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DUPIXENT demonstrated a safety and tolerability profile in clinical studies that is consistent in adults, adolescents and children1,2

  • DUPIXENT has a long-term safety and tolerability profile that has been investigated up to 3 years in clinical trials in adults3
  • The safety profile seen in adults is similar to the safety profile of adolescents in a 16-week, Phase 3 trial and of children aged 6–11 years old in a 16-week, Phase 3 trial1,4,5
  • DUPIXENT has a long-term safety profile seen in adults at 3 years, which is consistent with the safety profile of adolescents and children aged 6–11 years old up to 52 weeks1,6,7

The safety of DUPIXENT was investigated in atopic dermatitis (AD) clinical trials in adults, adolescents and children1

  • The safety of DUPIXENT was evaluated in four randomised, double-blind, placebo-controlled trials and one dose-ranging trial in adult patients with moderate-to-severe AD*1
  • In these five trials, 1,689 subjects were treated with DUPIXENT subcutaneous injections with or without concomitant TCS and a total of 305 patients were treated with DUPIXENT for at least 1 year*1
  • DUPIXENT was monitored in adolescents with moderate-to-severe AD (12–17 years old) in a 16-week trial which demonstrated a similar safety profile to the adult trials*1,4
  • DUPIXENT was also monitored in children with severe AD (6–11 years old) in a 16-week trial which demonstrated a similar safety profile to the adult and adolescent trials1,5
SYSTEM ORGAN CLASS ADVERSE REACTION FREQUENCY
Infections and infestations Conjunctivitis, oral herpes Common (≥1% to <10%)
Blood and lymphatic system disorders Eosinophilia Common (≥1% to <10%)
Immune system disorders Serum sickness/serum sickness-like reactions Very rare (0 to <0.0001%)
Anaphylactic reaction, angiodema Not known
Nervous system disorders Headache Common (≥1% to <10%)
Eye disorders Allergic conjunctivitis, eye pruritus, blepharitis Common (≥1% to <10%)
Keratitis, ulcerative keratitis Uncommon (≥0.1% to <1%)
Musculoskeletal and connective tissue disorders Arthralgia Not known
General disorders and administration site conditions Injection site reactions Very common (≥10%)

From post-marketing reporting.1

SYSTEM ORGAN CLASS ADVERSE REACTION FREQUENCY
Infections and infestations Conjunctivitis, oral herpes Common (≥1% to <10%)
Blood and lymphatic system disorders Eosinophilia Common (≥1% to <10%)
Immune system disorders Serum sickness reaction/serum sickness-like
reaction, anaphylactic react
Rare (≥0.01% to <0.1%)
Angioedema Uncommon (≥0.1% to <1%)
Eye disorders Allergic conjunctivitis Common (≥1% to <10%)
Eye pruritus‡§, blepharitis‡§, keratitis Uncommon (≥0.1% to <1%)
Ulcerative keratitis‡§ Rare (≥0.01% to <0.1%)
Musculoskeletal and connective tissue disorders Arthralgia Common (≥1% to <10%)
General disorders and administration site conditions Injection site reactions (includes erythema,
oedema, pruritus, pain and swelling)
Common (≥1% to <10%)

Eye disorders and oral herpes occurred predominately in atopic dermatitis studies.2
§The frequencies for eye pruritus and blepharitis were common and ulcerative keratitis was uncommon in atopic dermatitis studies.2

Adults

2,677 adult moderate-to-severe AD patients investigated for up to 3 years with DUPIXENT in an open label extension (OLE) trial3

ADULT SAFETY PROFILE

Not an actual patient.

Not an actual patient.

Adolescents

251 adolescent moderate-to-severe AD patients investigated for up to 16 weeks with DUPIXENT compared to placebo observed a similar safety profile to that seen for up to 52 weeks4,6

ADOLESCENT SAFETY PROFILE

Children

367 severe AD patients aged 6–11 years old investigated for 16 weeks with DUPIXENT compared to placebo, demonstrated a safety profile consistent with the known safety profile in adults and adolescents with moderate-to-severe AD5

CHILD SAFETY PROFILE

Not an actual patient.

*Pooled data from placebo-controlled monotherapy clinical studies and placebo-controlled concomitant therapy with TCS study; patients exposed to DUPIXENT 300 mg QW or 300 mg Q2W.1

AD, atopic dermatitis; OLE, open label extension; QW, once weekly; Q2W, once every two weeks; TCS, topical corticosteroids.

References

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: July 2021.
  2. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.ie/medicines/dupixent-200-mg-solution-for-injection-in-pre-filled-pen-34950/spc. Date accessed: July 2021.
  3. Thaçi D, et al. Favorable Safety and Sustained Efficacy With Long-Term Dupilumab Treatment in Adults With Moderate-to-Severe Atopic Dermatitis: An Analysis up to 3 Years (LIBERTY AD OLE) presented at the 20th Annual Las Vegas Dermatology Seminar, Nevada, USA, November 7–9 2019.
  4. Simpson EL, et al. JAMA Dermatol. 2020;156(1):44–56.
  5. Paller AS, et al. J Am Acad Dermatol. 2020;83(5):1282–1293.
  6. Cork MJ, et al. Br J Dermatol. 2020;182(1):85–96.
  7. Cork MJ, et al. Br J Dermatol. 2020. doi: 10.1111/bjd.19460. Epub ahead of print.