Baseline characteristics in subjects with risk factors for rapid decline in FVC in the SENSCIS trial
| <18 months since onset of first non-Raynaud symptom | Elevated inflammatory markers* | mRSS 15–40 | mRSS ≥18 | |||||
| Nintedanib (n=40) | Placebo (n=39) | Nintedanib (n=104) | Placebo (n=106) | Nintedanib (n=96) | Placebo (n=76) | Nintedanib (n=69) | Placebo (n=60) | |
| Age (years) | 56.3 (11.3) | 52.6 (14.5) | 53.0 (12.6) | 53.6 (12.5) | 52.5 (12.1) | 49.5 (13.5) | 52.2 (12.3) | 48.6 (13.7) |
| Female | 29 (72.5) | 25 (64.1) | 81 (77.9) | 75 (70.8) | 72 (75.0) | 61 (80.3) | 52 (75.4) | 49 (81.7) |
| Years since onset of first non-Raynaud symptom | 1.0 (0.4) | 0.9 (0.4) | 3.3 (1.5) | 3.4 (1.7) | 3.7 (1.7) | 4.1 (1.9) | 3.8 (1.7) | 4.0 (1.8) |
| Diffuse cutaneous SSc | 16 (40.0) | 13 (33.3) | 65 (62.5) | 64 (60.4) | 91 (94.8) | 71 (93.4) | 69 (100.0) | 60 (100.0) |
| ANA positive | 31 (77.5) | 31 (79.5) | 83 (79.8) | 83 (78.3) | 72 (75.0) | 62 (81.6) | 53 (76.8) | 49 (81.7) |
| ATA positive | 19 (47.5) | 22 (56.4) | 69 (66.3) | 64 (60.4) | 68 (70.8) | 48 (63.2) | 51 (73.9) | 36 (60.0) |
| ARA positive | 3 (7.5) | 5 (12.8) | 7 (6.7) | 9 (8.5) | 7 (7.3) | 8 (10.5) | 7 (10.1) | 8 (13.3) |
| ACA positive | 4 (10.0) | 7 (17.9) | 6 (5.8) | 10 (9.4) | 4 (4.2) | 4 (5.3) | 3 (4.3) | 4 (6.7) |
| Extent of fibrotic ILD on HRCT (%)† | 33.9 (20.8) | 33.1 (20.3) | 36.4 (21.9) | 37.0 (21.6) | 37.5 (23.1) | 39.3 (20.9) | 36.4 (22.1) | 41.3 (22.5) |
| Presence of honeycombing on HRCT | 4 (10.0) | 11 (28.2) | 17 (16.3) | 22 (20.8) | 13 (13.5) | 10 (13.2) | 9 (13.0) | 5 (8.3) |
| Presence of reticulation on HRCT | 33 (82.5) | 38 (97.4) | 95 (91.3) | 98 (92.5) | 88 (91.7) | 70 (92.1) | 64 (92.8) | 52 (86.7) |
| Presence of ground-glass opacities on HRCT | 32 (80.0) | 38 (97.4) | 89 (85.6) | 92 (86.8) | 85 (88.5) | 62 (81.6) | 60 (87.0) | 50 (83.3) |
| FVC (mL) | 2601 (925) | 2595 (942) | 2405 (757) | 2483 (878) | 2410 (713) | 2402 (817) | 2354 (697) | 2419 (865) |
| FVC % predicted | 75.1 (17.8) | 71.6 (16.5) | 70.0 (15.2) | 70.4 (16.0) | 68.7 (16.9) | 69.6 (16.2) | 67.4 (14.3) | 69.3 (16.1) |
| DLco % predicted‡ | 57.0 (15.7) | 54.9 (15.7) | 49.8 (14.5) | 49.3 (14.5) | 51.7 (17.3) | 53.8 (15.1) | 51.5 (16.6) | 51.6 (14.7) |
| SpO2 (%) | 97.4 (1.9) | 97.0 (3.9) | 97.3 (2.0) | 97.3 (2.5) | 97.3 (2.1) | 97.2 (3.3) | 97.2 (2.2) | 97.0 (3.1) |
| mRSS | 10.6 (10.4) | 10.4 (9.2) | 12.9 (9.8) | 12.7 (9.6) | 21.7 (5.9) | 21.1 (4.8) | 24.5 (6.2) | 24.7 (6.6) |
| Immunosuppressants§ | 34 (85.0) | 27 (69.2) | 96 (92.3) | 96 (90.6) | 91 (94.8) | 65 (85.5) | 67 (97.1) | 52 (86.7) |
| Most commonly used immunosuppressants¶ | ||||||||
| Mycophenolate mofetil | 14 (35.0) | 7 (17.9) | 50 (48.1) | 58 (54.7) | 50 (52.1) | 39 (51.3) | 40 (58.0) | 31 (51.7) |
| Acetylsalicylic acid | 7 (17.5) | 6 (15.4) | 19 (18.3) | 31 (29.2) | 17 (17.7) | 22 (28.9) | 13 (18.8) | 16 (26.7) |
| Prednisone | 7 (17.5) | 3 (7.7) | 24 (23.1) | 17 (16.0) | 23 (24.0) | 9 (11.8) | 19 (27.5) | 9 (15.0) |
| Prednisolone | 6 (15.0) | 8 (20.5) | 15 (14.4) | 19 (17.9) | 14 (14.6) | 9 (11.8) | 11 (15.9) | 7 (11.7) |
| Methotrexate | 4 (10.0) | 2 (5.1) | 7 (6.7) | 5 (4.7) | 11 (11.5) | 2 (2.6) | 8 (11.6) | 3 (5.0) |
| Corticosteroids§ | 21 (52.5) | 17 (43.6) | 61 (58.7) | 59 (55.7) | 58 (60.4) | 28 (36.8) | 43 (62.3) | 25 (41.7) |
Data are n (%) or mean (SD). Not all subjects provided data for all variables.
*C reactive protein ≥6 mg/L and/or platelets ≥330×109/L.
†Assessed in whole lung to nearest 5% by central review. Pure (non-fibrotic) ground-glass opacity was not included.
‡Corrected for haemoglobin.
§Customised drug grouping.
¶Taken by >10% of patients in the nintedanib and/or placebo group in any subgroup.
ACA, anti-centromere antibody; ANA, anti-nuclear antibody; ARA, anti-RNA polymerase III antibody; ATA, anti-topoisomerase I antibody; DLco, diffusing capacity of the lung for carbon monoxide; FVC, forced vital capacity; HRCT, high-resolution CT; ILD, interstitial lung disease; mRSS, modified Rodnan skin score; SpO2, oxygen saturation; SSc, systemic sclerosis.