TABLE 2.
Change from baseline at Weeks 24 and 52 in EQ‐VAS (general health status; ITT and subgroups)
|
Pooled SINUS‐24 and SINUS‐52 Week 24 n placebo/n dupilumab |
Baseline mean (SD) | Week 24 mean (SD) | Change from baseline at Week 24 | |||
|---|---|---|---|---|---|---|
| Placebo |
Dupilumab 300 mg q2w |
Placebo |
Dupilumab 300 mg q2w |
LS mean difference vs placebo (95% CI) | p‐value | |
| ITT (286/438) | 64.9 (20.6) | 65.8 (20.3) | 68.0 (19.9) | 76.7 (16.3) | 8.2 (5.7, 10.7) | <.0001 |
| With asthma (170/258) | 62.6 (20.5) | 64.5 (19.7) | 66.3 (20.0) | 75.3 (16.2) | 8.2 (5.0, 11.5) | <.0001 |
| Without asthma (116/180) | 68.1 (20.5) | 67.8 (21.0) | 70.5 (19.5) | 78.6 (16.1) | 7.9 (3.9, 11.9) | .0001 |
| With NSAID‐ERD (82/122) | 61.4 (19.5) | 63.9 (18.3) | 64.4 (20.3) | 76.7 (16.0) | 11.7 (7.1, 16.3) | <.0001 |
| Without NSAID‐ERD (204/316) | 66.3 (20.9) | 66.5 (21.0) | 69.5 (19.6) | 76.6 (16.4) | 6.8 (3.9, 9.8) | <.0001 |
| With prior NP surgery (187/272) | 65.6 (19.8) | 65.2 (19.1) | 68.0 (20.1) | 76.8 (15.9) | 8.7 (5.6, 11.8) | <.0001 |
| Without prior NP surgery (99/166) | 63.5 (22.2) | 66.8 (22.1) | 68.1 (19.6) | 76.5 (16.9) | 7.6 (3.3, 11.9) | .0006 |
|
SINUS‐52 Week 52 n placebo/n dupilumab |
Baseline mean (SD) | Week 52 mean (SD) | Change from baseline at Week 52 | |||
|---|---|---|---|---|---|---|
| Placebo |
Dupilumab 300 mg q2w |
Placebo |
Dupilumab 300 mg q2w |
LS mean difference vs placebo (95% CI) | p‐value | |
| ITT (153/150) | 63.9 (20.0) | 63.8 (21.8) | 66.8 (20.6) | 78.2 (18.1) | 11.2 (7.2, 15.2) | <.0001 |
| With asthma (91/85) | 60.9 (19.8) | 63.2 (21.0) | 64.1 (20.0) | 77.3 (18.9) | 11.9 (6.7, 17.2) | <.0001 |
| Without asthma (62/65) | 68.2 (19.6) | 64.6 (22.8) | 70.7 (21.0) | 79.3 (17.0) | 10.2 (3.8, 16.5) | .0428 |
| With NSAID‐ERD (44/35) | 62.8 (19.3) | 61.5 (18.3) | 64.6 (20.1) | 74.3 (21.9) | 10.4 (2.4, 18.5) | .0112 |
| Without NSAID‐ERD (109/115) | 64.4 (20.3) | 64.4 (22.7) | 67.7 (20.9) | 79.4 (16.6) | 11.4 (6.8, 16.1) | .0004 |
| With prior NP surgery (88/88) | 64.4 (19.6) | 64.1 (20.0) | 67.1 (21.4) | 78.5 (19.2) | 11.4 (6.2, 16.6) | <.0001 |
| Without prior NP surgery (65/62) | 63.2 (20.6) | 63.4 (24.1) | 66.3 (19.7) | 77.7 (16.4) | 11.0 (4.6, 17.3) | .0063 |
Abbreviations: CI, confidence interval; EQ‐VAS, EuroQoL‐visual analog scale; ITT, intention to treat; LS, least squares; NP, nasal polyp; NSAID‐ERD, non‐steroidal anti‐inflammatory drug‐exacerbated respiratory disease; q2w, every 2 weeks; SD, standard deviation.