TRAVERSE LONG‑TERM DATA
IN PATIENTS 12+ YEARS

DUPIXENT was studied in an OLE to assess
long-term safety and efficacy in asthma

Demonstrated safety data and sustained efficacy across key measures of asthma control up to ~3 years.

DUPIXENT was studied in >2200 asthma patients up to ~3 years1,2,a

The objectives of the TRAVERSE OLE (open-label extension) were as follows:

  • Primary Objective: To assess the long-term safety and tolerability of DUPIXENT
  • Select Secondary Objective: To assess the long-term efficacy of DUPIXENT

Patients who participated in a previous DUPIXENT asthma study were eligible for enrollment in the OLE study

TRAVERSE OLE Study (48 or 96 Weeks)

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.

a Subjects were initially enrolled for a 96-week treatment period; however, an amendment was issued to reduce the treatment period to 48 weeks for all patients who enrolled following the amendment.1

b With 400 mg loading dose.3

c With 600 mg loading dose.3,4

d Eligible patients completed the 16-week posttreatment follow-up period of the parent study before being rolled over into TRAVERSE.1

e Total number of subjects enrolled and exposed to treatment in OLE.2

f Total number of subjects who continued to be exposed to treatment beyond 48 weeks.2

  • Study Population: Pediatric patients (12-17 years) and adults (≥18 years) with moderate-to-severe asthma who completed the treatment period in a previous DUPIXENT asthma clinical study (QUEST, VENTURE, EXPEDITION) or subjects with asthma who completed the treatment and follow-up periods in the previous DUPIXENT asthma study DRI12544
  • Treatment Protocol: DUPIXENT 300 mg was administered subcutaneously every other week (Q2W) for up to 96 weeks, as an add-on to ICS in combination with other controller medications maintained from the parent study, including OCS for patients from the VENTURE studya
    • Patients enrolled from DRI12544 were administered a loading dose of 600 mg dupilumab on Day 1
    • Patients requiring a third controller medication (eg, LABA, LTRA, methylxanthine) were allowed to enroll
  • Primary Endpoint: Proportion of patients experiencing any TEAEs up to Week 96 of the OLE in populations from DRI12544, QUEST, EXPEDITION, and VENTURE
  • Other Endpoints:
    • Number and annualized rate of severe exacerbation events
    • Forced expiratory volume in 1 second (FEV1) (L)
    • In the OCS-dependent population, percent reduction from baseline in OCS dose and proportions of patients achieving ≥50% reduction and completely tapering off OCS
  • Exclusion Criteria: Subjects who developed a new medical condition, suffered a change in status of an established medical condition, developed a laboratory abnormality, or required a new treatment or medication during the screening period that would adversely affect participation in the study or require discontinuation of study medicationg

g Exclusion criteria of parent studies also applied, including pregnant/breast-feeding women, alcohol/drug abuse, clinically significant comorbid/lung disease other than asthma, smoking, and lung disease that would impair lung function tests (eg, COPD).1

View Parent STUDIES’ Baseline Demographics

DUPIXENT demonstrated sustained asthma control up to ~3 years

Consistently reduced asthma exacerbations1,5,h

Exacerbation reduction through weeks 48 to 96

Patients Rolled Into TRAVERSE From QUEST (n=364)

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

89% of patients from QUEST experienced zero exacerbations 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)1

  • 79.5% of patients from DRI12544 (n=396) experienced zero exacerbations during Weeks 48-96.1

74% of patients from DRI12544 and QUEST experienced zero exacerbations over ~3 years of DUPIXENT1

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 period1,i,j

h 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.3

i Analysis includes DRI12544 and QUEST patients enrolled in TRAVERSE.1

j Of 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).1

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.

Results are descriptive.

Sustained breathing relief patients can feel up to ~3 years1,2,6,7

Lung function improvement sustained in patients from QUEST (ITT) enrolled in Traversek,l

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 96m
DUPIXENT 300 mg + SOC (n=447) Placebo + SOC

k 1.78 L was the baseline FEV1 level from QUEST (n=633) compared with a placebo value of 1.75 L (n=321).6

l FEV1 was assessed in the exposed population (observed cases) using descriptive statistics. Week 0 (TRAVERSE) represents the start of the OLE, and Weeks refer to the time in OLE without regard to any time in any parent study.2

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

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 QUEST.1,6



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.


Results are descriptive.

Eliminated or reduced OCS dose for up to ~3 years1

79% of patients from VENTURE eliminated their OCS DOSE

A gradual increase in the number of patients eliminating their OCS dose was observed from 53.3% at Week 0 (n=48) to 59.6% at Week 48 (n=34) to 78.9% at Week 96 (n=15) in the DUPIXENT/DUPIXENT group (secondary endpoint)

  • 88% reduction in OCS dose in the DUPIXENT/DUPIXENT group in patients rolled over from the VENTURE study at Week 96 (n=19)

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.

Results are descriptive.
OCS reduction was at investigators’ discretion.

