Table 1.
Summary of baseline demographics of patients in the SENSCIS® trial
| Patients included in joint models (N = 574)a | Patients with all-cause hospitalisation events or death (n = 78) | Patients with SSc-related hospitalisation events or death (n = 42) | Patients with admission to ER or hospital followed by admission to ICU or death (n = 75) | |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Female | 431 (75.1) | 50 (64.1) | 28 (66.7) | 51 (68.0) |
| Age, years | 53.9 ± 12.2 | 56.1 ± 12.0 | 56.1 ± 12.0 | 54.4 ± 11.6 |
| Diffuse cutaneous SSc, n (%) | 298 (51.9) | 39 (50.0) | 21 (50.0) | 38 (50.7) |
| Time since the onset of the first non-Raynaud’s symptom, years | 3.5 ± 1.7 | 3.5 ± 1.9 | 3.2 ± 2.0 | 3.6 ± 1.7 |
| Extent of fibrosis of the lungs on HRCT, % | 36.0 ± 21.2 | 35.9 ± 20.2 | 38.5 ± 21.2 | 36.3 ± 21.9 |
| FVC, mL | 2501.2 ± 778.2 | 2532.0 ± 787.2 | 2498.2 ± 817.2 | 2455.7 ± 693.5 |
| FVC, % predicted | 72.5 ± 16.7 | 72.0 ± 16.4 | 70.5 ± 18.7 | 70.9 ± 16.7 |
| DLCO, % predictedb | 53.1 ± 15.1 | 48.4 ± 13.2 | 47.7 ± 12.6 | 49.2 ± 13.5 |
| ATA positive, n (%)c | 349 (60.8) | 42 (53.8) | 24 (57.1) | 43 (57.3) |
| mRSSd | 11.1 ± 9.0 | 12.3 ± 11.1 | 13.2 ± 11.6 | 11.6 ± 9.0 |
| Total score on the SGRQe | 39.9 ± 20.4 | 44.3 ± 18.8 | 41.3 ± 19.9 | 47.9 ± 17.9 |
| High-sensitivity C-reactive protein, mg/Lf | 6.2 ± 15.2 | 10.6 ± 30.4 | 14.5 ± 40.5 | 10.6 ± 31.4 |
Data are mean ± SD unless otherwise stated
aData on some variables were not available for all patients
bThe DLCO value was corrected for the haemoglobin level. DLCO values were available for 567 patients in total, 77, 41 and 74 patients with all-cause hospitalisation events or death, SSc-related hospitalisation events or death, and admission to ER or hospital followed by admission to ICU or death, respectively
cHistorical information on ATA status was used, or, if this information was not available to the trial sites, it was provided by a central laboratory
dScores were available for 572 patients in total, 77 and 74 patients with all-cause hospitalisation events or death, and admission to ER or hospital followed by admission to ICU or death, respectively
eTotal scores on the SGRQ range from 0 to 100, with higher scores indicating worse health-related quality of life. Scores were available for 563 patients in total, 75 and 73 in patients with all-cause hospitalisation events or death, and admission to ER or hospital followed by admission to ICU or death, respectively
fHigh-sensitivity C-reactive protein values were available for 529 patients in total, 71, 39 and 66 patients with all-cause hospitalisation events or death, SSc-related hospitalisation events or death, and admission to ER or hospital followed by admission to ICU or death, respectively
ATA, anti-topoisomerase I antibody, DLCO, diffusing capacity of the lungs for carbon monoxide, ER, emergency room, FVC, forced vital capacity, HRCT, high-resolution computed tomography, ICU, intensive care unit, mRSS, modified Rodnan Skin Score, SD, standard deviation, SGRQ, St. George’s Respiratory Questionnaire, SSc, systemic sclerosis