DUPIXENT has a unique mechanism of action. It is the only dual inhibitor of IL-4 and IL-13 signaling, two of the key sources of local and systemic type 2 inflammation in asthma. GINA guidelines define type 2 inflammation as an immune response identified in part by 1 or more biomarkers. The mechanism of dupilumab action has not been definitively established.^1-6

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.¹

Up to 84% of adult asthma patients present with type 2 inflammation, which can be both local and systemic. DUPIXENT targets both IL-4 and IL-13 signaling, two of the key sources of type 2 inflammation in asthma. The mechanism of dupilumab action has not been definitively established.^1-5,7,8

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.¹

DUPIXENT is the only dual inhibitor of IL-4 and IL-13 signaling. It is the only FDA-approved biologic indicated for OCS-dependent asthma patients. The mechanism of dupilumab action has not been definitively established.¹

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.

DUPIXENT is a GINA-recognized treatment option for children with asthma aged 6-11 years and has a demonstrated safety profile.^1,6,9

DUPIXENT is not an immunosuppressant and avoids broad immunosuppression. It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with preexisting helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves. DUPIXENT is a human monoclonal antibody that inhibits the signaling of IL-4 and IL-13, two of the key cytokines that contribute to type 2 inflammation in asthma. The mechanism of dupilumab action has not been definitively established.¹

In the DUPIXENT pivotal clinical trials, the most common adverse reactions (incidence ≥1%) in patients with asthma were injection site reactions, oropharyngeal pain, and eosinophilia. The safety profile of DUPIXENT in children 6-11 years of age with moderate-to-severe asthma through Week 52 was similar to the safety profile from studies in adult and pediatric subjects 12 years of age and older with moderate-to-severe asthma with the addition of helminth infections. Helminth infections were reported in 2.2% (6 subjects) in the DUPIXENT group and 0.7% (1 subject) in the placebo group. The majority of cases were enterobiasis, reported in 1.8% (5 subjects) in the DUPIXENT group and none in the placebo group. There was 1 case of ascariasis in the DUPIXENT group. All helminth infection cases were mild to moderate, and subjects recovered with anti-helminth treatment without DUPIXENT treatment discontinuation.¹

In addition to moderate-to-severe eosinophilic or OCS-dependent asthma, DUPIXENT is indicated in other disease states.¹

QUEST (12+ years)

DUPIXENT offers rapid breathing relief patients can feel as early as Week 2. Approximately 72% of the total FEV₁ improvement (470 mL improvement at Week 52 from baseline FEV₁ of 1.78 L) was seen at Week 2 in patients taking DUPIXENT 200 mg Q2W + SOC (n=264) (baseline blood EOS ≥300 cells/μL, QUEST, secondary endpoint).^1,10,11

A 320 mL improvement from baseline in pre-bronchodilator FEV₁ was seen at Week 12 with DUPIXENT 200 mg Q2W + SOC (n=631) vs 180 mL with placebo + SOC (n=317) (LSM difference: 140 mL [95% CI: 80, 190 mL]) (ITT population, QUEST, primary endpoint).^1,9

In QUEST, a significant difference from placebo + SOC was not observed at 12 weeks in change in pre-bronchodilator FEV₁ in patients with baseline blood EOS ≥150 to <300 cells/μL taking DUPIXENT 300 mg Q2W + SOC and in patients with baseline blood EOS <150 cells/μL taking DUPIXENT 200 mg Q2W or 300 mg Q2W + SOC.¹

QUEST (12+ years), TRAVERSE OLE (12+ years)

DUPIXENT offered up to ~3 years of breathing relief: 310 mL improvement in FEV₁ at Week 96 in the DUPIXENT/DUPIXENT group (n=447) from 1.78 L at baseline in the parent study for patients enrolled from QUEST (overall exposed population, TRAVERSE OLE study, secondary endpoint).^9,a,b

Results are descriptive. Definitive conclusions cannot be made.

Data were not multiplicity controlled and there are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attrition of non‑responders.

Patients with baseline blood EOS ≥300 cells/μL in QUEST experienced sustained breathing relief at Week 52: a 470 mL improvement from baseline in pre-bronchodilator FEV₁ with DUPIXENT 200 mg Q2W + SOC (n=264) vs 170 mL with placebo + SOC (n=148) (secondary endpoint).^1,11

At Week 12 in patients with no biomarker requirement: 320 mL improvement from baseline in pre-bronchodilator FEV₁ with DUPIXENT 200 mg Q2W + SOC (n=631) vs 180 mL with placebo + SOC (n=317) (LSM difference: 140 mL [95% CI: 80, 190 mL]) (ITT population, QUEST, primary endpoint)^1,9

DRI12544 (18+ years), QUEST (12+ years)

