DU burden throughout the treprostinil studies.
| Variable | Statistic | Start of DISTOL-1, 201, n = 51 | Start of DISTOL-EXT, 202, n = 50 | Baseline*, n = 51 | Time A*, n = 23 | Time B*, n = 30 |
|---|---|---|---|---|---|---|
| Active DU | Mean (SD) | 1.8 (1.14) | 0.6 (1.05) | 0.25 (0.63) | 1.62 (2.17) | 1.03 (2.34) |
| Median (Range) | 1.0 (1–6) | 0 (0–5) | 0 (0–3) | 1.0 (0–9) | 0 (0–12) | |
| Indeterminate DU | Mean (SD) | 0.9 (1.46) | 0.6 (0.90) | 0.2 (0.54) | 0.5 (0.79) | 0.4 (0.97) |
| Median (Range) | 0 (0–6) | 0 (0–3) | 0 (0–2) | 0 (0–3) | 0 (0–4) | |
| Total DU | Mean (SD) | 1.8 (1.14) | 1.2 (1.46) | 0.5 (0.78) | 2.1 (2.33) | 1.5 (2.47) |
| Median (Range) | 1.0 (1–6) | 1.0 (0–5) | 0 (0–3) | 1.0 (0–9) | 0 (0–12) |
↵* Baseline, Time A, and Time B defined as the end of the DISTOL-EXT open-label extension study, 3–6 months post–drug withdrawal, and > 6–12 months post–drug withdrawal, respectively. DU: digital ulcers; DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated with Oral Treprostinil Diethanolamine; DISTOL-EXT: DISTOL extended.