Frequently Asked Questions

DUPIXENT is an add-on maintenance treatment for adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). It is the first biologic FDA approved in CRSwNP. DUPIXENT targets two of the sources of inflammation underlying the disease by inhibiting IL-4 and IL-13 signaling and is not an immunosuppressant or steroid.^1,a

FDA, US Food and Drug Administration.

^aThe mechanism of dupilumab action has not been definitively established.¹

DUPIXENT is the first and only dual inhibitor of IL-4 and IL-13 signaling, addressing type 2 inflammation that contributes to CRSwNP.^1-3,a DUPIXENT is not a steroid.¹ DUPIXENT inhibits IL-4 and IL-13 cytokine-induced inflammatory responses and cell signaling.^1-3,a These cytokines contribute to IgE production, mast cell activation, eosinophil activation and trafficking, epithelial barrier dysfunction, and Th2 cell activation.^1-3

^aThe mechanism of dupilumab action has not been definitively established.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).¹

Some examples of CRSwNP patients who may be appropriate for DUPIXENT are¹:

• Patients who are uncontrolled despite use of systemic steroids or previous sinus 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.

DUPIXENT is the first biologic FDA approved in CRSwNP and is not an immunosuppressant.¹

Up to 87% of CRSwNP patients have evidence of type 2 inflammation.⁵

In addition to inadequately controlled CRSwNP, DUPIXENT is also indicated for other disease states.¹

SINUS-24 and SINUS-52

Improvement in sense of smell was investigated in 2 measures: UPSIT score and Daily LoS score.⁴

UPSIT: Week 24 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): 10.52 (95% CI: 8.98, 12.07) (9.71 from a baseline score of 13.53 vs -0.81 from a baseline score of 13.78, respectively).⁴

Rapid improvement in LoS was observed as early as Day 3.^6,a,b (Patient-reported outcome. Results are descriptive. Post hoc analysis. Definitive conclusions cannot be made.)^6,7

^aLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.12, -0.02).^6,8

^bWeek 24 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -0.98 (95% CI: -1.15, -0.81) (-1.21 from a baseline score of 2.77 vs -0.23 from a baseline score of 2.72, respectively) (P<0.0001).⁴

University of Pennsylvania Smell Identification Test (UPSIT) score (range 0-40): higher score indicates improvement.⁴

Loss of Smell (LoS) score (range 0-3): reduced score indicates improvement.¹

INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

SINUS-24 and SINUS-52

In SINUS-52, 51% total improvement in NC score with DUPIXENT 300 mg Q2W + INCS was seen at Week 24 (n=295, pooled DUPIXENT arms) (-1.25 from a baseline score of 2.46) vs 15% 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]) (coprimary endpoint) (P<0.0001).^1,4

Week 24 in SINUS-24 (coprimary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=143) and placebo + INCS (n=133): -0.89 (95% CI: -1.07, -0.71) (-1.34 from a baseline score of 2.26 vs -0.45 from a baseline score of 2.45, respectively) (P<0.0001).^1,4

Rapid relief in nasal congestion was seen as early as Day 2.^6,a (Post hoc analysis. Results are descriptive. Definitive conclusions cannot be made.)⁶

^aLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.13, -0.01).^6,8

Nasal congestion/obstruction (NC) score (range 0-3): reduced score indicates improvement.¹

INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

Up to 87% of patients with CRSwNP have evidence of type 2 inflammation.⁵ DUPIXENT helps address the underlying type 2 inflammation in CRSwNP by targeting two of the key drivers—IL-4 and IL-13 signaling.^1-3,a DUPIXENT is appropriate for surgery-naive or -experienced patients and may provide rapid results at Day 3 for Loss of Smell^b and Day 2 for nasal congestion,^c sustained through Week 52.^1,4,6,d-g

^a The mechanism of dupilumab action has not been definitively established.¹

^b LSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.12, -0.02).^6,8 Post hoc analysis. Results are descriptive. Definitive conclusions cannot be made. Patient-reported outcome.^6,7

^cLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.13, -0.01)^.6,8 Post hoc analysis. Results are descriptive. Definitive conclusions cannot be made.⁶

^d LoS at Week 24 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -0.98 (95% CI: -1.15, -0.81) (P<0.0001).⁴

^e NC at Week 24 in SINUS-52 (coprimary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -0.87 (95% CI: -1.03, -0.71) (P<0.0001).^1,4

^f LoS at Week 52 in SINUS-52 (other secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -1.10 (95% CI: -1.31, -0.89).^1,4 Analysis was not multiplicity controlled. Results are descriptive.⁴

^g NC at Week 52 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -0.98 (95% CI: -1.17, -0.79) (P<0.0001).⁴

Loss of Smell (LoS) score (range 0-3): reduced score indicates improvement.¹

Nasal congestion/obstruction (NC) score (range 0-3): reduced score indicates improvement.¹

INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks

SINUS-52

DUPIXENT 300 mg Q2W + INCS significantly decreased sinus opacification vs placebo + INCS, as measured by LMK-CT at Week 24 (key secondary endpoint), with sustained improvement through Week 52 (other secondary endpoint) in SINUS-52.⁴

Week 24 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -5.13 (95% CI: -5.80, -4.46) (-5.21 from a baseline score of 18.12 vs -0.09 from a baseline score of 17.65, respectively) (P<0.0001).⁴

