| focuSSced ILD Cohort (n = 136) . | |||
|---|---|---|---|
| Baseline characteristic . | Placebo, SC QW (n = 68) . | Tocilizumab, 162 mg SC QW (n = 68) . | All patients (n = 136) . |
| Female, n (%) | 55 (80.9) | 53 (77.9) | 108 (79.4) |
| Age, years | |||
| Mean (s.d.) | 48.7 (13.3) | 47.6 (12.5) | 48.1 (12.9) |
| Median (min, max) | 50.0 (20, 73) | 48.0 (19, 72) | 48.5 (19, 73) |
| Duration of SSc, months | |||
| Median (IQR) | 17.0 (9.4–31.6) | 18.3 (8.6–36.0) | 17.6 (9.4–33.8) |
| Mean (s.d.) | 22.6 (16.6) | 23.0 (17.2) | 22.8 (16.8) |
| ppFVC | |||
| Median (IQR) | 82.7 (71.3–92.3) | 78.1 (66.9–87.5) | 80.5 (68.7–90.9) |
| Mean (s.d.) | 81.5 (14.9) | 77.7 (13.9) | 79.6 (14.5) |
| IL-6 at screening, pg/mL | |||
| <10, n (%) | 47 (69.1) | 45 (66.2) | 92 (67.6) |
| ≥10, n (%) | 21 (30.9) | 23 (33.8) | 44 (32.4) |
| CRP, mg/mL | |||
| Median (IQR) | 4.1 (1.3–9.3) | 4.8 (1.5–12.4) | 4.3 (1.5–9.9) |
| Mean (s.d.) | 8.1 (13.0) | 11.2 (17.4) | 9.6 (15.4) |
| ESR, mm/h | n = 66 | n = 64 | n = 130 |
| Median (IQR) | 35.0 (25.0–45.0) | 36.0 (27.0–45.0) | 35.0 (27.0–45.0) |
| Mean (s.d.) | 36.2 (19.3) | 37.2 (17.7) | 36.7 (18.5) |
| Platelet count, ×109/l | |||
| Median (IQR) | 285.5 (228.5–355.0) | 315.0 (250.5–392.5) | 298.5 (240.5–378.0) |
| Mean (s.d.) | 297.0 (92.2) | 323.7 (95.1) | 310.4 (94.3) |
| Antinuclear antibody positive, n (%) | 58 (95.1) | 64 (98.5) | 122 (96.8) |
| n = 61 | n = 65 | n = 126 | |
| Anti-centromere antibody positive, n (%) | 1 (1.6) | 1 (1.5) | 2 (1.6) |
| n = 63 | n = 66 | n = 129 | |
| Anti-RNA polymerase 3 antibody positive, n (%) | 6 (9.5) | 13 (19.7) | 19 (14.7) |
| n = 63 | n = 66 | n = 129 | |
| Anti-topoisomerase 1 antibody positive, n (%) | 43 (68.3) | 45 (68.2) | 88 (68.2) |
| n = 63 | n = 66 | n = 129 | |
| SMART ILD cohort (n = 505) | |||
| Male, n (%) | 109 (21.6) | ||
| Age at SSc onset, mean (s.d.), years | 47.1 (13.3) | ||
| dcSSc subset, n (%) | 249 (49.3) | ||
| Overlap syndromes, n (%) | 99 (19.6) | ||
| Autoantibodies, n (%) | |||
| Anti-centromere | 36 (7.1) | ||
| Anti-topoisomerase 1 | 204 (40.4) | ||
| Anti-RNA polymerase | 59 (11.7) | ||
| Anti-U3RNP | 15 (3.0) | ||
| Anti-PmScl | 26 (5.1) | ||
| Othera | 98 (19.4) | ||
| ANA+/ENA− | 83 (16.4) | ||
| ANA− | 18 (3.6) | ||
| Organ complications, n (%) | |||
| Clinically significant pulmonary fibrosis | 474 (93.9) | ||
| Pulmonary hypertension | 99 (19.6) | ||
| Cardiac sclerodermab | 32 (6.3) | ||
| Renal crisis | 38 (7.5) | ||
| focuSSced ILD Cohort (n = 136) . | |||
