TABLE 3.
Summary of adverse events over 52 weeks by ECRS subgroup
| ITT | Non‐ECRS | Mild ECRS | Moderate ECRS | Severe ECRS | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 150) | Dupilumab | Placebo (n = 20) | Dupilumab | Placebo (n = 20) | Dupilumab | Placebo (n = 58) | Dupilumab | Placebo (n = 49) | Dupilumab | ||||||
| 300 mg q2w (n = 149) | 300 mg q2w–q4w (n = 148) | 300 mg q2w (n = 26) | 300 mg q2w–q4w (n = 27) | 300 mg q2w (n = 23) | 300 mg q2w–q4w (n = 18) | 300 mg q2w (n = 41) | 300 mg q2w–q4w (n = 44) | 300 mg q2w (n = 57) | 300 mg q2w–q4w (n = 54) | ||||||
| Any TEAE | 136 (90.7) | 124 (83.2) | 132 (89.2) | 15 (75.0) | 20 (76.9) | 24 (88.9) | 17 (85.0) | 19 (82.6) | 17 (94.4) | 53 (91.4) | 34 (82.9) | 40 (90.9) | 48 (98.0) | 49 (86.0) | 47 (87.0) |
| Any serious TEAE | 15 (10.0) | 8 (5.4) | 10 (6.8) | 1 (5.0) | 2 (7.7) | 3 (11.1) | 2 (10.0) | 3 (13.0) | 1 (5.6) | 3 (5.2) | 1 (2.4) | 2 (4.5) | 8 (16.3) | 2 (3.5) | 3 (5.6) |
| Any TEAE leading To death | 0 | 0 | 1 (0.7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.3) | 0 | 0 | 0 |
| Any TEAE leading to permanent treatment discontinuation | 17 (11.3) | 6 (4.0) | 2 (1.4) | 2 (10.0) | 0 | 1 (3.7) | 3 (15.0) | 2 (8.7) | 0 | 4 (6.9) | 2 (4.9) | 0 | 7 (14.3) | 2 (3.5) | 1 (1.9) |
| TEAEs occurring in ≥5% of patients in the ITT populationa (MedDRA PT) | |||||||||||||||
| Nasopharyngitis | 36 (24.0) | 30 (20.1) | 31 (20.9) | 2 (10.0) | 4 (15.4) | 9 (33.3) | 3 (15.0) | 6 (26.1) | 1 (5.6) | 14 (24.1) | 9 (22.0) | 10 (22.7) | 17 (34.7) | 11 (19.3) | 11 (20.4) |
| Upper respiratory tract infection | 19 (12.7) | 10 (6.7) | 8 (5.4) | 3 (15.0) | 2 (7.7) | 1 (3.7) | 1 (5.0) | 2 (8.7) | 2 (11.1) | 10 (17.2) | 2 (4.9) | 2 (4.5) | 4 (8.2) | 4 (7.0) | 3 (5.6) |
| Bronchitis | 8 (5.3) | 9 (6.0) | 9 (6.1) | 1 (5.0) | 2 (7.7) | 1 (3.7) | 0 | 1 (4.3) | 0 | 3 (5.2) | 5 (12.2) | 4 (9.1) | 4 (8.2) | 1 (1.8) | 4 (7.4) |
| Sinusitis | 17 (11.3) | 8 (5.4) | 13 (8.8) | 3 (15.0) | 0 | 1 (3.7) | 1 (5.0) | 4 (17.4) | 3 (16.7) | 10 (17.2) | 2 (4.9) | 5 (11.4) | 3 (6.1) | 2 (3.5) | 4 (7.4) |
| Headache | 18 (12.0) | 14 (9.4) | 16 (10.8) | 2 (10.0) | 3 (11.5) | 2 (7.4) | 3 (15.0) | 2 (8.7) | 3 (16.7) | 8 (13.8) | 2 (4.9) | 6 (13.6) | 4 (8.2) | 6 (10.5) | 4 (7.4) |
| Nasal polyps | 25 (16.7) | 8 (5.4) | 15 (10.1) | 1 (5.0) | 4 (15.4) | 1 (3.7) | 3 (15.0) | 0 | 0 | 12 (20.7) | 2 (4.9) | 5 (11.4) | 8 (16.3) | 2 (3.5) | 9 (16.7) |
| Epistaxis | 20 (13.3) | 13 (8.7) | 7 (4.7) | 3 (15.0) | 4 (15.4) | 1 (3.7) | 1 (5.0) | 1 (4.3) | 2 (11.1) | 12 (20.7) | 5 (12.2) | 1 (2.3) | 4 (8.2) | 3 (5.3) | 2 (3.7) |
| Cough | 8 (5.3) | 9 (6.0) | 9 (6.1) | 0 | 0 | 3 (11.1) | 1 (5.0) | 3 (13.0) | 1 (5.6) | 4 (6.9) | 2 (4.9) | 1 (2.3) | 3 (6.1) | 3 (5.3) | 3 (5.6) |
| Asthma | 19 (12.7) | 6 (4.0) | 13 (8.8) | 3 (15.0) | 0 | 1 (3.7) | 1 (5.0) | 0 | 0 | 7 (12.1) | 2 (4.9) | 3 (6.8) | 8 (16.3) | 4 (7.0) | 9 (16.7) |
| Injection‐site erythema | 11 (7.3) | 11 (7.4) | 10 (6.8) | 3 (15.0) | 3 (11.5) | 2 (7.4) | 1 (5.0) | 0 | 1 (5.6) | 2 (3.4) | 4 (9.8) | 3 (6.8) | 5 (10.2) | 3 (5.3) | 4 (7.4) |
| Injection‐site reaction | 3 (2.0) | 5 (3.4) | 8 (5.4) | 0 | 1 (3.8) | 1 (3.7) | 1 (5.0) | 0 | 3 (16.7) | 1 (1.7) | 2 (4.9) | 2 (4.5) | 1 (2.0) | 2 (3.5) | 1 (1.9) |
Values are n (%). ECRS subgroups were defined according to the JESREC algorithm.
Abbreviations: ECRS, eosinophilic chronic rhinosinusitis; ITT, intention‐to‐treat; JESREC, Japanese Epidemiological Survey of Refractory Eosinophilic Rhinosinusitis; MedDRA PT, Medical Dictionary for Regulatory Activities Preferred Term; q2w, every 2 weeks; q4w, every 4 weeks; TEAE, treatment‐emergent adverse event.
Any treatment arm.