Real-World Study Shows Dupixent Improves AD Symptoms in Children Under 12 Years

In pediatric patients with moderate-to-severe atopic dermatitis (AD), Dupixent (dupilumab) can reduce symptoms and improve pruritus with no serious adverse events (AEs) and reversible frequent AEs. The findings were published in Archives in Dermatologic Research.

On June 7, 2022, the FDA approved Dupixent for children as young as 6 months who have moderate-to-severe AD. Researchers from Second Affiliated Hospital of Xi’an Jiaotong University in China evaluated the efficacy and safety of Dupixent in patients younger than 12 years with AD in a real-world setting.

The therapy blocks the interleukin-4 receptor subunit α and suppresses the T helper type 2 cells, which play an important role in allergic inflammation. Atopic dermatitis is driven in part by type 2 inflammation.

Based on weight, patients were either administered an initial dose of 600 mg or 300 mg followed by a monthly maintenance dose of 300 mg. The researchers conducted The Eczema Area and Severity Index (EASI), the Children’s Dermatology Life Quality Index (CDLQI), and the SCORing AD (SCORAD) at baseline, after the first injection, 1 month after all treatment, and 6 months after all treatment.

In total, 15 patients (53.3% female) were enrolled aged 4 to 12 years (mean age 7.80 ± 2.60). Nearly half (46.7%) had 1 or more allergic comorbidity with the most frequent allergic diseases being rhinitis (27%), food allergy (20%), and asthma (6.7%). In addition, 46.7% had a family history of eczema.

At baseline, 6.7% of patients had eosinophils increase prior to treatment and total immunoglobin E levels were above the normal range in 40% of patients. All patients had previously received antihistamines with 53% receiving 2 kinds and also Chinese traditional herbal remedies and glucocorticoid for external application. “However, these traditional therapies had little relieving effect,” the authors noted.

With immunosuppressants, parents have been advised to closely monitor for side effects. With cyclosporine A, for instance, parents need to monitor renal function and blood pressure. As a result, “parents always refused to use them to treat AD,” the authors wrote. None of the patients have been treated with systemic immunosuppressants or glucocorticoids.

Both EASI score and pruritus improved 1 month after completing treatment. At baseline the mean EASI score was 19.23, which decreased to 2.17 at 1 month after completing treatment. Just after the first injection the score had decreased to 10.69. At 6 months after all treatment, the mean EASI score was 1.69.

At 6 months after completing treatment all patients had reached EASI50 (50% reduction in EASI score) and 53.3% of patients had reached EASI90.

Similarly, CLDQI and SCORAD scores saw improvements. At baseline, the mean CLDQI score was 13.53, which started decreasing after the first injection and was 2.27 at 1 month after completing all treatment. At the 6-month follow-up the mean score was 1.60. The mean SCORAD score was 43.27 at baseline, began to fall after the first injection, and was 10.0 at 1 month after all treatment. At the 6-month follow-up, the mean SCORAD score was 6.13.

The authors noted that future research should include multiple centers to increase the sample size and reduce selection bias. In addition, obtaining more clinical data could help with adjusting treatment plans for patients.

“Dupilumab improved pruritus and reduced the area of skin lesions in pediatric AD patients,” they concluded. “Further research should consider enrolling more patients and having longer observation times after treatment.”

This article was originally published by Managed Healthcare Executive.