)
DEMONSTRATED SAFETY PROFILE UP TO 52 WEEKS
IN AFRS WITH DUPIXENT1
The safety profile of DUPIXENT in patients with AFRS was similar
to the safety profile of DUPIXENT in patients with CRSwNP1
group in SINUS-24 and SINUS-52 and greater than placebo (24-week safety pool)
| Adverse reaction | DUPIXENT 300 mg Q2W + INCS n=440, n (%) |
Placebo + INCS n=282, n (%) |
|---|---|---|
| Injection site reactionsa | DUPIXENT 300 mg Q2W + INCS n=440, n (%)28 (6%) |
Placebo + INCS n=282, n (%)12 (4%) |
| Conjunctivitisb | DUPIXENT 300 mg Q2W + INCS n=440, n (%)7 (2%) |
Placebo + INCS n=282, n (%)2 (1%) |
| Arthralgia | DUPIXENT 300 mg Q2W + INCS n=440, n (%)14 (3%) |
Placebo + INCS n=282, n (%)5 (2%) |
| Gastritis | DUPIXENT 300 mg Q2W + INCS n=440, n (%)7 (2%) |
Placebo + INCS n=282, n (%)2 (1%) |
| Insomnia | DUPIXENT 300 mg Q2W + INCS n=440, n (%)6 (1%) |
Placebo + INCS n=282, n (%)0 (<1%) |
| Eosinophilia | DUPIXENT 300 mg Q2W + INCS n=440, n (%)5 (1%) |
Placebo + INCS n=282, n (%)1 (<1%) |
| Toothache | DUPIXENT 300 mg Q2W + INCS n=440, n (%)5 (1%) |
Placebo + INCS n=282, n (%)1 (<1%) |
aInjection site reactions cluster includes injection site reaction, pain, bruising, and swelling.1
bConjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.1
The safety profile of DUPIXENT through Week 52 in subjects with CRSwNP was generally consistent with the safety profile observed at Week 24.1
DUPIXENT is indicated as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
DUPIXENT Attributes and Considerations
NOT AN IMMUNOSUPPRESSANT
OR
A STEROID1
NO KNOWN DRUG-TO-DRUG
INTERACTIONS1
- Not metabolized through the liver or excreted
through the kidneys
NO INITIAL LAB TESTING OR ONGOING
LAB MONITORING, according to the
Prescribing Information1
NO BOXED WARNING1
Please see additional Warnings and
Precautions in the Prescribing Information
and Important Safety Information below.
Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.
AFRS, allergic fungal rhinosinusitis; CRSwNP, chronic rhinosinusitis with nasal polyps; INCS, intranasal corticosteroids; Q2W, once every 2 weeks.
DUPIXENT—THE FIRST BIOLOGIC APPROVED IN AFRS BASED
ON A PHASE 3, RANDOMIZED, MULTICENTER, DOUBLE-BLIND,
PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY1,2
and older with AFRS who have a history of sino-nasal surgery was evaluated over the
course of 52 weeks. This trial included a total of 62 subjects1
Primary Endpoint1:
- LMK-CT score at Week 52
Select Secondary Endpoints at
Week 241,2:
- NC score
- NPS
- LMK-CT score
- UPSIT score
Select Secondary Endpoints at
Week 521,2:
- NC score
- NPS
- Total serum IgE
- Proportion receiving systemic steroids or undergoing/
planning to undergo sinus surgery
AFRS, allergic fungal rhinosinusitis; LMK-CT, Lund-Mackay computed tomography; NC, nasal congestion; NPS, nasal polyp score;
Q2W, once every 2 weeks; Q4W, once every 4 weeks; R, randomized; SC, subcutaneously; UPSIT, University of Pennsylvania Smell
Identification Test.
Dosage and Administration
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