DUPIXENT demonstrated efficacy and safety across 3 clinical trials

See how DUPIXENT reduced severe exacerbations, improved lung function, reduced or eliminated OCS use, and has a demonstrated safety profile.

EXPLORE LONG-TERM EFFICACY AND SAFETY
See The Data
DUP.21.04.0161

Exacerbations

Reduced severe
exacerbations by up to 81%1,a

see results

Lung Function

Rapid and sustained
improvement in lung function
through 52 weeks1,b

see results

OCS Reduction

Reduced or eliminated OCS
use while simultaneously
improving asthma control1,2,c

see results

Quality of Life

Resulted in improved asthma
control and quality of life1,d,e

see results

Safety Data

Demonstrated safety across 3 clinical trials1

see safety data

Study Designs

Studied up to 1 year in nearly
3000 asthma patients1

see study designs

aWith DUPIXENT 300 mg + SOC (n=64) vs placebo + SOC (n=68) in annualized rate of severe exacerbations through Week 24 in patients with baseline blood eosinophils ≥300 cells/μL (Trial 1, secondary endpoint).

b470 mL improvement at Week 52 from baseline in pre-bronchodilator FEV1 with DUPIXENT 200 mg + SOC (n=264) vs 170 mL improvement with placebo + SOC (n=148) (Trial 2, EOS ≥300 cells/µL, secondary endpoint). ~72% of the total FEV1 improvement seen after the first dose at Week 2.

c86% of patients reduced or eliminated their OCS dose at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs 68% with placebo + SOC (n=107) (Trial 3, ITT population).

d75% of patients improved ACQ-5 (asthma control) score with DUPIXENT 200 mg + SOC vs 67% with placebo + SOC (OR: 1.46 [95% CI: 0.90, 2.35]) (Trial 2, secondary endpoint).

e71% of patients improved AQLQ (quality of life) score with DUPIXENT 200 mg + SOC vs 55% with placebo + SOC (OR: 2.02 [95% CI: 1.24, 3.32]) (Trial 2, secondary endpoint).

ACQ-5, Asthma Control Questionnaire, 5-item version; AQLQ, Asthma Quality of Life Questionnaire; OR, odds ratio.

Dosing and Administration
See the dosing and administration options for patients on DUPIXENT.
Explore ADMINISTRATION Options

References:

  1. DUPIXENT Prescribing Information.
  2. 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.

Important Safety
Information and Indication

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.

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 chronic rhinosinusitis with nasal polyposis 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.

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: The most common adverse reactions (incidence ≥1%) in patients with asthma are injection site reactions, oropharyngeal pain, and eosinophilia.

DRUG INTERACTIONS: Avoid use of live vaccines in patients treated with DUPIXENT.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or obtain information about the registry. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
  • Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

Please see accompanying full Prescribing Information.


Indication

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.