Exacerbation Reduction in PATIENTS 12+ YEARS

DUPIXENT demonstrated severe exacerbation reduction
up to ~3 years

Up to 81% reduction in severe exacerbations when added to SOC1,a

Baseline Blood EOS ≥300 cells/μL - DRI12544 (Secondary Endpoint)

  • 71% REDUCTION IN SEVERE EXACERBATIONS THROUGH WEEK 24 in patients with baseline blood eosinophil counts ≥300 cells/µL with DUPIXENT 200 mg + SOC (n=65) vs placebo + SOC (n=68) (0.30 vs 1.04; rate ratio: 0.29 [95% CI: 0.11, 0.76]) (DRI12544, secondary endpoint)1
  • 46% REDUCTION IN SEVERE EXACERBATIONS AT WEEK 52 in patients with no biomarker requirement with DUPIXENT 300 mg + SOC
    (n=633) vs placebo + SOC (n=321) (rate ratio: 0.54 [95% CI: 0.43, 0.68]) (DRI12544, primary endpoint)1

a Severe exacerbations were defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or hospitalization or ED visit
due to asthma that required systemic corticosteroids.1

Up to 90% reduction in severe exacerbations when added to SOC

Patients Rolled Into TRAVERSE OLE From QUEST (n=364)3

The analyses of these data are not multiplicity controlled. Results are descriptive only.


89%

OF PATIENTS FROM QUEST EXPERIENCED ZERO EXACERBATIONSd IN YEAR 3

(Weeks 48-96) when treated with DUPIXENT 200 mg/300 mg Q2W + SOC (n=816) for 52 weeks in QUEST and continued
with DUPIXENT 300 mg Q2W + SOC in the OLE period (other endpoint)4

  • 79.5% of patients from DRI12544 (n=396) experienced zero exacerbations during Weeks 48-96.3
74%

OF PATIENTS FROM DRI12544 AND QUEST EXPERIENCED ZERO EXACERBATIONS OVER ~3 YEARS OF DUPIXENT4

97%

OF PATIENTS FROM DRI12544 AND QUEST DID NOT HAVE AN EXACERBATION REQUIRING HOSPITALIZATION OR ED VISIT

when treated with DUPIXENT 300 mg Q2W + SOC (n=2062) during the second and third years in the OLE period4,e,f

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.

dSevere exacerbations were defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or hospitalization or ED visit due to asthma that required systemic corticosteroids.1

eAnalysis includes DRI12544 and QUEST patients enrolled in TRAVERSE.3

fOf the 542 patients who experienced at least 1 severe asthma exacerbation, 66 (3.2% of the overall study population) had an exacerbation that required hospitalization or ED visit during the TRAVERSE study period (unadjusted annualized event rate of 0.027).3

Results are descriptive.

OLE, open-label extension.

VIEW ADDITIONAL LONG-TERM
EFFICACY AND SAFETY DATA
QUEST

FeNO ≥25 ppbb,c

61% REDUCTION IN SEVERE EXACERBATIONS
AT WEEK 52

with DUPIXENT 300 mg + SOC (n=310) vs placebo + SOC (n=172) (rate ratio: 0.39 [95% CI: 0.28, 0.54]) (prespecified subgroup analysis)1

  • 65% reduction in severe exacerbations at Week 52 with DUPIXENT 200 mg + SOC (n=299) vs placebo + SOC (n=162) (rate ratio: 0.35 [95% CI: 0.25, 0.50]) (prespecified subgroup analysis)1

EOS ≥500 cells/μL

71% REDUCTION IN SEVERE EXACERBATIONS
AT WEEK 52

with DUPIXENT 300 mg + SOC (n=141) vs placebo + SOC (n=74) (rate ratio: 0.29 [95% CI: 0.18, 0.45]) (secondary endpoint)1

  • 74% reduction in severe exacerbations at Week 52 with DUPIXENT 200 mg + SOC (n=145) vs placebo + SOC (n=76) (rate ratio: 0.26 [95% CI: 0.16, 0.40])1

IgE ≥30 IU/mL and
EOS ≥300 cells/μLb

62% REDUCTION IN SEVERE EXACERBATIONS
AT WEEK 52

with DUPIXENT 300 mg + SOC (n=153) vs placebo + SOC (n=80) (0.44 [95% CI: 0.32, 0.60] vs 1.15 [95% CI: 0.84, 1.59]; rate ratio: 0.38) (post hoc analysis)2

  • 57% reduction in severe exacerbations at Week 52 with DUPIXENT 200 mg + SOC (n=148) vs placebo + SOC (n=89) (0.39 [95% CI: 0.28, 0.54] vs 0.90 [95% CI: 0.64, 1.25]; rate ratio: 0.43) (post hoc analysis)2

ED, emergency department.

References:

  1. DUPIXENT Prescribing Information.
  2. Corren J, Castro M, O’Riordan T, et al. Dupilumab efficacy in patients with uncontrolled, moderate-to-severe allergic asthma. J Allergy Clin Immunol Pract. 2020;8(2):516-526.
  3. Wechsler ME, Ford LB, Maspero JF, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022;10(1):11-25.
  4. Data on file, Sanofi US. LIBERTY ASTHMA TRAVERSE CSR, 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.