DUPIXENT Basics
DUPIXENT is an add-on maintenance treatment for adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). It is the first biologic FDA approved in CRSwNP. DUPIXENT targets inflammation underlying the disease by inhibiting IL-4 and IL-13 signaling and is not an immunosuppressant or steroid.1
FDA, US Food and Drug Administration.
See how DUPIXENT worksDUPIXENT is the first and only dual inhibitor of IL-4 and IL-13 signaling, addressing type 2 inflammation that contributes to CRSwNP. DUPIXENT is not a steroid. DUPIXENT inhibits IL-4 and IL-13 cytokine-induced inflammatory responses and cell signaling that contribute to IgE production, mast cell activation, eosinophil activation and trafficking, epithelial barrier dysfunction, and Th2 cell activation.1,2
View the unique Mechanism of Action of DUPIXENTDUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
Some examples of CRSwNP patients who may be appropriate for DUPIXENT are:
- Patients who are uncontrolled despite use of systemic corticosteroids or previous sino-nasal surgery
- Patients who are surgery naive
- Patients with a history of asthma
- Patients with comorbid NSAID-ERD
NSAID-ERD, nonsteroidal anti-inflammatory drug–exacerbated respiratory disease.
Explore patient types appropriate for DUPIXENTDUPIXENT is not a steroid. DUPIXENT is a biologic and can help reduce your patients' use of systemic corticosteroids. In SINUS-24 and SINUS-52, 74% fewer patients required SCS use at Week 52 with DUPIXENT 300 mg Q2W + INCS compared to placebo + INCS (HR: 0.26 [95% CI: 0.18, 0.38]). In those same trials, SCS courses were reduced by 75% per year (RR: 0.25 [95% CI: 0.17, 0.37]).1
DUPIXENT provided a 76% reduction in SCS use or CRSwNP surgery at Week 52 with DUPIXENT 300 mg Q2W + INCS vs placebo + INCS (HR: 0.24 [95% CI: 0.17, 0.35]).
Individually, SCS reduction was not a multiplicity-adjusted endpoint.
HR, hazard ratio; INCS, intranasal corticosteroid; Q2W, once every 2 weeks; RR, risk ratio; SCS, systemic corticosteroid.
Learn more about how DUPIXENT can reduce steroid useDUPIXENT is the first biologic FDA approved in CRSwNP and is not an immunosuppressant.
CRSwNP, chronic rhinosinusitis with nasal polyposis; FDA, US Food and Drug Administration.
Explore the Mechanism ofAction
Type 2 inflammation is the underlying cause of CRSwNP in 80% of patients. CRSwNP is predominantly characterized by type 2 inflammation of the nose and paranasal sinuses and is frequently associated with comorbidities of the lower airway. By inhibiting IL-4 and IL-13 signaling, DUPIXENT targets both upper and lower airway inflammation in CRSwNP and asthma.2-5,a
DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.
a In Western countries.
CRSwNP, chronic rhinosinusitis with nasal polyposis.
Explore the upper and lower airwayIn addition to moderate-to-severe CRSwNP, DUPIXENT is also indicated in 3 other disease states.
CRSwNP, chronic rhinosinusitis with nasal polyposis.
learn moreDUPIXENT Clinical Data
In SINUS-52, 67% of total improvement in sense of smell was seen after the first dose of DUPIXENT, as measured at Week 2 (LSM difference vs placebo: 5.36 [95% CI: 3.62, 7.10]). That improvement was sustained through Week 52 in the same study, increasing to 71% with DUPIXENT (baseline score 13.46) vs 6% worsening with placebo (baseline score 13.78) (LSM difference: 10.30 [95% CI: 8.50, 12.10]) (other secondary endpoint).6,a
Smell improvement was observed as early as Day 3.7,b
Improvement in sense of smell was investigated in 2 measures: UPSIT score and daily loss of smell score.
a Analysis of change at Week 52 was not multiplicity controlled; result is descriptive.
b Patient reported loss of smell as compared to placebo throughout the study period (LSM difference vs placebo at Day 3: -0.07 [95% CI: -0.12, -0.02]). (Post hoc analysis result is descriptive)
University of Pennsylvania Smell Identification Test (UPSIT) score (range 0 to 40): higher score indicates improvement.
LSM, least squares mean.
Learn more about how quickly DUPIXENT can improve sense of smell
DUPIXENT improved nasal congestion and obstruction as early as Week 4 as measured by NC score in SINUS-52: -0.52 with DUPIXENT 300 mg Q2W + INCS (n=295, pooled DUPIXENT arms) vs -0.16 with placebo + INCS (n=153) (LSM difference vs placebo: -0.37 [95% CI: -0.46, -0.27]).1,6
At Week 24 in the same study, patients experienced a 51% improvement in their NC score with DUPIXENT 300 mg Q2W + INCS (n=295, pooled DUPIXENT arms) (-1.25 from a baseline score of 2.46) vs 16% improvement with placebo + INCS (n=153) (-0.38 from a baseline score of 2.38) (LSM difference vs placebo: -0.87 [95% CI: -1.03, -0.71]).1
Nasal congestion/obstruction (NC) score (range 0 to 3): reduced score indicates improvement.
INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.
In DUPIXENT’s SINUS-52 trial, 59% of patients had 1 or more surgeries. With DUPIXENT, 83% fewer patients required sino-nasal surgery with DUPIXENT 300 mg Q2W + INCS (HR: 0.17 [95% CI: 0.07, 0.46]).1,a
DUPIXENT provided a 76% reduction in SCS use or CRSwNP surgery at Week 52 with DUPIXENT 300 mg Q2W + INCS vs placebo + INCS (HR: 0.24 [95% CI: 0.17, 0.35]).
a Individually, need for sino-nasal surgery was not a multiplicity-adjusted endpoint.6
CRSwNP, chronic rhinosinusitis with nasal polyposis; HR, hazard ratio; INCS, intranasal corticosteroid; Q2W, once every 2 weeks; SCS, systemic corticosteroid.
Learn more about sino-nasal surgery reductionDUPIXENT significantly decreased LMK-CT score vs placebo at Week 24 (key secondary endpoint) with sustained improvement through Week 52 (other secondary endpoint) in SINUS-52.a
DUPIXENT (300 mg + SOC) demonstrated 29% improvement at Week 24 from a baseline score of 18.12 (LSM difference vs placebo: -5.13 [95% CI: -5.80, -4.46]) and 37% improvement at Week 52 from a baseline score of 18.42 (LSM difference vs placebo: -6.94 [95% CI: -7.87, -6.01]). DUPIXENT demonstrated statistically significant reductions in opacification across all sinuses at Week 24.
a Analysis of change at Week 52 was not multiplicity controlled; result is descriptive.6
LMK-CT, Lund-Mackay computed tomography; LSM, least squares mean; SOC, standard of care.
DUPIXENT reduced polyp burden as early as Week 4 (LSM difference vs placebo: -1.15 [95% CI: -1.40, -0.91]) in SINUS-52.6
In the same study, patients saw a significant reduction in the size of nasal polyps, as measured by NPS:
- -1.71 improvement in NPS at Week 24 with DUPIXENT 300 mg Q2W + INCS (n=295, pooled DUPIXENT arms) (baseline score 6.18) vs 0.10 worsening with placebo + INCS (n=153) (baseline score 5.96) (LSM difference vs placebo: -1.80 [95% CI: -2.10, -1.51]) (coprimary endpoint)1
- -2.24 improvement in NPS at Week 52 with DUPIXENT 300 mg Q2W + INCS (n=150) (baseline score 6.07) vs 0.15 worsening with placebo + INCS (n=153) (baseline score 5.96) (LSM difference vs placebo: -2.40 [95% CI: -2.77, -2.02]) (key secondary endpoint)
Nasal polyp score (NPS) is the sum of right and left nostril scores (range 0 to 8) as evaluated by nasal endoscopy: reduced score indicates improvement.
INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.
Patients experienced rapid and sustained relief of symptoms and improved quality of life, as measured by SNOT-22. Improvement began as early as Week 4 and was maintained through Weeks 24 and 52 with DUPIXENT 300 mg Q2W + INCS (n=295, pooled DUPIXENT arms) (key secondary endpoints).6,a
a 22-item Sino-Nasal Outcome Test (SNOT-22) score (range 0 to
110): reduced score
indicates improvement.1
SNOT-22 includes 22 items assessing symptoms and symptom impact associated with CRSwNP.
SNOT-22 had a 2-week recall period. The meaningful clinically important difference is
8.9.6
Q2W, once every 2 weeks; INCS, intranasal corticosteroid.
See more about how DUPIXENT can improve symptoms & quality of life
The most common adverse reactions reported in SINUS-24 and SINUS-52 were injection site reactions, conjunctivitis, arthralgia, gastritis, insomnia, eosinophilia, and toothache. These adverse reactions occurred in ≥1% of patients on DUPIXENT 300 mg Q2W + INCS and at a higher rate than placebo + INCS in a 24-week safety pool.1
Q2W, once every 2 weeks; INCS, intranasal corticosteroid.
view the safety dataDUPIXENT was studied in the largest clinical trial program to date for CRSwNP: 724 total participants; SINUS-24: 276, Trial 2: 448, Combined: 724. Adults (≥18 years) on background INCSa with CRSwNP were included despite prior sino-nasal surgery or prior treatment with, or who were ineligible to receive or were intolerant to, systemic corticosteroids in the past 2 years were enrolled in the clinical trials.
