)
Injection site reactionsb
Injection site reactionsb
DEMONSTRATED SAFETY PROFILE UP TO 52 WEEKS1
Adverse reactions occurring in ≥1% of patients taking DUPIXENT and at a
higher rate than placebo
higher rate than placebo
SINUS-24 and SINUS-52 in adults (24-week safety pool)
DUPIXENT 300 mg
Q2W + INCS n=440 n (%)
Q2W + INCS n=440 n (%)
DUPIXENT 300 mg
Q2W + INCS
n=440
n (%)
Q2W + INCS
n=440
n (%)
Injection site reactionsb
28 (6%)
Conjunctivitisc
7 (2%)
Arthralgia
14 (3%)
Gastritis
7 (2%)
Insomnia
6 (1%)
Eosinophilia
5 (1%)
Toothache
5 (1%)
Placebo + INCS n=282 n (%)
Placebo + INCS
n=282
n (%)
n=282
n (%)
Injection site reactionsb
12 (4%)
Conjunctivitisc
2 (1%)
Arthralgia
5 (2%)
Gastritis
2 (1%)
Insomnia
0 (<1%)
Eosinophilia
1 (<1%)
Toothache
1 (<1%)
bInjection site reactions cluster includes injection site reaction, pain, bruising, and swelling.1
cConjunctivitis 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 was generally consistent with the safety profile observed at Week 24.1
In subjects with CRSwNP, the frequency of conjunctivitis was 2% in the DUPIXENT group compared with 1% in the placebo group in the 24-week safety pool; these subjects recovered. There were no cases of keratitis reported in the CRSwNP development program.1
In SINUS-52 (52 weeks), the frequency of conjunctivitis was 3% in the DUPIXENT group compared with 1% in the placebo group; all of these subjects recovered.1
Rates of discontinuation
due to adverse events
were 2% with
DUPIXENT
and 5% with placebo1
- Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment1
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.
CRSwNP, chronic rhinosinusitis with nasal polyps; INCS, intranasal corticosteroids; Q2W, once every 2 weeks.
ALL PRIMARY AND KEY SECONDARY ENDPOINTS WERE MET WITH STATISTICAL
SIGNIFICANCE1,2
Patients enrolled received background INCS throughout the
duration of both trials1,2
duration of both trials1,2
SINUS-24
(N=276) 24 WEEKS
Randomized
DUPIXENT + INCS
300 mg Q2W for 24 weeks (n=143)
300 mg Q2W for 24 weeks (n=143)
Placebo + INCS for 24 weeks (n=133)
Study
population
Adults (≥18 years) on background INCSf with CRSwNP despite prior sinus surgery or prior treatment with (unless ineligible to receive or intolerant to) SCS in the past 2 years
Patients with chronic rhinosinusitis without nasal polyps were not included in these trials
Rescue with SCS or surgery was allowed at investigators’ discretion
The total population of patients in SINUS-24 and SINUS-52 was unrestricted by minimum baseline blood eosinophil count
Coprimary
endpoints
Change from baseline at Week 24 in:
- NC score averaged over 28 days
- Bilateral endoscopic NPS
Key secondary
endpoints
Change from baseline at Week 24 in:
- Daily LoS score
- LMK-CT score
- SNOT-22 score
- UPSIT score
Prespecified
pooled analysis
Change from baseline at Week 24 in proportion of patients requiring SCS or sinus surgery
SINUS-52
(N=448) 52 WEEKS
Randomized
DUPIXENT +
INCS
300 mg Q2W for 52 weeks (n=150)d
DUPIXENT +
INCS
300 mg Q2W for 24 weeks, followed by Q4We through
Week 52 (n=145)d
Placebo + INCS for 52 weeks (n=153)
Study
population
Adults (≥18 years) on background INCSf with CRSwNP despite prior sinus surgery or prior treatment with (unless ineligible to receive or intolerant to) SCS in the past 2 years
Patients with chronic rhinosinusitis without nasal polyps were not included in these trials
Rescue with SCS or surgery was allowed at investigators’ discretion
The total population of patients in SINUS-24 and SINUS-52 was unrestricted by minimum baseline blood eosinophil count
Coprimary
endpoints
Change from baseline at Week 24 in:
- NC score averaged over 28 days
- Bilateral endoscopic NPS
Key secondary
endpoints
Change from baseline at Week 24 in:
- Daily LoS score
- LMK-CT score
- SNOT-22 score
- UPSIT score
Change from baseline at Week 52 in:
- NC score
- NPS
Other secondary
endpoints
Change from baseline at Week 52 in:
- Daily LoS score
- LMK-CT score
- UPSIT score
- SNOT-22 score
Prespecified
pooled analysis
Change from baseline at Week 52 in proportion of patients requiring SCS or sinus surgery
Patient demographics1
SINUS-24: 24 WEEKS (N=276)—Mean age: 50 years; male: 57%; mean CRSwNP duration: 11 years; patients with ≥1 prior surgery: 72%; patients with SCS use in previous 2 years: 65%; mean bilateral endoscopic NPS,g range 0-8: 5.8; mean NC score,g range 0-3: 2.4; mean LMK sinus CT total score,g range 0-24: 19; mean LoS scoreg (AM), range 0-3: 2.7; mean SNOT-22 total score,g range 0-110: 49.4; mean blood eosinophil count: 440 cells/μL; mean total IgE: 212 IU/mL; atopic medical history, overall: 75%; asthma: 58%; NSAID-ERD: 30%.