Up to 81% reduction in severe exacerbations^c was observed through Week 24 with DUPIXENT 300 mg Q2W + SOC (n=64) vs placebo + SOC (n=68) (0.20 vs 1.04; rate ratio: 0.19 [95% CI: 0.07, 0.56]) (baseline blood EOS ≥300 cells/μL, DRI12544, secondary endpoint).¹

A 48% reduction in severe exacerbations was seen at Week 52 in patients with no biomarker requirement with DUPIXENT 200 mg Q2W + SOC (n=631) vs placebo + SOC (n=317) (rate ratio: 0.52 [95% CI: 0.41, 0.66]) (ITT population, QUEST, primary endpoint).¹

A 46% reduction in severe exacerbations was observed at Week 52 in patients with no biomarker requirement with DUPIXENT 300 mg Q2W + SOC (n=633) vs placebo + SOC (n=321) (rate ratio: 0.54 [95% CI: 0.43, 0.68]) (ITT population, QUEST, primary endpoint).¹

No statistically significant differences were observed during the 52-week treatment period in patients with baseline blood EOS <150 cells/μL taking DUPIXENT 200 mg Q2W or 300 mg Q2W + SOC and in the ≥150 to <300 cells/μL eosinophil subgroup treated with DUPIXENT 200 mg Q2W + SOC vs matching placebo + SOC.^1,9

^cSevere exacerbations were defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or hospitalization or ED visit due to asthma that required systemic corticosteroids.¹

VENTURE (12+ years), TRAVERSE OLE (12+ years)

86% of patients reduced or eliminated their OCS dose at Week 24 with DUPIXENT 300 mg Q2W + SOC (n=103) vs 68% with placebo + SOC (n=107) (No biomarker requirement, ITT population, VENTURE).¹³

A 70% significant reduction in OCS dose (median 100%) from baseline was observed at Week 24 with DUPIXENT 300 mg Q2W + SOC (n=103) (95% CI: 60%, 80%) vs 42% (median 50%) with placebo + SOC (n=107) (primary endpoint).¹

89% reduction in OCS dose at Week 96

From PSBL for patients who received DUPIXENT 300 mg Q2W + SOC in the parent study and continued on DUPIXENT during the open-label extension study (n=19)^14,d

By Week 96 in TRAVERSE OLE, a 79% reduction in exacerbations and a 250 mL improvement in lung function from PSBL were observed.^9,14,e

In addition, 79% of patients from VENTURE eliminated their OCS dose at Week 96 in TRAVERSE OLE (secondary endpoint).^9,14

• A gradual increase in the number of patients eliminating their OCS dose was observed from 53.3% at Week 0 (n=48) to 59.6% at Week 48 (n=34) to 78.9% at Week 96 (n=15) in the DUPIXENT/DUPIXENT group^f

TRAVERSE OLE results are descriptive. Definitive conclusions cannot be made.

Data were not multiplicity controlled, and there are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attritions of nonresponders.

DUPIXENT has efficacy and safety results in children aged 6-11 with moderate-to-severe asthma through Year 2 (EXCURSION OLE).¹⁵

Long-term lung function results¹⁵

~2X improvement was seen with DUPIXENT at Week 12 in percent predicted pre-bronchodilator FEV1 vs placebo (key secondary endpoint)

• 5.21% improvement in percent predicted pre-bronchodilator FEV₁ in children aged 6-11 with EOS ≥150 cells/μL or FeNO ≥20 ppb at Week 12 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=229) vs placebo + SOC (n=110)
• 5.32% improvement in percent predicted pre-bronchodilator FEV_₁ in children aged 6-11 with EOS ≥300 cells/μL at Week 12 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=168) vs placebo + SOC (n=80)^1,15

Long-term lung function results were observed in children who continued with DUPIXENT from the parent study (VOYAGE) through Week 52 in EXCURSION OLE (n=209).

• By Week 52 in EXCURSION OLE, percent predicted pre-bronchodilator FEV₁ improvement results from baseline were 12.6% in the DUPIXENT/DUPIXENT group (n=209) and 9.4% in the placebo/DUPIXENT group (n=106) (secondary endpoint)
• By Week 52 in EXCURSION OLE, 78% of children in the DUPIXENT/DUPIXENT group (n=184) had percent predicted pre-bronchodilator FEV₁ ≥80%

Exacerbation reduction results¹⁵

DUPIXENT significantly reduced exacerbations in children aged 6-11 through year 1^1,15

• 59% reduction in annualized severe exacerbations in children aged 6-11 with EOS >/= 150 cells/uL or FeNO >/= 20 ppb at Week 52 with DUPIXENT 100 mg/200 mg Q2W + SOC (0.31) vs placebo + SOC (0.75), Rate Ratio: 0.41 (95% CI: 0.27, 0.61) P<0.001
• 65% reduction in annualized severe exacerbations in children aged 6-11 with EOS >/= 300 cells/uL at Week 52 with DUPIXENT 100 mg/200 mg Q2W + SOC (0.24) vs placebo + SOC (0.67), Rate Ratio: 0.35 (95% CI: 0.21, 0.56) P<0.001

Reductions in exacerbations were observed from the parent study (VOYAGE) in children who continued with DUPIXENT treatment through Week 52 in EXCURSION OLE (n=209) and in children on placebo in VOYAGE who switched to DUPIXENT in EXCURSION OLE (n=106).

