Lung Function Improvement in PATIENTS 12+ YEARS

DUPIXENT demonstrated rapid lung
function improvement, sustained
up to ~3 years

Rapid breathing relief patients can feel in 2 weeks and sustained through 1 year1,2

Baseline Blood EOS ≥300 cells/μL - QUEST (Secondary Endpoint)

  • At Week 12 in patients with no biomarker requirement: 320 mL improvement from baseline in pre-bronchodilator FEV1 with
    DUPIXENT 200 mg + SOC (n=631) vs 180 mL with placebo + SOC (n=317) (LSM difference: 140 mL [95% CI: 80, 190 mL]) (QUEST, primary endpoint)1
  • At Week 52 in patients with EOS ≥300 cells/μL: 480 mL improvement from baseline in pre-bronchodilator FEV1 with DUPIXENT
    300 mg + SOC (n=277) vs 230 mL with placebo + SOC (n=142) (QUEST, secondary endpoint)1
  • In QUEST, a significant difference from placebo + SOC was not observed at 12 weeks in change in pre-bronchodilator FEV1 in patients with baseline blood EOS ≥150 to <300 cells/μL taking DUPIXENT 300 mg + SOC and in patients with baseline blood EOS <150 cells/μL taking DUPIXENT 200 mg or
    300 mg + SOC1

Change in lung function over ~3 years6-8,c,d

Patients rolled into TRAVERSE OLE from QUEST (ITT) (secondary endpoint)

Mean

absolute

pre-BD

FEV1 (mL)

  • 2150
  • 2100
  • 2050
  • 2000
  • 1950
  • 1900
  • 1850
  • 1800
  • 1750
  • WEEKS:
  • YEARS:
SWIPE TO SEE SUSTAINED
IMPROVEMENT
  • 0
  • 2
  • 4
  • 6
  • 8
  • 10
  • 12
  • 16
  • 20
  • 24
  • 28
  • 32
  • 36
  • 40
  • 44
  • 48
  • 0
  • 2
  • 4
  • 8
  • 12
  • 24
  • 48
  • 72
  • 84
  • 96
QUEST TRAVERSE
Year 1 Year 2 Year 3
310mL IMPROVEMENT
AT WEEK 96e
DUPIXENT 300 mg + SOC (n=447) Placebo + SOC

310 mL improvement in FEV1 at Week 96 in the DUPIXENT/DUPIXENT group (n=447) from baseline in the parent study of 1.78 L for patients enrolled from QUEST (secondary endpoint)6,7

330 mL improvement in FEV1 at Week 96 in the placebo/DUPIXENT group (n=219) from baseline in the parent study of 1.75 L for patients enrolled from QUEST6,7

There are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attrition of nonresponders.

c1.78 L was the baseline FEV1 level from QUEST (n=633) compared with a placebo value of 1.75 L (n=321).7

dFEV1 was assessed in the exposed population (observed cases) using descriptive statistics. Week 0 (TRAVERSE) represents the start of the OLE, and Weeks refers to the time in OLE without regard to any time in any parent study.8

eImprovement in FEV1 at Week 96 (n=447) in the DUPIXENT/DUPIXENT group from baseline in the parent study of 1.78 L.

Results are descriptive.

BD, bronchodilator; OLE, open-label extension.

VIEW THE FULL LONG-TERM EFFICACY AND SAFETY DATA
QUEST

FeNO ≥25 ppba,b

450 mL IMPROVEMENT IN LUNG FUNCTION AT WEEK 12

from baseline in pre-bronchodilator FEV1 with DUPIXENT 300 mg + SOC (n=295) vs 210 mL with placebo + SOC (n=167) (LSM difference: 240 mL [95% CI: 160, 310 mL])1,3

  • 440 mL improvement in lung function at Week 12 from baseline in pre-bronchodilator FEV1 with DUPIXENT 200 mg + SOC (n=288) vs 210 mL with placebo + SOC (n=157) (LSM difference: 230 mL [95% CI: 150, 310 mL])1,3

a Results are descriptive.

b The clinical interpretation of FeNO in asthma is not established and levels may be influenced by confounding factors.

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. Castro M, Rabe KF, Corren J, et al. Dupilumab improves lung function in patients with uncontrolled, moderate-to-severe asthma. ERJ Open Res. 2020;6(1):00204-2019. doi:10.1183/23120541.00204-2019
  4. Data on file, Sanofi US. QUEST CSR efficacy response data, 2017.
  5. Data on file, Sanofi US. Dupilumab/SAR231893.
  6. Data on file, Sanofi US. QUEST CSR, 2017.
  7. Data on file. Sanofi US. LIBERTY ASTHMA TRAVERSE CSR, 2020.
  8. Wechsler ME, Ford LB, Maspero JF, et al. Dupilumab long-term safety and efficacy in patients with asthma: LIBERTY ASTHMA TRAVERSE. Poster presented at: 30th International Congress of the European Respiratory Society; September 7-9, 2020.

Important Safety
Information and Indications

CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT compared to those who received placebo, with conjunctivitis being the most frequently reported eye disorder. Conjunctivitis also occurred more frequently in chronic rhinosinusitis with nasal polyposis subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

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. Healthcare providers 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 subjects who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult subjects who participated in the asthma development program as well as in adult subjects with co-morbid asthma in the CRSwNP 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 of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Patients with Co-morbid Asthma: Advise patients with atopic dermatitis or CRSwNP who have co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.

Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

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.

Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

ADVERSE REACTIONS:

  • Atopic dermatitis: The most common adverse reactions (incidence ≥1% at Week 16) in adult patients are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile in children and adolescents through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT in adolescents and children observed through Week 52 was consistent with that seen in adults with atopic dermatitis.
  • Asthma: The most common adverse reactions (incidence ≥1%) are injection site reactions, oropharyngeal pain, and eosinophilia.
  • Chronic rhinosinusitis with nasal polyposis: The most common adverse reactions (incidence ≥1%) are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

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.

Indications

Asthma: DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 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.

Chronic rhinosinusitis with nasal polyposis (CRSwNP): DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled CRSwNP.

Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.