乌鸦传媒

WASHINGTON -- Dupilumab (Dupixent) appeared safe and effective for children with moderate to severe atopic dermatitis (AD), a retrospective review showed.

After receiving a mean of 16.5 doses over an average treatment period of 9 months, most of the 109 patients saw improvements in modified Investigator's Global Assessment (IGA) scale scores, according to Sean Igelman, MD, of Saint Louis University in Missouri, and colleagues.

On the instrument's 5-point scale, 70% had improvements of at least 2 points and 22.5% showed a 1-point improvement, he reported.

Adverse events found among the cohort included: facial eruption (6.3%), injection site reaction (2.1%), upper respiratory infection (1.0%), and conjunctivitis (8.3%), Igelman also reported here at the American Academy of Dermatology meeting.

"Dupilumab is a IL-4 receptor monoclonal antibody, approved almost two years ago for adults with moderate to severe atopic dermatitis," he explained. "It's dosed as a 600-mg loading dose, followed by a 300-mg maintenance dose every other week. There are currently industry-sponsored clinical trials including children [at least] 6 months of age that are in process, but there are only a limited number of children that have the opportunity to participate in these clinical trials."

Pending completion of those trials and approval of a pediatric indication for dupilumab, the current data may help to inform the drug's use in children, Igelman said. Optimal dosing for children still needs to be defined rigorously, Igelman said, noting that insurers often will not cover dupilumab in this population.

The researchers evaluated 109 children at seven sites with pediatric dermatologists. Over 21 months, they collected data on all pediatric patients (up to age 18), focusing on those receiving dupilumab for AD.

Participants' mean age at baseline was 13.1 years and 41% were girls. About one-third of patients had been hospitalized at some point for their AD and most had received other medications including corticosteroids, antihistamines, and/or immunosuppressants.

Records for all of the included patients indicated that prior authorizations for dupilumab were required. Insurance coverage was ultimately denied for 12%, and the mean delay in starting treatment was 9.4 weeks.

The mean loading dose in the cohort was 8.5 mg/kg with 82% of the participants receiving a loading dose. Maintenance doses were based on weight, with the mean being 5 mg/kg.

Of the 79 children that received a loading dose, 75% received the 600-mg adult dose, while the rest received less.

The 300-mg adult maintenance dose was given to 74% of participants, while 26% received less than the adult dose. Looking at maintenance dosing another way, Igelman said that among the 79 patients receiving a loading dose of some kind, 72 got half that dose as their maintenance dose. For participants ages 6 to 11 years (26% of the entire cohort), weight-based doses ranged widely, although 48% were given the adult maintenance amount.

Six of the cohort showed no response to dupilumab. Three of those patients received at least three doses.

Igelman also highlighted some incidental efficacy results, including improvements in patients' mental health and resolution of warts and molluscum.