Follow-up data at week 12 compared with baseline data in two clinical trial populations
| (Sub)population | Parameters | Mean value (SD) of parameter at baseline | Mean value (SD) of parameter at week 12 | % Improvement between baseline and week 12 | Effect size week 12 | |
| TNFα trial population | Total group | Original BASDAI | 6.49 (1.23) | 3.06 (2.01) | 52.9% | 2.79 |
| Mini-BASDAI | 6.98 (1.25) | 3.41 (2.01) | 51.1% | 2.86 | ||
| Patient global | 7.20 (1.73) | 3.10 (2.33) | 56.9% | 2.37 | ||
| BASFI | 6.23 (1.62) | 3.28 (2.36) | 47.4% | 2.28 | ||
| “P−” group | Original BASDAI | 6.08 (1.26) | 2.75 (2.23) | 54.8% | 2.64 | |
| Mini-BASDAI | 6.70 (1.21) | 3.09 (2.32) | 53.9% | 2.99 | ||
| Patient global | 6.83 (1.94) | 2.94 (2.70) | 57.0% | 2.01 | ||
| BASFI | 5.73 (1.30) | 2.89 (2.44) | 49.6% | 1.23 | ||
| “P+” group | Original BASDAI | 6.76 (1.15) | 3.27 (1.86) | 51.6% | 3.05 | |
| Mini-BASDAI | 7.16 (1.25) | 3.63 (1.91) | 49.3% | 2.82 | ||
| Patient global | 7.44 (1.56) | 3.20 (2.08) | 57.0% | 2.72 | ||
| BASFI | 6.56 (1.73) | 3.53 (2.29) | 46.2% | 1.24 | ||
| NSAID trial population* | Total group | Original BASDAI | 4.66 (1.59) | 3.37 (2.09) | 27.7% | 0.81 |
| Mini-BASDAI | 5.54 (1.64) | 3.87 (2.24) | 30.1% | 1.02 | ||
| Patient global | 6.23 (1.76) | 3.88 (2.44) | 37.7% | 1.34 | ||
| BASFI | 4.27 (2.22) | 3.43 (2.52) | 19.7% | 0.34 | ||
Mean values and SD.
*By definition patients in the non-steroidal anti-inflammatory drug (NSAID) trial had no peripheral arthritis.25
BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; mini-BASDAI, BASDAI without Q3arthritis and Q4enthesitis; BASFI, Bath Ankylosing Spondylitis Functional Index.