Table 2.
Baseline characteristics
| Characteristic | Overall SERAPHIN population [5] (N = 742) | Combination therapy: macitentan 10 mg + background therapya (N = 154) | Monotherapy: placebo + background therapya (N = 154) |
|---|---|---|---|
| Female sex | 565 (77) | 117 (76) | 113 (73) |
| Age, years | 46 ± 16 | 45 ± 15 | 46 ± 17 |
| Race | |||
| White | 403 (54.5) | 71 (46.1) | 73 (47.4) |
| Black | 19 (2.6) | 4 (2.6) | 5 (3.2) |
| Asian | 205 (27.7) | 50 (32.5) | 51 (33.1) |
| Hispanic | 109 (14.7) | 29 (18.8) | 24 (15.6) |
| Other | 3 (0.4) | – | 1 (0.6) |
| Year from diagnosis of PAHb | 2.7 ± 4.0 | 2.6 ± 3.4 | 2.7 ± 4.1 |
| PAH classificationb | |||
| Idiopathic PAH | 404 (55.0) | 91 (59.1) | 80 (52.3) |
| Hereditary PAH | 13 (1.8) | 1 (0.6) | 2 (1.3) |
| Associated with CTD | 224 (30.5) | 43 (27.9) | 49 (32.0) |
| Associated with CHD | 62 (8.4) | 12 (7.8) | 13 (8.5) |
| Associated with HIV | 10 (1.4) | 4 (2.6) | 2 (1.3) |
| Associated with drug use or toxin exposure | 22 (3.0) | 3 (1.9) | 7 (4.6) |
| 6MWD, m | 360 ± 100 | 364 ± 97 | 360 ± 111 |
| WHO FC | |||
| Ic | 1 (0.1) | – | – |
| II | 387 (52.4) | 73 (47.4) | 78 (50.6) |
| III | 337 (45.6) | 77 (50.0) | 74 (48.1) |
| IV | 14 (1.9) | 4 (2.6) | 2 (1.3) |
| Background therapy | |||
| Patients receiving background therapyd | 471 (63.7) | 154 (100.0) | 154 (100.0) |
| PDE-5i | 454 (96.4) | 150 (97.4) | 150 (97.4) |
| Oral or inhaled prostanoid | 40 (5.4) | 16 (10.4) | 7 (4.5) |
Data are presented as n (%) or mean ± SD
6MWD 6-minute walk distance, CHD congenital heart disease, CTD connective tissue disease, HIV human immunodeficiency virus, PAH pulmonary arterial hypertension, PDE-5i phosphodiesterase type 5 inhibitor, SD standard deviation, WHO FC World Health Organization functional class
aActelion unpublished data
b N = 153 for the placebo group
cOne patient in WHO FC I was incorrectly included in the study
dPatients could have received more than one background PAH therapy