IN ASTHMA
CARE
PARTNER
IN ASTHMA
RELIEF
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
APPROPRIATE ASTHMA PATIENTS GAIN CONTROL
DUPIXENT MAY BE APPROPRIATE FOR
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:
- Exacerbation requiring hospitalization/ED visit in the past year
- 2 courses of oral corticosteroids (OCS) in the past year despite maximum inhaler therapy
- Still uncontrolled on medium- or high-dose inhaled corticosteroids (ICS) + LABA
- Elevated EOS with or without IgE/FeNO
- Impaired lung function and decreased quality of life
DUPIXENT MAY OFFER ASTHMA
SYMPTOM RELIEF TO YOUR
APPROPRIATE
PATIENTS, INCLUDING:
Allergic asthma
patients
with
elevated
eosinophils
OCS-dependent asthma
patients—DUPIXENT
is the
only biologic
indicated for this
patient
population1
Patients with coexisting diseases, such
as atopic dermatitis or
chronic rhinosinusitis with
nasal polyposis1,2
Extensive clinical trial and real-world experience across indications
>10,000 patients studied and >300K patient prescriptions3,4
DUPIXENT has proven efficacy and demonstrated safety in nearly 3000 patients with moderate-to-severe asthma1
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
Most Common
Adverse Reactions
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 Designs and Results
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 mechanism of dupilumab action in asthma has not been definitively established.
Frequently asked questions about DUPIXENT
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.1
SEE HOW DUPIXENT WORKSDUPIXENT 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.1
SEE THE EFFICACY AND SAFETY DATA OF DUPIXENT EXPLORE APPROPRIATE PATIENT TYPESDUPIXENT 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:
- 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 provides eligible patients with access supportg,h
We are committed to helping ensure patients have access to DUPIXENT and are provided 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.
iTHIS IS NOT INSURANCE. Program has an annual maximum of $13,000. 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. Additional terms and conditions apply. Any savings provided by this program may vary depending on patients' out-of-pocket costs. Upon registration, patients will receive all program details.
Refer your appropriate asthma patients to a specialist today
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.
References:
- DUPIXENT Prescribing Information.
- Gandhi NA, Bennett BL, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35-50.
- Data on file, Sanofi Genzyme and Regeneron, US. LH Patient View file dated 2/3/21 (data through December 31, 2020).
- Data on file, Regeneron Pharmaceuticals, Inc.
- Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018;378(26):2475-2485.
- Santanello NC, Zhang J, Seidenberg B, Reiss TF, Barber BL. What are minimal important changes for asthma measures in a clinical trial? Eur Respir J. 1999;14(1):23-27.
- The Dedham Group Quality of Access Tracking Report. April 2021.
