DUPIXENT is a biologic indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with 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
your moderate-to-severe asthma patients with an eosinophilic phenotype or who are OCS-dependent. These patients may present with any of the following despite current therapy1:
is the only biologic
indicated for this
Patients with coexisting diseases, such
as atopic dermatitis or
chronic rhinosinusitis with nasal polyposis1,2
DUPIXENT has proven efficacy and demonstrated safety in nearly 3000 patients with moderate-to-severe asthma1
Exacerbation reduction1SEE THE DATA
OCS reduction5SEE THE DATA
Rapid and sustained
and quality of life1
At home or in-office
a ~72% of the total FEV1 improvement was seen at Week 2 with DUPIXENT 200 mg + SOC (n=264). Up to 470 mL improvement from baseline in pre-bronchodilator FEV1 at Week 52 with DUPIXENT 200 mg + SOC (n=264) vs 170 mL with placebo + SOC (n=148) (Trial 2, EOS ≥300 cells/µL, secondary endpoint). 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]) (Trial 2, ITT population, primary endpoint). In Trial 2, a significant difference from placebo + SOC was not observed at 12 weeks in change in pre-bronchodilator FEV1 in patients with baseline blood eosinophil levels <150 cells/µL taking DUPIXENT 200 mg + SOC.1
b A patient or caregiver may inject DUPIXENT after training in subcutaneous injection technique.1
The most common adverse reactions (incidence ≥1%) in patients with asthma were injection site reactions,
oropharyngeal pain, and
eosinophilia. In Trials 1 and 2, the proportion of subjects who discontinued treatment due to adverse events was 4% of the placebo + SOC
group, 3% of the DUPIXENT 200 mg Q2W + SOC group, and 6% of the DUPIXENT 300 mg Q2W + SOC group.1
TRIAL 1: 24-WEEK STUDY–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 Q2Wc + SOC (n=150), DUPIXENT 300 mg Q2Wd + SOC (n=157), or placebo + SOC (n=158). Subjects enrolled in Trial 1 were required to have a history of 1 or more asthma exacerbations that required treatment with systemic corticosteroids or emergency department visit or hospitalization for the treatment of asthma in the year prior to trial entry. DUPIXENT was administered as an add-on to background asthma treatment. Primary endpoint: Mean change from baseline to Week 12 in FEV1 in patients with baseline eosinophils ≥300 cells/µL. Other endpoint: Annualized rate of severe exacerbation events during the 24-week treatment period.e Selected baseline demographics: Mean age: 49 years; female: 63%; White: 78%; mean duration of asthma: 22 years; mean exacerbations in previous year: 2.2; high-dose ICS use: 50%; pre-dose 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
TRIAL 2: 52-WEEK STUDY–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 Q2Wc + SOC (n=631) or placebo + SOC (n=317); or DUPIXENT 300 mg Q2Wd + SOC (n=633) or placebo + SOC (n=321). Subjects enrolled in Trial 2 were required to have a history of 1 or more asthma exacerbations that required treatment with systemic corticosteroids or emergency department visit or hospitalization for the treatment of asthma in the year prior to trial entry. DUPIXENT was administered as add-on to background asthma treatment. Subjects with baseline blood eosinophil levels >1500 cells/μL (<1.3%) were excluded. Two primary endpoints: 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 FEV1 in the overall population. Selected secondary endpoint: Mean change from baseline to Week 52 in FEV1 in patients with different baseline levels of eosinophils. Selected baseline demographics: Mean age: 48 years; female: 63%; White: 83%; mean duration of asthma: 21 years; mean exacerbations in previous year: 2.1; high-dose ICS use: 52%; pre-dose 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
TRIAL 3: 24-WEEK STUDY–210 subjects (≥12 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 Q2Wd + SOC + OCS (n=103) or placebo + SOC + OCS (n=107). Subjects with baseline blood eosinophil levels >1500 cells/μL (<1.3%) were excluded. Primary endpoint: Percent reduction from baseline in OCS dose at Week 24, while maintaining asthma control, in the overall population. Other endpoints: Annualized rate of severe exacerbation events during the 24-week treatment period and mean change from baseline to Week 24 in FEV1. Selected baseline demographics: Mean age: 51 years; female: 61%; White: 94%; mean duration of asthma: 20 years; mean exacerbations in previous year: 2.1; high-dose ICS use: 89%; pre-dose 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.1,5
c With 400 mg loading dose.
d With 600 mg loading dose.
e Results were evaluated in the overall population and subgroups based on baseline blood eosinophil count.
fDupilumab is a dual inhibitor of IL-4 and IL-13 signaling. The mechanismof dupilumab action in asthma has not been definitively established.
