TRAVERSE demonstrated a long-term safety profile through ~3 years3,4
TEAEs occurring in ≥10% in any treatment group during the OLE period4
| Patients enrolled from DRI12544 |
|
| DUPIXENT/DUPIXENT (n=421) n (%) |
|
| TEAEs | |
| Nasopharyngitis | 109 (26) |
| Bronchitis | 80 (19) |
| Upper respiratory tract infection |
60 (14) |
| Influenza | 45 (11) |
| Pharyngitis | 37 (9) |
| Headache | 47 (11) |
| Injection site erythema |
55 (13) |
| Injection site pruritus |
16 (4) |
| Patients enrolled from DRI12544 |
|
| PLACEBO/DUPIXENT (n=111) n (%) |
|
| TEAEs | |
| Nasopharyngitis | 27 (24) |
| Bronchitis | 15 (14) |
| Upper respiratory tract infection |
18 (16) |
| Influenza | 5 (5) |
| Pharyngitis | 16 (14) |
| Headache | 13 (12) |
| Injection site erythema |
26 (23) |
| Injection site pruritus |
12 (11) |
| Patients enrolled from QUEST |
|
| DUPIXENT/DUPIXENT (n=1013) n (%) |
|
| TEAEs | |
| Nasopharyngitis | 191 (19) |
| Bronchitis | 118 (12) |
| Upper respiratory tract infection |
130 (13) |
| Influenza | 69 (7) |
| Pharyngitis | 59 (6) |
| Headache | 74 (7) |
| Injection site erythema |
50 (5) |
| Injection site pruritus |
7 (1) |
| Patients enrolled from QUEST |
|
| PLACEBO/DUPIXENT (n=517) n (%) |
|
| TEAEs | |
| Nasopharyngitis | 99 (19) |
| Bronchitis | 63 (12) |
| Upper respiratory tract infection |
65 (13) |
| Influenza | 30 (6) |
| Pharyngitis | 26 (5) |
| Headache | 47 (9) |
| Injection site erythema |
35 (7) |
| Injection site pruritus |
15 (3) |
| Patients enrolled from VENTURE |
|
| DUPIXENT/DUPIXENT (n=90) n (%) |
|
| TEAEs | |
| Nasopharyngitis | 16 (18) |
| Bronchitis | 14 (16) |
| Upper respiratory tract infection |
6 (7) |
| Influenza | 7 (8) |
| Pharyngitis | 4 (4) |
| Headache | 5 (6) |
| Injection site erythema |
2 (2) |
| Injection site pruritus |
0 |
| Patients enrolled from VENTURE |
|
| PLACEBO/DUPIXENT (n=97) n (%) |
|
| TEAEs | |
| Nasopharyngitis | 17 (18) |
| Bronchitis | 9 (9) |
| Upper respiratory tract infection |
8 (8) |
| Influenza | 9 (9) |
| Pharyngitis | 1 (1) |
| Headache | 4 (4) |
| Injection site erythema |
5 (5) |
| Injection site pruritus |
2 (2) |
- Other TEAEs occurred in ≥1% in any treatment group in TRAVERSE, including but not limited to oropharyngeal pain and eosinophilia3
Primary endpoint results: 86% of patients enrolled from DRI12544, 79% of patients enrolled from QUEST, and 77% of patients enrolled from VENTURE experienced at least one TEAE up to Week 96 of the OLE period.3
- In DRI12544 and QUEST, the adverse reactions that occurred at a rate of at least 1% in subjects treated with DUPIXENT and at a higher rate than in their respective comparator groups were injection site reactions, oropharyngeal pain, and eosinophilia (6-month safety pool)1
Long-term safety profile was consistent with that seen
in the
placebo-controlled parent studies3,4
OLE, open-label extension; TEAE, treatment-emergent adverse event.