argenx SE has announced that it will discontinue the phase 3 UNITY study of efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate-to-severe Sjögren's disease.

The decision is based on the recommendation from an Independent Data Monitoring Committee (IDMC) to stop the study for futility following an interim analysis. The IDMC concluded that the UNITY study is unable to meet its primary endpoint. Safety was consistent with efgartigimod's established profile and no new safety signals were identified.

Luc Truyen, MD, PhD, Chief Medical Officer, argenx, said, "We are disappointed by this outcome, most of all for people living with Sjögren's disease, who are still waiting for treatments that fundamentally change the course of their disease. Sjögren's Disease is one of the most heterogeneous and complicated diseases in immunology, and unraveling the biology of complex diseases is at the heart of what we do. We will analyse these data in depth and share what we learn with the Sjögren's community. We are grateful to the patients, families, investigators and site staff who made this study possible."

Following study close and database lock, argenx will conduct a comprehensive analysis of the data to understand the study's outcome and generate insights that may inform future research in Sjögren's disease.

UNITY is a phase 3, randomised, 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 randomised 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.