Pfizer Showcases Dermatology Innovations Xibike (Abrocitinib) at CIIE and Celebrates First Anniversary of Eucrisa (Crisaborole)

SHANGHAI, Nov. 7, 2021 /PRNewswire/ -- At the fourth China International Import Expo (CIIE), Pfizer made its debut with Abrocitinib, a treatment for moderate-to-severe atopic dermatitis (AD). The showcased Abrocitinib will provide a new treatment option for adult and adolescent patients aged 12 and above with moderate-to-severe AD. Currently approved in the United Kingdom and Japan under the brand name CIBINQO, the drug was granted priority review status by China's Center for Drug Evaluation (CDE) in March this year. On the day of its debut, the Chinese name for CIBINQO was officially announced as "Xibike" (希必可).

Professor Yao Zhirong, Director of the Department of Dermatology at Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, stated: “The CIBINQO (abrocitinib) showcased here is a highly selective JAK1 inhibitor. It reaches peak plasma concentration within 1 hour, with improvement in pruritus observed within 1 day, and significant improvement in skin lesions within 2 weeks. Multiple studies have demonstrated that abrocitinib can rapidly improve the symptoms and signs of moderate-to-severe atopic dermatitis (AD), particularly pruritus, which is one of the most distressing symptoms for patients. Furthermore, its oral administration and availability in multiple dosage strengths facilitate improved patient adherence and allow for flexible dose adjustment. We look forward to the swift launch of abrocitinib in China, which will provide a new systemic treatment option for moderate-to-severe AD.”

It is worth mentioning that the innovative dermatological PDE-4 inhibitor Shutanming (crisaborole), which made its debut at the 2nd CIIE and was officially launched at the 3rd CIIE, celebrated its first anniversary at the 4th CIIE. Taking this opportunity, attending experts released on-site the interim results of the first 《Blue Book on Long-term Comprehensive Management of AD Patients in China》.

*The Blue Book on Long-term Management of Atopic Dermatitis (AD) Patients in China* was initiated by the Beijing Dayi Public Welfare Foundation. The project aims to increase public awareness and emphasis on the long-term management of AD, elevate the standards of AD diagnosis, treatment, and management, help AD patients alleviate their disease burden, and contribute to the advancement of national public health initiatives. The findings indicate that 30% of patients believe AD can be completely cured without relapse; over 80% of surveyed individuals seeking hospital care have moderate-to-severe AD; approximately half of adult AD patients do not use emollients; 54% of surveyed patients discontinue medication immediately upon the resolution of skin lesions and pruritus; and 22% of adult and 29% of pediatric patients use medications for a total duration of less than one week. In response, Professor Ding Yangfeng from Shanghai Skin Disease Hospital emphasized that patient education should be strengthened, and public education and awareness campaigns on AD should be expanded to enhance patients' awareness of long-term management. Patients and their families must recognize the importance of long-term management, strictly adhere to prescribed medication schedules and dosages, commit to regular follow-up visits, and actively cooperate with physicians for effective management. Only through these measures can relapses be reduced and prevented, thereby improving patients' quality of life.

The interim findings of 《Blue Paper on Long-Term Management of Atopic Dermatitis (AD) Patients in China》 indicate that AD requires long-term treatment, and a strong physician-patient relationship should be established to achieve optimal therapeutic outcomes through comprehensive, full-course disease management. During follow-up visits, physicians should closely monitor changes in the patient's condition, promptly adjust treatment regimens, and employ maintenance therapy to achieve prolonged symptom control and minimize relapse rates. Following clearance of skin lesions in patients with moderate-to-severe or relapse-prone AD, treatment should transition to long-term "proactive maintenance therapy"; however, approximately 60% of patients are currently unaware that AD necessitates proactive maintenance treatment.

The objective of maintenance therapy is to provide patients with continuous treatment once AD symptoms enter the remission phase, aiming to stabilize the condition and reduce the risk of relapse. Professor Ding Yangfeng stated: “Scholars have indicated that patients with mild, moderate, and severe AD require maintenance therapy for 3 months, 6 months, and 9–12 months, respectively. For patients who are hesitant to use corticosteroids, particularly children, non-steroidal agents are recommended for long-term maintenance. Furthermore, even in the absence of symptoms, AD patients must not neglect daily skincare routines and should cultivate healthy lifestyle habits to prevent potential flare-ups proactively.”

AD is primarily characterized by recurrent pruritus, which in severe cases can lead to anxiety and depression.

Atopic Dermatitis (AD) is a distinct form of eczema with a familial genetic predisposition, characterized by a chronic, relapsing, and inflammatory course, with dry skin, chronic eczematous lesions, and intense pruritus as its primary clinical manifestations. Given that patients frequently present with concurrent atopic conditions such as allergic rhinitis and asthma, it is therefore considered a systemic disease.

