Baseline demographics and disease characteristics (modified intent-to-treat population; n=43)
| Parameter | VX-509 | |||
|---|---|---|---|---|
| Placebo (n=12) | 100 mg qd (n=11) | 200 mg qd (n=10) | 300 mg qd (n=10) | |
| Age, years | ||||
| Mean (SD) | 52.8 (12.3) | 56.7 (6.5) | 50.5 (11.9) | 54.9 (5.0) |
| Median (range) | 56.5 (26–65) | 59.0 (41–63) | 53.5 (29–65) | 55.5 (48–61) |
| Sex, n (%) | ||||
| Male | 2 (16.7) | 3 (27.3) | 5 (50.0) | 2 (20.0) |
| Female | 10 (83.3) | 8 (72.7) | 5 (50.0) | 8 (80.0) |
| Race, n (%) | ||||
| White | 9 (75.0) | 5 (45.5) | 9 (90.0) | 9 (90.0) |
| Black | 1 (8.3) | 5 (45.5) | 0 | 0 |
| Other | 2 (16.7) | 1 (9.1) | 1 (10.0) | 1 (10.0) |
| Ethnicity | ||||
| Hispanic/Latino | 3 (25.0) | 0 | 2 (20.0) | 2 (20.0) |
| Not Hispanic/Latino | 9 (75.0) | 11 (100.0) | 8 (80.0) | 8 (80.0) |
| Region | ||||
| USA | 10 (83.3) | 11 (100.0) | 9 (90.0) | 8 (80.0) |
| Other | 2 (16.7) | 0 | 1 (10.0) | 2 (20.0) |
| Disease duration, years | ||||
| Mean (SD) | 9.2 (8.8) | 6.8 (6.5) | 10.8 (8.8) | 11.0 (7.1) |
| Median (range) | 5.9 (1.1–32.7) | 4.6 (0.6–17.8) | 7.9 (3.2–26.1) | 9.8 (0.7–19.6) |
| Prior anti-TNF use, n (%) | ||||
| Yes | 4 (33.3) | 4 (36.4) | 5 (50.0) | 3 (30.0) |
| No | 8 (66.7) | 7 (63.6) | 5 (50.0) | 7 (70.0) |
| Previous number of DMARDs used | ||||
| Mean (SD) | 2.0 (1.4) | 2.3 (1.6) | 3.3 (1.8) | 2.8 (1.1) |
| Median (range) | 1.0 (1–5) | 2.0 (1–6) | 3.0 (1–6) | 3.0 (1–5) |
| CRP, mg/L | ||||
| Mean (SD) | 16.0 (16.7) | 19.7 (29.9) | 12.5 (9.5) | 16.2 (16.0) |
| Median (range) | 12.0 (1.0–62.8) | 7.1 (1.2–102.3) | 9.4 (2.2–27.6) | 9.3 (2.7–57.4) |
| ESR, mm/h | ||||
| Mean (SD) | 47.3 (15.1) | 45.5 (31.4) | 38.7 (26.6) | 37.3 (15.8) |
| Median (range) | 43.0 (28–80) | 38.0 (6–96) | 39.0 (8–86) | 38.5 (2–54) |
| RF status, n (%) | ||||
| Negative | 1 (8.3) | 0 | 0 | 0 |
| Positive | 11 (91.7) | 11 (100.0) | 10 (100.0) | 10 (100.0) |
| Anti-CCP status, n (%) | ||||
| Negative | 1 (8.3) | 1 (9.1) | 2 (20.0) | 0 |
| Positive | 11 (91.7) | 10 (90.9) | 8 (80.0) | 10 (100.0) |
| Tender joint count | ||||
| Mean (SD) | 37.4 (16.6) | 22.1 (11.2) | 27.6 (12.7) | 31.6 (18.3) |
| Median (range) | 28.0 (20–64) | 26.0 (8–42) | 26.0 (10–47) | 27.0 (10–62) |
| Swollen joint count | ||||
| Mean (SD) | 25.3 (9.3) | 22.2 (9.2) | 20.6 (9.2) | 23.3 (16.8) |
| Median (range) | 22.0 (12–39) | 22.0 (9–34) | 19.5 (7–38) | 19.0 (6–62) |
Anti-CCP, anti-cyclic citrullinated peptide; CRP, C reactive protein; DMARD, disease-modifying anti-rheumatic drug; ESR, erythrocyte sedimentation rate; qd, every day; RF, rheumatoid factor; TNF, tumour necrosis factor.