Table 2.
Composite endpoint scores in the OPAL Broaden and OPAL Beyond studies (FAS)
| 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] | – | – | – | – |
aFor baseline and month 3 visits, patients from the two placebo sequences were combined into a single placebo group
bOnly patients with psoriasis body surface area (BSA) of greater than or equal to 3% were included
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