▎WuXi AppTec Content Team Report

Screenshot source: CDE official website

The JAK family is a class of non-receptor tyrosine kinases, including four subtypes: JAK1, JAK2, JAK3, and TYK2. They play important roles in the signal cascades of various type I and type II cytokine receptors. The signaling pathways mediated by JAK are associated with processes such as cell proliferation, differentiation, apoptosis, and inflammation.

Upadacitinib sustained-release tablets are a selective JAK inhibitor. Previous studies have shown that this product exhibits greater inhibitory potency against JAK1 than against JAK2, JAK3, and TYK2. In China, upadacitinib sustained-release tablets have previously been approved for the treatment of various indications, covering atopic dermatitis, rheumatoid arthritis, active psoriatic arthritis, ulcerative colitis, Crohn's disease, active radiographic-negative axial spondyloarthritis (nr-axSpA), active ankylosing spondylitis (AS), and more.

Upadacitinib is proposed to be included in the breakthrough therapy category for a new indication ——Non-segmental vitiligo (NSV)。In October 2023, AbbVie announced that the extended-release tablets of upadacitinib had met the primary endpoint in a Phase 2b clinical trial for the treatment of adult patients with non-segmental vitiligo. The data showed:

• At week 24, compared with placebo, 11mg and 22mg doses of upadacitinib achievedFacial VitiligoF-VASI (Facial Vitiligo Area Scoring Index)Percentage change from baseline (%CFB) as the primary endpoint;

• In addition,In all upadacitinib dose groups, the mean percentage decrease in F-VASI from baseline at Week 52 was numerically greater than the results at Week 24.

Vitiligo is a chronic autoimmune disease,NSV is the most common form of vitiligo, affecting approximately 80% of patients. VitiligoPatients will develop white patches of pigment loss on their skin, most commonly around the mouth and eyes, fingers and wrists, armpits, and groin, etc.The most troublesome plaques appear on the face, which makesF-VASI Becomes a Key Indicator for Patients and Dermatologists to Assess Clinical Vitiligo Improvement.Due to the characteristics of the disease, patients with vitiligo oftenThere will also be emotional and psychological burdens, affecting their quality of life.Quantity。

Hope the subsequent clinical research of this Upadacitinib Sustained-Release Tablets for vitiligo also proceeds smoothly, bringing new treatment options to more patients as soon as possible.

References:

[1] Website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved May 17，2024, From https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] AbbVie Announces Upadacitinib (RINVOQ®) Met the Primary Endpoint in Phase 2 Clinical Trial of Vitiligo as Program Advances to Phase 3. Retrieved October 12, 2023, from https://www.prnewswire.com/news-releases/abbvie-announces-upadacitinib-rinvoq-met-the-primary-endpoint-in-phase-2-clinical-trial-of-vitiligo-as-program-advances-to-phase-3-301954354.html

[3] RuiFu® (Upadacitinib Sustained-Release Tablets) Approved for Two New Rheumatology Indications, Becoming the First Oral Targeted Drug in China to Cover the Entire Course of axSpA (Axial Spondyloarthritis) . Retrieved Oct 27，2023, From https://mp.weixin.qq.com/s/7-Tofx4S3E6nUntLmYmZVA