Combination therapy (CTD) (n=103) | Monotherapy pooled (CTD) (n=84) | Combination therapy (SSc) (n=71) | Monotherapy pooled (SSc) (n=47) | |
---|---|---|---|---|
Median (Q1, Q3) time from diagnosis to study drug administration (days) | 20 (8, 49) | 21.5 (8, 49) | 20 (8, 45) | 16 (8, 35) |
Mean (SD) age (years) | 58.4 (12.3) | 57.9 (13.1) | 62.0 (9.2) | 60.7 (10.7) |
Sex, n (%) | ||||
Female | 89 (86) | 76 (90) | 58 (82) | 41 (87) |
Male | 14 (14) | 8 (10) | 13 (18) | 6 (13) |
WHO functional class, n (%) | ||||
II | 26 (25) | 22 (26) | 16 (23) | 11 (23) |
III | 77 (75) | 62 (74) | 55 (77) | 36 (77) |
6-min walk distance (m) | ||||
Mean (SD) | 324.8 (86.3) | 327.9 (98.0) | 312.8 (87.7) | 328.9 (98.2) |
Median | 333.1 | 346.8 | 313.2 | 352.0 |
Median (Q1, Q3) NT-proBNP (ng/L) | 1321 (372, 2995) n=98 | 1128 (337, 2357) n=82 | 1713 (332, 3294) n=68 | 1152 (382, 2576) n=46 |
Mean (SD) % of predicted normal TLC | 89.0 (15.7) n=102 | 88.6 (17.6) n=83 | 89.8 (16.4) n=70 | 90.0 (18.4) |
Mean (SD) % of predicted normal FEV1 | 84.3 (18.8) | 81.4 (16.4) | 86.2 (19.8) | 85.9 (17.4) |
Prior medications, n (%) | ||||
Immunosuppressants | 14 (14) | 13 (15) | 4 (6) | 5 (11) |
Steroids | 18 (17) | 17 (20) | 10 (14) | 7 (15) |
Mean (SD) mean right atrial pressure (mm Hg) | 7.4 (4.2) n=102 | 7.7 (4.5) | 7.4 (4.2) | 7.6 (4.7) |
Mean (SD) cardiac index (L/min/m2) | 2.55 (0.63) | 2.67 (0.73) n=83 | 2.57 (0.60) | 2.54 (0.62) n=46 |
Mean (SD) mean pulmonary arterial pressure (mm Hg) | 43.5 (10.4) | 45.1 (10.0) | 43.7 (10.3) | 45.7 (10.1) |
Mean (SD) pulmonary capillary wedge pressure (mm Hg) | 8.2 (3.0) n=102 | 9.1 (3.3) n=82 | 8.3 (3.0) | 8.6 (3.3) n=45 |
Mean (SD) pulmonary vascular resistance (dyne·s/cm5) | 672.3 (274.5) | 667.1 (257.8) | 674.7 (267.8) | 702.2 (265.3) |
Post hoc summary.
CTD, connective tissue disease; FEV1, forced expiratory volume in 1 s; NT-proBNP, N-terminal pro-B-type natriuretic peptide; PAH, pulmonary arterial hypertension; Q1, quartile 1; Q3, quartile 3; SSc, systemic sclerosis; TLC, total lung capacity.