DUPILUMAB

By Gary M. White, MD

Note, this is a brief summary only and is meant to emphasize dermatologic aspects. More complete information, including the package insert and recent studies should be consulted before prescribing.


Dupilumab (Dupixent), a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13--key drivers of type 2 helper T-cell (Th2)-mediated inflammation--is highly effective for atopic dermatitis.

Dosing

Adverse Reactions

Decreased risk of Infection

Dupilumab is associated with a decreased incidence of skin infections and eczema herpeticum in adults with moderate-to-severe AD [JAAD 2018;78;62–69.e1].

Drug Interactions

Pregnancy

There are no available data on Dupixent use in pregnant women to inform any drug associated risk. Human IgG antibodies are known to cross the placental barrier; therefore, Dupixent may be transmitted from the mother to the developing fetus.

Lactation

There are no data on the presence of Dupixent in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dupixent and any potential adverse effects on the breastfed child from Dupixent or from the underlying maternal condition.

INDICATION

Dupixent is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Dupilumab for Atopic Dermatitis

Dupilumab, a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13--key drivers of type 2 helper T-cell (Th2)-mediated inflammation--was proven highly effective for atopic dermatitis. A 12-week DBPCT of dupilumab monotherapy found that 85% of patients on dupilumab, as compared with 35% of those on placebo, had a 50% reduction in the EASI score [N Engl J Med. 2014 Jul 10;371(2):130-9]. In combination with topical steroids, 100% of the subjects in the dupilumab group met the criterion for EASI-50, compared with 50% in the placebo group. At 16 weeks in one study of patients with relatively severe disease, 40% were clear or almost clear.

Safety

There does not appear to be an increase in infections or cancer. In fact, patients in the placebo arm had more infections than the dupilumab arm in some studies. This makes sense in that dupilumab-treated patients had improved skin, making them less susceptible to infection. The main side effects are injection site reaction and noninfectious conjunctivitis. Herpes simplex infections do occur.

Conjunctivitis was much more common in the dupilumab arm (36%) than the placebo arm (3%) in one study. This side effect usually responded to topical steroids or cyclosporin.

Pediatric

Dupixent is not FDA approved for children. However, there is data in patients 6-17 years of age using doses of both 2 mg/kg and 4 mg/kg. (Dupixent comes as a 300 mg injection). In this phase 2a open label study, the drug was effective and without major safety issues.

RegionalDerm

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