argenx因无效终止efgartigimod SC治疗干燥综合征III期UNITY研究

UNITY Study Design

UNITY is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study with an open-label extension, designed to evaluate the efficacy, safety and tolerability of efgartigimod SC in adults with moderate-to-severe Sjögren's disease. To be eligible, patients had to meet the 2016 ACR/EULAR classification criteria for primary Sjögren's disease, test positive for anti-Ro/SSA autoantibodies and have moderate-to-severe systemic disease activity (clinESSDAI ≥6) while receiving stable background standard of care. Patients were randomized 1:1 to receive weekly efgartigimod SC or placebo during the double-blind treatment period. The primary endpoint was change from baseline in systemic disease activity, as measured by the clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI), at Week 48. Key secondary endpoints included the proportion of patients achieving low disease activity (clinESSDAI <5), responder status on the Sjögren's Tool for Assessing Response (STAR), change in patient-reported symptoms as measured by the Diary of Sjögren's Symptoms Assessment (DiSSA), and safety and tolerability.

About Sjögren's Disease

Sjögren's disease is a chronic, slowly progressive, inflammatory systemic autoimmune disease characterized by immune-mediated destruction of the exocrine glands. It can be severely debilitating and have a negative impact on patient quality of life, with commonly reported symptoms including dry eyes and mouth, fatigue and joint pain. In addition, a substantial subset of patients suffer from extraglandular systemic disease. While the presence of anti-Ro and IgG autoantibodies is considered a hallmark of the disease, its underlying cause is believed to be multifactorial, with environmental triggers leading to autoimmunity and chronic inflammation. The disease predominantly affects women, with a 9:1 female-to-male incidence ratio. Given its heterogeneous nature, the treatment journey can be challenging, with long delays and high rates of misdiagnosis.

About VYVGART

VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART Hytrulo® is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics.

VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions.

About argenx

argenx is a global immunology innovation company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit  www.argenx.com  and follow us on LinkedIn, Instagram, Facebook, and YouTube.

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