TABLE 2.
Change in patient‐reported “taste” and proportion of patients achieving ≥1‐, ≥2‐, and ≥3‐point improvement with dupilumab versus placebo at Weeks 24 and 52
| Population a (n placebo/dupilumab) | Change from baseline LS mean (SE) | LS mean difference (95% CI) versus placebo b | p value | |
|---|---|---|---|---|
| Placebo | Dupilumab | |||
| Week 24 | ||||
| SINUS‐24 ITT (133/143) | −0.17 (0.08) | −1.11 (0.08) | −0.94 (−1.14, −0.74) | <.0001 |
| SINUS‐24 enriched c (121/123) | −0.26 (0.09) | −1.25 (0.08) | −0.99 (−1.21, −0.78) | <.0001 |
| SINUS‐52 ITT (153/295) | −0.36 (0.08) | −1.13 (0.06) | −0.77 (−0.95, −0.59) | <.0001 |
| SINUS‐52 enriched c (144/262) | −0.46 (0.08) | −1.26 (0.07) | −0.80 (−0.98, −0.62) | <.0001 |
| Week 52 | ||||
| SINUS‐52 ITT (153/150) d | −0.24 (0.08) | −1.17 (0.09) | −0.93 (−1.14, −0.71) | <.0001 |
| Population (n placebo/dupilumab) | Placebo | Dupilumab | Risk difference (95% CI) | p value e |
|---|---|---|---|---|
| % achieving ≥1‐point improvement | ||||
| Week 24 | ||||
| Pooled SINUS‐24/SINUS‐52 enriched c (265/385) | 28.3 | 69.6 | 41.3 (34.20, 48.42) | <.0001 |
| Week 52 | ||||
| SINUS‐52 enriched c (144/262) | 23.6 | 70.6 | 47.0 (38.14, 55.86) | <.0001 |
| % achieving ≥2‐point improvement | ||||
| Week 24 | ||||
| Pooled SINUS‐24 & SINUS‐52 enriched c (265/385) | 8.7 | 37.4 | 28.7 (22.82, 34.63) | <.0001 |
| Week 52 | ||||
| SINUS‐52 enriched c (144/262) | 7.6 | 45.0 | 37.4 (29.98, 44.82) | <.0001 |
| % achieving ≥3‐point improvement | ||||
| Week 24 | ||||
| Pooled SINUS‐24 & SINUS‐52 enriched c (265/385) | 0.8 | 8.6 | 7.8 (4.83, 10.80) | <.0001 |
| Week 52 | ||||
| SINUS‐52 enriched c (144/262) | 2.8 | 13.4 | 10.6 (5.66, 15.50) | .0015 |
Abbreviations: CI, confidence interval; ITT, intention‐to‐treat; LS, least squares; NSAID‐ERD, non‐steroidal anti‐inflammatory drug‐exacerbated respiratory disease; SE, standard error.
Patients with missing values were recorded as non‐responders. In the pooled SINUS‐24 & SINUS‐52 ITT population, for placebo n = 83/203 for imputed/observed data and for dupilumab n = 62/376; in the SINUS‐52 ITT population, n = 77/76 and n = 54/241, respectively. “Observed” includes observed events and observed non‐responder. “Imputed” only includes imputed non‐responder; no events are imputed.
Each of the imputed complete data were analysed by fitting an analysis of variance model with the corresponding baseline value, treatment group, asthma/NSAID‐ERD status, prior surgery history and regions as covariates.
Enriched population includes patients with loss‐of‐taste severity >0 at baseline.
Dupilumab 300 mg q2w treatment arm only.
p values derived by Cochran–Mantel–Haenszel test stratified by study, asthma/NSAID‐ERD status, prior surgery history and region.