Baseline patient demographic and clinical characteristics (Full Analysis set*)
| ABX464 100 mg (N=19) | ABX464 50 mg (N=21) | Placebo (N=20) | All (N=60) | ||
| Age (years) | Mean (SD) | 54.4 (10.6) | 57.9 (11.4) | 58.6 (11.0) | 57.0 (11.0) |
| Sex | Male | 8 (42.1%) | 6 (28.6%) | 9 (45.0%) | 23 (38.3%) |
| Female | 11 (57.9%) | 15 (71.4%) | 11 (55.0%) | 37 (61.7%) | |
| BMI (kg/m2) | Mean (SD) | 26.8 (5.0) | 25.8 (4.4) | 28.4 (5.9) | 27.0 (5.2) |
| Range | 20.2–37.0 | 18.7–35.1 | 21.1–42.9 | 18.7–42.9 | |
| RA duration (years†) | Mean (SD) | 6.0 (4.7) | 7.3 (9.1) | 5.8 (7.8) | 6.4 (7.4) |
| Range | 0.9–18.8 | 0.6–29.7 | 0.4–32.7 | 0.4–32.7 | |
| MTX dose on day 0 (mg/week) | Mean (SD) | 16.4 (3.0) | 17.9 (3.4) | 18.0 (3.4) | 17.4 (3.3) |
| Range | 10–20 | 0–25 | 10–20 | 0–25 | |
| History of anti-TNFα therapy | N (%) | 6 (31.6%) | 6 (28.6%) | 6 (30.0%) | 18 (30.0%) |
| Anti-TNFα washout (months) | Mean (SD) | 27.0 (35.2) | 45.4 (89.2) | 7.3 (2.3) | 25.5 (51.2) |
| Range | 3–93.2 | 1.1–204.9 | 3.4–10.1 | 1.1–204.9 | |
| Patients with corticosteroids | N (%) | 9 (47.4%) | 10 (47.6%) | 13 (65.0%) | 32 (53.3%) |
| DAS28-CRP | Mean (SD) | 5.5 (0.8) | 5.5 (0.7) | 5.3 (0.7) | 5.4 (0.7) |
| Range | 3.7–6.5 | 4.2–6.8 | 3.7–6.4 | 3.7–6.8 | |
| DAS28-ESR | Mean (SD) | 5.9 (1.1) | 5.9 (0.8) | 5.8 (0.8) | 5.8 (0.9) |
| Range | 4.2–7.7 | 3.4–7.0 | 3.9–7.4 | 3.4–7.7 | |
| ESR | Mean (SD) | 31.5 (18.4) | 37.4 (24.8) | 38.3 (24.2) | 35.8 (22.6) |
| Range | 5–85 | 2–105 | 3–89 | 2–105 | |
| CRP (mg/L) | Mean (SD) | 20.6 (28.6) | 22.7 (24.6) | 14.9 (13.5) | 19.5 (22.9) |
| Range‡ | 1.1–129.0 | 1.9–99.5 | 2.5–58.4 | 1.1–129.0 | |
| TJC | Mean (SD) | 12.2 (5.8) | 12.2 (4.6) | 10.7 (4.5) | 11.7 (4.9) |
| Range | 4–27 | 5–24 | 4–22 | 4–27 | |
| SJC | Mean (SD) | 9.5 (3.8) | 8.3 (3.5) | 7.8 (3.4) | 8.5 (3.6) |
| Range | 3–19 | 4–15 | 3–16 | 3–19 | |
| HAQ-DI | Mean (SD) | 1.28 (0.48) | 1.49 (0.63) | 1.48 (0.66) | 1.42 (0.60) |
| Range | 0.12–2.0 | 0–2.5 | 0–2.37 | 0–2.50 | |
| FACIT-Fatigue | Mean (SD) | 28.3 (10.7) | 26.7 (11.2) | 24.4 (10.5) | 26.5 (10.7) |
| Range | 7–49 | 3–45 | 12–45 | 3–49 |
The denominator for each percentage is the number of non-missing observations within the column.
*The Full Analysis dataset (FAS population) was defined as those patients included in the study, who had received at least one dose of the study treatment, and who had at least one baseline data.
†The disease onset was defined as the date of diagnosis.
‡A value of CRP ≥5 mg/L was requested at screening but eight patients had baseline CRP values ranging from 1.1 to 4.8 mg/L (two patients in the placebo; four patients in ABX464 50 mg group and 2 patients in ABX464 100 mg group).
BMI, body mass index; 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; MTX, methotrexate; RA, rheumatoid arthritis; SDAI, simplified disease activity score; SJC, swollen joint count; TJC, tender/painful joint count.