Table 3.
Changes from baseline at week 12 in ESR, DAS28-CRP, DAS28-ESR, SDAI, CDAI, SJC, TJC, CRP, Pain-VAS, HAQ-DI and FACIT-Fatigue (ITT set)
| ABX464 100 mg (N=19) | ABX464 50 mg (N=21) | Placebo (N=20) | ||
| ESR | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | −0.3 (6.8) | −2.6 (19.3) | −2.7 (16.6) | |
| 95% CI | −4 to 3 | −11 to 6 | −10 to 5 | |
| Min – Max | −22 to 18 | −37 to 49 | −38 to 41 | |
| p-value* | 0.564 | 0.988 | ||
| DAS28-CRP | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | −0.72 (1.13) | −1.41 (1.45) | −0.60 (0.98) | |
| 95% CI | −1.3 to −0.2 | −2.1 to −0.7 | −1.1 to −0.1 | |
| Min – Max | −3.3 to 0.0 | −4.8 to 0.1 | −3.3 to 0.6 | |
| p-value* | 0.727 | 0.043 | ||
| DAS28-ESR | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | −0.7 (1.1) | −1.4 (1.3) | −0.5 (1.0) | |
| 95% CI | −1.3 to −0.2 | −2.1 to −0.8 | −1.1 to −0.1 | |
| Min – Max | −3.1 to 0.0 | −4.5 to 0.0 | −3.5 to 0.6 | |
| p-value* | 0.678 | 0.034 | ||
| SDAI | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | −9.3 (14.4) | −20.2 (33.2) | −7.5 (22.6) | |
| 95% CI | −16.3 to −2.4 | −35.4 to −5.1 | −18.2 to 3.0 | |
| Min – Max | −39.5 to 0.0 | −85.2 to 62.7 | −44.5 to 63.1 | |
| p-value* | 0.772 | 0.165 | ||
| CDAI | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | −9.9 (15.8) | −15.8 (13.2) | −6.9 (10.1) | |
| 95% CI | −17.6 to −2.4 | −21.9 to −9.8 | −11.7 to −2.2 | |
| Min – Max | −51.1 to 0.0 | −48.0 to 0.3 | −26.0 to 9.0 | |
| p-value* | 0.474 | 0.020 | ||
| SJC | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | −3.2 (5.3) | −4.4 (4.2) | −2.1 (4.2) | |
| 95% CI | −6.0 to −1.0 | −6.0 to −3.0 | −4.0 to −0.0 | |
| Min – Max | −18.0 to 0.0 | −12.0 to 1.0 | −12.0 to 5.0 | |
| p-value* | 0.492 | 0.084 | ||
| TJC | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | −4.1 (6.6) | −6.8 (6.4) | −2.9 (3.8) | |
| 95% CI | −7.0 to −1.0 | −10.0 to −4.0 | −5.0 to −1.0 | |
| Min – Max | −24.0 to 0.0 | −24.0 to 0.0 | −11.0 to 4.0 | |
| p-value* | 0.487 | 0.022 | ||
| CRP | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | 0.6 (4.8) | −4.3 (28.8) | −0.6 (18.7) | |
| 95% CI | −1.7 to −3.0 | −17.4 to 8.8 | −9.4 to 8.1 | |
| Min – Max | −8.8 to 13.4 | −54.9 to 87.5 | −36.3 to 65.5 | |
| p-value* | 0.776 | 0.634 | ||
| Pain-VAS | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | −0.8 (1.9) | −2.6 (2.4) | −0.7 (2.3) | |
| 95% CI | −1.8 to −0.1 | −3.7 to −1.5 | −1.9 to 0.3 | |
| Min – Max | −8.2 to 0.0 | −7.3 to 0.0 | −7.0 to 3.6 | |
| p-value* | 0.876 | 0.018 | ||
| HAQ-DI | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | −0.10 (0.34) | −0.43 (0.61) | −0.18 (0.48) | |
| 95% CI | −0.27 to 0.06 | −0.71 to −0.15 | −0.40 to 0.04 | |
| Min – Max | −1.37 to 0.37 | −1.75 to 0.62 | −1.75 to 0.87 | |
| p-value* | 0.576 | 0.153 | ||
| FACIT-Fatigue | N | 19 (100.0%) | 21 (100.0%) | 20 (100.0%) |
| Mean (SD) | 2.9 (7.4) | 6.2 (6.0) | 3.1 (6.3) | |
| 95% CI | −1 to 6 | 3 to 9 | 0 to 6 | |
| Min – Max | −4 to 26 | 0 to 20 | −11 to 15 | |
| p-value* | 0.944 | 0.105 |
*Analysis of covariance, ABX-464 versus placebo; mixed model analysis of covariance is conducted for the changes from baseline for each parameter.
CDAI, clinical disease activity score; CRP, C reactive protein; DAS, disease activity score; ESR, erythrocyte sedimentation rate; FACIT, functional assessment of chronic illness therapy; HAQ-DI, Healthy Assessment Questionnaire - Disability Index; max, maximum; min, minimum; Pain-VAS, Patient assessment of joint pain; SDAI, simplified disease activity score.