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DUPIXENT has a unique mechanism of action. It is the first and only dual inhibitor of IL-4 and IL-13 signaling, inhibiting two key sources of type 2 inflammation in asthma. IL-4 and IL-13 signaling impact type 2 inflammation both locally and systemically. DUPIXENT is not an immunosuppressant. The mechanism of action of dupilumab has not been definitively established.1-3Watch a video on how DUPIXENT targets IL-4 and IL-13 signaling
DUPIXENT is indicated as an add-on maintenance treatment of patients 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.1See EXAMPLES OF APPROPRIATE PATIENT TYPES FOR DUPIXENT
Type 2 inflammation is present in up to 84% of adult asthma patients and can be both local and systemic. DUPIXENT targets both IL-4 and IL-13 signaling, inhibiting two key sources of type 2 inflammation in asthma. The mechanism of action of dupilumab has not been definitively established.1-5
DUPIXENT is indicated as an add-on maintenance treatment of patients 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.1Learn more about patients who may be affected by Type 2 inflammation
DUPIXENT is the first and only dual inhibitor of IL-4 and IL-13 signaling. It is the only biologic indicated for OCS-dependent asthma patients. The mechanism of action of dupilumab has not been definitively established.1WATCH A VIDEO ON THE UNIQUE MOA OF DUPIXENT
Yes. DUPIXENT treatment decreased FeNO (up to 35% reduction from baseline by Week 2a) and circulating concentrations of eotaxin-3, total IgE (up to 83% reduction from baseline at Week 96b), allergen-specific IgE, TARC, and periostin in asthma subjects relative to placebo. DUPIXENT decreased these markers of type 2 inflammation and sustained the effects throughout treatment. In addition, there was an impact on eosinophil activation and trafficking (up to 35% median percent reduction from baseline at Week 96b). The mechanism of dupilumab action has not been definitively established.1,6-11
bTRAVERSE OLE.Explore the role these biomarkers have in the pathogenesis of asthma
In addition to moderate-to-severe asthma, DUPIXENT is also indicated in 3 other disease states.1LEARN MORE
DUPIXENT Clinical Data
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 compared to baseline FEV1 of 1.78 L) was seen at Week 2 in patients in QUEST with baseline blood EOS ≥300 cells/μL taking DUPIXENT 200 mg + SOC (n=264) (secondary endpoint).1,12
320 mL improvement from baseline in pre-bronchodilator FEV1 at Week 12 with DUPIXENT 200 mg + SOC (n=631) vs 180 mL with placebo + SOC (n=317) (LSM difference: 140 mL [95% CI: 80, 190 mL]) (QUEST, ITT population, primary endpoint).1
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 + SOC and in patients with baseline blood EOS <150 cells/μL taking DUPIXENT 200 mg or 300 mg + SOC.1
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 + SOC (n=264) vs 170 mL with placebo + SOC (n=148) (secondary endpoint).1,12
DUPIXENT reduced severe exacerbations by up to 81% in subjects with EOS ≥300 cells/μL with DUPIXENT 300 mg + SOC (n=64) vs placebo + SOC (n=68) (0.20 vs 1.04; rate ratio: 0.19 [95% CI: 0.07, 0.56]) (secondary endpoint) in DRI12544.
In addition, DUPIXENT demonstrated a 60% reduction in severe exacerbations in subjects with EOS ≥150 cells/µL with DUPIXENT 300 mg + SOC (n=452) vs placebo + SOC (n=237) (rate ratio: 0.40 [95% CI: 0.31, 0.53]) (secondary endpoint) in QUEST.
DUPIXENT also reduced severe exacerbations by 46% in patients with no biomarker requirement (ITT population) with DUPIXENT 300 mg + SOC (n=633) vs placebo + SOC (n=321) (rate ratio: 0.54 [95% CI: 0.43, 0.68]) (primary endpoint) in QUEST.
No statistically significant differences were observed during the 52-week treatment period in patients with baseline blood eosinophils <150 cells/μL taking DUPIXENT 200 mg or 300 mg + SOC and in the ≥150 to <300 cells/μL EOS subgroup treated with DUPIXENT 200 mg + SOC vs matching placebo + SOC in QUEST.1,10View the exacerbation data
In VENTURE in the ITT population, 86% of OCS-dependent asthma patients reduced or eliminated their OCS dose at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs 68% with placebo + SOC (n=107). Overall, more than half of patients receiving DUPIXENT 300 mg + SOC (n=103) in the ITT population in VENTURE completely eliminated OCS use at Week 24 vs 29% with placebo + SOC (n=107) (secondary endpoints).
70% significant reduction in OCS dose (median 100%) from baseline at Week 24 with DUPIXENT 300 mg + SOC (n=103) (95% CI: 60%, 80%) vs 42% (median 50%) with placebo + SOC (n=107) (primary endpoint).1,13
DUPIXENT simultaneously improved asthma control (ie, reducing severe exacerbations, improving lung function) while reducing or eliminating steroid use in the ITT population at Week 24 (VENTURE, no biomarker requirement, secondary endpoints).