|---|---|---|---|
| Baseline characteristic . | Placebo, SC QW (n = 68) . | Tocilizumab, 162 mg SC QW (n = 68) . | All patients (n = 136) . |
| Female, n (%) | 55 (80.9) | 53 (77.9) | 108 (79.4) |
| Age, years | |||
| Mean (s.d.) | 48.7 (13.3) | 47.6 (12.5) | 48.1 (12.9) |
| Median (min, max) | 50.0 (20, 73) | 48.0 (19, 72) | 48.5 (19, 73) |
| Duration of SSc, months | |||
| Median (IQR) | 17.0 (9.4–31.6) | 18.3 (8.6–36.0) | 17.6 (9.4–33.8) |
| Mean (s.d.) | 22.6 (16.6) | 23.0 (17.2) | 22.8 (16.8) |
| ppFVC | |||
| Median (IQR) | 82.7 (71.3–92.3) | 78.1 (66.9–87.5) | 80.5 (68.7–90.9) |
| Mean (s.d.) | 81.5 (14.9) | 77.7 (13.9) | 79.6 (14.5) |
| IL-6 at screening, pg/mL | |||
| <10, n (%) | 47 (69.1) | 45 (66.2) | 92 (67.6) |
| ≥10, n (%) | 21 (30.9) | 23 (33.8) | 44 (32.4) |
| CRP, mg/mL | |||
| Median (IQR) | 4.1 (1.3–9.3) | 4.8 (1.5–12.4) | 4.3 (1.5–9.9) |
| Mean (s.d.) | 8.1 (13.0) | 11.2 (17.4) | 9.6 (15.4) |
| ESR, mm/h | n = 66 | n = 64 | n = 130 |
| Median (IQR) | 35.0 (25.0–45.0) | 36.0 (27.0–45.0) | 35.0 (27.0–45.0) |
| Mean (s.d.) | 36.2 (19.3) | 37.2 (17.7) | 36.7 (18.5) |
| Platelet count, ×109/l | |||
| Median (IQR) | 285.5 (228.5–355.0) | 315.0 (250.5–392.5) | 298.5 (240.5–378.0) |
| Mean (s.d.) | 297.0 (92.2) | 323.7 (95.1) | 310.4 (94.3) |
| Antinuclear antibody positive, n (%) | 58 (95.1) | 64 (98.5) | 122 (96.8) |
| n = 61 | n = 65 | n = 126 | |
| Anti-centromere antibody positive, n (%) | 1 (1.6) | 1 (1.5) | 2 (1.6) |
| n = 63 | n = 66 | n = 129 | |
| Anti-RNA polymerase 3 antibody positive, n (%) | 6 (9.5) | 13 (19.7) | 19 (14.7) |
| n = 63 | n = 66 | n = 129 | |
| Anti-topoisomerase 1 antibody positive, n (%) | 43 (68.3) | 45 (68.2) | 88 (68.2) |
| n = 63 | n = 66 | n = 129 | |
| SMART ILD cohort (n = 505) | |||
| Male, n (%) | 109 (21.6) | ||
| Age at SSc onset, mean (s.d.), years | 47.1 (13.3) | ||
| dcSSc subset, n (%) | 249 (49.3) | ||
| Overlap syndromes, n (%) | 99 (19.6) | ||
| Autoantibodies, n (%) | |||
| Anti-centromere | 36 (7.1) | ||
| Anti-topoisomerase 1 | 204 (40.4) | ||
| Anti-RNA polymerase | 59 (11.7) | ||
| Anti-U3RNP | 15 (3.0) | ||
| Anti-PmScl | 26 (5.1) | ||
| Othera | 98 (19.4) | ||
| ANA+/ENA− | 83 (16.4) | ||
| ANA− | 18 (3.6) | ||
| Organ complications, n (%) | |||
| Clinically significant pulmonary fibrosis | 474 (93.9) | ||
| Pulmonary hypertension | 99 (19.6) | ||
| Cardiac sclerodermab | 32 (6.3) | ||
| Renal crisis | 38 (7.5) | ||
Includes anti-Th/To, SL, Ku, Jo1, Ro, La, XR, nRNP, hnRNP, rRNP, PL4, PL7, PL12, Sm.
