DUPIXENT HAS BEEN STUDIED IN PATIENTS ACROSS 6 INDICATIONS DRIVEN IN PART BY TYPE 2 INFLAMMATION1
Extensive clinical trial and real-world experience with >7600 patients studied and >1,000,000 patients on therapy across approved indications worldwide1,2,a,b
Proven efficacy and a demonstrated safety profile in nearly 3000 patients with moderate-to-severe asthma1,c
Most common adverse reactions
The most common adverse reactions (incidence ≥1%) in patients with asthma were injection site reactions, oropharyngeal pain, and eosinophilia.1
TRIAL DESIGNS AND RESULTS
776 adults (≥18 years) with moderate-to-severe asthma on a standard of care of medium- or high-dose ICS and a long-acting beta agonist were randomized to either DUPIXENT 200 mg Q2We + SOC (n=150), DUPIXENT 300 mg Q2Wf + SOC (n=157), or placebo + SOC (n=158). Subjects enrolled in DRI12544 were required to have, within 1 year of trial enrollment, treatment with systemic corticosteroids for worsening asthma at least once, or ED visit or hospitalization for worsening asthma. DUPIXENT was administered as an add-on to background asthma treatment.1
Mean change from baseline to Week 12 in prebronchodilator FEV1 in patients with baseline eosinophils ≥300 cells/µL.1
Annualized rate of severe exacerbation events during the 24-week treatment period.1,g
Mean age: 49 years; female: 63%; White: 78%; mean duration of asthma: 22 years; never smoked: 77%; mean exacerbations in previous year: 2.2; high-dose ICS use: 50%; prebronchodilator FEV1 at baseline: 1.84 L; mean FeNO: 39 ppb; mean total IgE: 435 IU/mL; and mean baseline blood eosinophil count: 350 cells/µL.1
1902 adolescents (12-17 years) and adults (≥18 years) with moderate-to-severe asthma on a standard of care of medium- or high-dose ICS and a minimum of 1 and up to 2 additional controller medications were randomized into 2 groups: DUPIXENT 200 mg Q2We + SOC (n=631) or placebo + SOC (n=317); or DUPIXENT 300 mg Q2Wf + SOC (n=633) or placebo + SOC (n=321). Subjects enrolled in QUEST were required to have, within 1 year of trial enrollment, treatment with systemic corticosteroids for worsening asthma at least once, or ED visit or hospitalization for worsening asthma. DUPIXENT was administered as add-on to background asthma treatment. Subjects with baseline blood eosinophil levels >1500 cells/μL were excluded.1
Annualized rate of severe exacerbation events during the 52-week treatment period in the overall population and mean change from baseline to Week 12 in prebronchodilator FEV1 in the overall population.1
Mean change from baseline to Week 52 in prebronchodilator FEV1 in patients with different baseline levels of eosinophils.1
Mean age: 48 years; female: 63%; White: 83%; mean duration of asthma: 21 years; never smoked: 81%; mean exacerbations in previous year: 2.1; high-dose ICS use: 52%; prebronchodilator FEV1 at baseline: 1.78 L; mean FeNO: 35 ppb; mean total IgE: 432 IU/mL; and mean baseline blood eosinophil count: 360 cells/µL.1
210 subjects (≥15 years) with asthma who required daily OCS in addition to regular use of standard of care of high-dose ICS and a minimum of 1 and up to 2 additional controller medications were randomized to receive either DUPIXENT 300 mg Q2Wf + SOC + OCS (n=103) or placebo + SOC + OCS (n=107). Subjects with baseline blood eosinophil levels >1500 cells/μL were excluded.1,3
Percent reduction from baseline in OCS dose at Week 24, while maintaining asthma control, in the overall population.1
Annualized rate of severe exacerbation events during the 24-week treatment period and mean change from baseline to Week 24 in prebronchodilator FEV1.1,3
Mean age: 51 years; female: 61%; White: 94%; mean duration of asthma: 20 years; never smoked: 81%; mean exacerbations in previous year: 2.1; high-dose ICS use: 89%; prebronchodilator FEV1 at baseline: 1.58 L; mean FeNO: 38 ppb; mean total IgE: 431 IU/mL; and mean baseline blood eosinophil count: 350 cells/μL.1
aAdult and pediatric patients (6+ months of age) with uncontrolled moderate-to-severe atopic dermatitis, adult and pediatric patients (6+ years of age) with moderate-to-severe asthma (eosinophilic/OCS-dependent), adult and pediatric patients (12+ years of age) with CRSwNP, adult and pediatric patients (1+ years of age) weighing at least 15 kg with EoE, adult patients with prurigo nodularis, and adult patients with COPD and an eosinophilic phenotype.1
bThis worldwide number is largely comprised from 10 countries (Canada, China, France, Germany, Italy, Japan, the Netherlands, Spain, the UK, and the US), with the rest of the world comprising ≈10% of this number. This number is comprised of the following US approved indications: AD, asthma, CRSwNP, PN, and EoE. Data through August 2024.
