BASDAI 50, BASDAI 20, ASAS 40 responses and ASAS partial remission
| Placebo (n=13) | 20 mg (n=11) | p Value, 20 mg vs Placebo | 50 mg (n=12) | p Value, 50 mg vs Placebo | |
|---|---|---|---|---|---|
| BASDAI 50 | 8 (1 to 33) | 27 (8 to 61) | 0.30 | 33 (12 to 65) | 0.16 |
| ASAS 20 | 23 (7 to 52) | 39 (20 to 73) | 0.08 | 58 (29 to 82) | 0.19 |
| ASAS 40 | 15 (3 to 43) | 27 (8 to 61) | 0.63 | 33 (12 to 65) | 0.38 |
| ASAS PR | 0 (0 to 22) | 18 (3 to 50) | 0.20 | 17 (3 to 45) | 0.22 |
| BASDAI (mean, 95% CI) | 0.66 (−0.34 to 1.66) | 1.19 (0.12 to 2.27) | 0.41 | 2.39* (1.38 to 3.40) | 0.033 |
| BASDAI morning stiffness (mean, 95% CI) | 1.03 (−0.32 to 2.38) | 1.27 (−0.19 to 2.74) | 0.79 | 3.41* (2.01 to 4.81) | 0.020 |
| BASFI (mean, 95% CI) | 0.74 (−0.39 to 1.86) | 0.94 (−0.37 to 2.24) | 0.83 | 1.76 (0.51 to 3.01) | 0.20 |
| PG (mean, 95% CI) | 0.94 (−0.65 to 2.52) | 1.67 (−0.06 to 3.40) | 0.47 | 3.04 (1.41 to 4.68) | 0.056 |
| Pain (mean, 95% CI) | 1.22 (−0.29 to 2.73) | 1.83 (0.18 to 3.48) | 0.51 | 3.25 (1.68 to 4.82) | 0.062 |
| BASMI (mean, 95% CI) | −0.13 (−0.80 to 0.53) | 0.32 (−0.41 to 1.04) | 0.36 | 0.93* (0.21 to 1.65) | 0.020 |
| ASDAS (mean, 95% CI) | 0.34 (−0.22 to 0.90) | 1.16* (0.45 to 1.88) | 0.0036 | 1.56* (0.93 to 2.20) | 0.010 |
| CRP (mean, 95% CI) | 3.19 (−3.35 to 9.74) | 19.94* (11.54 to 28.34) | 0.0016 | 15.58* (8.10 to 23.07) | 0.036 |
Unless otherwise stated values are percentage (95% CI). Mean changes from baseline at week 2 adjusted for baseline values are shown with 95% CIs; positive values indicate better outcomes at week 2. Negative values indicate worsening, positive values indicate improvement of the parameters.
ASAS 20, 20% improvement according to the ASAS criteria; ASAS 40, 40% improvement according to the ASAS criteria; ASAS PR, partial remission according to the ASAS criteria; ASAS, Assessments in SpondyloArthritis International Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI 50, 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index; BASDAI morning stiffness, mean of BASDAI question 5 and 6 for morning stiffness; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CRP, C reactive protein; PG, patient global assessment.