MAKE DUPIXENT YOUR FIRST-CHOICE BIOLOGIC

FOR ASTHMA IN PATIENTS AGED 6 AND OLDER

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.

Only DUPIXENT Targets Both IL-4 and IL-13 Signaling, Inhibiting Two Key Sources of Type 2 Inflammation1,a

a The mechanism of dupilumab action in asthma has not been definitively established.1

DEMONSTRATED EFFICACY IN KEY AREAS OF ASTHMA CONTROL IN CHILDREN AGED 6-11 YEARS

significantly reduced exacerbations in children with TYPE 2 INFLAMMATORY BIOMARKERS2,b

ANNUALIZED SEVERE EXACERBATION REDUCTION through Week 52 IN EOSINOPHILIC PHENOTYPE (primary endpoint)


Weight-based dosing: DUPIXENT 100 mg Q2W (≤30 kg) or 200 mg Q2W (>30 kg)

b Severe exacerbations were defined as deterioration of asthma requiring the use of SCSs for at least 3 days or hospitalization or emergency department visit due to asthma that required SCSs.1


RAPID AND SUSTAINED BREATHING RELIEF2

Significant improvement in lung function observed at Week 2, maintained at Week 52
MEAN CHANGE FROM BASELINE IN Percent predicted FEV1 through Week 52 (other secondary endpoint)


Weight-based dosing: DUPIXENT 100 mg Q2W (≤30 kg) or 200 mg Q2W (>30 kg)

c Eosinophilic phenotype.


Sustained breathing relief through Week 52, as measured by percent predicted pre-BD FEV1
in children with EOS ≥150 cells/µL or FeNO ≥20 ppb vs placebo and in children with EOS ≥300 cells/µL vs placebo

Percent predicted pre-BD FEV1 at Week 12 (key secondary endpoint)
  • 5.21% improvement in percent predicted pre-BD FEV1 vs placebo in children with EOS ≥150 cells/μL or FeNO ≥20 ppb (eosinophilic phenotype) at Week 12 with DUPIXENT 100 mg/200 mg Q2W + SOC vs placebo + SOC2
  • 5.32% improvement in percent predicted pre-BD FEV1 vs placebo in children with EOS ≥300 cells/μL at Week 12 with DUPIXENT 100 mg/200 mg Q2W + SOC vs placebo + SOC2

DUPIXENT REDUCED SYSTEMIC STEROID USE AND IMPROVED ASTHMA CONTROL

SCS reduction through Week 52 in eosinophilic phenotype

EOS ≥150 cells/μL or FeNO ≥20 ppb

in SCS courses in children aged 6-11 years with DUPIXENT 100 mg/200 mg Q2W + SOC (n=236) vs placebo + SOC (n=114) (adjusted annualized total SCS courses in all patients: 0.35 [95% CI: 0.26, 0.48] vs 0.86 [95% CI: 0.62, 1.20]) (Trial 4, other secondary endpoint)2

EOS ≥300 cells/µL

in SCS courses in children aged 6-11 years with DUPIXENT 100 mg/200 mg Q2W + SOC (n=175) vs placebo + SOC (n=84) (adjusted annualized total SCS courses in all patients: 0.27 [95% CI: 0.19, 0.40] vs 0.81 [95% CI: 0.56, 1.15]) (Trial 4, other secondary endpoint)2


DUPIXENT IMPROVED ASTHMA CONTROL AND QUALITY OF LIFE IN CHILDREN

Significantly improved asthma control at Week 24, as measured by ACQ-7-IA2,d

EOS ≥150 cells/μL or FeNO ≥20 ppb (eosinophilic phenotype)

  • 79% responder rate vs 69% responder rate in the placebo group at Week 24 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=236) vs placebo + SOC (n=114) (odds ratio: 1.82 [95% CI: 1.02, 3.24]) (other secondary endpoint)

EOS ≥300 cells/µL

  • 81% responder rate vs 64% responder rate in the placebo group at Week 24 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=175) vs placebo + SOC (n=84) (odds ratio: 2.79 [95% CI: 1.43, 5.44]) (other secondary endpoint)

A responder was defined as a patient with a reduction of ≥0.5 in ACQ-7-IA score from baseline (minimal clinically important difference for this outcome).

Improved quality of life, as measured by PAQLQ(S)-IA2,e,f

EOS ≥150 cells/μL or FeNO ≥20 ppb (eosinophilic phenotype)

  • 0.34-point LSM difference vs placebo at Week 52 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=211) vs placebo + SOC (n=107) (95% CI: 0.16, 0.52)

EOS ≥300 cells/µL

  • 0.33-point LSM difference vs placebo at Week 52 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=158) vs placebo + SOC (n=81) (95% CI: 0.12, 0.53)

d ACQ-7-IA: Asthma Control Questionnaire, Interviewer Administered version: Children aged 6-16 years respond to 7 questions about symptoms, lung function, and medication use on a 7-point scale (0=no impairment; 6=maximum impairment). Lower scores indicate better asthma control. The minimal clinically important difference is 0.5.2,3

e PAQLQ(S)-IA: Pediatric Asthma Quality of Life Questionnaire With Standardized Activities-Interviewer Administered: Children aged ≥7 to <12 years responded to questions about health-related quality of life on a 7-point scale (7=no impairment; 1=severe impairment) at Weeks 12, 24, 36, and 52. The ability of DUPIXENT to impact health-related quality of life was assessed by evaluating the LSM change in PAQLQ(S)-IA score at randomization.2

f Analysis of change at Week 52 was not multiplicity controlled; result is descriptive.

