Secondary efficacy outcomes observed in patients with osteoarthritis (intent-to-treat population)
| Outcomes | IDEA-033 (n = 138) | Celecoxib (n = 132) | Placebo (n = 127) | |
|---|---|---|---|---|
| LS, least squares; OMERACT-OARSI, Outcome Measures in Rheumatology initiative/Osteoarthritis Research Society International. | ||||
| *Statistically significant difference (p<0.05) compared with placebo. | ||||
| †Total number of rescue medication capsules taken/total number of days in study. | ||||
| ‡Post hoc analysis of responder rates according to the recently updated OMERACT-OARSI criteria.15 | ||||
| Results are given as changes from baseline to end of study unless stated otherwise. | ||||
| PGA of osteoarthritis at end of study | ||||
| Very good (1), n (%) | 12 (8.7%) | 13 (9.8%) | 4 (3.1%) | |
| Good (2), n (%) | 62 (44.9%) | 48 (36.4%) | 41 (32.3%) | |
| Fair (3), n (%) | 47 (34.1%) | 50 (37.9%) | 46 (36.2%) | |
| Poor (4), n (%) | 14 (10.1%) | 16 (12.1%) | 29 (22.8%) | |
| Very poor (5), n (%) | 3 (2.2%) | 5 (3.8%) | 7 (5.5%) | |
| Mean (SD) | 2.5 (0.9) | 2.6 (1.0) | 3.0 (1.0) | |
| LS mean (SE) | 2.5 (0.1)* | 2.6 (0.1)* | 2.9 (0.1) | |
| 95% CI | 2.3 to 2.7 | 2.4 to 2.8 | 2.7 to 3.1 | |
| p Value, comparison with placebo | 0.0009 | 0.0141 | ||
| WOMAC Index stiffness score | ||||
| Mean (SD) chang | −14.7 (22.8) | −16.7 (26.4) | −10.0 (21.3) | |
| LS mean (SE) change | −14.3 (1.9)* | −15.8 (2.0)* | −8.2 (2.0) | |
| 95% CI | −18.1 to −10.5 | −19.7 to −12.0 | −12.1 to −4.3 | |
| p Value, comparison with placebo | 0.0215 | 0.0044 | ||
| Use of rescue medication† | ||||
| Mean (SD) | 0.24 (0.43) | 0.16 (0.34) | 0.37 (0.60) | |
| LS mean (SE) | 0.26 (0.04)* | 0.17 (0.04)* | 0.38 (0.04) | |
| 95% CI | 0.2 to 0.3 | 0.1 to 0.2 | 0.3 to 0.5 | |
| p Value, comparison with placebo | 0.0291 | 0.0002 | ||
| OMERACT-OARSI responder‡ | ||||
| n (%) at end of study | 95 (68.8)* | 84 (63.6) | 70 (55.1) | |
| 95% CI | 61.1 to 76.6 | 55.4 to 71.8 | 46.5 to 63.8 | |
| p Value, comparison with placebo | 0.0247 | 0.1551 | — | |
| Number needed to treat (vs placebo) | 8.0 | 12.0 | — | |
| 95% CI | 2.1 to 25.3 | −3.4 to 20.4 | — | |