See how DUPIXENTsignificantly reduced severe exacerbations when added to SOC.
Significant reductions in severe exacerbations when added to SOC1,a
Severe exacerbations through Week 24 (secondary endpoint)
Significant reductions in severe exacerbations when added to SOC1,2,a
Severe exacerbations through Week 52 (secondary endpoint)
No statistically significant differences were observed during the 52-week treatment period in patients with baseline blood eosinophils <150 cells/μL taking DUPIXENT 200 mg or 300 mg + SOC and in the ≥150 to <300 cells/μL eosinophil subgroup treated with DUPIXENT 200 mg + SOC vs matching placebo + SOC.1
aSevere exacerbations were defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or hospitalization or emergency department visit due to asthma that required systemic corticosteroids.1
bITT population was unrestricted by minimum baseline eosinophils or other Type 2 biomarkers (eg, FeNO or IgE).3
cFor inclusion in the study, all patients were required to have had
≥1 severe asthma exacerbation in the prior year. Placebo-treated patients with greater numbers of prior
exacerbations had greater numbers of exacerbations during the treatment period. A severe asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids for ≥3 days or asthma-related hospitalization or emergency department visit requiring systemic corticosteroids between the first dose and last dose plus 14 days. Subjects with baseline blood eosinophil levels >1500 cells/µL (<1.3%) were excluded.1,4
FeNO, fractional exhaled nitric oxide; ITT, intention-to-treat; SOC, standard of care.
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
Please see accompanying full Prescribing Information.
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.