Molgramostim efficacy and safety
1 evidence topic · 3 sources
Summary
IMPALA-2 randomized 164 participants, 81 to molgramostim and 83 to placebo. At week 24, the reported change in DLCO percent predicted was 9.8% with molgramostim and 3.8% with placebo, an estimated treatment difference of 6.0 percentage points (P<0.001). The SGRQ Total Score comparison had P=0.0072; the SGRQ Activity Score comparison had nominal P=0.0149 but was not statistically significant under the prespecified testing hierarchy. In the 48-week safety report, symptomatic COVID-19 infection occurred in 22% versus 10% and diarrhea in 11% versus 2%, respectively. No deaths were reported.