Dupilumab Use in Moderate-to-Severe Atopic Dermatitis

Marcia L. Buck, PharmD, FCCP, FPPAG, BCPPS


Pediatr Pharm. 2019;25(6) 

In This Article

Adverse Effects

In pooled data from three premarketing clinical trials in adults, the most common adverse effects with dupilumab were injection site reactions (reported in 10% of patients receiving doses of either 200 mg or 300 mg), conjunctivitis (reported in 10% of patients receiving 300 mg and 9% in patients receiving 200 mg), blepharitis (< 1% and 5%), oral herpes (4% and 3%), keratitis (< 1% and 4%), eye pruritus (1% and 2%), other herpes simplex virus infections (2% and 1%), and dry eye (<1% and 2%).[2] Fewer than 2% of patients taking dupilumab discontinued therapy because of adverse effects. Data from a trial of 250 adolescents treated for 16 weeks produced similar results. Safety assessment during an open-label continuation study found no differences in the adverse effects reported at weeks 16 and 52.

As with other biologic proteins, dupilumab treatment may result in the formation of antibodies. In studies of patients treated for asthma, 9% developed antibodies to dupilumab, with 4% having neutralizing antibodies. Studies of adolescents being treated for atopic dermatitis have identified antibodies in 16% of patients after 16 weeks of therapy, with 5% having neutralizing antibodies. Dupilumab dose does not appear to be correlated with higher antibody titers.[2]