Table 2: Efficacy outcomes across sotatercept clinical trials.
|
Characteristic |
Pulsar |
Spectra |
Stellar |
Zenith |
|
Primary endpoint |
PVR reduction |
Peak VO₂ increase |
6 MWD improvement |
Composite of death, transplant, or hospitalization |
|
6 MWD change |
+ 29.4 m (0.3 mg vs. placebo) |
Improved (secondary) |
+ 34.4 m vs. +1.0 m placebo (diff: ~ 40.8 m, p < 0.001) |
Not specified |
|
PVR change |
-146 and -240 dyn·s·cm⁻⁵ (0.3 and 0.7 mg) |
Not specified |
Not specified |
Not specified |
|
NT-proBNP |
Reduced |
Not specified |
Not specified |
Not specified |
|
WHO-FC |
Improved |
Not specified |
Not specified |
Not specified |
|
Peak VO₂ |
Not specified |
+ 102.7 mL/min (p < 0.01) |
Not specified |
Not specified |
|
RV function |
Not specified |
Improved |
Not specified |
Not specified |
|
Clinical worsening |
Not specified |
Not specified |
Not specified |
17.4% vs. 54.7% (HR 0.24, p < 0.0001) |
|
Secondary endpoints |
Not specified |
Not specified |
8 of 9 favored Sotatercept |
Not specified |