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DEMONSTRATED LONG-TERM SAFETY PROFILE THROUGH WEEK 52

Adverse reactions occurring in ≥2% of patients (and greater than placebo)
up to Week 521
Adverse
reaction
DUPIXENT
300 mg Q2W 
+ OCSa 
(n=53)
%
Placebo
+ OCSa 
(n=53)
%
Arthralgia 9 6
Conjunctivitis 8 0
Vison blurred 8 0
Herpes viral
infectionsb
6 0
Keratitis 4 0
  • aAll subjects received DUPIXENT or placebo in combination with a tapering course of oral corticosteroids (OCS).
  • bHerpes viral infections include herpes simplex and herpes zoster.
  • A case of acute generalized exanthematous pustulosis (AGEP) was reported in 1 subject with BP treated with DUPIXENT compared with 0 subjects in the placebo group1
  • At the time of safety analysis, 87 subjects had completed Week 36 and 65 subjects had completed Week 521

Rate of treatment discontinuation through Week 522

Discontinuations due to adverse events
4% DUPIXENT
vs
9% Placebo
  • Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection
    resolves in a patient who does not respond to anti-helminth treatment1

DUPIXENT Attributes And Considerations

NOT AN
IMMUNOSUPPRESSANT
OR A STEROID1

At-home
self-administration1

  • Train patients and/or
    caregivers on
    proper
    administration prior to use

NO INITIAL LAB
TESTING OR
ONGOING
LAB MONITORING

according to the
Prescribing Information1

NO boxed warning1

Please see additional
Warnings and Precautions
in the Prescribing
Information and Important
Safety Information below.

NO KNOWN DRUG‑TO‑DRUG
INTERACTIONS1

  • Not metabolized through
    the liver or
    excreted
    through the kidneys

Select important
safety information

WARNINGS AND PRECAUTIONS

  • Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, acute generalized exanthematous pustulosis (AGEP), serum sickness or serum sickness-like
    reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. A case of AGEP was reported in an adult
    subject who participated in the bullous pemphigoid development program. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy
    and discontinue DUPIXENT.
  • Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.

OCS, oral corticosteroids; Q2W, once every 2 weeks.