| Variable | Celecoxib | Diclofenac | |
| 200 mg once a day | 200 mg twice a day | 75 mg twice a day | |
| VAS pain (0–100 mm) | |||
| Baseline | 65.6 (14.9) | 68.1 (16.4) | 64.3 (16.6) |
| Week 12 | 37.4 (25.6) | 38.7 (24.9) | 33.8 (27.1) |
| Mean change from baseline† | −28.2 (27.2) | −29.8 (25.1) | −30.8 (25.6) |
| LS mean treatment contrast‡ | 2.9 (2.7) | 2.1 (2.8) | NA |
| 95% CI for the treatment contrast | −2.4 to 8.2 | −3.3 to 7.6 | NA |
| ASAS 20 response (PP population) | |||
| Week 12 (χ2 test: 0.039) | n = 58 (46.0%) | n = 74 (59.7%) | n = 74 (60.2%) |
| Parameter estimator for treatment | −0.448 | 0.267 | NA |
| 95% CI for parameter estimator | −0.758 to −0.137 | −0.050 to 0.584 | NA |
| Odds ratio (celecoxib/diclofenac) | 0.533 | 1.090 | NA |
| BASDAI (0–10) | |||
| Baseline | 4.66 (1.63) | 4.86 (1.64) | 4.75 (1.78) |
| Week 12 | 3.69 (2.19) | 3.55 (2.07) | 3.27 (2.21) |
| Mean change from baseline† | −0.99 (2.11) | −1.32 (1.72) | −1.48 (1.76) |
| LS mean treatment contrast‡ | 0.42 (0.20) | 0.11 (0.20) | NA |
| 95% CI for the treatment contrast | 0.03 to 0.81 | −0.29 to 0.51 | NA |
| BASFI (0–10) | |||
| Baseline | 4.5 (2.3) | 4.5 (2.2) | 4.2 (2.3) |
| Week 12 | 3.7 (2.6) | 3.6 (2.5) | 3.4 (2.5) |
| Mean change from baseline† | −0.8 (2.0) | −0.9 (1.5) | −0.9 (1.8) |
| LS mean treatment contrast‡ | 0.1 (0.2) | −0.0 (0.2) | NA |
| 95% CI for the treatment contrast | −0.3 to 0.5 | −0.4 to 0.3 | NA |
| GA disease activity, subjects (0–10) | |||
| Baseline | 6.1 (1.8) | 6.5 (1.7) | 6.1 (1.8) |
| Week 12 | 4.1 (2.4) | 4.3 (2.5) | 3.8 (2.6) |
| Mean change† | −2.0 (2.7) | −2.2 (2.5) | −2.3 (2.6) |
| LS mean treatment contrast‡ | 0.3 (0.3) | 0.3 (0.3) | NA |
| 95% CI for the treatment contrast | −0.2 to 0.8 | −0.2 to 0.8 | NA |
| BASMI (0–10) | |||
| Baseline | 4.1 (2.5) | 3.8 (2.3) | 3.8 (2.2) |
| Week 12 | 3.8 (2.6) | 3.5 (2.4) | 3.4 (2.2) |
| Mean change† | −0.3 (1.4) | −0.3 (1.4) | −0.5 (1.3) |
| LS mean treatment contrast‡ | 0.1 (0.1) | 0.1 (0.1) | NA |
| 95% CI for the treatment contrast | −0.1 to 0.4 | −0.1 to 0.4 | NA |
| C-reactive protein (mg/L) | |||
| Baseline | 12.6 (14.3) | 13.4 (13.8) | 13.8 (14.6) |
| Week 12 | 10.6 (10.7) | 9.7 (12.7) | 10.7 (9.8) |
| Mean change† | −2.2 (11.3) | −3.4 (11.3) | −3.5 (10.0) |
| LS mean treatment contrast‡ | 0.6 (1.0) | −0.1 (1.0) | NA |
| 95% CI for the treatment contrast | −1.4 to 2.5 | −2.1 to 1.9 | NA |
*Data of the FAS with “last observation carried forward” approach are given apart from the ASAS 20 response (here: PP population). For continuous variables: baseline, week 12 values and related changes are the mean (SD); values of treatment contrasts are LS means (SEM). For ASAS 20 response: Logistic progression is described with parameter estimator for treatment compared to diclofenac after adjusting for baseline VAS, sex, centre, and age; results represent the comparison with the reference class “diclofenac”.
†Calculated as post-baseline values minus baseline values.
‡Calculated as the difference in the respective celecoxib group minus the difference in the diclofenac group; derived from pooled centre ANCOVA with baseline VAS and age as covariates and treatment, sex and centre as factors.
ASAS 20, Ankylosing Spondylitis Assessment Study group 20%; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; FAS, full analysis set; GA, global assessment; LS, least square; NA, not applicable; PP, per protocol; VAS, visual analogue scale.