Defined as haemodynamically significant arrhythmias, pericardial effusion or congestive heart failure (left ventricular ejection fraction below 50%) requiring specific treatment in the absence of other known cardiac causes.
dcSSc: diffuse cutaneous SSc; ILD: interstitial lung disease; IQR: interquartile range; ppFVC: percent predicted forced vital capacity; QW: every week; SC: subcutaneously.
| focuSSced ILD Cohort (n = 136) . | |||
|---|---|---|---|
| Baseline characteristic . | Placebo, SC QW (n = 68) . | Tocilizumab, 162 mg SC QW (n = 68) . | All patients (n = 136) . |
| Female, n (%) | 55 (80.9) | 53 (77.9) | 108 (79.4) |
| Age, years | |||
| Mean (s.d.) | 48.7 (13.3) | 47.6 (12.5) | 48.1 (12.9) |
| Median (min, max) | 50.0 (20, 73) | 48.0 (19, 72) | 48.5 (19, 73) |
| Duration of SSc, months | |||
| Median (IQR) | 17.0 (9.4–31.6) | 18.3 (8.6–36.0) | 17.6 (9.4–33.8) |
| Mean (s.d.) | 22.6 (16.6) | 23.0 (17.2) | 22.8 (16.8) |
| ppFVC | |||
| Median (IQR) | 82.7 (71.3–92.3) | 78.1 (66.9–87.5) | 80.5 (68.7–90.9) |
| Mean (s.d.) | 81.5 (14.9) | 77.7 (13.9) | 79.6 (14.5) |
| IL-6 at screening, pg/mL | |||
| <10, n (%) | 47 (69.1) | 45 (66.2) | 92 (67.6) |
| ≥10, n (%) | 21 (30.9) | 23 (33.8) | 44 (32.4) |
| CRP, mg/mL | |||
| Median (IQR) | 4.1 (1.3–9.3) | 4.8 (1.5–12.4) | 4.3 (1.5–9.9) |
| Mean (s.d.) | 8.1 (13.0) | 11.2 (17.4) | 9.6 (15.4) |
| ESR, mm/h | n = 66 | n = 64 | n = 130 |
| Median (IQR) | 35.0 (25.0–45.0) | 36.0 (27.0–45.0) | 35.0 (27.0–45.0) |
| Mean (s.d.) | 36.2 (19.3) | 37.2 (17.7) | 36.7 (18.5) |
| Platelet count, ×109/l | |||
| Median (IQR) | 285.5 (228.5–355.0) | 315.0 (250.5–392.5) | 298.5 (240.5–378.0) |
| Mean (s.d.) | 297.0 (92.2) | 323.7 (95.1) | 310.4 (94.3) |
| Antinuclear antibody positive, n (%) | 58 (95.1) | 64 (98.5) | 122 (96.8) |
| n = 61 | n = 65 | n = 126 | |
| Anti-centromere antibody positive, n (%) | 1 (1.6) | 1 (1.5) | 2 (1.6) |
| n = 63 | n = 66 | n = 129 | |
| Anti-RNA polymerase 3 antibody positive, n (%) | 6 (9.5) | 13 (19.7) | 19 (14.7) |
| n = 63 | n = 66 | n = 129 | |
| Anti-topoisomerase 1 antibody positive, n (%) | 43 (68.3) | 45 (68.2) | 88 (68.2) |
| n = 63 | n = 66 | n = 129 | |
| SMART ILD cohort (n = 505) | |||
| Male, n (%) | 109 (21.6) | ||
| Age at SSc onset, mean (s.d.), years | 47.1 (13.3) | ||
| dcSSc subset, n (%) | 249 (49.3) | ||
| Overlap syndromes, n (%) | 99 (19.6) | ||
| Autoantibodies, n (%) | |||
| Anti-centromere | 36 (7.1) | ||
| Anti-topoisomerase 1 | 204 (40.4) | ||
| Anti-RNA polymerase | 59 (11.7) | ||
| Anti-U3RNP | 15 (3.0) | ||
| Anti-PmScl | 26 (5.1) | ||
| Othera | 98 (19.4) | ||
| ANA+/ENA− | 83 (16.4) | ||
| ANA− | 18 (3.6) | ||
| Organ complications, n (%) | |||
| Clinically significant pulmonary fibrosis | 474 (93.9) | ||
| Pulmonary hypertension | 99 (19.6) | ||
| Cardiac sclerodermab | 32 (6.3) | ||
| Renal crisis | 38 (7.5) | ||
| focuSSced ILD Cohort (n = 136) . | |||
|---|---|---|---|
