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Table 2 Composite endpoint scores in the OPAL Broaden and OPAL Beyond studies (FAS)

From: Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease

Mean composite endpoint scores (SD) [number of patients evaluable at time point]

 

OPAL Broaden (N = 422)

OPAL Beyond (N = 394)

Tofacitinib

5 mg BID

N = 107

Tofacitinib

10 mg BID

N = 104

Adalimumab 40 mg SC Q2W

N = 106

Placebo - > tofacitinib

5 mg BID

N = 52a

Placebo - > tofacitinib

10 mg BID

N = 53a

Tofacitinib

5 mg BID

N = 131

Tofacitinib

10 mg BID

N = 132

Placebo - > tofacitinib

5 mg BID

N = 66a

Placebo - > tofacitinib

10 mg BID

N = 65a

PASDAS

 Baseline

6.03 (1.15) [105]

6.01 (1.06) [102]

5.92 (1.25) [106]

6.03 (1.15) [103]

6.09 (1.22) [124]

6.43 (1.21) [128]

5.97 (1.26) [128]

 Month 3

4.17 (1.69) [98]

3.70 (1.43) [102]

3.89 (1.57) [98]

4.97 (1.41) [100]

4.26 (1.71) [122]

4.24 (1.78) [114]

5.07 (1.86) [117]

 Month 6

3.63 (1.61) [99]

3.43 (1.45) [98]

3.41 (1.47) [98]

4.00 (1.49) [48]

3.69 (1.46) [47]

3.87 (1.72) [117]

3.97 (1.75) [109]

3.81 (1.68) [55]

3.60 (1.71) [55]

 Month 12

3.29 (1.37) [95]

3.05 (1.22) [95]

3.20 (1.56) [93]

3.50 (1.40) [44]

3.15 (1.21) [43]

–

–

–

–

DAPSA

 Baseline

45.55 (20.33) [107]

43.69 (19.51) [104]

38.52 (18.17) [105]

43.81 (22.46) [105]

45.53 (23.51) [130]

51.54 (27.80) [132]

42.64 (22.99) [131]

 Month 3

26.08 (23.53) [101]

20.29 (18.86) [103]

21.44 (20.43) [99]

31.64 (23.64) [101]

24.32 (20.53) [123]

29.14 (25.21) [117]

33.69 (27.69) [117]

 Month 6

21.42 (21.71) [100]

16.86 (17.99) [99]

16.34 (18.63) [99]

19.93 (18.14) [48]

19.42 (21.17) [48]

20.69 (17.55) [123]

28.30 (28.92) [113]

21.12 (20.75) [56]

20.28 (20.94) [55]

 Month 12

15.14 (14.29) [95]

13.21 (13.87) [96]

13.84 (15.50) [93]

15.60 (18.07) [44]

14.83 (14.84) [44]

–

–

–

–

CPDAIb

 Baseline

9.9 (2.39) [81]

10.0 (2.76) [68]

9.7 (2.84) [77]

9.9 (2.65) [81]

10.1 (2.58) [79]

10.7 (2.56) [79]

9.6 (2.86) [85]

 Month 3

7.4 (3.57) [77]

6.0 (3.01) [68]

6.9 (3.19) [75]

8.0 (2.95) [78]

7.1 (3.23) [70]

7.1 (3.33) [74]

8.0 (3.80) [73]

 Month 6

6.2 (3.39) [76]

5.1 (2.87) [66]

5.6 (3.30) [74]

6.4 (3.45) [39]

6.4 (3.36) [34]

6.3 (3.42) [75]

6.5 (3.11) [69]

6.3 (3.43) [32]

6.1 (3.39) [35]

 Month 12

5.1 (2.96) [73]

4.4 (2.71) [65]

5.0 (3.19) [71]

4.9 (3.17) [36]

5.1 (2.63) [32]

–

–

–

–

DAS28–3(CRP)

 Baseline

4.56 (0.92) [107]

4.48 (0.97) [104]

4.38 (1.02) [106]

4.50 (1.04) [105]

4.51 (1.04) [131]

4.67 (1.17) [132]

4.40 (1.03) [131]

 Month 3

3.25 (1.26) [101]

2.94 (1.15) [103]

2.96 (1.15) [99]

3.85 (1.30) [101]

3.18 (1.22) [123]

3.41 (1.39) [118]

3.77 (1.32) [117]

 Month 6

2.90 (1.25) [100]

2.60 (1.09) [99]

2.62 (1.08) [99]

2.99 (1.23) [48]

2.86 (1.23) [48]

2.98 (1.21) [123]

3.29 (1.36) [113]

2.87 (1.17) [56]

2.95 (1.35) [55]

 Month 12

2.64 (1.11) [95]

2.43 (0.99) [96]

2.44 (1.04) [93]

2.60 (1.20) [44]

2.52 (1.05) [44]

–

–

–

–

  1. aFor baseline and month 3 visits, patients from the two placebo sequences were combined into a single placebo group
  2. bOnly patients with psoriasis body surface area (BSA) of greater than or equal to 3% were included
  3. Abbreviations: BID twice daily, CPDAI Composite Psoriatic Disease Activity Index, DAPSA Disease Activity Index for Psoriatic Arthritis, DAS28–3(CRP) 3-component Disease Activity Score using 28 joints with C-reactive protein, FAS full analysis set, N number of patients in the full analysis set, OPAL Oral Psoriatic Arthritis triaL, PASDAS Psoriatic Arthritis Disease Activity Score, Q2W once every 2 weeks, SC subcutaneous, SD standard deviation
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Arthritis Research & Therapy

ISSN: 1478-6362

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