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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