VOYAGE demonstrated the
safety profile of DUPIXENT
in children
aged 6-11
through Year 11
TEAEs occurring in ≥5% of patients in the DUPIXENT group and greater than placebo1
| TEAEs | DUPIXENT 100 mg/200 mg Q2W + SOC (n=271) n (%) |
PLACEBO + SOC (n=134) n (%) |
|---|---|---|
| Injection site erythema | 35 (13) | 13 (10) |
| Viral upper respiratory tract infection |
33 (12) | 13 (10) |
| Injection site edema | 28 (10) | 7 (5) |
| Injection site nodule | 17 (6) | 3 (2) |
| Eosinophilia | 16 (6) | 1 (1) |
- The safety profile of DUPIXENT through Week 52 was similar to the safety profile from studies in adult and pediatric subjects 12 years of age and older with moderate-to-severe asthma with the addition of helminth infections2
- Helminth infections were reported in 2.2% (6 subjects) in the DUPIXENT group and 0.7% (1 subject) in the placebo group. The majority of cases were enterobiasis, reported in 1.8% (5 subjects) in the DUPIXENT group and none in the placebo group. There was one case of ascariasis in the DUPIXENT group. All helminth infection cases were mild to moderate, and subjects recovered with anti-helminth treatment without DUPIXENT treatment discontinuation2
- The overall treatment discontinuation rate due to adverse events was similar between treatment groups (1.8% in the DUPIXENT group vs 1.5% in the placebo group)1
DUPIXENT long-term safety profile in children aged 6-11 through Year 23
| TEAEs | DUPIXENT/ DUPIXENT (n=240) n (%) |
Placebo/ DUPIXENT (n=125) n (%) |
|---|---|---|
| Nasopharyngitis | 21 (9) | 12 (10) |
| Pharyngitis | 15 (6) | 12 (10) |
| Upper respiratory tract infection | 19 (8) | 5 (4) |
| Influenza | 13 (5) | 7 (6) |
| Eosinophilia | 8 (3) | 7 (6) |
| Rhinitis (allergic) | 7 (3) | 9 (7) |
| Diarrhea | 10 (4) | 7 (6) |
| Injection site reaction | 8 (3) | 9 (7) |
aAdverse events are reported at the preferred-term level of the Medical Dictionary for Regulatory Activities (MedDRA) hierarchy.
Primary endpoint results: 64% (n=365) of patients enrolled from VOYAGE experienced at least 1 TEAE up to Week 52 of the OLE period (DUPIXENT/DUPIXENT: 61% [n=147/240]; placebo/DUPIXENT: 68% [n=85/125]).
- As seen in the parent study, cases of parasitic infections were reported in 6 (2%) of 365 children (2% in the DUPIXENT/DUPIXENT group and 2% in the placebo/DUPIXENT group). None of these cases were considered serious; however, 1 case (ascariasis) led to permanent treatment discontinuation, and 3 were considered by the investigators to be treatment related
- SAEs were reported in 7 total patients in EXCURSION (DUPIXENT/DUPIXENT group: n=6; placebo/DUPIXENT group: n=1)
Long-term safety profile in children aged 6-11 through Year 2 was similar to that observed in the VOYAGE parent study
Q2W, once every 2 weeks; OLE, open-label extension; SAE, serious adverse event; SOC, standard of care; TEAE, treatment-emergent adverse event.