This pooled subgroup analysis of the ReOpen1 and ReOpen2 RCTs (N=547) evaluated whether baseline blood eosinophil count (0–299 vs ≥300 cells/µL), comorbid asthma, or environmental allergy modified the response to EDS-FLU (186 µg or 372 µg twice daily) vs EDS-placebo over 24 weeks in adults with CRS.
EDS-FLU significantly improved composite symptom scores vs placebo at week 12 across all subgroups (all P<0.01): asthma (−2.12 vs −1.36), no asthma (−2.40 vs −1.52), allergy (−2.12 vs −1.24), no allergy (−2.37 vs −1.60), EOS 0–299 cells/µL (−2.11 vs −1.56), and EOS ≥300 cells/µL (−2.48 vs −1.36); SNOT-22 and PGIC results were consistent, with no significant treatment-by-subgroup interaction.
- Subgroup analysis was post hoc and not pre-specified for primary inference, limiting causal conclusions. - Eosinophil and comorbidity subgroups were defined by self-report or a single blood draw, which may not reflect true endotype. - Authors explicitly note further investigation is warranted, suggesting underpowering within individual subgroups.
Clinicians can expect meaningful symptom benefit from EDS-FLU in CRS patients regardless of whether they have comorbid asthma, environmental allergy, or elevated blood eosinophils—endotype profiling should not delay or withhold this treatment. Both doses were effective, so choice may be guided by tolerability and formulary access.
