Industry Watch I Advances in new therapies for atopic dermatitis
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It is a chronic, recurrent, inflammatory skin disease. Because the patients are often complicated with allergic rhinitis, asthma and other atopic diseases, it is considered to be a systemic disease. People with AD often have intense itching, which seriously affects quality of life. In the past 30 years, the prevalence of AD has gradually increased worldwide, and the prevalence of AD in children in developed countries has reached 10% to 20%. The increase of the prevalence of AD in China is later than that in western developed countries, Japan and South Korea, but it has increased rapidly in the past 10 years. According to an epidemiological survey conducted by using Williams diagnostic criteria in China in 1998, the total prevalence rate of AD among school-age adolescents (6-20 years old) was 0.70%, that of preschool children (1-7 years old) in 10 cities in 2002 was 2.78%, and that of children aged 3-6 years old in Shanghai in 2012 was 8.3%. In 2014, using the diagnostic criteria of clinicians, the prevalence of AD in children aged 1 to 7 years in 12 cities in China reached 12.94%l6], and the prevalence of AD in infants from 1 to 12 months was 30.48%.

The continued prevalence of this inflammatory skin disease has driven the development of topical corticosteroids (TCS) and calcineurin inhibitors (TCI). For decades, these therapies have been considered central to the treatment of AD. Not only because they are considered effective, but because they are also the only option.

Regardless of the effectiveness of these topical corticosteroids and emollients, there are still concerns about their durability and long-term safety. Side effects reported in previous cases include local skin atrophy, telangiectasia, skin lines, perioral dermatitis, and acne.

It is encouraging that research on AD has increased dramatically in recent years, which has led to an overall increase in understanding of the disease. Although there are still many mechanisms to be uncovered, some studies have succeeded in revealing some important underlying factors in the disease.

We are now entering a revolution in medicine. The introduction of JAK inhibitors, such as lucotinib and abcitinib, is considered a breakthrough in the therapeutic field, not only for AD, but also for a variety of other diseases.

Ruxolitinib, the first JAK inhibitor cream for the treatment of AD, was approved by the U.S. Food and Drug Administration (FDA) in September 2021. It is aimed at the short-term, non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients over the age of 12 years. Based on data from the TRuE-AD (Local Rucotinib Assessment) atopic dermatitis clinical trial program, patients experience significantly cleaner skin and less itching. To increase its therapeutic efficacy, a recent study published in the Journal of the European Academy of Dermatology and Venereology found that Rucotinib cream studies showed rapid improvement in itching symptoms in patients with mild to moderate AD within eight weeks.

Dupilumab is the first biologic drug approved by the FDA for use in adults and children 6 years of age and older with moderate to severe atopic dermatitis. Dupilumab is popular with dermatologists and their patients.

"Until today, treatment options for atopic dermatitis in the United States for infants and children under 6 years of age with moderate to severe disease have been limited to topical steroids - long-term use can pose significant safety risks." Naimish Patel, M.D., Senior Vice president and global Head of development, immunology and inflammation at Sanofi.

Recently, dupilumab was also approved by the FDA as the first and only drug to treat tuberous prurigo.

Several other clinical trials of other biologic drugs for AD are in preparation or underway.

Lindmik View

Development and market progress of new therapies for atopic dermatitis

Data source: internal data of Leming BD

These novel therapeutic approaches reflect an urgent clinical need and a large unmet "blue ocean" market. Not only do they provide new drug types for clinicians to choose outside of TCS and TCI therapy, but these new biologics are more effective and provide longer-lasting results. As researchers continue to conduct trials and studies, we can be confident that more promising treatments and drug formulations will emerge in the coming years.

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