• A 95% reduction was observed in the unadjusted annualized severe exacerbation rate in patients who enrolled in EXCURSION OLE (DUPIXENT/DUPIXENT group [rate: 0.118; n=209]) from PSBL through Year 2 in patients with moderate-to-severe asthma (EOS count ≥150 cells/μL or FeNO ≥20 ppb) (PSBL rate: 2.56) (secondary endpoint)
• A 94% reduction was observed in unadjusted annualized severe exacerbation rate in patients who enrolled in EXCURSION OLE (placebo/DUPIXENT group [rate: 0.124; n=106]) from PSBL through Year 2 in patients with moderate-to-severe asthma (EOS count ≥150 cells/μL or FeNO ≥20 ppb) (PSBL rate: 2.16)
• Zero exacerbations were observed in 91% of children aged 6-11 through Year 2 in EXCURSION OLE

Long-term safety¹⁵

The long-term safety profile in EXCURSION OLE was similar to that observed in the VOYAGE parent study.

EXCURSION OLE results are descriptive. Definitive conclusions cannot be made.

Data were not multiplicity controlled, and there are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attrition of nonresponders.

VENTURE (12+ years)

DUPIXENT reduced or eliminated steroids while simultaneously improving more than one measure of asthma control (ie, reduced severe exacerbation rates and improved lung function) at Week 24 in the ITT population (no biomarker requirement, VENTURE, secondary endpoints).^1,13

• 86% of patients reduced or eliminated their OCS dose at Week 24 with DUPIXENT 300 mg Q2W + SOC (n=103) vs 68% with placebo + SOC (n=107)¹³
  • A 70% significant reduction in OCS dose (median 100%) from baseline was observed at Week 24 with DUPIXENT 300 mg Q2W + SOC (n=103) (95% CI: 60%, 80%) vs 42% (median 50%) with placebo + SOC (n=107) (primary endpoint)¹
• A 59% reduction in severe exacerbations was seen at Week 24 with DUPIXENT 300 mg Q2W + SOC (n=103) vs placebo + SOC (n=107) (0.65 vs 1.60; rate ratio: 0.41 [95% CI: 0.26, 0.63])¹
• A 220 mL improvement in lung function was achieved at Week 24 with DUPIXENT 300 mg Q2W + SOC (n=103) vs 10 mL with placebo + SOC (n=107) (LSM difference: 220 mL [95% CI: 90, 340 mL])¹³

QUEST (12+ years), VOYAGE (6-11 years)

DUPIXENT improved quality of life in asthma patients.^1,9

Up to 71% of asthma patients aged 12+ years experienced an improved quality of life, as measured by AQLQ(S),^g-i with DUPIXENT 200 mg Q2W + SOC vs 55% with placebo + SOC (OR: 2.02 [95% CI: 1.24, 3.32]) (baseline blood EOS ≥300 cells/µL, QUEST).¹

65% of patients experienced an improved quality of life with DUPIXENT 300 mg Q2W + SOC vs 55% with placebo + SOC (OR: 1.79 [95% CI: 1.13, 2.85]) (baseline blood EOS ≥300 cells/μL, QUEST).¹

Up to 73% of children with asthma experienced an improved quality of life, as measured by PAQLQ(S)-IA.^9,j,k

PAQLQ(S)-IA was studied in children aged ≥7 to <12 years. Results are descriptive.

• 73% of children with EOS ≥300 cells/μL improved their quality of life at Week 24 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=158) vs 63% with placebo + SOC (n=81)
• 73% of children with EOS ≥150 cells/μL or FeNO ≥20 ppb (eosinophilic phenotype) improved their quality of life at Week 24 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=211) vs 65% with placebo + SOC (n=107)

DRI12544 (18+ years), QUEST (12+ years), VOYAGE (6-11 years)

The most common adverse reactions from the DUPIXENT asthma trials were injection site reactions,^l oropharyngeal pain, and eosinophilia.^m These adverse reactions occurred in ≥1% of patients receiving DUPIXENT + SOC and at a higher rate than in patients receiving placebo + SOC in DRI12544 and QUEST (6-month safety pool).¹

