Patient-reported outcome measure | ASAS Response | ASAS Response | ASAS Response | ASAS Response | p-value |
---|---|---|---|---|---|
 | Nonresponder | ASAS20 | ASAS50 | ASAS70 |  |
Mean change from baseline to Week 12 (SE) Effect Size (ES) | Â | Â | Â | Â | Â |
FACIT-Fatigue | -0.24 (0.95) | 9.42 (1.24) | 14.33 (1.89) | 15.20 (2.50) | < 0.0001 |
FACIT-Fatigue | ES = 0.02 | ES = 0.92 | ES = 1.40 | ES = 1.49 | < 0.0001 |
FACIT-Fatigue | n = 54 | n = 12 | n = 6 | n = 10 | < 0.0001 |
SF-36 | Â | Â | Â | Â | Â |
   PCS | 0.79 (0.42) | 6.36 (1.00) | 11.38 (1.12) | 14.28 (0.77) | <0.0001 |
   PCS | ES = 0.10 | ES = 0.81 | ES = 1.44 | ES = 1.81 | < 0.0001 |
   PCS | n = 217 | n = 63 | n = 42 | n = 60 | < 0.0001 |
   MCS | 0.54 (0.70) | 3.33 (1.24) | 1.86 (1.70) | 9.61 (1.14) | < 0.0001 |
   MCS | ES = 0.05 | ES = 0.30 | ES = 0.17 | ES = 0.86 | < 0.0001 |
   MCS | n = 217 | n = 63 | n = 42 | n = 60 | < 0.0001 |
   Physical function | 0.48 (1.11) | 14.82 (1.98) | 17.30 (2.90) | 25.34 (2.72) | < 0.0001 |
   Physical function | ES = 0.02 | ES = 0.67 | ES = 0.79 | ES = 1.15 | < 0.0001 |
   Physical function | n = 222 | n = 64 | n = 43 | n = 60 | < 0.0001 |
   Role- physical | 5.31 (1.80) | 22.66 (4.16) | 37.21 (6.30) | 55.00 (4.40) | < 0.0001 |
   Role- physical | ES = 0.18 | ES = 0.77 | ES = 1.27 | ES = 1.88 | < 0.0001 |
   Role- physical | n = 223 | n = 64 | n = 43 | n = 60 | < 0.0001 |
   Bodily pain | 3.03 (0.96) | 17.50 (2.18) | 30.40 (2.97) | 41.02 (2.24) | < 0.0001 |
   Bodily pain | ES = 0.19 | ES = 1.11 | ES = 1.92 | ES = 2.60 | < 0.0001 |
   Bodily pain | n = 223 | n = 64 | n = 43 | n = 60 | < 0.0001 |
   General health | -0.12 (0.93) | 4.78 (1.84) | 13.19 (2.50) | 21.40 (2.17) | < 0.0001 |
   General health | ES = 0.01 | ES = 0.24 | ES = 0.66 | ES = 1.07 | < 0.0001 |
   General health | n = 221 | n = 63 | n = 42 | n = 60 | < 0.0001 |
   Vitality | 2.50 (1.07) | 13.52 (1.84) | 18.49 (2.68) | 31.56 (2.36) | < 0.0001 |
   Vitality | ES = 0.14 | ES = 0.77 | ES = 1.05 | ES = 1.79 | < 0.0001 |
   Vitality | n = 222 | n = 64 | n = 43 | n = 60 | < 0.0001 |
   Social function | 1.79 (1.36) | 11.91 (2.62) | 9.01 (3.36) | 27.08 (2.63) | < 0.0001 |
   Social function | ES = 0.07 | ES = 0.49 | ES = 0.37 | ES = 1.12 | < 0.0001 |
   Social function | n = 223 | n = 64 | n = 43 | n = 60 | < 0.0001 |
   Role- emotional | 3.32 (2.88) | 13.54 (5.74) | 15.50 (7.87) | 32.22 (4.95) | < 0.0001 |
   Role- emotional | ES = 0.08 | ES = 0.32 | ES = 0.36 | ES = 0.76 | < 0.0001 |
   Role- emotional | n = 221 | n = 64 | n = 43 | n = 60 | < 0.0001 |
   Mental health | -0.01 (1.09) | 5.98 (1.63) | 4.23 (2.54) | 17.20 (1.77) | < 0.0001 |
   Mental health | ES = 0.00 | ES = 0.32 | ES = 0.23 | ES = 0.92 | < 0.0001 |
   Mental health | n = 222 | n = 64 | n = 43 | n = 60 | < 0.0001 |