SINUS-52: 52 WEEKS (N=448)—Mean age: 52 years; male: 62%; mean CRSwNP duration: 11 years; patients with ≥1 prior surgery: 58%; patients with SCS use in previous 2 years: 80%; mean bilateral endoscopic NPS,g range 0-8: 6.1; mean NC score,g range 0-3: 2.4; mean LMK sinus CT total score,g range 0-24: 18; mean LoS scoreg (AM), range 0-3: 2.8; mean SNOT-22 total score,g range 0-110: 51.9; mean blood eosinophil count: 430 cells/μL; mean total IgE: 240 IU/mL; atopic medical history, overall: 82%; asthma: 60%; NSAID-ERD: 27%.
~79% of patients enrolled in both trials had atopic diseases. In SINUS-24 and SINUS-52, all subjects had evidence of sinus opacification on the LMK sinus CT scan, and 73% to 90% of subjects had opacification of all sinuses. Patients with prior surgery had a mean of 2.0 prior surgeries, and patients with prior SCS use had a mean of 1.6 SCS courses in the previous 2 years.
dIn SINUS-52, data from baseline to Week 24 are pooled from DUPIXENT 300 mg Q2W treatment arms (n=295).2
eThe recommended dose of DUPIXENT for CRSwNP is 300 mg given subcutaneously every other week.1
fAll patients in the placebo and DUPIXENT arms were on a background therapy of INCS, mometasone furoate nasal spray.2
gHigher scores indicate greater disease severity.1
AM, morning; CRSwNP, chronic rhinosinusitis with nasal polyps; INCS, intranasal corticosteroids; LMK-CT, Lund-Mackay computed tomography; LoS, Loss of Smell; NC, nasal congestion/obstruction; NPS, nasal polyp score; NSAID-ERD, nonsteroidal anti‑inflammatory drug–exacerbated respiratory disease; Q2W, once every 2 weeks; Q4W, once every 4 weeks; SCS, systemic corticosteroids; SNOT-22, 22-item Sino-Nasal Outcome Test; UPSIT, University of Pennsylvania Smell Identification Test.
Patient demographics1
SINUS-24: 24 WEEKS (N=276)—Mean age: 50 years; male: 57%; mean CRSwNP duration: 11 years; patients with ≥1 prior surgery: 72%; patients with SCS use in previous 2 years: 65%; mean bilateral endoscopic NPS,g range 0-8: 5.8; mean NC score,g range 0-3: 2.4; mean LMK sinus CT total score,g range 0-24: 19; mean LoS scoreg (AM), range 0-3: 2.7; mean SNOT-22 total score,g range 0-110: 49.4; mean blood eosinophil count: 440 cells/μL; mean total IgE: 212 IU/mL; atopic medical history, overall: 75%; asthma: 58%; NSAID-ERD: 30%.
SINUS-52: 52 WEEKS (N=448)—Mean age: 52 years; male: 62%; mean CRSwNP duration: 11 years; patients with ≥1 prior surgery: 58%; patients with SCS use in previous 2 years: 80%; mean bilateral endoscopic NPS,g range 0-8: 6.1; mean NC score,g range 0-3: 2.4; mean LMK sinus CT total score,g range 0-24: 18; mean LoS scoreg (AM), range 0-3: 2.8; mean SNOT-22 total score,g range 0-110: 51.9; mean blood eosinophil count: 430 cells/μL; mean total IgE: 240 IU/mL; atopic medical history, overall: 82%; asthma: 60%; NSAID-ERD: 27%.
~79% of patients enrolled in both trials had atopic diseases. In SINUS-24 and SINUS-52, all subjects had evidence of sinus opacification on the LMK sinus CT scan, and 73% to 90% of subjects had opacification of all sinuses. Patients with prior surgery had a mean of 2.0 prior surgeries, and patients with prior SCS use had a mean of 1.6 SCS courses in the previous 2 years.
dIn SINUS-52, data from baseline to Week 24 are pooled from DUPIXENT 300 mg Q2W treatment arms (n=295).2
eThe recommended dose of DUPIXENT for CRSwNP is 300 mg given subcutaneously every other week.1
fAll patients in the placebo and DUPIXENT arms were on a background therapy of INCS, mometasone furoate nasal spray.2
gHigher scores indicate greater disease severity.1
AM, morning; CRSwNP, chronic rhinosinusitis with nasal polyps; INCS, intranasal corticosteroids; LMK-CT, Lund-Mackay computed tomography; LoS, Loss of Smell; NC, nasal congestion/obstruction; NPS, nasal polyp score; NSAID-ERD, nonsteroidal anti‑inflammatory drug–exacerbated respiratory disease; Q2W, once every 2 weeks; Q4W, once every 4 weeks; SCS, systemic corticosteroids; SNOT-22, 22-item Sino-Nasal Outcome Test; UPSIT, University of Pennsylvania Smell Identification Test.
CRSwNP, chronic rhinosinusitis with nasal polyps; INCS, intranasal corticosteroids; Q2W, once every 2 weeks. Use of DUPIXENT for the CRSwNP indication in patients aged 12-17 years is supported by evidence from studies of DUPIXENT as add-on maintenance treatment in adults with inadequately controlled CRSwNP.1