The atopic dermatitis-targeting biological agent “Dabito” (duprilumab injection) was exhibited at the CIIE. The Paper reporter Chen Sisi data map
Has appeared at the Expo for many times, the world’s first targeted biological agent “Dabito” (duprilumab injection) approved for the treatment of moderate to severe atopic dermatitis in adults ) has expanded its indications. In the past, it was approved in China only for adolescents and adults over the age of 12. Now it can also be used for children aged 6-12.
On February 24, The Paper reporter learned the news from the website of the State Drug Administration of China.
Atopic dermatitis is a systemic immune disorder caused by a type 2 inflammatory response, often described simply as “eczema.” As early as May 2019, “Dabito” was included in the second batch of overseas new drugs urgently needed for clinical use by the Center for Drug Evaluation (CDE) of the State Drug Administration, accelerating the marketing approval process. In June 2020, “Dabito” was approved by the China National Medical Products Administration (NMPA) for the treatment of moderate to severe atopic dermatitis in adults, two years earlier than planned, and has been included in the 2020 National Medical Insurance content. In June 2021, “Dabito” submitted the indications for children aged 6 and above to below 12 years old in China and obtained the priority review qualification. In September 2021, “Dabito” was approved in China for the treatment of moderate-to-severe atopic dermatitis in adolescents and adults aged 12 years and above who are poorly controlled or not recommended for topical medication.
Approval of the new pediatric indication is based on a pivotal global pediatric Phase III clinical trial and data extrapolation from the indication for moderate-to-severe atopic dermatitis in adults and adolescents in China . This is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of “Dabito” combined with topical corticosteroids (hereinafter referred to as TCS) in the treatment of severe atopic dermatitis in children.
In the trial, children who received the combination of Dalbitux and TCS had significant improvements in overall disease severity, skin clearance and pruritus compared with TCS alone. The trial showed that the number of patients with clear or nearly cleared skin lesions in the “Dabito” and TCS combination treatment group was more than twice that of the TCS single-agent group, and the number of patients with significant relief of pruritus was more than four times that of the TCS single-agent group. , nearly three-quarters of patients had an overall improvement in disease of at least 75%, with an average improvement of about 80%.
Previous studies have pointed out that Chinese patients with moderate to severe atopic dermatitis suffer from atopic dermatitis for an average of nearly 10 years, and are often associated with other type 2 inflammatory diseases such as allergic rhinitis and asthma. 85%-90% of patients with atopic dermatitis are younger than 5 years of age at the onset of symptoms or onset, and have not received effective treatment in childhood. During the onset of atopic dermatitis, children often experience severe itching and skin lesions, leading to skin cracking, erythema, papules, and exudation, which seriously affects children’s learning and life, physical and mental development and healthy growth, including emotional psychology, sleep, Attention and quality of life, etc., and even psychological problems such as anxiety and depression may occur, and most parents of children will suffer from lack of sleep and mental stress.
Professor Yao Zhirong, director of the Department of Dermatology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, said: “Atopic dermatitis is a common childhood disease with a high incidence, most of which are mild atopic dermatitis. After conventional treatment, good control can be achieved, but there are still some cases that are resistant to existing treatments and have poor symptom control. It has been confirmed by multiple clinical studies and real-world studies that this innovative drug can take into account both efficacy and safety, and does not It has an inhibitory effect on growth and development, and is of great significance for long-term disease control and improvement of life quality in children with atopic dermatitis.”