The safety profile of DUPIXENT through Week 52 was similar to the safety profile from studies in adult and pediatric subjects 12 years of age and older with moderate-to-severe asthma with the addition of helminth infections.¹

DRI12544 (18+ years), QUEST (12+ years), VENTURE (12+ years), VOYAGE (6-11 years)

Subjects enrolled in DRI12544 and QUEST were required to have a history of at least 1 severe asthma exacerbation in the year prior to trial entry. A severe asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or asthma-related hospitalization or emergency department visit requiring systemic corticosteroids.¹

Subjects enrolled in DRI12544 and QUEST were receiving the SOC for their moderate-to-severe asthma. Those enrolled in VENTURE required dependence on daily OCS in addition to regular use of high-dose ICS plus a minimum of 1 and up to 2 additional controller medications as SOC for their asthma. In all 3 trials, enrollment was unrestricted by minimum baseline blood eosinophil count. In QUEST and VENTURE, subjects with baseline blood eosinophil levels >1500 cells/μL (<1.3%) were excluded.^1,13

Subjects enrolled in VOYAGE were children (6-11 years) with uncontrolled moderate-to-severe asthma on an SOC of medium-dose ICS with a second controller medication or high-dose ICS with or without a second controller medication. Subjects were evaluated in 2 prespecified populations: blood EOS ≥300 cells/μL and blood EOS ≥150 cells/μL or FeNO ≥20 ppb (eosinophilic phenotype).⁹

DUPIXENT is an injectable medicine that is administered by subcutaneous injection. A patient may self-inject DUPIXENT—or a caregiver may administer DUPIXENT—after training has been provided by a healthcare provider on proper subcutaneous injection technique using the pre-filled syringe or pen. In children 12 years of age and older, it is recommended that DUPIXENT be administered under the supervision of an adult. In children 6 to less than 12 years of age, DUPIXENT should be given by a caregiver.¹

If your patient is 12+ years and has moderate-to-severe asthma characterized by an eosinophilic phenotype, DUPIXENT is available in 200 mgⁿ and 300 mg^o doses. The 200 mg treatment, given every 2 weeks, has an initial loading dose of 400 mg (2 x 200 mg pre-filled pens or syringes), and the 300 mg treatment, given every 2 weeks, has an initial loading dose of 600 mg (2 x 300 mg pre-filled pens or syringes).^o

If your patient is 12+ years and has OCS-dependent asthma or comorbid moderate-to-severe atopic dermatitis or is an adult with comorbid chronic rhinosinusitis with nasal polyposis, the recommended dose is an initial loading dose of 600 mg (2 x 300 mg pre-filled pens or syringes) followed by every-2-week dosing of a 300 mg pre-filled pen or syringe.^p

If your patient is aged 6-11 years with uncontrolled moderate-to-severe asthma for which DUPIXENT is indicated, the dosing is weight-based. For children weighing 15 kgⁿ to less than 30 kg, the recommended dose is 300 mg given every 4 weeks via a pre-filled pen or syringe. For children weighing 30 kg^p or more, the recommended dose is 200 mg given every 2 weeks via a pre-filled pen or syringe. For children aged 6-11 years with asthma and comorbid moderate-to-severe atopic dermatitis, follow the recommended dosage for atopic dermatitis, which includes an initial loading dose.¹

The pre-filled syringe and pre-filled pen come with their own set of specific instructions and guidelines for administration. After choosing your preferred method of treatment, it is important to provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use to ensure each step is followed correctly.

It is recommended that children 12 years of age and older administer DUPIXENT under the supervision of an adult. In children 6 to less than 12 years of age, DUPIXENT should be given by a caregiver.¹

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

Advise patients to follow sharps disposal recommendations after administration of DUPIXENT. Patients and/or caregivers should read the appropriate Instructions for Use prior to injecting.¹

Download the full Instructions for Use below.

If a dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the 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 (for an every-other-week dose) or administer the dose, starting a new schedule based on this date (for an every-4-week dose).¹

DUPIXENT should be refrigerated at 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. Do NOT freeze. Do NOT shake.¹

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.

Overall, ~99% of commercially insured patients nationally are covered for DUPIXENT (FUN Documents, MMIT, and Policy Reporter as of December 8, 2023). Coverage varies by type and plan.¹⁶

With 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.

Patients may be eligible for the DUPIXENT MyWay Copay Card if:

• They have commercial insurance
• They have a DUPIXENT prescription for an FDA-approved condition
• They are a resident of the 50 United States, the District of Columbia, Puerto Rico, Guam, or the USVI
• The patient or caregiver is aged 18 years or older

Eligible patients covered by commercial health insurance may pay as little as a $0^r copay per fill of DUPIXENT (maximum of $13,000 per patient per calendar year).

^rApproval 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.

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