DUPIXENT is indicated for the treatment of 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.
SWIPE TO EXPLORE
DUPIXENT was evaluated in
patients
with severe disease aged 6 to 11
years and with
moderate-to-severe
disease aged 12 years and older
whose disease was inadequately
controlled on topical Rx
therapies3,4,a,b
NUMBER
OF PATIENTS
PIVOTAL
TRIALSd
DOSAGE
BASELINE
DISEASE SEVERITY
ADULTS

18+ years of age
DUPIXENT monotherapy
and + TCS

NUMBER OF PATIENTS
>2100
PIVOTAL TRIALSc
2 Monotherapy
(Trials 1 and 2; 16 weeks)
1 Concomitant TCS
(Trial 3; 52 weeks)
DOSAGE
A loading dose of 600 mg
(2 x 300 mg SC injections) followed
by 300 mg (1 SC injection) Q2W
BASELINE DISEASE SEVERITY
  • Moderate disease (IGA 3): 52%
  • Severe disease (IGA 4): 48%
  • EASI 16 (mean 33 out of 72)
  • BSA involvement 10%
    (mean 55%)
  • Peak Pruritus NRS score (mean
    7 out of 10)e
ADOLESCENTS

12-17 years of age
DUPIXENT monotherapy

NUMBER OF PATIENTS251
PIVOTAL TRIALSc
1 Monotherapy
(Trial 6; 16 weeks)
DOSAGE
Patients <60 kg:
A loading dose of 400 mg
(2 x 200 mg SC injections) followed
by 200 mg (1 SC injection) Q2W

Patients 60 kg:
A loading dose of 600 mg
(2 x 300 mg SC injections) followed
by 300 mg (1 SC injection) Q2W
BASELINE DISEASE SEVERITY
  • Moderate disease (IGA 3): 46%
  • Severe disease (IGA 4): 54%
  • EASI 16 (mean 36 out of 72)
  • BSA involvement 10%
    (mean 57%)
  • Peak Pruritus NRS score (mean
    8 out of 10)e
CHILDRENc

6-11 years of age
DUPIXENT + TCS

NUMBER OF PATIENTS367
PIVOTAL TRIALSc
1 Concomitant TCS
(Trial 8; 16 weeks)
DOSAGE
Patients 15 kg to <30 kg:
A loading dose of 600 mg
(2 x 300 mg SC injections) followed
by 300 mg (1 SC injection) Q4W

Patients 30 kg:
A loading dose of 400 mg
(2 x 200 mg SC injections) followed
by 200 mg (1 SC injection) Q2W
BASELINE DISEASE SEVERITY
  • Severe disease (IGA 4): 100%
  • EASI 21 (mean 38 out of 72)
  • BSA involvement 15%
    (mean 57.6%)
  • Peak Pruritus NRS score (mean
    7.8 out of 10)e

The results presented are not intended to be
comparative among the child, adolescent,
and adult DUPIXENT trials.

BSA, body surface area; EASI, Eczema Area and
Severity Index; IGA, Investigator’s Global Assessment;
NRS, numerical rating scale;
Q2W, once every 2 weeks;
Q4W, once every 4 weeks; SC, subcutaneous; TCS,
topical corticosteroids.

aThese baseline characteristics are not meant for
comparison.

bAt baseline, mean disease duration was ≈28 years for
adults, ≈12 years for adolescents, and ≈7 years for
children. Mean age was 38
years for
adults, 14.5 years for adolescents, and 8.5 years for children.

cThe study population in Trial 8 included children with only severe atopic dermatitis.

dIn atopic dermatitis, Trial 4 was a dose-ranging trial to
evaluate the safety of DUPIXENT monotherapy
through Week 16. Trial 5 evaluated
multiple
DUPIXENT monotherapy dose regimens for
maintaining treatment response for 36 weeks.

eWeekly averaged Peak Pruritus NRS score (10
indicates most severe).

fFull Analysis Set (FAS) includes all subjects
randomized.

gIn the primary analyses of the efficacy endpoints,
subjects who received rescue treatment or with
missing data were considered nonresponders.

hIn Trial 3, as needed, subjects received topical
calcineurin inhibitors for problem areas only, such as
the face, neck, and intertriginous and
genital areas.

iAt Day 1, subjects (baseline weight <30 kg) received
600 mg of DUPIXENT.

jAt Day 1, subjects (baseline weight ≥30 kg) received
400 mg of DUPIXENT.

kIGA scale was defined as 0=clear, 1=almost clear,
2=mild, 3=moderate, and 4=severe.

lData analyses reflect patients with baseline Peak
Pruritus NRS score ≥4. In Trial 1, DUPIXENT (n=213)
and placebo (n=212). In Trial 2, DUPIXENT
(n=225)
and placebo (n=221). In Trial 3, DUPIXENT + TCS
(n=102) and placebo + TCS (n=299).

