Frequency of patients with each measure of outcome at each assessment by study arm and results of logistic regressions. Data are shown as n (%) unless otherwise specified.
| Trial arm | 3 Mos | 6 Mos, Randomization | 9 Mos | 12 Mos |
|---|---|---|---|---|
| Clinical response* | ||||
| 25 mg | 14 (60.9) | 23 (100) | 14 (60.9) | 12 (52.2) |
| 50 mg | 19 (79.2) | 24 (100) | 22 (91.7) | 22 (91.7) |
| Chi-square p value | 0.293 | — | 0.032 | 0.007 |
| OR (95% CI) | 0.41 (0.11–1.49) | — | 0.14 (0.03–0.75) | 0.10 (0.02–0.52) |
| Adjusted OR** (95% CI) | — | — | — | — |
| Mixed effects OR† (95% CI) | 0.15 (0.05–0.47), p = 0.001 | |||
| ASAS20 | ||||
| 25 mg | 13 (59.1) | 18 (81.8) | 10 (47.6) | 14 (63.6) |
| 50 mg | 17 (81.0) | 19 (90.5) | 20 (90.9) | 20 (90.9) |
| Chi-square p value | 0.219 | 0.71 (0.66)‡ | 0.006 | 0.072 (0.069)‡ |
| OR (95% CI) | 0.34 (0.09–1.35) | 0.47 (0.08–2.91) | 0.09 (0.02–0.49) | 0.18 (0.03–0.95) |
| Adjusted OR** (95% CI) | — | — | 0.09 (0.02–0.56) | 0.18 (0.03–1.15) |
| Mixed effects OR† (95% CI) | 0.25 (0.08–0.80), p = 0.019 | |||
| ASAS40 | ||||
| 25 mg | 10 (45.5) | 12 (54.5) | 8 (38.1) | 10 (45.5) |
| 50 mg | 13 (61.9) | 18 (85.7) | 17 (77.3) | 18 (81.8) |
| Chi-square p value | 0.438 | 0.058 (0.045)‡ | 0.022 | 0.028 (0.027)‡ |
| OR (95% CI) | 0.51 (0.15–1.73) | 0.20 (0.05–0.88) | 0.18 (0.05–0.69) | 0.19 (0.05–0.73) |
| Adjusted OR** (95% CI) | — | — | 0.18 (0.04–0.78) | 0.19 (0.04–0.87) |
| Mixed effects OR† (95% CI) | 0.24 (0.10–0.61), p = 0.003 | |||
| ASAS5 of 6 | ||||
| 25 mg | 9 (64.3) | 12 (80.0) | 6 (40.0) | 9 (56.2) |
| 50 mg | 12 (66.7) | 14 (77.8) | 13 (65.0) | 16 (94.1) |
| Chi-square p value | 1.00 | 1.00 (1.00)‡ | 0.26 | 0.033 (0.017)‡ |
| OR (95% CI) | 0.90 (0.21–3.91) | 1.14 (0.21–6.16) | 0.36 (0.09–1.43) | 0.08 (0.01–0.76) |
| Adjusted OR** (95% CI) | — | — | 0.28 (0.06–1.36) | 0.06 (0.01–0.83) |
| Mixed effects OR† (95% CI) | 0.44 (0.17–1.11), p = 0.082 | |||
| ASAS partial remission | ||||
| 25 mg | 1 (4.3) | 2 (8.7) | 1 (4.3) | 1 (4.3) |
| 50 mg | 4 (16.7) | 4 (16.7) | 8 (33.3) | 7 (29.2) |
| Chi-square p value | 0.37 | 0.70 (0.67)‡ | 0.031 | 0.061 (0.048)‡ |
| OR (95% CI) | 0.23 (0.02–2.21) | 0.48 (0.08–2.89) | 0.09 (0.01–0.80) | 0.11 (0.01–0.99) |
| Adjusted OR** (95% CI) | — | — | 0.00 | 0.08 (0.01–1.12) |
| Mixed effects OR† (95% CI) | 0.07 (0.01–0.50), p = 0.008 | |||
↵* 50% reduction in BASDAI score or change in BASDAI score of ≥ 2 points.
↵** Adjusted for 6-mo score.
↵† Fixed effect for study group, random effect for 6-mo score.
↵‡ Fisher’s exact test. ASAS: Assessment of Spondyloarthritis international Society; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index.