- 86% of OCS-dependent asthma patients reduced or eliminated their OCS dose at Week 24 with
DUPIXENT 300 mg + SOC (n=103) vs 68% with placebo + SOC (n=107)
- 70% significant reduction in OCS dose (median 100%) from baseline at Week 24 with DUPIXENT 300 mg + SOC (n=103) (95% CI: 60%, 80%) vs 42% (median 50%) with placebo + SOC (n=107) (primary endpoint)
- 59% reduction in severe exacerbations at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs placebo + SOC (n=107) (0.65 vs 1.60; rate ratio: 0.41 [95% CI: 0.26, 0.63])
- 220 mL improvement in lung function at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs 10 mL with placebo + SOC (n=107) (LSM difference: 220 mL [95% CI: 90, 340 mL])1,13
The most common adverse reactions from the DUPIXENT asthma trials were injection site reactions, oropharyngeal pain, and eosinophilia. 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
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 screening blood eosinophil levels >1500 cells/μL (<1.3%) were excluded.1,13
Subjects enrolled in the 52-week pediatric trial were pediatric patients (6-11 years), with uncontrolled moderate-to-severe asthma on an SOC of medium-dose ICS with a second controller or high-dose ICS with or without a second controller. Patients were evaluated in 2 prespecified populations: blood EOS ≥300 cells/μL and blood EOS ≥150 cells/μL or FeNO ≥20 ppb.14View the full study designs
DUPIXENT is an injectable medicine that is administered by subcutaneous injection. DUPIXENT is intended for use under the guidance of a healthcare provider. However, patients 12 years of age and older may self-inject DUPIXENT after receiving training in subcutaneous injection technique using the pre-filled syringe or pen. In pediatric patients 12 years of age and older, it is recommended that DUPIXENT be administered under the supervision of an adult. The DUPIXENT pre-filled syringe should be given by a caregiver in pediatric patients (6-11 years).1LEARN MORE ABOUT DOSING INSTRUCTIONS, SCHEDULES, AND RECOMMENDATIONS
If your patient is 12+ years and has moderate-to-severe asthma with an eosinophilic phenotype, DUPIXENT is available in 200 mg and 300 mg 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).1
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 300 mg given every 2 weeks.1
If your patient is aged 6-11 years with uncontrolled asthma for which DUPIXENT is indicated, the dosing is weight-based. For pediatric patients 15 kg to less than 30 kg,c the recommended dose is 100 mg given every 2 weeks or 300 mg given every 4 weeks via pre-filled syringe. For pediatric patients 30 kg or more,d the recommended dose is 200 mg given every 2 weeks via pre-filled syringe. For pediatric patients 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
c15 kg is equal to 33lb.
d30 kg is equal to 66 lb.LEARN MORE ABOUT DOSING INSTRUCTIONS, SCHEDULES, AND RECOMMENDATIONS
Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT. You should avoid the use of live vaccines in patients being treated with DUPIXENT. It is unknown if administration of live vaccines during DUPIXENT treatment will impact the efficacy or safety of these vaccines.
Immune responses to non-live vaccines were assessed in a study in which adult subjects with atopic dermatitis were treated once weekly for 16 weeks with 300 mg of dupilumab (twice the recommended dosing frequency). After 12 weeks of DUPIXENT administration, subjects were vaccinated with a Tdap vaccine (Adacel®) and a meningococcal polysaccharide vaccine (Menomune®). Antibody responses to tetanus toxoid and serogroup C meningococcal polysaccharide were assessed 4 weeks later. Antibody responses to both tetanus vaccine and meningococcal polysaccharide vaccine were similar in dupilumab-treated and placebo-treated subjects. Immune responses to the other active components of the Adacel and Menomune vaccines were not assessed.1
If a dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient’s 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.1LEARN MORE ABOUT DOSING INSTRUCTIONS, SCHEDULES, AND RECOMMENDATIONS
DUPIXENT 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 temperature1
- For the 200 mg/1.14 mL pre-filled pen or syringe, allow 30 minutes1
- For the 100mg/0.67 mL pre-filled syringe, allow 30 minutes for DUPIXENT to reach room temperature1
DUPXIENT 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.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.
|English Enrollment Form|
|Spanish Enrollment Form|
|FOR ENT SPECIALISTS/
|English Enrollment Form|
|Spanish Enrollment Form|
Overall, 98% of commercially insured patients nationally are covered for DUPIXENT (MMIT Lives as of November 2021). Coverage varies by type and plan.15
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.USE THE DUPIXENT FORMULARY STATUS TOOL
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, or 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 $0e copay per fill of DUPIXENT (maximum of $13,000 per patient per calendar year).
EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; ITT, intention-to-treat; LSM, least squares mean; OCS, oral corticosteroid; SOC, standard of care; TARC, thymus and activation-regulated chemokine.