Improved quality of life and asthma control

In a 52-week trial, DUPIXENT improved asthma control and quality of life in patients with EOS ≥300 cells/µL.1

DUPIXENT improved asthma control (ACQ‑5) and quality of life (AQLQ[S]) in patients with EOS ≥300 cells/µL

Responder rates at Week 52 in Trial 2 (secondary endpoints)1,2,a-d

ACQ-5 (asthma control)
75%
of patients improved

with DUPIXENT 200 mg + SOC
vs 67% with placebo + SOC
(OR: 1.46 [95% CI: 0.90, 2.35])

71%
of patients improved

with DUPIXENT 300 mg + SOC vs 64% with placebo + SOC (OR: 1.39 [95% CI: 0.88, 2.19])

AQLQ(S) (quality of life)
71%
of patients improved

with DUPIXENT 200 mg + SOC
vs 55% with placebo + SOC
(OR: 2.02 [95% CI: 1.24, 3.32])

65%
of patients improved

with DUPIXENT 300 mg + SOC
vs 55% with placebo + SOC
(OR: 1.79 [95% CI: 1.13, 2.85])

aResponder rates were defined as an improvement in score of 0.5 or more (scale ranged from 0 to 6 for ACQ-5 and 1 to 7 for AQLQ[S]).

bACQ-5 and AQLQ(S) were assessed as secondary endpoints, but were ordered after the point at which the hierarchical break occurred. Results are descriptive.

cACQ-5: Asthma Control Questionnaire, 5-item version, a patient-reported measure of asthma control. Higher scores indicate less asthma control; a global score is calculated ranging from 0 to 6. The meaningful clinically important difference is 0.5.

dAQLQ(S): Asthma Quality of Life Questionnaire, Standardized Version, a patient-reported measure of asthma-related quality of life. Higher scores indicate better quality of life; a global score is calculated ranging from 1 to 7. The meaningful clinically important difference is 0.5.

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Dosing and Administration
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References:

  1. DUPIXENT Prescribing Information.
  2. Data on file, Sanofi US. QUEST CSR, 2017.

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, erythema multiforme, 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.

Risk Associated with Abrupt 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. Helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old in the pediatric asthma development program.

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: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1‑877‑311‑8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. 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 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.