Baseline characteristics and antibody status of patients with systemic sclerosis by treatment group. Values are median (IQR) unless otherwise indicated.
| Characteristic | Protocol 1 n = 29 | Protocol 2 n = 25 | Protocol 3 n = 61 | Protocol 4 n = 19 | Protocol 5 n = 13 | p** | Total (overall) n = 147 |
|---|---|---|---|---|---|---|---|
| Age, yrs | 55.1 (49.9–64.1) | 52.7 (45.7–57.8) | 54.4 (43.0–61.3) | 55.6 (50.1–67.2) | 40.9 (32.3–51.5) | 0.01 | 53.1 (43.3–61) |
| Women (%) | 18 (62) | 20 (80) | 44 (72) | 13 (68) | 8 (62) | 0.60 | 103 (70) |
| Antitopoisomerase (anti-Scl-70) no. (%)* | 8 (33) | 5 (20) | 14 (24) | 6 (33) | 4 (33) | 0.72 | 37 (27) |
| Anti-RNA polymerase III, no. (%)* | 1 (8) | 1 (4) | 9 (22) | 1 (14) | 0 (0) | 0.15 | 13 (12) |
| On corticosteroids, no. (%) | 9 (31) | 17 (68) | 16 (26) | 7 (37) | 8 (62) | 0.002 | 57 (39)1 |
| Pulmonary hypertension, no. (%) | 6 (21) | 0 (0) | 0 (0) | 2 (11) | 0 (0) | 0.001 | 8 (6) |
| Pulmonary fibrosis, no. (%) | 16 (57) | 7 (28) | 11 (18) | 6 (32) | 3 (23) | 0.008 | 43 (30) |
| Cardiac involvement, no. (%) | 8 (28) | 1 (4) | 3 (5) | 2 (11) | 1 (8) | 0.024 | 15 (10) |
| mRSS, (0–51) | 24 (20.5–30) | 32 (30–41) | 23.5 (18–30) | 20.5 (18–22) | 21 (13–27) | 0.0001 | 24 (19–32) |
| HAQ-DI score, 0–3 | 1.19 (0.56–2.00) | 1.63 (1.38–2.50) | 1.50 (0.75–2.13) | 1.00 (0.25–2.00) | 1.50 (0.00–2.63) | 0.41 | 1.50 (0.75–2.13) |
| Functional Questionnaire, 0–33 | 11.5 (3–18) | 18 (10–21) | 14.5 (7–21) | 10 (1–23) | 10 (0–11) | 0.10 | 13.5 (6–19) |
| Hemoglobin, g/l | 127 (114–134) | 117 (114–130) | 124 (116–137) | 123 (112–131) | 121 (114–134) | 0.60 | 123 (114–134)2 |
| Platelets × 109/l | 312 (257–350) | 324 (270–414) | 329 (297–399) | 370 (284–441) | 370 (305–432) | 0.29 | 328 (278–403) |
| ESR, mm/h | 22 (7–37) | 21 (8.5–36) | 22 (10–34.5) | 28 (13.5–36) | 13 (9–18) | 0.72 | 22 (10–36) |
| Plasma creatinine, μmol/l | 70 (57–87) | 68 (64–82) | 70 (63–83) | 78 (72–104) | 63.5 (58–72) | 0.067 | 71 (63–84) |
| Pulmonary function tests | |||||||
| FVC, % predicted | 76.0 (64.0–91.0) | 93.3 (86.2–101.5) | 87.8 (70.1–97.0) | 88.7 (81.0–97.0) | 84.7 (89.9–100.5) | 0.16 | 87.7 (70.4–97.0) |
| DLCO, % predicted | 58.5 (45.0–79.0) | 76.1 (64.3–81.6) | 71.5 (54.0–87.0) | 69.4 (48.6–85.0) | 81.0 (65.5–91.4) | 0.091 | 71.0 (54.0–84.0) |
↵* Percentages related to the numbers tested.
↵** Significance p: Fisher’s exact test, for categorical variables; Kruskal-Wallis test, for continuous variables.
↵1 Mean dose 15.7 mg (SD 10.2).
↵2 24/76 women (32%) and 18/39 men (46%) were anemic (hemoglobin < 115 g/l for women and 135 g/l for men. IQR: interquartile range; mRSS: modified Rodnan skin score; HAQ-DI: Health Assessment Questionnaire-Disability Index; ESR: erythrocyte sedimentation rate; FVC: forced vital capacity; DLCO: diffusion capacity for carbon monoxide.