Table 1.
Participant demographics and clinical characteristics at baseline (safety population, unless stated otherwise)
| Characteristics | Placebo (n = 8) | GSK2330811 100 mg (n = 3)a | GSK2330811 300 mg (n = 24) | Total (N = 35) |
|---|---|---|---|---|
| Age, years, mean (s.d.) | 50.8 (15.4) | 66.7 (NA) | 52.6 (12.6) | 53.4 (13.2) |
| Female, n (%) | 6 (75) | 1 (33) | 19 (79) | 26 (74) |
| Race, n (%) | ||||
| White | 7 (88) | 3 (100) | 20 (83) | 30 (86) |
| Black or African American | 0 | 0 | 3 (13) | 3 (9) |
| Asian | 1 (13) | 0 | 0 | 1 (3) |
| American Indian or Alaska Native | 0 | 0 | 1 (4) | 1 (3) |
| BMI, kg/m2, mean (s.d.) | 23.9 (4.1) | 27.9 (NA) | 29.4 (6.7) | 28.0 (6.4) |
| Time since onset of first non-Raynaud manifestation of disease, months, median (range) | 12.0 (7–21) | 14.0 (11–21) | 17.5 (4–60) | 16.0 (4–60) |
| Pulmonary fibrosisc, n (%) | 1 (13) | 1 (33) | 8 (33) | 10 (29) |
| Mycophenolate use at day 1, n (%) | 7 (88) | 2 (67) | 20 (83)a | 29 (83)a |
| Baseline mRSS | ||||
| Mean (s.d.) | 20.5 (4.5) | 32.0 (NA) | 20.5 (6.6) | 21.5 |
| Median (range) | 19 (16–29) | 31 (29–36) | 19 (11–32) | 19 (11–36) |
| Baseline FVC (% predicted)a | ||||
| Mean (s.d.) | 105 (23.1) | 104 (NA) | 87.7 (18.6) | – |
| Median (range) | 104 (79–155) | 105 (103–105) | 87 (54–129) | – |
| Baseline DLCO (% haemoglobin)a, corrected | ||||
| Mean (s.d.) | 78.8 (22.7) | 89.0 (NA) | 72.6 (18.7) | – |
| Median (range) | 72 (55–126) | 88 (80–99) | 69 (44–123) | – |
| Baseline CRP, mg/L,a median (range) | 2.0 (0.1–11.6) | 2.1 (0.7–3.3) | 1.7 (0.2–82.5) | – |
| Baseline PhGA,a median (range) | 3.5 (2–7) | 2.0 (2–6) | 4.0 (0–7) | – |
| Baseline PtGA,a,d median (range) | 2.0 (0–5) | 0 | 5.0 (1–8) | – |
| Baseline autoantibody profile, n (%) | ||||
| ANA | 8 (100) | 3 (100) | 21 (88) | 32 (91) |
| Anti-RNA polymerase III | 5 (63) | 2 (67) | 8 (33) | 15 (43) |
| Anti-Scl-70 | 2 (25) | 1 (33) | 4 (17) | 7 (20) |
| Anti-centromere | 1 (13) | 0 | 1 (4) | 2 (6) |
a
Data from the per-protocol population where one participant in the GSK2330811 300 mg group was excluded (n = 23).
b
s.d. not calculated in the GSK2330811 100 mg group, as there were only three participants.
c
Confirmed by high-resolution CT.
d
Data missing from one participant in the placebo group (n = 7) and two participants in the GSK2330811 100 mg group (n = 1).
DLCO: diffusing capacity of the lungs for carbon monoxide; NA: not applicable; PhGA: Physician’s Global Assessment; PtGA: Patient’s Global Assessment.