Pooled analysis of subgroup factor effect on subjective and objective
outcomes at day 90. The changes from baseline to day 90 in symptomatic and
endoscopic outcomes across subgroups based on analysis of the pooled data
from 2 RCTs, totaling 375 patients with NP grade ≥ 2 on each side at
screening who were indicated for RESS, are shown. The treatment group
underwent in-office bilateral placement of MF sinus implants, and the
control group underwent a sham procedure. All patients (treatment and
control) were required to use MFNS once daily. Summary statistics include
estimates of the treatment effect (mean difference or odds ratio between
treatment groups, 95% CI) within subgroups, the overall treatment effect
when accounting for subgroups effect, and the interaction of treatment by
subgroup. Subgroups representing <10% of ITT population were omitted.
Treatment effects with P < .05 were considered
statistically significant and are highlighted in bold font and with blue
shaded diamonds. A, Change in NO/C score (scale 0–3, with higher scores
indicating greater severity). B, Change in mean BPG (scale 0–8, with higher
scores indicating greater severity), as determined based on a centralized
blinded video-endoscopy review by an independent panel of 3 sinus surgeons.
C, Change in ESO (VAS 0–100, with higher scores indicating greater
severity), as determined by the independent panel. D, Proportion of patients
still indicated for RESS. AERD, aspirin-exacerbated respiratory disease; CI,
confidence interval; ESO, ethmoid sinus obstruction; ESS, endoscopic sinus
surgery; ITT, intent-to-treat; MF, mometasone furoate; MFNS, MF nasal spray;
n/a, not applicable; NO/C, nasal obstruction/congestion; NP, nasal polyps;
RCT, randomized controlled trial; RESS, revision ESS; VAS = visual analog
scale.