TABLE 4.
Patients requiring SCS or sinus surgery up to week 24*
| Number of prior surgeries | |||||
|---|---|---|---|---|---|
| Parameter | No surgery | ≥1 | 1 | 2 | ≥3 |
| Patients with SCS/surgery, n/N (%) | |||||
| Placebo | 24/99 (24.2) | 51/187 (27.3) | 29/101 (28.7) | 9/39 (23.1) | 13/47 (27.7) |
| Dupilumab | 16/166 (9.6) | 20/272 (7.4) | 10/153 (6.5) | 5/55 (9.1) | 5/64 (7.8) |
| Probability of SCS use/surgery, (95% CI)a | |||||
| Placebo | 0.244 (0.165–0.332) | 0.276 (0.214–0.342) | 0.290 (0.205–0.381) | 0.232 (0.115–0.373) | 0.283 (0.162–0.417) |
| Dupilumab | 0.097 (0.058–0.148) | 0.074 (0.047–0.110) | 0.066 (0.034–0.113) | 0.092 (0.034–0.187) | 0.079 (0.029–0.162) |
| Hazard ratio (95% CI) | 0.338 (0.178–0.640) | 0.220 (0.130–0.372) | 0.187 (0.090–0.387) | 0.325 (0.099–1.060) | 0.246 (0.086–0.698) |
| Interaction p value vs no surgery | 0.29 | 0.22 | 0.89 | 0.53 | |
| Time since most recent surgery (years) | ||||
|---|---|---|---|---|
| Parameter | <3 | ≥3 and <5 | ≥5 and <10 | ≥10 |
| Patients with SCS/surgery, n/N (%) | ||||
| Placebo | 17/55 (30.9) | 10/34 (29.4) | 16/53 (30.2) | 8/45 (17.8) |
| Dupilumab | 7/81 (8.6) | 2/47 (4.3) | 4/80 (5.0) | 7/63 (11.1) |
| Probability of SCS use/surgery (95% CI)a | ||||
| Placebo | 0.315 (0.197–0.440) | 0.295 (0.154–0.451) | 0.302 (0.185–0.427) | 0.182 (0.085–0.308) |
| Dupilumab | 0.087 (0.038–0.160) | 0.047 (0.008–0.140) | 0.050 (0.016–0.113) | 0.111 (0.049–0.203) |
| Hazard ratio (95% CI) | 0.178 (0.069–0.463) | 0.078 (0.016–0.383) | 0.124 (0.041–0.380) | 0.590 (0.212–1.641) |
| Interaction p value vs < 3 years | 0.32 | 0.46 | 0.15 | |
*Hazard ratios derived from Cox proportional hazard model in each subgroup, with the event of first SCS use and/or surgery up to week 24 as the response variable, and treatment, asthma/NSAID‐ERD status, region (pooled country), and study indicator (EFC14280 = 0 and EFC14146 = 1) as covariates. Interaction p value, derived from Cox proportional hazard model with the event of first SCS use and/or surgery as the response variable, and treatment, asthma/NSAID‐ERD status, region (pooled country), study indicator (EFC14280 = 0 and EFC14146 = 1), and the subgroup and the subgroup‐by‐treatment interaction as covariates.
Kaplan‐Meier estimates.
CI = confidence interval; NSAID‐ERD = nonsteroidal anti‐inflammatory drug–exacerbated respiratory tract disease; SCS = systemic corticosteroids.