RAPID BREATHING RELIEF
PATIENTS CAN FEEL IN
2 WEEKS AND SUSTAINED
THROUGH 1 YEAR1,2

See how DUPIXENT provided
lung function
improvement
when added to SOC vs placebo
+ SOC as early as Week 2, at
Week 12, and
maintained
through Week 52.1,3,4

TRIAL 2 BASELINE BLOOD EOS ≥300 CELLS/µL

Lung function improvement when added to SOC1
Change in lung function over 1 year (secondary endpoint)


Improvements vs placebo at Week 12 (secondary endpoint) and Week 52 (secondary endpoint) in patients with EOS ≥300 cells/µL

Week 12

470 mL improvement from baseline in pre-bronchodilator FEV1 with DUPIXENT 300 mg + SOC (n=277) vs 220 mL with placebo + SOC (n=142) (LSM difference: 240 mL [95% CI: 160, 320 mL])1


Week 52

480 mL improvement from baseline in pre-bronchodilator FEV1 with DUPIXENT 300 mg + SOC (n=277) vs 230 mL with placebo + SOC (n=142)1

LSM, least squares mean.

Greater improvements vs placebo seen as early as Week 2, at
Week 12, and maintained through Week 52 in patients with no
biomarker requirement
1,3,4,a

Change in lung function over 1 year (secondary endpoint)
TRIAL 2 NO BIOMARKER
REQUIREMENT (ITT
POPULATION)
~70 %
OF THE TOTAL LUNG FUNCTION
IMPROVEMENT AT WEEK 2

with DUPIXENT 200 mg + SOC

360 mL
SUSTAINED IMPROVEMENT
IN LUNG FUNCTION

from baseline in pre-bronchodilator FEV1 at Week 52
with DUPIXENT 200 mg + SOC (n=631) vs 160 mL with
placebo + SOC (n=317) (LSM difference: 200 mL)
(secondary endpoint)


At Week 12 in the ITT population (primary endpoint):

340 mL IMPROVEMENT

from baseline in pre-bronchodilator fev1 with DUPIXENT 300 mg + SOC (n=633) vs 210 mL with
placebo + SOC (n=321) (LSM difference: 130 mL [95% CI: 80, 180 mL])1,3


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 to <300 cells/μL taking DUPIXENT 300 mg + SOC and in patients with baseline blood eosinophil levels
<150 cells/μL taking DUPIXENT 200 mg or 300 mg + SOC.1

aITT population was unrestricted by minimum baseline eosinophils or other Type 2 biomarkers (eg, FeNO or IgE).4

References:

  1. DUPIXENT Prescribing Information.
  2. 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.
  3. Data on file, Sanofi US. QUEST CSR efficacy response data, 2017.
  4. Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018;378(26):2486-2496.

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.