cThe asthma development program for patients aged 12 years and older included 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter trials (DRI12544, QUEST, and VENTURE) of 24 to 52 weeks in treatment duration, which enrolled a total of 2888 subjects.1
dA patient or caregiver may inject DUPIXENT after training in subcutaneous injection technique.1
eWith 400 mg loading dose.1
fWith 600 mg loading dose.1
gResults were evaluated in the overall population and subgroups based on baseline blood eosinophil count.1
DUPIXENT provides eligible patients with access supporth,i
AS LITTLE AS $0i COPAY MAY BE AVAILABLE
Overall, ~99% of commercially insured patients nationally are covered for DUPIXENT4,j
Coverage varies by type and plan.
hEligible patients with commercial health insurance may pay as little as $0 in copay per fill of DUPIXENT® (dupilumab). Terms and conditions apply.
iSubject to the program maximum per patient per calendar year. Approval is not guaranteed. 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.
jThe Dedham Group Quality of Access Tracking Report. March 2024.
Frequently asked questions about DUPIXENT
DUPIXENT has a unique mechanism of action (MOA). 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.1,5,6
WATCH A VIDEO ON HOW DUPIXENT TARGETS IL-4 AND IL-13 SIGNALINGDUPIXENT 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. Limitations of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.1
VIEW THE EFFICACY AND SAFETY DATA EXPLORE APPROPRIATE PATIENT TYPESDUPIXENT is not an immunosuppressant and avoids broad immunosuppression. It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing 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
VIEW THE SAFETYDATA VIEW THE SAFETY DATA FOR CHILDREN (6-11 YEARS)
DUPIXENT is typically prescribed by an asthma specialist, such as an allergist or a pulmonologist. If you have patients 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma who you think might be appropriate for DUPIXENT, consider referring them to an asthma specialist.1,7,8
FOR HELP FINDING A SPECIALIST IN YOUR AREA, USE THE Healthgrades® TOOLOverall, ~99% of commercially insured patients nationally are covered for DUPIXENT.k Coverage varies by type and plan.4
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.
kThe Dedham Group Quality of Access Tracking Report. March 2024.
For patients with a valid prescription for DUPIXENT, support is available through the DUPIXENT MyWay patient support program. Patients who enroll can receive:
- Insightful tips and tools to help them along the way
- Supplemental injection training virtually or over the phone
- Financial assistance for eligible patients
- Assistance with insurance questions
- Assistance locating a specialty pharmacy that can dispense DUPIXENT
DUPIXENT can be administered at home or in the office.1
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 at home after receiving training in subcutaneous injection technique using the pre-filled syringe or pen. It is recommended that pediatric patients 12 to 17 years of age administer DUPIXENT under the supervision of an adult. In pediatric patients 6 to less than 12 years of age, DUPIXENT should be given by a caregiver.1
LEARN MORE ABOUT DOSAGESIf your patient is aged 12+ years and has moderate-to-severe asthma characterized by an eosinophilic phenotype, DUPIXENT is available in 200 mgl and 300 mgm 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 aged 12+ years and has OCS-dependent asthma or comorbid moderate-to-severe atopic dermatitis or is an adult with comorbid chronic rhinosinusitis with nasal polyps, the recommended dosage is an initial loading dose of 600 mg (2 x 300 mg pre-filled pens or syringes) followed by every-2-week dosing with a 300 mg pre-filled pen or syringe.1
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 dosage is 300 mg given every 4 weeks via a pre-filled pen or syringe. For children weighing 30 kgo or more, the recommended dosage 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
l200 mg=1.14 mL solution.1
m300 mg=2 mL solution.1
n15 kg=33 lb.
o30 kg=66 lb.
AD, atopic dermatitis; COPD, chronic obstructive pulmonary disease; CRSwNP, chronic rhinosinusitis with nasal polyps; ED, emergency department; EoE, eosinophilic esophagitis; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; OCS, oral corticosteroid; PN, prurigo nodularis; Q2W, once every 2 weeks; SOC, standard of care.
