New research determined the safety and efficacy of dupilumab for atopic dermatitis in adolescents with inadequately controlled eczema.
Atopic dermatitis is a chronic inflammatory disease that causes red and itchy skin. Commonly seen in children, atopic dermatitis or eczema is a long-lasting condition that flares up periodically and may be accompanied by asthma or hay fever. The treatment for atopic dermatitis is limited due to the toxicity and side effects of the available therapeutics. However, new studies on a monoclonal antibody, dupilumab for atopic dermatitis has shown promising results.
Current treatments for atopic dermatitis provide symptomatic relief
Atopic dermatitis pathology involves immunological abnormalities and altered skin composition. There is also an increased susceptibility to infections. Current treatment options in the form of topical emollients and topical anti-inflammatory agents, however, only provide symptomatic relief. Other treatment options such as immunosuppressive agents and corticosteroids are usually short-term options due to their side effects. Therefore, dupilumab for atopic dermatitis is a promising alternative.
How does dupilumab work?
Dupilumab is a fully human monoclonal antibody that is effective in reducing inflammation. Several studies have shown that treatment with dupilumab for atopic dermatitis reduces the signs and symptoms of the disease. Dupilumab is already approved for the treatment of atopic dermatitis in patients who are 12 years or older. The use of dupilumab for atopic dermatitis in younger children is being studied for efficacy and safety of the drug.
Dupilumab is safe and effective in adolescents
A new randomized, double-blinded trial with 251 adolescents with moderate to severe atopic dermatitis was conducted at 45 US and Canadian centers between March 2017 and June 2018. The study was recently published in the JAMA Dermatology. The patients included in the trial had atopic dermatitis that was not completely controlled by topical medications. These patients were randomized to 16-week treatment with 200mg or 300 mg dupilumab or placebo. The researchers evaluated the effectiveness of dupilumab treatment by assessing the improvement from baseline in Eczema Area and Severity Index (EASI) and Investigator’s Global Assessment, with higher scores indicating greater severity of atopic dermatitis.
Dupilumab significantly improved signs and symptoms of atopic dermatitis
The results showed that treatment with dupilumab in adolescents achieved the same level of efficacy and safety as seen in adult patients. The results showed clinically significant improvements in itch, sleep, quality of life, and other signs and symptoms of atopic dermatitis. Both 200 mg and 300 mg dupilumab treatment groups showed improvements compared with the placebo group.
The effect of dupilumab is consistent between adults and adolescents
Since the disease mediators of atopic dermatitis are different for adults and children, it was important to evaluate the effectiveness of the dupilumab treatment separately in these two populations. This study clearly showed that the efficacy and safety results were consistent between the adult and adolescent patient populations. There was marked improvement observed in the mean percentage change in EASI that reflects a significant improvement in disease.
This is the largest trial of systemic treatment for atopic dermatitis in adolescents
The results of this large study highlight the similarity in safety and effectiveness of dupilumab for atopic dermatitis in adolescents and children. However, the short treatment period of 16 weeks and absence of a comparison of dupilumab treatment with other medications are the two main limitations of this study.
The researchers observed significant improvements in disease signs and symptoms after treatment dupilumab for atopic dermatitis in adolescents with moderate to severe disease. These improvements were similar to those observed in adults with the same disease.
Written by Preeti Paul
Reference: Eric L. Simpson et al. Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis. A Phase 3 Randomized Clinical Trial. JAMA Dermatol. November 6, 2019. doi:10.1001/jamadermatol.2019.3336
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