EFFICACY IN PEDIATRIC
PATIENTS (6‑11 YEARS)

Demonstrated efficacy in key areas of asthma control in pediatric patients (6‑11 years)

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.

SIGNIFICANTLY REDUCED EXACERBATIONS THROUGH 1 YEAR

Significant exacerbation reduction in pediatric patients (6‑11 years) with Type 2 inflammatory biomarkers1,a

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)

a Severe 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.2

RAPID AND SUSTAINED BREATHING RELIEF1

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)

bEosinophilic phenotype.

Percent predicted pre-BD FEV1 at Week 12 (key secondary endpoint)

  • 5.21% improvement in percent predicted pre-BD FEV1 vs placebo in pediatric patients (6‑11 years) with EOS ≥150 cells/μL or FeNO ≥20 ppb
    (eosinophilic phenotype) at Week 12 with DUPIXENT 100 mg/200 mg Q2W + SOC vs placebo + SOC1
  • 5.32% improvement in percent predicted pre-BD FEV1 vs placebo in pediatric patients (6‑11 years) with EOS ≥300 cells/μL at Week 12 with DUPIXENT
    100 mg/200 mg Q2W + SOC vs placebo + SOC1

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 pediatric patients (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]) (VOYAGE, other secondary endpoint)1

EOS ≥300 cells/µL

in SCS courses in pediatric patients (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]) (VOYAGE, other secondary endpoint)1

IMPROVED ASTHMA CONTROL AND QUALITY OF LIFE

Significantly improved asthma control at Week 24, as measured by ACQ-7-IA1,c

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)-IA1,d,e

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)

c ACQ-7-IA: Asthma Control Questionnaire, Interviewer Administered version: Pediatric patients (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 0.5.1,3

d PAQLQ(S)-IA: Pediatric Asthma Quality of Life Questionnaire With Standardized Activities-Interviewer Administered: Pediatric patients (≥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.1

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

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

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.