

8.3 (8.3)

11.0 (20.9)

16.3 (29.9)

13.6 (27.8)

14.7 (21.1)

8.9 (15.1)

14.5 (28.7)

10.6 (21.0)

11.2 (18.9)

10.5 (17.7)

17.7 (33.4)

9.7 (11.3)

9.4 (16.5)

LEI, mean (SD)

3.3 (1.6)

3.4 (1.6)

3.3 (1.7)

1.0 (0.0)

2.0 (0.0)

4.2 (1.1)

3.7 (1.7)

4.0 (1.6)

3.9 (1.8)

1.0 (0.0)

2.0 (0.0)

4.4 (1.1)

3.3 (1.6)

3.5 (1.5)

3.4 (1.7)

1.0 (0.0)

2.0 (0.0)

4.1 (1.1)

SPARCC, mean (SD) [N1]c

7.2 (3.8) [95]

7.2 (3.9) [88]

6.9 (4.2) [82]

2.7 (1.8) [33]

5.0 (2.4) [44]

8.4 (3.6) [70]

7.6 (4.3) [116]

8.3 (4.1) [95]

8.1 (4.4) [89]

2.3 (1.7) [30]

5.2 (2.3) [35]

8.9 (3.7) [92]

6.6 (3.8) [105]

7.0 (3.6) [85]

6.7 (3.7) [76]

2.8 (1.8) [36]

4.5 (2.7) [39]

8.0 (3.4) [74]

Dactylitis presence, DSS > 0, n (%)

56 (54.9)

56 (59.6)

53 (60.9)

19 (51.4)

25 (53.2)

46 (63.0)

65 (54.6)

53 (53.0)

52 (56.5)

15 (48.4)

22 (59.5)

51 (53.7)

59 (53.6)

50 (54.9)

48 (59.3)

17 (45.9)

21 (48.8)

46 (59.0)

TJC68, mean (SD) [N1]d

26.2 (14.4) [49]

24.8 (15.1) [41]

21.8 (14.3) [34]

18.2 (11.6) [18]

21.2 (10.5) [28]

28.3 (16.0) [28]

25.8 (13.4) [50]

24.9 (11.8) [36]

27.4 (14.5) [33]

17.4 (9.5) [13]

22.6 (16.5) [16]

28.3 (12.3) [35]

25.7 (16.3) [43]

29.1 (16.5) [42]

26.5 (15.4) [32]

13.9 (8.0) [12]

25.3 (14.5) [21]

29.6 (16.4) [32]

SJC66, mean (SD) [N1]d

15.5 (12.7) [49]

12.7 (8.6) [41]

15.6 (12.6) [34]

11.0 (7.2) [18]

14.6 (11.2) [28]

16.1 (12.6) [28]

12.4 (8.0) [50]

13.5 (8.5) [36]

14.8 (9.6) [33]

10.3 (5.9) [13]

11.4 (7.4) [16]

14.2 (8.7) [35]

13.2 (10.8) [43]

13.9 (11.0) [42]

11.9 (10.3) [32]

7.9 (5.1) [12]

13.0 (8.5) [21]

14.1 (11.6) [32]

PASDAS, mean (SD) [N1]d

6.4 (1.1) [98]

6.5 (1.1) [90]

6.6 (1.1) [83]

5.9 (1.3) [27]

6.4 (1.1) [38]

6.8 (1.1) [52]

6.5 (1.1) [116]

6.7 (1.1) [97]

6.7 (1.1) [90]

6.4 (1.0) [22]

6.3 (1.2) [29]

7.0 (1.1) [65]

6.3 (1.1) [108]

6.4 (1.2) [89]

6.5 (1.1) [79]

5.8 (1.2) [24]

6.8 (0.9) [29]

6.7 (1.0) [58]

DAPSA, mean (SD) [N1]d

54.8 (25.1) [101]

51.5 (24.3) [93]

52.6 (24.1) [86]

41.9 (23.3) [27]

49.3 (18.5) [38]

60.1 (26.2) [54]

56.8 (26.9)

57.0 (26.2)

60.5 (26.8)

44.1 (21.2) [22]

49.3 (25.8) [29]

63.9 (27.5) [66]

50.3 (26.0)

52.8 (25.8)

53.1 (25.0)

33.6 (15.6) [24]

50.6 (21.3) [29]

59.9 (26.5) [58]

CPDAI, mean (SD) [N1]e

11.0 (2.2) [62]

11.3 (2.2) [61]

11.4 (2.1) [60]

11.0 (2.1) [20]

10.7 (1.9) [27]

11.9 (2.2) [41]

11.3 (2.5) [70]

11.7 (2.2) [57]

11.9 (2.1) [52]

11.1 (2.5) [14]

10.9 (2.3) [24]

12.4 (2.2) [44]

10.8 (2.6) [67]

11.1 (2.2) [61]

11.2 (2.4) [55]

10.3 (2.6) [18]

12.1 (1.7) [25]

11.5 (2.4) [41]

FACIT-F total score, mean (SD) [N1]d

26.3 (11.0) [101]

26.2 (11.0) [93]

25.0 (12.1) [86]

25.4 (12.3)

25.0 (10.4)

26.0 (11.6) [72]

25.0 (10.5)

24.9 (9.8)

24.3 (9.1)

27.2 (10.8)

30.1 (10.6)

23.1 (8.9)

27.5 (11.0)

26.2 (10.3)

27.6 (10.3)

31.2 (9.5)

26.6 (12.3)

26.7 (9.9)

Arthritis pain (VAS), mean (SD) [N1]d

58.0 (21.2) [101]

57.6 (21.0) [93]

60.5 (21.0) [86]

55.1 (30.1)

60.9 (18.0)

58.1 (19.7) [72]

59.3 (21.4)

61.0 (22.1)

59.8 (22.6)

61.4 (22.5)

50.6 (24.8)

62.0 (20.6)

53.7 (23.8)

57.3 (23.2)

56.5 (22.6)

48.2 (25.4)

59.4 (21.4)

55.7 (22.9)

  1. aEach site was assessed bilaterally, and results were combined
  2. bThe total number of patients from each severity group does not equal 479 patients due to one patient for whom individual site was reported as “Not Done” at baseline in one of the bilateral sites, and therefore was not included in any of the severity groups
  3. cN1, number of patients with non-missing data and baseline SPARCC > 0, if different from N
  4. dN1, number of patients with non-missing data, if different from N
  5. eN1, number of patients with non-missing data and baseline affected body surface area ≥ 3%, if different from N
  6. BID, twice daily; BMI, body mass index; CPDAI, Composite Psoriatic Disease Activity in Psoriatic Arthritis; CRP, C-reactive protein; DAPSA, Disease Activity Index for Psoriatic Arthritis; DSS, Dactylitis Severity Score; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; LEI, Leeds Enthesitis Index; N, total number of patients; n, number of patients applicable for each category; PASDAS, Psoriatic Arthritis Disease Activity Score; PsA, psoriatic arthritis; SD, standard deviation; SJC66, swollen joint count (out of 66 joints); SPARCC, Spondyloarthritis Research Consortium of Canada Enthesitis Index; TJC68, tender joint count (out of 68 joints); VAS, Visual Analog Scale
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Arthritis Research & Therapy

ISSN: 1478-6362

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