YUPELRI improved lung function over 12 weeks in concomitant use with LABA or ICS/LABA and as monotherapy11
Studies 1 and 2: Pooled subgroup analysis11
LS mean difference in trough FEV1 over 12-weeks: Concomitant use data
These pooled analyses are adequately powered and robust (derived from appropriate statistical tests, prespecified in the statistical analysis plan, with type 1 error controlled using a hierarchical testing strategy), allowing for conclusions to be drawn about the OTE of YUPELRI in patients with or without concomitant LABA containing therapy (ie, LABA or LABA/ICS).
YUPELRI with concomitant LABA or ICS/LABA vs placebo with concomitant LABA or ICS/LABA11§:
- LS mean change from baseline in trough FEV1 on day 85 was 111.82 mL (YUPELRI, n=118) and -27.37 mL (placebo, n=89) (P<0.0001)
- LS mean difference from placebo was 139.19 mL (95% CI, 82.87-195.51)
YUPELRI only vs placebo only (data not shown in graph above):
- LS mean change from baseline in trough FEV1 on day 85 was 117.66 mL (YUPELRI, n=192) and -33.27 mL (placebo, n=207) (P<0.0001)
- LS mean difference from placebo was 150.93 mL (95% CI, 110.26-191.61)
§Note: The safety and efficacy of mixing therapies with YUPELRI in a nebulizer has not been established.