Summary of efficacy endpoints
| Placebo-crossed (n=30) | Continued-sotatercept (n=67) | ||||||||||
| Baseline | EOP | Months 18–24 | Change from baseline to months 18–24 | p-value | Baseline | EOP | Months 18–24 | Change from baseline to months 18–24# | Change from EOP to months 18–24 | p-value¶ | |
| PVR, dyn·s cm−5 | 802±331 (n=30) | 774±355 (n=30) | 583±310 (n=25) | −223±58 (n=30)+,§ | <0.0001+ | 784±372 (n=67) | 564±268 (n=67) | 538±199 (n=57) | −213±254 (n=57) | −3±159 (n=57) | 0.8745 |
| 6MWD, m | 409±66 (n=30) | 439±85 (n=30) | 480±73 (n=25) | 61±13+,§ (n=30) | <0.0001+ | 398±86 (n=67) | 451±96 (n=67) | 458 ±110 (n=62) | 60±81 (n=62) | 7±61 (n=62) | 0.3987 |
| WHO FC, numeric | 2.4±0.5 (n=30) | 2.3±0.5 (n=30) | 1.9±0.6 (n=28) | −0.6±0.7 (n=28) | <0.0001 | 2.4±0.5 (n=67) | 2.1±0.5 (n=67) | 1.9±0.5 (n=63) | −0.4±0.6 (n=63) | −0.2±0.5 (n=63) | 0.0001 |
| NT-proBNP, pg/mL | 840±1247 (n=30) | 1059.2±1334.08 (n=30) | 363±702 (n=28) | −506.2±1190 (n=28) | 0.0004ƒ | 777.4±1051.03 (n=66) | 350±648 (n=67) | 268±457 (n=64) | −470.5±910.44 (n=63) | −76±598 (n=64) | 0.1384 |
All values shown are mean±sd unless otherwise indicated. Baseline refers to month 0 (start of the study). #: all p-values <0.0001; ¶: nominal p-values corresponding to change from end of placebo-controlled treatment period (EOP) to months 18–24; +: multiple imputation; §: values are mean±se; ƒ: nominal p-value. PVR: pulmonary vascular resistance; 6MWD: 6-min walk distance; WHO FC: World Health Organization functional class; NT-proBNP: N-terminal pro-B-type natriuretic peptide.