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Child 16-week safety profile is consistent with adults and adolescents1,2

  • Safety of DUPIXENT in children was assessed in a randomised, placebo-controlled, double-blind, parallel-group, Phase 3 trial of severe atopic dermatitis (AD) patients aged 6–11 years old, whose disease was inadequately controlled by TCS2
  • Patients were randomised to receive either a) 300 mg DUPIXENT Q4W + TCS (n=122) (licensed dose), b) 100 mg or 200 mg DUPIXENT Q2W (n=122) or c) placebo + TCS (n=123) for 16 weeks2

Adverse events in ≥5% of patients during the 16-week treatment period in children with severe AD2

PATIENTS WITH EVENT, (%) DUPIXENT 300 mg Q4W (n=120)
n (%)
PLACEBO (n=120)
n (%)
Dermatitis atopic, exacerbation 8 (6.7) 17 (14.2)
Asthma 2 (1.7) 12 (10.0)
Nasopharyngitis 15 (12.5) 8 (6.7)
Upper respiratory tract infection 13 (10.8) 12 (10.0)
Vomiting 6 (5.0) 8 (6.7)
Cough 3 (2.5) 9 (7.5)
Headache 6 (5.0) 10 (8.3)
Conjunctivitis* 8 (6.7) 5 (4.2)
Skin infection (adjudicated) 7 (5.8) 16 (13.3)
Injection site reactions 12 (10.0) 7 (5.8)
Herpes viral infection 2 (1.7) 6 (5.0)
SAFETY OVERVIEW DUPIXENT 2 MG KG-1
(n=17)
DUPIXENT 4 MG KG-1
(n=16)
Total TEAEs 136 139
Total serious TEAEs§ 2 5
Total TEAEs related to DUPIXENT 14 2
Total serious TEAEs related to DUPIXENT 0 0
Total TEAEs resulting in permanent DUPIXENT discontinuation 0 0
FULL TEAE PROFILE n (%) n (%)
Any infection 12 (71) 15 (94)
Skin infection (HLT) 5 (29) 6 (38)
Non-herpetic skin infections (adjudicated) 4 (24) 3 (19)
Herpes viral infections (HLT) 2 (12) 4 (25)
Injection-site reactions (HLT) 2 (12) 1 (6)
Conjunctivitis|| 2 (12) 5 (31)


MOST COMMON TEAES DUPIXENT 2 MG KG-1
(n=17)
n (%)
DUPIXENT 4 MG KG-1
(n=16)
n (%)
Nasopharyngitis 8 (47) 9 (56)
Atopic dermatitis 5 (29) 2 (13)
Cough 2 (12) 5 (31)
Infected dermatitis 2 (12) 0
Headache 4 (24) 2 (13)
Upper respiratory tract infection 2 (12) 4 (25)
Herpes simplex 0 4 (25)

The Child 16-week trial showed:

1.7%

DUPIXENT + TCS

vs

1.7%

Placebo + TCS

Comparable rates of serious adverse events
between DUPIXENT + TCS and placebo + TCS2

Non-herpetic skin infections reported in:

5.8%

DUPIXENT + TCS

vs

13.3%

Placebo + TCS

Non-herpetic skin infections reported were less common with DUPIXENT + TCS than
placebo + TCS2

0%

DUPIXENT + TCS

vs

1.7%

Placebo + TCS

No discontinuation
due to adverse events with DUPIXENT + TCS compared to placebo + TCS2

DUPIXENT:

  • Does not require routine laboratory monitoring1
  • Is a targeted immunomodulator1
  • Antibody response to non-live vaccines were similar between DUPIXENT and placebo groups1

52 Weeks

  • The long-term safety of DUPIXENT was assessed in an open-label extension trial (AD-1412) up to 52 weeks in patients aged 6–11 years old3
  • The long-term safety profile seen in patients aged 6–11 years old is consistent in adults and adolescents3

Precautions for use1

Systemic Hypersensitivity If a systemic hypersensitivity reaction (immediate or delayed) occurs, DUPIXENT should be discontinued immediately and appropriate therapy initiated.1
Conjunctivitis Patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis should undergo ophthalmological examination, as appropriate.1
Asthma Patients with comorbid asthma should not adjust or stop their asthma treatments without consulting their physicians. Monitor patients with comorbid asthma carefully following discontinuation of DUPIXENT.1
Helminth Infections Patients with pre-existing helminth infections should be treated before initiating DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, DUPIXENT should be discontinued until infection resolves.1

*Conjunctivitis cluster (narrow conjunctivitis) includes preferred terms conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis and atopic keratoconjunctivitis.

Skin infections were adjudicated on a case-by-case basis and included bacterial, viral and fungal infections.

Adverse event reported at the high-level term of the MedDRA hierarchy.

§Serious TEAEs reported included lymphadenopathy, anaphylactic reaction, pneumonia, allergy test, arthralgia, complex regional pain syndrome and postural dizziness.3

||Includes PTs, allergic conjunctivitis, bacterial conjunctivitis, conjunctivitis, viral conjunctivitis and atopic keratoconjunctivitis.3

Includes all MedRA PTs reported in ≥20% of patients in any treatment group of the OLE.3


AD, atopic dermatitis; MedDRA, Medical Dictionary for Regulatory Activities; OLE, open label extension; PT, preferred term; QW, once weekly; Q2W, once every two weeks; Q4W, once every four weeks; TCS, topical corticosteroids; TEAE, treatment-emergent adverse event.

References

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: July 2021.
  2. Paller AS, et al. J Am Acad Dermatol. 2020;83(5):1282–1293.
  3. Cork MJ, et al. Br J Dermatol. 2020. doi: 10.1111/bjd.19460. Epub ahead of print.