DUPIXENT was evaluated in patients
with severe disease aged 6 to 11
years and with moderate-to-severe
disease aged 12 years and older
whose disease was inadequately
controlled on topical Rx therapies3,4,a,b
NUMBER
OF PATIENTS
PIVOTAL
TRIALS
d
DOSAGE
BASELINE
DISEASE SEVERITY
ADULTS

18+ years of age
DUPIXENT monotherapy and + TCS

NUMBER OF PATIENTS
>2100
PIVOTAL TRIALSc
2 Monotherapy (Trials 1 and 2; 16 weeks)
1 Concomitant TCS (Trial 3; 52 weeks)
DOSAGE
A loading dose of 600 mg
(2 x 300 mg SC injections) followed
by 300 mg (1 SC injection) Q2W
BASELINE DISEASE SEVERITY
  • Moderate disease (IGA 3): 52%
  • Severe disease (IGA 4): 48%
  • EASI 16 (mean 33 out of 72)
  • BSA involvement 10% (mean 55%)
  • Peak Pruritus NRS score (mean 7 out of 10)d
ADOLESCENTS

12-17 years of age
DUPIXENT monotherapy

NUMBER OF PATIENTS
251
PIVOTAL TRIALSc
1 Monotherapy (Trial 6; 16 weeks)
DOSAGE
Patients <60 kg:
A loading dose of 400 mg
(2 x 200 mg SC injections) followed
by 200 mg (1 SC injection) Q2W

Patients ≥60 kg:
A loading dose of 600 mg
(2 x 300 mg SC injections) followed
by 300 mg (1 SC injection) Q2W
BASELINE DISEASE SEVERITY
  • Moderate disease (IGA 3): 46%
  • Severe disease (IGA 4): 54%
  • EASI 16 (mean 36 out of 72)
  • BSA involvement 10% (mean 57%)
  • Peak Pruritus NRS score (mean 8 out of 10)d
CHILDRENe

6-11 years of age
DUPIXENT + TCS

NUMBER OF PATIENTS
367
PIVOTAL TRIALSc
1 Concomitant TCS (Trial 8; 16 weeks)
DOSAGE
Patients 15 kg to <30 kg:
A loading dose of 600 mg
(2 x 300 mg SC injections) followed
by 300 mg (1 SC injection) Q4W

Patients ≥30 kg:
A loading dose of 400 mg
(2 x 200 mg SC injections) followed
by 200 mg (1 SC injection) Q2W
BASELINE DISEASE SEVERITY
  • Severe disease (IGA 4): 100%
  • EASI 21 (mean 38 out of 72)
  • BSA involvement 15% (mean 57.6%)
  • Peak Pruritus NRS score (mean 7.8 out of 10)e

In atopic dermatitis, significant
improvement was seen at Week 16 in
children, adolescents, and adults3-8,f,g

The results presented are not intended to be
comparative among the child, adolescent,
and adult DUPIXENT trials.

BSA, body surface area; EASI, Eczema Area and
Severity Index; IGA, Investigator’s Global Assessment;
NRS, numerical rating scale;
Q2W, once every 2 weeks;
Q4W, once every 4 weeks; SC, subcutaneous; TCS,
topical corticosteroids.

aThese baseline characteristics are not meant for
comparison.

bAt baseline, mean disease duration was ≈28 years for
adults, ≈12 years for adolescents, and ≈7 years for
children. Mean age was 38
years for
adults, 14.5 years for adolescents, and 8.5 years for children.

cThe study population in Trial 8 included children with only severe atopic dermatitis.

dIn atopic dermatitis, Trial 4 was a dose-ranging trial to
evaluate the safety of DUPIXENT monotherapy
through Week 16. Trial 5 evaluated
multiple
DUPIXENT monotherapy dose regimens for
maintaining treatment response for 36 weeks.

eWeekly averaged Peak Pruritus NRS score (10
indicates most severe).

fFull Analysis Set (FAS) includes all subjects
randomized.

gIn the primary analyses of the efficacy endpoints,
subjects who received rescue treatment or with
missing data were considered nonresponders.

hIn Trial 3, as needed, subjects received topical
calcineurin inhibitors for problem areas only, such as
the face, neck, and intertriginous and
genital areas.

iAt Day 1, subjects (baseline weight <30 kg) received
600 mg of DUPIXENT.

jAt Day 1, subjects (baseline weight ≥30 kg) received
400 mg of DUPIXENT.

kIGA scale was defined as 0=clear, 1=almost clear,
2=mild, 3=moderate, and 4=severe.

lData analyses reflect patients with baseline Peak
Pruritus NRS score ≥4. In Trial 1, DUPIXENT (n=213)
and placebo (n=212). In Trial 2, DUPIXENT
(n=225)
and placebo (n=221). In Trial 3, DUPIXENT + TCS
(n=102) and placebo + TCS (n=299).

WHEN TOPICAL Rx THERAPIES ARE
NOT ENOUGH, THERE'S DUPIXENT

See trial designs and results
 
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Atopic dermatitis is a chronic, recurring, and systemic disease that can leave patients trapped in an endless cycle of flares driven in part by persistent underlying inflammation.1,2 Even when patients are not in a flare, they continue to experience underlying inflammation.1 Unlike topical and oral corticosteroids, DUPIXENT is a biologic with a novel mechanism of action. DUPIXENT targets a source of underlying inflammation to proactively treat uncontrolled moderate-to-severe atopic dermatitis in patients aged 6 years and older.1,3

 
 

References: 1. Gandhi NA, Bennett BL, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35-50. 2. Leung DYM, Boguniewicz M, Howell MD, Nomura I, Hamid QA. New insights into atopic dermatitis. J Clin Invest. 2004;113(5):651-657. 3. DUPIXENT Prescribing Information. 4. Data on file, Regeneron Pharmaceuticals, Inc. 5. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303. 6. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348. 7. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44-56. 8. Paller AS, Siegfried EC, Thaçi D, et al. Efficacy and safety of dupilumab with concomitant corticosteroids in children 6 to 11 years old with severe atopic dermatitis: a randomized, double-blinded, placebo- controlled phase 3 trial. J Am Acad Dermatol. 2020;83(11):1282-1293.