Summary of baseline demographic characteristics. Values are n (%) unless otherwise specified.
| Demographic Variables | Pirfenidone, 2403 mg/day | ||
|---|---|---|---|
| 2-week Titration Group, n = 32 | 4-week Titration Group, n = 31 | Total, n = 63 | |
| Age, yrs, mean (SD) | 49.3 (12.08) | 51.9 (12.52) | 50.6 (12.27) |
| Female | 26 (81.3) | 26 (83.9) | 52 (82.5) |
| Primary race/ethnicity | |||
| White | 21 (65.6) | 27 (87.1) | 48 (76.2) |
| Black or African American | 5 (15.6) | 2 (6.5) | 7 (11.1) |
| Other | 6 (18.8) | 2 (6.5) | 8 (12.7) |
| Hispanic or Latino ethnicity | 4 (12.5) | 3 (9.7) | 7 (11.1) |
| Weight, kg, mean (SD) | 74.6 (19.79) | 70.8 (14.62) | 72.7 (17.40) |
| Background SSc-ILD treatment | |||
| None | 12 (37.5) | 11 (35.5) | 23 (36.5) |
| MMF | 20 (62.5) | 20 (64.5) | 40 (63.5) |
| SSc type | |||
| Limited | 20 (62.5) | 12 (38.7) | 32 (50.8) |
| Diffuse | 12 (37.5) | 19 (61.3) | 31 (49.2) |
| SSc duration, mos, mean (SD) | 36.4 (25.84) | 40.3 (26.53) | 38.3 (26.04) |
| SSc-ILD duration, mos, mean (SD) | 25.3 (20.01) | 28.1 (25.36) | 26.7 (22.66) |
| Predicted FVC, %, mean (SD) | 72.8 (14.39) | 79.4 (13.32) | 76.0 (14.15) |
| ≥ 70% | 16 (50.0) | 23 (74.2) | 39 (61.9) |
| < 70% | 16 (50.0) | 8 (25.8) | 24 (38.1) |
| DLCO, %, mean (SD)* | 59.3 (14.36) | 60.1 (18.64) | 59.7 (16.47) |
| Concomitant medication taken by > 20% of patients in either titration group | |||
| Drugs for acid-related disorders | 26 (81.3) | 24 (77.4) | 50 (79.4) |
| Immunosuppressants | 20 (62.5) | 21 (67.7) | 41 (65.1) |
| Vitamins | 12 (37.5) | 17 (54.8) | 29 (46.0) |
| Calcium channel blockers | 11 (34.4) | 11 (35.5) | 22 (34.9) |
| Antithrombotics | 6 (18.8) | 10 (32.3) | 16 (25.4) |
| Lipid-modifying agents | 9 (28.1) | 6 (19.4) | 15 (23.8) |
| Analgesics | 9 (28.1) | 5 (16.1) | 14 (22.2) |
| Agents acting on renin-angiotensin system | 8 (25.0) | 6 (19.4) | 14 (22.2) |
| Antianemic preparations | 8 (25.0) | 5 (16.1) | 13 (20.6) |
| Antiinflammatory and antirheumatics | 8 (25.0) | 4 (12.9) | 12 (19.0) |
| Mineral supplements | 7 (21.9) | 5 (16.1) | 12 (19.0) |
| Systemic corticosteroids** | 7 (21.9) | 5 (16.1) | 12(19.0) |