Change from baseline in key efficacy variables at weeks 2 and 4 for the phase IIa CREATE study
| Placebo (n=22) | AZD9056 100 mg (n=20) | AZD9056 400 mg (n=20) | |
|---|---|---|---|
| ACR20 response, n (%) | |||
| Week 2 | 2 (9) | 5 (25) | 9 (45)* |
| Week 4 | 6 (27) | 8 (40) | 13 (65)* |
| DAS28 | |||
| Week 2 | –0.65±0.52 | –0.72±0.70 | –1.18±0.86* |
| Week 4 | –0.89±0.72 | –0.97±1.00 | –1.36±0.68* |
| Swollen joints (%) | |||
| Week 2 | –31±32 | –36±42 | –59±34* |
| Week 4 | –37±35 | –42±48 | –65±28* |
| Tender joints (%) | |||
| Week 2 | –12±23 | –22±26 | –39±30** |
| Week 4 | –17±27 | –27±40 | –45±26** |
| Physician's GDA (mm) | |||
| Week 2 | –8±11 | –9±11 | –14±13 |
| Week 4 | –13±14 | –12±17 | –18±12 |
| Patient's GDA (mm) | |||
| Week 2 | –11±13 | –11±15 | –12±17 |
| Week 4 | –16±14 | –16±18 | –14±11 |
| Pain (mm) | |||
| Week 2 | –10±14 | –12±16 | –14±19 |
| Week 4 | –17±16 | –21±23 | –17±10 |
| CRP (%), median (range) | |||
| Week 2 | –17 (–87, 86) | 34 (–70, 490) | 50 (–87, 746) |
| Week 4 | –21 (–86, 131) | –6 (–70, 147) | –3 (–76, 400) |
| ESR (%), median (range) | |||
| Week 2 | –4 (–58, 33) | –6 (–57, 113) | –7 (–58, 56) |
| Week 4 | –7 (–65, 79) | –15 (–71, 133) | –9 (–69, 56) |
| HAQ-DI | |||
| Week 2 | –0.05±0.27 | –0.26±0.31* | –0.28±0.30** |
| Week 4 | –0.11±0.19 | –0.32±0.51 | –0.36±0.38** |
Values are mean±SD unless stated otherwise. Data shown represent the predefined protocol analysis set (see the Methods).
* p<0.05 versus placebo; **p<0.01 versus placebo.
ACR20, American College of Rheumatology 20% response criteria; CRP, C-reactive protein; DAS28, Disease Activity Score 28; ESR, erythrocyte sedimentation rate; GDA, Global Assessment of Disease Activity; HAQ-DI, Health Assessment Questionnaire Disability Index.