| Baseline characteristic . | Placebo, SC QW (n = 68) . | Tocilizumab, 162 mg SC QW (n = 68) . | All patients (n = 136) . |
| Female, n (%) | 55 (80.9) | 53 (77.9) | 108 (79.4) |
| Age, years | |||
| Mean (s.d.) | 48.7 (13.3) | 47.6 (12.5) | 48.1 (12.9) |
| Median (min, max) | 50.0 (20, 73) | 48.0 (19, 72) | 48.5 (19, 73) |
| Duration of SSc, months | |||
| Median (IQR) | 17.0 (9.4–31.6) | 18.3 (8.6–36.0) | 17.6 (9.4–33.8) |
| Mean (s.d.) | 22.6 (16.6) | 23.0 (17.2) | 22.8 (16.8) |
| ppFVC | |||
| Median (IQR) | 82.7 (71.3–92.3) | 78.1 (66.9–87.5) | 80.5 (68.7–90.9) |
| Mean (s.d.) | 81.5 (14.9) | 77.7 (13.9) | 79.6 (14.5) |
| IL-6 at screening, pg/mL | |||
| <10, n (%) | 47 (69.1) | 45 (66.2) | 92 (67.6) |
| ≥10, n (%) | 21 (30.9) | 23 (33.8) | 44 (32.4) |
| CRP, mg/mL | |||
| Median (IQR) | 4.1 (1.3–9.3) | 4.8 (1.5–12.4) | 4.3 (1.5–9.9) |
| Mean (s.d.) | 8.1 (13.0) | 11.2 (17.4) | 9.6 (15.4) |
| ESR, mm/h | n = 66 | n = 64 | n = 130 |
| Median (IQR) | 35.0 (25.0–45.0) | 36.0 (27.0–45.0) | 35.0 (27.0–45.0) |
| Mean (s.d.) | 36.2 (19.3) | 37.2 (17.7) | 36.7 (18.5) |
| Platelet count, ×109/l | |||
| Median (IQR) | 285.5 (228.5–355.0) | 315.0 (250.5–392.5) | 298.5 (240.5–378.0) |
| Mean (s.d.) | 297.0 (92.2) | 323.7 (95.1) | 310.4 (94.3) |
| Antinuclear antibody positive, n (%) | 58 (95.1) | 64 (98.5) | 122 (96.8) |
| n = 61 | n = 65 | n = 126 | |
| Anti-centromere antibody positive, n (%) | 1 (1.6) | 1 (1.5) | 2 (1.6) |
| n = 63 | n = 66 | n = 129 | |
| Anti-RNA polymerase 3 antibody positive, n (%) | 6 (9.5) | 13 (19.7) | 19 (14.7) |
| n = 63 | n = 66 | n = 129 | |
| Anti-topoisomerase 1 antibody positive, n (%) | 43 (68.3) | 45 (68.2) | 88 (68.2) |
| n = 63 | n = 66 | n = 129 | |
| SMART ILD cohort (n = 505) | |||
| Male, n (%) | 109 (21.6) | ||
| Age at SSc onset, mean (s.d.), years | 47.1 (13.3) | ||
| dcSSc subset, n (%) | 249 (49.3) | ||
| Overlap syndromes, n (%) | 99 (19.6) | ||
| Autoantibodies, n (%) | |||
| Anti-centromere | 36 (7.1) | ||
| Anti-topoisomerase 1 | 204 (40.4) | ||
| Anti-RNA polymerase | 59 (11.7) | ||
| Anti-U3RNP | 15 (3.0) | ||
| Anti-PmScl | 26 (5.1) | ||
| Othera | 98 (19.4) | ||
| ANA+/ENA− | 83 (16.4) | ||
| ANA− | 18 (3.6) | ||
| Organ complications, n (%) | |||
| Clinically significant pulmonary fibrosis | 474 (93.9) | ||
| Pulmonary hypertension | 99 (19.6) | ||
| Cardiac sclerodermab | 32 (6.3) | ||
| Renal crisis | 38 (7.5) | ||
Includes anti-Th/To, SL, Ku, Jo1, Ro, La, XR, nRNP, hnRNP, rRNP, PL4, PL7, PL12, Sm.
Defined as haemodynamically significant arrhythmias, pericardial effusion or congestive heart failure (left ventricular ejection fraction below 50%) requiring specific treatment in the absence of other known cardiac causes.
dcSSc: diffuse cutaneous SSc; ILD: interstitial lung disease; IQR: interquartile range; ppFVC: percent predicted forced vital capacity; QW: every week; SC: subcutaneously.
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