In both SINUS-24 and SINUS-52, 73% to 90% of subjects had opacification of all sinuses. Prior surgery patients had a mean of 2.0 prior surgeries, and SCS use patients had 1.6 SCS courses in the previous 2 years. ~79% of patients enrolled in both trials had atopic diseases. 60% of patients had history of asthma, and 27% had NSAID-ERD.
Patients with chronic rhinosinusitis without nasal polyposis were not included in these trials. Rescue with systemic corticosteroids 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.1
a All patients in the placebo and DUPIXENT arms were on a background therapy of INCS, mometasone furoate nasal spray.8
CRSwNP, chronic rhinosinusitis with nasal polyposis; INCS, intranasal corticosteroid; SCS, systemic corticosteroid; NSAID-ERD, nonsteroidal anti-inflammatory drug-exacerbated respiratory disease.
view the study designsUsing DUPIXENT
DUPIXENT is an injectable medicine that is administered by subcutaneous injection. You may decide whether patients self-administer DUPIXENT at home, or you administer in office.
DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT after receiving training in subcutaneous injection technique using the 300 mg pre-filled syringe or 300 mg pre-filled pen. No loading dose is required for the pre-filled syringe or pre-filled pen.
Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the Instructions for Use.1
Learn more about dosing for DUPIXENTIf an every-other-week dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume their original schedule. If the missed dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule.1
Learn more about dosing for DUPIXENTDUPIXENT should be refrigerated at 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light. However, before DUPIXENT is injected, it must be removed from the refrigerator and allowed to reach room temperature without removing the needle cap.
- For the 300 mg/2 mL pre-filled pen or syringe, allow 45 minutes for DUPIXENT to reach room temperature
Administer the subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. The upper arm can also be used if a caregiver administers the injection. Rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred.1
See the Instructions for Use for more details Learn more about dosing for DUPIXENTThe pre-filled syringe and pre-filled pen each come with their own set of specific instructions and guidelines for administration. After choosing your preferred method of treatment, you and your patient should go through the Instructions for Use to ensure each step is followed correctly. No loading dose is required.
Download the full Instructions for Use
Pre-filled Pen Instructions for Use – 300 mg Pre-filled Syringe Instructions for Use – 300 mgDUPIXENT Access and Support
DUPIXENT MyWay is a patient support program that can help enable access to DUPIXENT through benefits verification and assistance navigating the insurance process. It also offers financial assistance for eligible patients, one-on-one nursing support, and more. Our team can provide assistance during the insurance approval process. Support begins when your patients enroll in DUPIXENT MyWay.
DUPIXENT® and DUPIXENT MyWay® are registered trademarks of Sanofi Biotechnology. LEARN MORE ABOUT THE SUPPORT OFFERED BY DUPIXENT MyWay
When filling out the DUPIXENT MyWay Enrollment Form, both you and your patient will be required to supply information, such as the patient’s insurance, diagnosis, and prescription. You can email or print the enrollment forms below.
DUPIXENT MyWay
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| FOR ALLERGISTS | |||
| English Enrollment Form | |||
| Spanish Enrollment Form | |||
| FOR ENT SPECIALISTS/ PULMONOLOGISTS |
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| English Enrollment Form | |||
| Spanish Enrollment Form | |||
Overall, 97% of commercial patients nationally are covered for DUPIXENT. By using the DUPIXENT formulary status tool, you can see which insurance plans offer coverage for DUPIXENT in your area. Contact the health plan or DUPIXENT MyWay® to verify coverage for a specific patient. Coverage varies by type and plan9
USE THE DUPIXENT FORMULARY STATUS TOOLPatients may be eligible for the DUPIXENT MyWay® Copay Card if they have commercial insurance, have a DUPIXENT prescription for an FDA-approved condition, and are a resident of the 50 United States, the District of Columbia, or Puerto Rico. The patient or caregiver must be aged 18 years or older to be eligible.
Eligible patients covered by commercial health insurance may pay as little as $0a copay per fill of DUPIXENT (maximum of $13,000 per patient per calendar year).
aApproval is not guaranteed. Program has an annual maximum of $13,000. THIS IS NOT INSURANCE. Not valid for prescriptions paid, in whole or in part, by Medicaid, Medicare, VA, DOD, TRICARE, or other federal or state programs including any state pharmaceutical assistance programs. This program is not valid where prohibited by law, taxed or restricted. DUPIXENT MyWay reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Any savings provided by the program may vary depending on patients' out-of-pocket costs. The program is intended to help patients afford DUPIXENT. Patients may have insurance plans that attempt to dilute the impact of the assistance available under the program. In those situations, the program may change its terms. Additional terms and conditions apply.
FDA, US Food and Drug Administration.
COPAY CARD ONLINE OFFERDUPIXENT MyWay®
and appeal letters.