Demonstrated long-term safety data1-3

DUPIXENT demonstrated up to ~3 years of safety data in >2200 asthma patients

TEAEs occurring in ≥10% in any treatment group during the OLE period

Nasopharyngitis
DUPIXENT/DUPIXENT
(n=421) n (%)
109 (26)
Placebo/DUPIXENT
(n=111) n (%)
27 (24)
Bronchitis
DUPIXENT/DUPIXENT
(n=421) n (%)
80 (19)
Placebo/DUPIXENT
(n=111) n (%)
15 (14)
Upper respiratory
tract infection
DUPIXENT/DUPIXENT
(n=421) n (%)
60 (14)
Placebo/DUPIXENT
(n=111) n (%)
18 (16)
Influenza
DUPIXENT/DUPIXENT
(n=421) n (%)
45 (11)
Placebo/DUPIXENT
(n=111) n (%)
5 (5)
Pharyngitis
DUPIXENT/DUPIXENT
(n=421) n (%)
37 (9)
Placebo/DUPIXENT
(n=111) n (%)
16 (14)
Headache
DUPIXENT/DUPIXENT
(n=421) n (%)
47 (11)
Placebo/DUPIXENT
(n=111) n (%)
13 (12)
Injection site erythema
DUPIXENT/DUPIXENT
(n=421) n (%)
55 (13)
Placebo/DUPIXENT
(n=111) n (%)
26 (23)
Injection site pruritus
DUPIXENT/DUPIXENT
(n=421) n (%)
16 (4)
Placebo/DUPIXENT
(n=111) n (%)
12 (11)
Nasopharyngitis
DUPIXENT/DUPIXENT
(n=1013) n (%)
191 (19)
Placebo/DUPIXENT
(n=517) n (%)
99 (19)
Bronchitis
DUPIXENT/DUPIXENT
(n=1013) n (%)
118 (12)
Placebo/DUPIXENT
(n=517) n (%)
63 (12)
Upper respiratory
tract infection
DUPIXENT/DUPIXENT
(n=1013) n (%)
130 (13)
Placebo/DUPIXENT
(n=517) n (%)
65 (13)
Influenza
DUPIXENT/DUPIXENT
(n=1013) n (%)
69 (7)
Placebo/DUPIXENT
(n=517) n (%)
30 (6)
Pharyngitis
DUPIXENT/DUPIXENT
(n=1013) n (%)
59 (6)
Placebo/DUPIXENT
(n=517) n (%)
26 (5)
Headache
DUPIXENT/DUPIXENT
(n=1013) n (%)
74 (7)
Placebo/DUPIXENT
(n=517) n (%)
47 (9)
Injection-site erythema
DUPIXENT/DUPIXENT
(n=1013) n (%)
50 (5)
Placebo/DUPIXENT
(n=517) n (%)
35 (7)
Injection-site pruritus
DUPIXENT/DUPIXENT
(n=1013) n (%)
7 (1)
Placebo/DUPIXENT
(n=517) n (%)
15 (3)
Nasopharyngitis
DUPIXENT/DUPIXENT
(n=90) n (%)
16 (18)
Placebo/DUPIXENT
(n=97) n (%)
17 (18)
Bronchitis
DUPIXENT/DUPIXENT
(n=90) n (%)
14 (16)
Placebo/DUPIXENT
(n=97) n (%)
9 (9)
Upper respiratory
tract infection
DUPIXENT/DUPIXENT
(n=90) n (%)
6 (7)
Placebo/DUPIXENT
(n=97) n (%)
8 (8)
Influenza
DUPIXENT/DUPIXENT
(n=90) n (%)
7 (8)
Placebo/DUPIXENT
(n=97) n (%)
9 (9)
Pharyngitis
DUPIXENT/DUPIXENT
(n=90) n (%)
4 (4)
Placebo/DUPIXENT
(n=97) n (%)
1 (1)
Headache
DUPIXENT/DUPIXENT
(n=90) n (%)
5 (6)
Placebo/DUPIXENT
(n=97) n (%)
4 (4)
Injection-site erythema
DUPIXENT/DUPIXENT
(n=90) n (%)
2 (2)
Placebo/DUPIXENT
(n=97) n (%)
5 (5)
Injection-site pruritus
DUPIXENT/DUPIXENT
(n=90) n (%)
0
Placebo/DUPIXENT
(n=97) n (%)
2 (2)
  • Other TEAEs occurred in ≥1% in any treatment group in TRAVERSE, including but not limited to oropharyngeal pain and eosinophilia1

Primary endpoint results: 86% of patients enrolled from DRI12544, 79% of patients enrolled from QUEST, and 77% of patients enrolled from VENTURE experienced at least one TEAE up to Week 96 of the OLE period.1

  • In DRI12544 and QUEST, the adverse reactions that occurred at a rate of at least 1% in subjects treated with DUPIXENT and at a higher rate than in their respective comparator groups were injection site reactions, oropharyngeal pain, and eosinophilia (6-month safety pool)3

Long-term safety profile was consistent with that seen in the placebo-controlled parent studies1

BD, bronchodilator; COPD, chronic obstructive pulmonary disease; ED, emergency department; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; ITT, intention-to-treat; LABA, long-acting beta agonist; LSM, least squares mean; LTRA, leukotriene receptor antagonist; OCS, oral corticosteroid; Q4W, once every 4 weeks; SOC, standard of care; TEAE, treatment-emergent adverse event.

References:

  1. Data on file, Sanofi US. LIBERTY ASTHMA TRAVERSE CSR, 2020.
  2. 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.
  3. DUPIXENT Prescribing Information.
  4. Data on file, Sanofi US. EXPEDITION Amended Clinical Trial Protocol 2, 2016.
  5. 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.
  6. Data on file, Sanofi US. QUEST CSR, 2017.
  7. 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.

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.