Week 52 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -6.94 (95% CI: -7.87, -6.01) (-6.83 from a baseline score of 18.42 vs 0.11 from a baseline score of 17.65, respectively).⁴

Analysis of change at Week 52 was not multiplicity controlled; result is descriptive.⁴

Lund-Mackay computed tomography (LMK-CT) score (range 0-24): reduced score indicates improvement.¹

INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

SINUS-24 and SINUS-52

DUPIXENT 300 mg Q2W + INCS reduced polyp burden as early as Week 4, sustained through Week 52 in SINUS-52, compared to placebo + INCS.⁴

There was a reduction in bilateral NPS as follows:

• Week 4 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -1.18 (95% CI: -1.47, -0.90) (-1.13 from a baseline score of 6.07 vs 0.05 from a baseline score of 5.96, respectively)⁴
• Week 24 in SINUS-52 (coprimary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -1.80 (95% CI: -2.10, -1.51) (-1.71 from a baseline score of 6.18 vs 0.10 from a baseline score of 5.96, respectively) (P<0.0001)^1,4
• Week 52 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -2.40 (95% CI: -2.77, -2.02) (-2.24 from a baseline score of 6.07 vs 0.15 from a baseline score of 5.96, respectively) (P<0.0001)⁴
• Week 24 in SINUS-24 (coprimary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=143) and placebo + INCS (n=133): -2.06 (95% CI: -2.43, -1.69) (-1.89 from a baseline score of 5.64 vs 0.17 from a baseline score of 5.86, respectively) (P<0.0001)^1,4

Nasal polyp score (NPS), the sum of right and left nostril scores (range 0-4 for each nostril, range 0-8 in total) as evaluated by nasal endoscopy: reduced score indicates improvement.¹

INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

SINUS-52

Patients experienced improvement in QoL, as measured by SNOT-22, as follows:

• Week 4 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -10.57 (95% CI: -14.47, -6.66) (-18.97 from a baseline score of 50.16 vs -8.40 from a baseline score of 53.48, respectively)⁴
• Week 24 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -16.76 (95% CI: -20.85, -12.67) (-27.08 from a baseline score of 50.16 vs -10.32 from a baseline score of 53.48, respectively)⁴

Analysis was not multiplicity controlled. Results are descriptive. Definitive conclusions cannot be made.⁴

• Week 52 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -20.96 (95% CI: -25.03, -16.89) (-29.84 from a baseline score of 50.16 vs -8.88 from a baseline score of 53.48, respectively)⁴

• Week 24 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -17.36 (95% CI: -20.87, -13.85) (-27.77 from a baseline score of 51.02 vs -10.40 from a baseline score of 53.48, respectively) (P<0.0001)⁴

The SNOT-22 score is calculated from a patient questionnaire in which 22 symptoms are rated from 0 (“no problem”) to 5 (“problem as bad as it can be”) based on the severity and frequency of each particular item.^1,9

22-item Sino-Nasal Outcome Test (SNOT-22) score (range 0-110): reduced score indicates improvement.¹

INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

SINUS-24 and SINUS-52

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

INCS, intranasal corticosteroid; Q2W, once every 2 weeks.

SINUS-24 and SINUS-52

DUPIXENT was studied in the largest CRSwNP biologics trial program to date.^1,4,a There were 724 total participants: 276 in SINUS-24 and 448 in SINUS-52. Adults (≥18 years) on background INCS^b with CRSwNP despite prior sinus surgery or prior treatment with (unless ineligible to receive or intolerant to) SCS in the past 2 years were enrolled in the clinical trials.¹

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 a mean of 1.6 SCS courses in the previous 2 years.¹

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.¹

^aValid as of February 2024.

^bAll patients in the placebo and DUPIXENT arms were on a background therapy of INCS, mometasone furoate nasal spray.⁴

INCS, intranasal corticosteroid; SCS, systemic corticosteroid.

If 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

DUPIXENT should be refrigerated between 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light. If necessary, DUPIXENT may be kept at room temperature up to 77 °F (25 °C) for a maximum of 14 days. Do not store above 77 °F (25 °C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded.¹

Do not expose DUPIXENT to heat or direct sunlight.¹

Do NOT freeze. Do NOT shake.¹

• For the 300 mg/2 mL pre-filled pen or syringe, allow 45 minutes for DUPIXENT to reach room temperature before injecting

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

The 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 for CRSwNP patients.¹

Download the full Instructions for Use

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.

When filling out the DUPIXENT MyWay Enrollment Form, both you and your patient will be required to provide information such as insurance information, patient diagnosis, and prescription information. You can email or print the enrollment forms below.

Overall, ~99% of commercially insured patients nationally are covered for DUPIXENT.^10,a,b 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.

^aFUN Documents, MMIT, and Policy Reporter as of June 2024.

^bCoverage varies by type and plan.

Patients may be eligible for the DUPIXENT MyWay Copay Card if they have commercial health insurance, have a DUPIXENT prescription for an FDA-approved condition, and are a resident of the 50 United States, District of Columbia, Puerto Rico, Guam, or the USVI. 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 $0^a copay per fill of DUPIXENT (maximum of $13,000^b per patient per calendar year).

^aApproval is not guaranteed. Program has an annual maximum of $13,000.^b 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.

^bAnnual maximum subject to change.

FDA, US Food and Drug Administration.