DEMONSTRATED SAFETY PROFILE IN CHILDREN WITH ASTHMA

DUPIXENT is a fully human monoclonal antibody studied up to 1 year in children aged 6-11 years with uncontrolled asthma2
TEAEs OCCURRING IN ≥5% OF PATIENTS IN THE DUPIXENT GROUP AND GREATER THAN PLACEBO
Adverse Reaction DUPIXENT 100 mg /200 mg
Q2W + SOC
n=271
n (%)
Placebo + SOC

n=134
n (%)
Injection site erythema 35 (13) 13 (10)
Viral upper respiratory
tract infection
33 (12) 13 (10)
Injection site edema 28 (10) 7 (5)
Injection site nodule 17 (6) 3 (2)
Eosinophilia 16 (6) 1 (1)

The safety profile of DUPIXENT through Week 52 was similar to the safety profile from studies in adults and adolescents with moderate-to-severe asthma with the addition of helminth infections1

  • Helminth infections were reported in 2.2% (6 subjects) in the DUPIXENT group and 0.7% (1 subject) in the placebo group. The majority of cases were enterobiasis, reported in 1.8% (5 subjects) in the DUPIXENT group and none in the placebo group. There was one case of ascariasis in the DUPIXENT group. All helminth infection cases were mild to moderate and patients recovered with anti-helminth treatment without DUPIXENT treatment discontinuation1
  • The overall treatment discontinuation rate due to adverse events was similar between treatment groups (1.8% in the DUPIXENT group vs 1.5% in the placebo group)2

Other attributes

DUPIXENT is not an immunosuppressant1

WEIGHT-BASED DOSING, FLEXIBLE ADMINISTRATION AT HOME OR IN OFFICE1

30 kg or moreg

Every 2 Weeks
200 mg
1 pre-filled syringe

15 kg to
<30 kgh

Every 2 Weeks
100 mg
1 pre-filled syringe
OR
Every 4 Weeks
300 mg
1 pre-filled syringe

No loading dose

For children (6-11 years) with asthma and co-morbid moderate-to-severe atopic dermatitis, follow the recommended dosage for atopic dermatitis, which includes an initial loading dose.

g 30 kg is equal to 66 lb.
h 15 kg is equal to 33 lb.

DUPIXENT is intended for use under the guidance of a healthcare provider. A caregiver may inject a child with DUPIXENT after training in subcutaneous injection technique using the pre-filled syringe. Provide proper training to caregivers on the preparation and administration of DUPIXENT prior to use according to the Instructions for Use.

  • DUPIXENT can be administered in the office under the guidance of a healthcare provider if the caregiver is not an appropriate candidate for administration

DUPIXENT WAS STUDIED IN OVER 400 MODERATE-TO-SEVERE ASTHMA PATIENTS (6-11 YEARS) THROUGH 1 YEAR1,2

52-week pediatric trial (n=408)
Randomized

Subjects were randomized to DUPIXENT (n=273) or matching placebo (n=135) Q2W based on body weight
≤30 kg (100 mg Q2W) or >30 kg (200 mg Q2W)

Study population

Children (aged 6-11 years) with moderate-to-severe asthma on a medium-dose ICS with a second controller medication or high-dose ICS with or without a second controller medication


Patients with markers of Type 2 inflammation:

  • Blood EOS ≥300 cells/μL
  • Blood EOS ≥150 cells/μL or FeNO ≥20 ppb
Primary endpoint

Annualized rate of severe exacerbations during the 52-week placebo-controlled treatment period

Key secondary endpoint

Mean change from baseline at Week 12 in percent predicted pre-BD FEV1

Other secondary endpoints
  • Change from baseline in percent predicted pre-BD FEV1 at Weeks 2, 4, 8, 24, 36, and 52 and other time points assessed
  • ACQ-7-IA
  • PAQLQ(S)-IA
  • Use of reliever medication and SCSs
  • Nocturnal awakenings due to asthma symptoms requiring reliever medication
Selected demographics and baseline characteristics1,2
Patients with EOS ≥150 cells/μL or FeNO ≥20 ppb
Patients with EOS ≥300 cells/μL
Mean age
9 years
9 years
Body weight at baseline >30 kg
68%
67.6%
Body weight at baseline ≤30 kg
32%
32.4%
Mean duration of asthma
5.6 years
6 years
Mean number of exacerbations in previous year
2.5
2.6
Percent predicted pre-BD FEV1 at baseline
78%
77%
Mean baseline blood EOS count
570 cells/µL
710 cells/µL
Mean FeNO
31 ppb
34 ppb
Mean total IgE
906 IU/mL
1077 IU/mL

BD, bronchodilator; BL, baseline; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; IA, Interviewer Administered; ICS, inhaled corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks; SCS, systemic corticosteroid; SOC, standard of care; TEAE, treatment-emergent adverse event.

References:

  1. DUPIXENT Prescribing Information.
  2. Data on file, Sanofi US. LIBERTY ASTHMA VOYAGE. CSR, 2020.
  3. Juniper EF, Gruffydd-Jones K, Ward S, Svesson K. Asthma Control Questionnaire in children: validation, measurement properties, interpretation. Eur Respir J. 2010;36(6):1410-1416.

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.