TABLE 2.
Endpoint | LS mean of treatment effect of dupilumab versus placebo (95% CI) | p value | |
---|---|---|---|
Non‐/mild ECRS | Moderate/severe ECRS | ||
Week 24 | |||
NPS | −1.37 (−1.88, −0.86) | −1.99 (−2.36, −1.61) | 0.0945 |
NC | −0.79 (−1.09, −0.48) | −0.92 (−1.11, −0.72) | 0.5073 |
LMK‐CT | −3.82 (−5.07, −2.57) | −5.59 (−6.38, −4.80) | 0.0275 |
TSS | −1.94 (−2.77, −1.11) | −2.70 (−3.20, −2.20) | 0.1205 |
UPSIT | 8.45 (5.68, 11.23) | 11.74 (9.83, 13.64) | 0.0692 |
SNOT‐22 | −14.78 (−21.03, −8.54) | −19.16 (−23.49, −14.83) | 0.2802 |
CRSwNP VAS | −2.41 (−3.45, −1.36) | −3.28 (−3.90, −2.67) | 0.1462 |
Week 52 | |||
NPS | −1.83 (−2.42, −1.23) | −2.50 (−2.90, −2.10) | 0.0911 |
NC | −0.93 (−1.24, −0.62) | −1.11 (−1.31, −0.91) | 0.3374 |
LMK‐CT | −5.39 (−6.97, −3.82) | −6.64 (−7.61, −5.67) | 0.1995 |
TSS | −2.68 (−3.56, −1.80) | −3.32 (−3.83, −2.81) | 0.1768 |
UPSIT | 8.35 (5.42, 11.28) | 11.63 (9.75, 13.51) | 0.0733 |
SNOT‐22 | −18.65 (−24.88, −12.42) | −23.92 (−28.20, −19.65) | 0.1676 |
CRSwNP VAS | −3.24 (−4.32, −2.16) | −3.94 (−4.61, −3.28) | 0.2723 |
ECRS subgroups were defined according to the JESREC algorithm (Figure 1).
Data were analyzed using an ANCOVA model with the corresponding baseline value, treatment group, asthma/N‐ERD status, prior surgery history, and regions (except for the subgroups of Region and Territory) as covariates, plus the subgroup variable and the subgroup‐by‐treatment interaction.
Abbreviations: ANCOVA, analysis of covariance; CI, confidence interval; CRSwNP, chronic rhinosinusitis with nasal polyps; ECRS, eosinophilic chronic rhinosinusitis; JESREC, Japanese Epidemiological Survey of Refractory Eosinophilic Rhinosinusitis; LMK‐CT, Lund‐Mackay score assessed by CT; LS, least squares; NC, nasal congestion; NPS, nasal polyp score; NSAID‐ERD, nonsteroidal antiinflammatory drug‐exacerbated respiratory disease; SNOT‐22,22‐item Sinonasal Outcome Test; TSS, Total Symptom Score; UPSIT, University of Pennsylvania Smell Identification Test; VAS, visual analog scale.