Table 1.
Changes from baseline in secondary efficacy endpoints at Week 12 in Norwegian patients with ankylosing spondylitis stratified according to treatment group (celecoxib 200 or 400 mg daily [qd] or diclofenac 50 mg three times daily [tid]): intention-to-treat population.
| Parameter | Celecoxib |
Diclofenac group | |
|---|---|---|---|
| 200 mg group | 400 mg group | ||
| Nocturnal pain, n | 107 | 108 | 115 |
| Baseline | 61.3 ± 24.2 | 57.9 ± 23.3 | 62.0 ± 21.7 |
| Week 12 | 35.9 ± 26.3 | 27.6 ± 23.4 | 34.4 ± 25.7 |
| LS mean change from baselinea | −25.9 ± 2.5 | −33.1 ± 2.5 | −28.0 ± 2.4 |
| Difference in LS mean (95% CI) | |||
| Celecoxib vs diclofenaca,b,c | 2.1 (−5.3, 9.5) | −5.1 (−12.5, 2.3) | – |
| Celecoxib 200 mg vs celecoxib 400 mga,b,c | 7.2 (−0.4, 14.7) | – | |
| BASFI, n | 107 | 108 | 113 |
| Baseline | 48.1 ± 21.8 | 45.5 ± 22.1 | 48.3 ± 20.1 |
| Week 12 | 34.0 ± 21.2 | 29.4 ± 22.7 | 30.8 ± 20.0 |
| LS mean change from baselinea | −14.9 ± 1.8 | −18.2 ± 1.8 | −18.1 ± 1.7 |
| Difference in LS mean (95% CI) | |||
| Celecoxib vs diclofenaca,b,c | 3.2 (−2.1, 8.6) | −0.04 (−5.4, 5.3) | – |
| Celecoxib 200 mg vs celecoxib 400 mga,b,c | 3.3 (−2.2, 8.7) | – | |
| BASDAI, n | 107 | 107 | 114 |
| Baseline | 58.4 ± 20.7 | 52.8 ± 19.3 | 56.2 ± 18.8 |
| Week 12 | 40.6 ± 21.0 | 33. ± 21.6 | 37.5 ± 21.3 |
| LS mean change from baselinea | − 17.5 ± 1.9 | −20.8 ± 1.9 | −19.5 ± 1.8 |
| Difference in LS mean (95% CI) | |||
| Celecoxib vs diclofenaca,b,c | 2.0 (−3.7, 7.6) | −1.3 (−7.0, 4.3) | – |
| Celecoxib 200 mg vs celecoxib 400 mga,b,c | 3.3 (−2.5, 9.1) | – | |
| Physician’s Global Assessment of Disease Severity, n | 107 | 108 | 114 |
| Baseline | 58.3 ± 16.6 | 55.2 ± 17.0 | 59.0 ± 16.3 |
| Week 12 | 36.6 ± 18.7 | 33.1 ± 20.0 | 35.6 ± 20.7 |
| LS mean change from baselinea | −21.1 ± 2.0 | −23.5 ± 1.9 | −22.9 ± 1.9 |
| Difference in LS mean (95% CI) | |||
| Celecoxib vs diclofenaca,b,c | 1.8 (−4.0, 7.5) | −0.7 (−6.5, 5.1) | – |
| Celecoxib 200 mg vs celecoxib 400 mga,b,c | 2.5 (−3.4, 8.3) | – | |
| Patient’s Global Assessment of Disease Severity, n | 105 | 107 | 112 |
| Baseline | 65.9 ± 19.6 | 62.6 ± 21.3 | 67.5 ± 18.0 |
| Week 12 | 43.4 ± 24.7 | 37.2 ± 25.4 | 40.7 ± 26.7 |
| LS mean change from baselinea | −23.0 ± 2.7 | −28.1 ± 2.7 | −26.5 ± 2.6 |
| Difference in LS mean (95% CI) | |||
| Celecoxib vs diclofenaca,b,c | 3.5 (−4.4, 11.4) | −1.5 (−9.4, 6.4) | – |
| Celecoxib 200 mg vs celecoxib 400 mga,b,c | 5.0 (−3.0, 13.0) | – | |
| ASAS 20 responders, n (%)d | 107 | 108 | 115 |
| Responders at Week 12 | 55 (51.4) | 65 (60.2) | 66 (57.4) |
Data presented as: n or n (%) patients; 95% CI; mean ± SD (baseline and Week 12 data); mean ± SEM (LS mean change from baseline).
Derived from analysis of covariance with baseline as a covariate, and treatment and centre as factors.
Calculated as difference between treatment groups in change from baseline. A negative difference indicates a numerical superiority of celecoxib over diclofenac.
Tukey–Kramer multiple comparison procedure used to generate confidence interval and P-value.
Pairwise comparisons between treatment groups at Week 12 were made using Fisher’s exact test.
No significant between-group differences (200 mg qd celecoxib vs diclofenac, 400 mg celecoxib vs diclofenac, or 200 mg celecoxib vs 400 mg celecoxib; P ≥ 0.05).
BASFI, Bath Ankylosing Spondylitis Functional Index; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CI, confidence interval; LS mean, least squares mean; ASAS, Assessments in Ankylosing Spondylitis.