Table 2.
Efficacy endpoints at 12 weeks in the per-protocol set
| Parameter | TAS5315 | Placebo (n=30) |
||
| 4 mg (n=28) | 2 mg (n=29) | Combined (n=57) | ||
| ACR20 improvement | ||||
| Responders, n (%) | 23 (82.1) | 22 (75.9) | 45 (78.9) | 18 (60.0) |
| 90% CI | 66.1–92.7 | 59.4–88.1 | 68.1–87.4 | 43.4–75.0 |
| P value* | 0.058 | 0.153 | 0.053 | – |
| ACR50 improvement | ||||
| Responders, n (%) | 10 (35.7) | 9 (31.0) | 19 (33.3) | 4 (13.3) |
| 95% CI | 18.6–55.9 | 15.3–50.8 | 21.4–47.1 | 3.8–30.7 |
| P value* | 0.067 | 0.125 | 0.072 | – |
| ACR70 improvement | ||||
| Responders, n (%) | 1 (3.6) | 3 (10.3) | 4 (7.0) | 0 (0.0) |
| 95% CI | 0.1–18.3 | 2.2–27.4 | 1.9–17.0 | 0.0–11.6 |
| P value* | 0.483 | 0.112 | 0.294 | – |
| DAS28-hsCRP | ||||
| LS mean | 3.3109 | 3.5024 | 3.4084 | 3.9842†, 3.9841‡ |
| LS mean difference§ | –0.6733 | –0.4818 | –0.5757 | – |
| 95% CI§ | –1.0938, –0.2527 | –0.8982, –0.0654 | –0.9359, –0.2155 | – |
| hsCRP, mg/dL | ||||
| LS mean | 0.93 | 1.11 | 1.02 | 1.34 |
| LS mean difference§ | –0.42 | –0.24 | –0.32 | – |
| 95% CI§ | –0.97, 0.13 | –0.78, 0.30 | –0.79, 0.14 | – |
| ESR | ||||
| LS mean | 25.3 | 31.3 | 28.3 | 33.4 |
| LS mean difference§ | –8.1 | –2.2 | –5.1 | – |
| 95% CI§ | –14.2, –2.1 | –8.1, 3.8 | –10.3, 0.2 | – |
| SDAI | ||||
| LS mean | 15.00 | 13.77 | 14.37 | 17.92 |
| LS mean difference§ | –2.93 | –4.15 | –3.55 | – |
| 95% CI§ | –6.49, 0.64 | –7.69, –0.62 | –6.60, –0.50 | – |
| CDAI | ||||
| LS mean | 14.05 | 12.67 | 13.35 | 16.59 |
| LS mean difference§ | –2.53 | –3.91 | –3.24 | – |
| 95% CI§ | –5.92, 0.85 | –7.27, –0.56 | –6.14, –0.34 | – |
| HAQ-DI | ||||
| LS mean | 0.569 | 0.453 | 0.510 | 0.690 |
| LS mean difference§ | –0.121 | –0.237 | –0.181 | – |
| 95% CI§ | –0.296, 0.053 | –0.410, –0.065 | –0.331, –0.030 | – |
*Fisher’s exact test versus placebo.
†For comparison with TAS5315 4 mg and TAS5315 2 mg.
‡For comparison with TAS5315 combined.
§TAS5315 minus placebo.
ACR20, 20% improvement in American College of Rheumatology criteria; CDAI, Clinical Disease Activity Index; DAS28, 28-joint Disease Activity Score; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; hsCRP, high sensitivity C reactive protein; LS, least squares; SDAI, Simple Disease Activity Index.