Although AD can develop at any age, its clinical manifestations vary across different age groups. Prof. Yao Zhirong from Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine pointed out: "Infantile lesions typically present within the first two years of life, commonly affecting the cheeks, forehead, and scalp, and are predominantly characterized by acute eczema; as the disease progresses, the risk of developing asthma and food allergies significantly increases; the adult phase may evolve from childhood onset or occur de novo, typically involving the antecubital and popliteal fossae, anterior neck, and other areas, with some patients presenting prurigo-like lesions. If a patient exhibits eczematous skin lesions, the possibility of AD should be suspected. Heightened vigilance is required, and prompt diagnosis and treatment at a dermatology department are essential."

“Recurrent itching is the most prominent symptom of AD. Scratching tends to exacerbate the itch, readily forming a vicious ‘itch-scratch’ cycle. Moreover, itching frequently occurs at night, subjecting patients to sleep disturbances. It can also lead to issues such as dietary restrictions and attention deficits, and may even trigger psychological conditions including negative emotions, depression, and anxiety. This not only impairs patients’ work and daily life but also imposes a heavy burden on their families and society,” Professor Yao Zhirong further stated. “Currently, the pathogenesis of AD remains unclear, but research indicates it is closely associated with genetic and environmental factors. Genetic factors primarily influence skin barrier function and immune homeostasis; individuals with a personal or family history of allergic diseases are more susceptible to AD. Environmental factors, including climate changes, lifestyle alterations, improper bathing practices, and exposure to pathogens and allergens, can also trigger or exacerbate AD. Additionally, psychological factors such as mental stress and depression also play a contributory role in the pathogenesis of AD.”

Innovative Drugs Fill Treatment Gaps, Bringing New Hope for Breakthrough Therapies in Immune-Mediated Dermatoses

For atopic dermatitis (AD), clinical management primarily relies on pharmacotherapy. Commonly prescribed medications include topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), and topical phosphodiesterase-4 (PDE-4) inhibitors. Professor Xu Jinhua from Huashan Hospital Fudan University noted: “Topical agents are a cornerstone of AD treatment, yet each class exhibits distinct characteristics. Among them, TCS serves as the first-line therapy for AD, providing rapid and effective relief from pruritus and inflammation. However, many patients harbor concerns regarding potential adverse effects from long-term, extensive application, such as skin atrophy or hyperpigmentation, leading to treatment reluctance. The most common adverse reactions following TCI use are a burning sensation and localized pruritus. Furthermore, certain TCIs necessitate sun exposure restrictions and are contraindicated in immunocompromised individuals. The innovative topical PDE-4 inhibitor launched last year is a small-molecule, non-steroidal anti-inflammatory drug. In China, it is approved for topical treatment in children aged 2 years and older, as well as adults with mild-to-moderate AD. It carries no specific population restrictions, not only circumventing the adverse effects associated with corticosteroids but also exerting minimal impact on systemic immune function, thereby making it suitable for long-term use.”

For patients with moderate-to-severe atopic dermatitis (AD), the primary treatment goal is rapid relief of pruritus. However, currently available therapeutic options offer limited efficacy, and their duration of action, safety profile, convenience, and accessibility all require further optimization. Currently, the development of JAK1 inhibitors, which represent a novel mechanism of action for AD therapy, is poised to deliver transformative breakthroughs for patients.

“As the first and only topical PDE-4 inhibitor approved in China for AD, Shutanming shares a profound connection with the CIIE. It made its debut at the 2nd CIIE and was officially launched at the 3rd CIIE. Following a year of development and exploration, Shutanming has expanded across China, and we believe it will continue to deliver greater benefits to patients. This year, Cibinqo makes its first appearance on the CIIE stage, and we look forward to Cibinqo providing new treatment options for AD patients in China in the near future,” said Ms. Yang Ying, Head of Global Strategy & Business Development, Asia, Pfizer. “Looking ahead, Pfizer will remain steadfast in its unwavering commitment to ‘deliver breakthroughs that change patients’ lives,’ bringing more innovative dermatology products to patients in China.”

Renowned experts and senior scholars in the field of atopic dermatitis (AD) in China convened for in-depth discussions on disease knowledge, current diagnostic and therapeutic practices, and long-term management. They provided expert recommendations to advance the standardized long-term management of AD, aiming to raise awareness and emphasize its importance among both clinicians and patients. By advocating for evidence-based, long-term management strategies, the initiative seeks to help a broader population of AD patients achieve optimal disease control and minimize recurrence.

Note:CIBINQO (Abrocitinib) has not yet been approved for marketing in China.