Table 2. Summary of TEAEs—exposed patients from phase 2b and QUEST who were recruited from Korean centers and rolled over into TRAVERSE.
| TEAEs | Patients from phase 2b study* | Patients from QUEST | Overall | |||
|---|---|---|---|---|---|---|
| PBO/DPL (n = 4, PY = 8.3) | DPL/DPL (n = 17, PY = 35.2) | PBO/DPL (n = 19, PY = 26.3) | DPL/DPL (n = 34, PY = 49.1) | (n = 74, PY = 118.9) | ||
| Category, No. (%) | ||||||
| Patients with any TEAE | 3 (75.0) | 17 (100) | 18 (94.7) | 32 (94.1) | 70 (94.6) | |
| Patients with any treatment-emergent SAE | 1 (25.0) | 1 (5.9) | 2 (10.5) | 7 (20.6) | 11 (14.9) | |
| Patients with any TEAE leading to death | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Patients with any TEAE leading to permanent treatment discontinuation | 0 (0.0) | 0 (0.0) | 1 (5.3) | 5 (14.7) | 6 (8.1) | |
| No. of patients with any TEAE (PT ≥ 2% in any treatment group), No. (%), nP/PY (nP/100 PY) | ||||||
| Upper respiratory tract infection | 3 (75.0) | 7 (41.2) | 10 (52.6) | 12 (35.3) | 32 (43.2) | |
| 3/4.0 (75.2) | 7/24.5 (28.6) | 10/18.8 (53.1) | 12/31.2 (38.5) | 32/78.5 (40.8) | ||
| Nasopharyngitis | 0 (0.0) | 2 (11.8) | 1 (5.3) | 6 (17.6) | 9 (12.2) | |
| 0/8.3 | 2/32.8 (6.1) | 1/25.5 (3.9) | 6/44.2 (13.6) | 9/110.8 (8.1) | ||
| Bronchitis | 0 (0.0) | 0 (0.0) | 1 (5.3) | 2 (5.9) | 3 (4.1) | |
| 0/8.3 | 0/35.2 | 1/25.7 (3.9) | 2/47.5 (4.2) | 3/116.8 (2.6) | ||
| Herpes zoster | 0 (0.0) | 2 (11.8) | 0 (0.0) | 1 (2.9) | 3 (4.1) | |
| 0/8.3 | 2/33.0 (6.1) | 0/26.3 | 1/48.7 (2.1) | 3/116.4 (2.6) | ||
| Pharyngitis | 1 (25.0) | 0 (0.0) | 1 (5.3) | 1 (2.9) | 3 (4.1) | |
| 1/6.4 (15.6) | 0/35.2 | 1/25.5 (3.9) | 1/47.8 (2.1) | 3/115.0 (2.6) | ||
| Periodontitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.9) | 1 (1.4) | |
| 0/8.3 | 0/35.2 | 0/26.3 | 1/47.0 (2.1) | 1/116.9 (0.9) | ||
| Neutropenia | 0 (0.0) | 0 (0.0) | 1 (5.3) | 2 (5.9) | 3 (4.1) | |
| 0/8.3 | 0/35.2 | 1/25.6 (3.9) | 2/47.7 (4.2) | 3/116.9 (2.6) | ||
| Eosinophilia† | 0 (0.0) | 1 (5.9) | 1 (5.3) | 0 (0.0) | 2 (2.7) | |
| 0/8.3 | 1/34.1 (2.9) | 1/24.3 (4.1) | 0/49.1 | 2/115.8 (1.7) | ||
| Headache | 1 (25.0) | 1 (5.9) | 0 (0.0) | 4 (11.8) | 6 (8.1) | |
| 1/7.9 (12.7) | 1/33.4 (3.0) | 0/26.3 | 4/46.7 (8.6) | 6/114.3 (5.3) | ||
| Oropharyngeal pain | 0 (0.0) | 1 (5.9) | 2 (10.5) | 2 (5.9) | 5 (6.8) | |
| 0/8.3 | 1/33.6 (3.0) | 2/24.5 (8.2) | 2/46.7 (4.3) | 5/113.1 (4.4) | ||
| Productive cough | 0 (0.0) | 2 (11.8) | 0 (0.0) | 2 (5.9) | 4 (5.4) | |
| 0/8.3 | 2/32.8 (6.1) | 0/26.3 | 2/46.9 (4.3) | 4/114.3 (3.5) | ||
| Diarrhoea | 0 (0.0) | 1 (5.9) | 0 (0.0) | 2 (5.9) | 3 (4.1) | |
| 0/8.3 | 1/33.3 (3.0) | 0/26.3 | 2/47.7 (4.2) | 3/115.6 (2.6) | ||
| Nausea | 0 (0.0) | 1 (5.9) | 2 (10.5) | 0 | 3 (4.1) | |
| 0/8.3 | 1/33.2 (3.0) | 2/23.8 (8.4) | 0/49.1 | 3/114.3 (2.6) | ||
| Eczema | 1 (25.0) | 0 | 0 | 0 | 1 (1.4) | |
| 1/8.3 (12.0) | 0/35.2 | 0/26.3 | 0/49.1 | 1/118.9 (0.8) | ||
| Arthralgia | 2 (50.0) | 1 (5.9) | 1 (5.3) | 1 (2.9) | 5 (6.8) | |
| 2/6.0 (33.5) | 1/33.3 (3.0) | 1/25.4 (3.9) | 1/49.0 (2.0) | 5/113.8 (4.4) | ||
| Back pain | 1 (25.0) | 1 (5.9) | 1 (5.3) | 2 (5.9) | 5 (6.8) | |
| 1/6.3 (16.0) | 1/35.2 (2.8) | 1/25.4 (3.9) | 2/46.3 (4.3) | 5/113.1 (4.4) | ||
| Injection site erythema | 1 (25.0) | 1 (5.9) | 3 (15.8) | 5 (14.7) | 10 (13.5) | |
| 1/6.2 (16.0) | 1/33.2 (3.0) | 3/22.8 (13.2) | 5/41.5 (12.0) | 10/103.7 (9.6) | ||
| Injection site pruritus | 0 (0.0) | 1 (5.9) | 1 (5.3) | 1 (2.9) | 3 (4.1) | |
| 0/8.3 | 1/33.2 (3.0) | 1/24.3 (4.1) | 1/47.0 (2.1) | 3/112.8 (2.7) | ||
| Injection site pain | 0 (0.0) | 1 (5.9) | 0 | 0 | 1 (1.4) | |
| 0/8.3 | 1/33.2 (3.0) | 0/26.3 | 0/49.1 | 1/116.9 (0.9) | ||
| Blood creatine phosphokinase increased | 0 (0.0) | 0 | 1 (5.3) | 1 (2.9) | 2 (2.7) | |
| 0/8.3 | 0/35.2 | 1/24.4 (4.1) | 1/47.5 (2.1) | 2/115.5 (1.7) | ||
TEAE, treatment-emergent adverse event; PBO, placebo; DPL, dupilumab; PY, patient-years; nP, number of patients with any event; nP/100 PY, number of patients with at least one event per 100 patient-years; PT, preferred term; SAE, serious adverse event.
*For the patients from the phase 2b study, there was a gap (≥ 16 weeks) between the last dose in the phase 2b study and the first dose in TRAVERSE, because the patients needed to complete the 16-week follow-up of phase 2b study to enroll in TRAVERSE; †Blood eosinophils > 3,000 cells/μL.