DUPIXENT is a biologic therapy and has a unique mechanism of action. DUPIXENT is the first and only dual inhibitor of IL-4 and IL-13 signaling, inhibiting two key sources of Type 2 inflammation in asthma. DUPIXENT is not an immunosuppressant or steroid. The mechanism of dupilumab action in asthma has not been established.1SEE HOW DUPIXENT WORKS
DUPIXENT is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. It is the only biologic indicated for an OCS-dependent asthma population. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.1SEE THE EFFICACY AND SAFETY DATA OF DUPIXENT EXPLORE APPROPRIATE PATIENT TYPES
DUPIXENT is typically prescribed by a specialist, such as an allergist or pulmonologist. If you have a patient aged 12 years or older with moderate-to-severe asthma with an eosinophilic phenotype, or with OCS-dependent asthma, who you think might be appropriate for DUPIXENT, consider referring them to an asthma specialist.1
For help finding a specialist in your area, use the Healthgrades® tool below.
Overall, 98% of commercially insured patients nationally are covered for DUPIXENT.7,g Coverage varies by type and plan.
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.
gMMIT Lives as of April 2021.
For patients with a valid prescription for DUPIXENT, support is available through the DUPIXENT MyWay® patient support program. Patients who enroll can receive:
DUPIXENT provides eligible patients with access supportg,h
We are committed to helping ensure patients have access to DUPIXENT and areprovided with assistance in navigating the insurance process
Overall, 98% of commercially insured patients nationally are covered for DUPIXENT.7,g
Coverage varies by type of plan.
gMMIT Lives as of April 2021.
hEligible patients subject to program restrictions.
Partner with an asthma specialist to help your patients. Use the Healthgrades®
tool to easily find nearby specialists.
Sanofi US and Regeneron neither endorse nor recommend any particular physician, and
search results do not include a comprehensive list of doctors in your area.
ED, emergency department; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in one second; ICS, inhaled corticosteroids; ITT, intention-to-treat; LABA, long-acting beta agonist; LSM, least squares mean; Q2W, once every 2 weeks; SOC, standard of care.
Information and Indications
CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum, anaphylaxis and serum sickness or serum sickness-like reactions, were reported in <1% of subjects who received DUPIXENT in clinical trials. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT with conjunctivitis being the most frequently reported eye disorder in these patients. Conjunctivitis also occurred more frequently in chronic rhinosinusitis with nasal polyposis subjects who received DUPIXENT. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.
Eosinophilic Conditions: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA), conditions which are often treated with systemic corticosteroid therapy. These events may be associated with the reduction of oral corticosteroid therapy. Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adult patients who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult patients who participated in the asthma development program as well as in adult patients with co-morbid asthma in the CRSwNP development program. A causal association between DUPIXENT and these conditions has not been established.
Acute Asthma Symptoms or Deteriorating Disease: Do not use DUPIXENT to treat acute asthma symptoms, acute exacerbations, acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of DUPIXENT.
Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Patients with Co-Morbid Asthma: Advise patients with atopic dermatitis or CRSwNP who have co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.
Parasitic (Helminth) Infections: 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.ADVERSE REACTIONS:
DRUG INTERACTIONS: Avoid use of live vaccines in patients treated with DUPIXENT.USE IN SPECIFIC POPULATIONS
Please see accompanying full Prescribing Information.
Atopic Dermatitis: DUPIXENT is indicated for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.
Asthma: DUPIXENT is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with 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.
Chronic rhinosinusitis with nasal polyposis (CRSwNP): DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled CRSwNP.