A phase III trial found that long-term dupilumab treatment demonstrated acceptable safety and sustained efficacy in children aged 6–11 years with severe atopic dermatitis.
Atopic dermatitis (AD) is the most prevalent inflammatory skin disease in children. Treatment options are limited in children aged 6–11 years with severe AD inadequately controlled by topical therapies. Dupilumab has been approved for use in this population; however, long-term data are lacking.
A study in Dermatology and Therapy evaluated the long-term safety and efficacy of dupilumab in children with severe AD.
Study Population
The study included 321 children aged 6–11 years with severe AD. The mean age was 8.6 years. Half of the patients were male, and most (72%) were White. All had participated in a 16-week dupilumab clinical trial in which they received dupilumab or a placebo. At the end of that trial, they were all given dupilumab for up to a year.
Dupilumab Showed Significant and Sustained Improvement in Atopic Dermatitis
There was an incremental improvement over time in AD clinical signs. The improvement was observable by week 4 and sustained with continued dupilumab therapy through week 52. There was an increase in the proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0/1 or Eczema Area and Severity Index (EASI)-75 from baseline through week 52. By week 52, of 257 patients, 41% had achieved an IGA score of 0/1, 97%, 82%; 50% had achieved EASI-50, EASI-75, and EASI-90, respectively; and 88% showed clear/almost clear skin or mild disease (IGA ≤2). Incremental improvements in achieving IGA 0/1 or EASI-75 were similar between patients weighing <30kg or ≥30kg.
Significant Improvements in Eczema Severity and Quality of Life
Substantial improvements were observed in the mean percent changes in EASI (−86%) and Scoring Atopic Dermatitis (SCORAD) (−67%) from baseline to week 52. The mean EASI was 5.2 at week 52 (a mean change of −32.5). There was a decrease in the percentage of body surface area affected by AD (a mean percent change of −47.3). Moreover, there was an incremental improvement in health-related quality of life, with 88% of patients having a clinically meaningful improvement in Children’s Dermatology Life Quality Index scores by week 52 (a mean change of −12.3).
Sustained 12-Week Iga 0/1 Response in Dupilumab Treatment
Of the 254 patients who completed the week 52 visit, 29% had achieved a sustained 12-week IGA 0/1 response and consequently stopped dupilumab treatment. Most of these patients experienced a gradual worsening of symptoms, and 40% relapsed and needed re-initiation of therapy.
The Majority of Patients Experienced Mild or Moderate Adverse Events
Treatment-emergent adverse events (TEAEs) of grade ≥1 were reported in 79% of patients, mostly mild or moderate and transient. Of the 1434 TEAEs reported, 170 were attributable to treatment, 16 were severe, and 18 were serious. The majority of serious TEAEs were transient. TEAEs led to permanent treatment discontinuation in three patients. The most frequently reported TEAEs were dermatitis atopic, nasopharyngitis, and upper respiratory tract infections.
Source:
Cork, M. J., Thaçi, D., Eichenfield, L. F., Arkwright, P. D., Chen, Z., Thomas, R. B., Kosloski, M. P., Dubost-Brama, A., Prescilla, R., Bansal, A., & Levit, N. A. (2023). Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6–11 Years of Age with Severe Atopic Dermatitis. Dermatology and Therapy. https://doi.org/10.1007/s13555-023-01016-9
