argenx Publishes ADHERE Study Data in The Lancet Neurology on Chronic Inflammatory Demyelinating Polyneuropathy

Researchers have published the results of the pivotal ADHERE Study, the largest clinical trial to date for chronic inflammatory demyelinating polyneuropathy (CIDP), in The Lancet Neurology. CIDP is a rare and debilitating autoimmune disease affecting the peripheral nervous system, often resulting in progressive muscle weakness and sensory loss. The trial focused on evaluating the efficacy of VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), an FDA-approved treatment specifically for CIDP and generalized myasthenia gravis (gMG).

ADHERE was a multicenter, randomized, double-blind, placebo-controlled trial involving 322 adult patients diagnosed with CIDP. Participants were divided into two stages: an initial open-label Stage A, followed by a randomized, placebo-controlled Stage B. To be eligible for the trial, patients had to demonstrate active disease through various clinical assessments such as INCAT, I-RODS, or grip strength tests. Those showing clinical improvement with VYVGART Hytrulo during Stage A advanced to Stage B, where they were randomly assigned to receive either the drug or a placebo for up to 48 weeks.

Key findings from the ADHERE study showed that VYVGART Hytrulo significantly reduced the risk of disease relapse by 61% compared to placebo. This was measured through the hazard ratio for time to first adjusted INCAT deterioration, with a primary endpoint p-value of less than 0.0001. The treatment also demonstrated a 53.7% reduction in disease progression based on the time-to-first ≥4-point decrease in I-RODS score compared to baseline. Furthermore, the drug exhibited a rapid onset of action, with initial improvement in clinical metrics observed within nine days for the fastest-responding patients.

The safety profile of VYVGART Hytrulo remained consistent with previous studies and real-world usage, showing it was well-tolerated. Common side effects included respiratory tract infections, headaches, and urinary tract infections, but no new or unexpected safety concerns were identified. Remarkably, 99% of trial participants opted to continue receiving VYVGART Hytrulo in the open-label extension of the study.

VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20 (rHuPH20), which facilitates the delivery of the drug. By targeting the neonatal Fc receptor (FcRn), VYVGART Hytrulo significantly reduces circulating IgG levels, which are believed to play a key role in the pathogenesis of CIDP.

Dr. Luc Truyen, Chief Medical Officer of argenx, highlighted the transformative impact of VYVGART Hytrulo on patients' lives since its approval in June 2024. He emphasized that the publication of the ADHERE study not only advances scientific understanding of CIDP but also paves the way for future innovations in treating this and other autoimmune diseases.

CIDP affects approximately 24,000 patients in the U.S. and can severely impact daily functioning. Without effective treatment, about one-third of those affected may eventually require a wheelchair. The publication of the ADHERE study marks a significant milestone in addressing the unmet medical needs of CIDP patients, offering new hope for improved disease management and quality of life.

argenx, the global immunology company behind VYVGART Hytrulo, is dedicated to improving the lives of those suffering from severe autoimmune diseases. Through its Immunology Innovation Program, argenx collaborates with leading academic researchers to develop a portfolio of novel antibody-based treatments. The company continues to evaluate efgartigimod in various autoimmune conditions and is advancing several early-stage experimental medicines within its therapeutic franchises.