No Lab Monitoring Needed in Adolescents on Dupilumab

Bruce Jancin

November 03, 2020

No clinically meaningful changes in laboratory values occurred in adolescents during 52 weeks on dupilumab for atopic dermatitis in a large, open-label safety study, Michael J. Cork, MBBS, PhD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

These reassuring results from the ongoing LIBERTY AD PED-OLE study confirm that, as previously established in adults, no blood monitoring is required in adolescents on the monoclonal antibody, which inhibits signaling of interleukins-4 and -13, said Cork, professor of dermatology and head of Sheffield Dermatology Research at the University of Sheffield (England).

"The practical importance of this finding is that there are no other systemic drugs available that don't require blood samples. Cyclosporine, methotrexate, and the others used for atopic dermatitis require a lot of blood monitoring, and they're off-license anyway for use in children and adolescents," he said in an interview.

Many pediatric patients are afraid of needles and have an intense dislike of blood draws. And in a pandemic, no one wants to come into the office for blood draws if they don't need to.

"Blood draws are very different from the injection for dupilumab. Taking a blood sample is much more painful for children. The needle in the autoinjector is really, really tiny; you can hardly feel it, and with the autoinjector you can't even see it," noted Cork, who is both a pediatric and adult dermatologist.

This report from the ongoing LIBERTY AD PED-OLE study included 105 patients aged 12-17 years who completed 52 weeks on dupilumab (Dupixent) with assessments of hematologic and serum chemistry parameters at baseline and weeks 16 and 52.

"The results were anticipated, but we want to know the drug is safe in every age group. The immune system is different in different age groups, so we have to be really careful," Cork said.

The clinical side-effect profile was the same as in adults, consisting mainly of mild conjunctivitis and injection-site reactions. It's a much less problematic side effect picture than with the older drugs.

"We're finding the conjunctivitis to be slightly less severe than in adults, maybe because we've learned from the first trials in adults and from clinical experience to use prophylactic therapy. There would be no child going on dupilumab now – and no adult – that I wouldn't put on prophylactic eye drops with replacement tears. I start them 2 weeks before I start dupilumab," the dermatologist explained.

He and others with extensive experience using the biologic agent also work closely with an ophthalmologist.

"If we see an eye problem before going on dupilumab we get an assessment and then ophthalmologic monitoring during treatment," Cork said.

As a dermatologist specializing in atopic dermatitis, he confessed to feeling deprived over the years as he watched the multitude of targeted biologic agents being developed for psoriasis. When he became involved in the first pediatric clinical trials of dupilumab, he had a realization: "It's a miraculous treatment."

"The first child I put on dupilumab spent 70 days in the hospital for IV antibiotics in the prior year. Seventy days! He almost died from MRSA septicemia. His serum IgE was 155,000 kU/L. And his IgE just went down and down and down as the dupilumab took effect. It was just incredible," he recalled.

Cork reported receiving research funding from and serving as a consultant to Sanofi and Regeneron, which fund the LIBERTY AD PED-OLE study, as well as numerous other pharmaceutical companies.

SOURCE: Cork MJ. EADV 2020, Abstract 1772.

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