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Long-term safety and tolerability profile investigated up to 3 years in an adult open label extension (OLE) trial1,2

  • 2,826 patients were screened, of which 2,677 were enrolled and participated in the trial2
  • At the time of database lock (February 2019), most patients (82.4%) had completed the trial up to Week 52, and 13.0% had completed up to Week 1482

Adult moderate-to-severe atopic dermatitis (AD) patients on DUPIXENT 300 mg QW (N=2,677)2

The most common reason for patient withdrawal from the study was termination by the sponsor (n=552):2

  • Of the 492 withdrawals by patient, 255 were due to availability of commercial drug or trial termination
  • 100 (3.7%) patients withdrew from the study due to adverse events (AEs)
Dupixent 300 MG QW n=2,677
SAFETY OVERVIEW TOTAL NUMBER OF EVENTS n (%)
TEAE 13,826 2,264 (84.6)
Severe TEAE 355 246 (9.2)
SAE 354 256 (9.6)
SAE related to DUPIXENT 36 31 (1.2)
TEAE leading to DUPIXENT discontinuation 116 95 (3.5)
MOST COMMON AES (≥5% OF PATIENTS ON OLE) DUPIXENT 300 MG QW N=2,677 n (%)
Nasopharyngitis 725 (28.1)
Conjunctivitis* 521 (19.5)
AD 438 (16.4)
Upper respiratory tract infection 350 (13.1)
Headache 216 (8.1)
Oral herpes 188 (7.0)
Injection-site reaction 138 (5.2)

Over 6,000 patient-years of experience in clinical trials3

1.8%

DUPIXENT + TCS

vs

7.6%

Placebo + TCS

Discontinuation rates due to adverse events were lower than placebo in adults at 52 weeks1

0.2%

DUPIXENT + TCS

vs

0.6%

Placebo + TCS

Not associated with increased overall risk of infections, including serious and opportunistic1

DUPIXENT:

  • Does not require routine laboratory monitoring1
  • Is a targeted immunomodulator, not a broad immunosuppressant or steroid tertament1,2
  • Is not associated with increased overall risk of infections, including serious and opportunistic1,4
  • Antibody response to non-live vaccines were similar to placebo groups1

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

*Includes the following MedDRA PTs: conjunctivitis, conjunctivitis allergic, conjunctivitis bacterial, conjunctivitis viral, and atopic keratoconjunctivitis.1


AD, atopic dermatitis; AE, adverse events; MedDRA, Medical Dictionary for Regulatory Activities; MedDRA PT, MedDRA Preferred Term; OLE, open label extension; QW, once weekly; Q2W, once every two weeks; SAE, serious adverse events; TCS, topical corticosteroids; TEAE, treatment-emergent adverse events.

References

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: December 2020.
  2. 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.
  3. Sanofi Data on File. SAGB.DUP.19.09.1537. September 2019.
  4. Blauvelt A, et al. Lancet. 2017;389(10086):2287–2303.