Secondary efficacy endpoints at Week 12: ACR20 response rates by age, sex, baseline disease activity, baseline duration of disease, region, or concomitant use of steroids; ACR50; ACR70; DAS28-3-CRP; HAQ-DI (full analysis set; last observation carried forward).
| Endpoint | Placebo, n = 47 | CE-224,535, 500 mg bid, n = 53 |
|---|---|---|
| ACR20 response rate by age, % | ||
| ≤ 65 yrs | 33.3 | 35.6 (p = 0.413) |
| > 65 yrs | 60.0 | 25.0 (p = 0.999) |
| ACR20 response rate by sex, % | ||
| Male | 0 | 33.3 (p = 0.188) |
| Female | 38.6 | 34.1 (p = 0.671) |
| ACR20 response rate by baseline disease activity (DAS28-3-CRP), % | ||
| < 3.2 (low activity) | —* | —* |
| 3.2–5.1 (moderate activity) | 45.5 | 28.6 (p = 0.891) |
| ≥ 5.1 (high activity) | 28.0 | 40.0 (p = 0.185) |
| ACR20 response rate by baseline duration of disease, % | ||
| Duration ≤ 5 yrs | 37.5 | 45.8 (p = 0.279) |
| Duration > 5 yrs | 34.8 | 24.1 (p = 0.800) |
| ACR20 response rate by region, % | ||
| Latin America | 40.0 | 60.0 (p = 0.377) |
| United States | 44.4 | 29.2 (p = 0.846) |
| Europe | 38.9 | 33.3 (p = 0.635) |
| Asia | 0.0 | 33.3 (p = 0.098) |
| ACR20 response rate by concomitant use of steroids, % | ||
| Yes | 35.5 | 36.1 (p = 0.478) |
| No | 37.5 | 29.4 (p = 0.688) |
| ACR20 response rate by baseline CRP, % | ||
| ≥ 6 mg/l | 26.1 | 50.0 |
| < 6 mg/l | 45.5 | 20.7 |
| ≥ 8 mg/l | 30.0 | 47.4 |
| < 8 mg/l | 40.7 | 26.5 |
| ACR50 response rate, % | 17.0 | 11.3 (p = 0.793) |
| ACR70 response rate, % | 0.0 | 3.8 (p = 0.121) |
| Least-squares mean change from baseline in DAS28-3-CRP (SEM) | −0.8 (0.15) | −0.9 (0.14) (p = 0.752) |
| Least-squares mean change from baseline in HAQ-DI (SEM) | −0.3 (0.07) | −0.2 (0.07) (p = 0.784) |
↵* Per the protocol, patients with low disease activity at baseline were excluded. p values are difference from placebo. ACR: American College of Rheumatology; bid: twice daily; CRP: C-reactive protein; DAS: Disease Activity Score; HAQ-DI: Health Assessment Questionnaire-Disability Index; SEM: standard error of the mean.