Demonstrated safety profile across 52 weeks in adults
Injection site reaction | ||
---|---|---|
DUPIXENTc (n=529) n(%) | 51 (10) | |
PLACEBO (n=517) n(%) | 28 (5) |
Conjunctivitisd | ||
---|---|---|
DUPIXENTc (n=529) n(%) | 51 (10) | |
PLACEBO (n=517) n(%) | 12 (2) |
Blepharitis | ||
---|---|---|
DUPIXENTc (n=529) n(%) | 2 (<1) | |
PLACEBO (n=517) n(%) | 1 (<1) |
Oral herpes | ||
---|---|---|
DUPIXENTc (n=529) n(%) | 20 (4) | |
PLACEBO (n=517) n(%) | 8 (2) |
Keratitise | ||
---|---|---|
DUPIXENTc (n=529) n(%) | 1 (<1) | |
PLACEBO (n=517) n(%) | 0 |
Eye pruritus | ||
---|---|---|
DUPIXENTc (n=529) n(%) | 3 (1) | |
PLACEBO (n=517) n(%) | 1 (<1) |
Oral herpes simplex virus infectionf | ||
---|---|---|
DUPIXENTc (n=529) n(%) | 10 (2) | |
PLACEBO (n=517) n(%) | 6 (1) |
Dry eye | ||
---|---|---|
DUPIXENTc (n=529) n(%) | 1 (<1) | |
PLACEBO (n=517) n(%) | 0 |
Injection site reaction | ||
---|---|---|
DUPIXENTc (n=110) n(%) | 11 (10) | |
PLACEBO (n=315) n(%) | 18 (6) |
Conjunctivitisd | ||
---|---|---|
DUPIXENTc (n=110) n(%) | 10 (9) | |
PLACEBO (n=315) n(%) | 15 (5) |
Blepharitis | ||
---|---|---|
DUPIXENTc (n=110) n(%) | 5 (5) | |
PLACEBO (n=315) n(%) | 2 (1) |
Oral herpes | ||
---|---|---|
DUPIXENTc (n=110) n(%) | 3 (3) | |
PLACEBO (n=315) n(%) | 5 (2) |
Keratitise | ||
---|---|---|
DUPIXENTc (n=110) n(%) | 4 (4) | |
PLACEBO (n=315) n(%) | 0 |
Eye pruritus | ||
---|---|---|
DUPIXENTc (n=110) n(%) | 2 (2) | |
PLACEBO (n=315) n(%) | 2 (1) |
Oral herpes simplex virus infectionf | ||
---|---|---|
DUPIXENTc (n=110) n(%) | 1 (1) | |
PLACEBO (n=315) n(%) | 1 (<1) |
Dry eye | ||
---|---|---|
DUPIXENTc (n=110) n(%) | 2 (2) | |
PLACEBO (n=315) n(%) | 1 (<1) |
aPooled analysis of Trials 1, 2, and 4 (phase 2 dose-ranging study).
bAnalysis of Trial 3 in which subjects were on background TCS therapy.
cDUPIXENT 600 mg at Week 0, followed by 300 mg every 2 weeks.
dConjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.
eKeratitis cluster includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.
fOther herpes simplex virus infection cluster includes herpes simplex, genital herpes, herpes simplex otitis externa, and herpes virus infection, but excludes eczema herpeticum.
- Most patients experiencing conjunctivitis recovered or were recovering during the treatment period1
Select adverse events in the 52-week trial in adults
- The rate of serious adverse events with DUPIXENT + TCS was comparable to placebo + TCS (4% vs 5%, respectively)2
- Keratitis was reported in 4% of the DUPIXENT + TCS group and in 0% of the placebo + TCS group1
- Conjunctivitis was reported in 16% of the DUPIXENT + TCS group and in 9% of the placebo + TCS group1