Positive Topline Data Available on VYVGART Hytrulo for People Living with CIDP

 

In June 2023, the U.S. Food and Drug Administration (FDA) approved the use of VYVGART Hytrulo for people living with generalized myasthenia gravis (gMG), a chronic autoimmune neuromuscular disease that causes muscle weakness. But researchers have also been exploring the use of VYVGART Hytrulo for other indications. According to an article from RTTNews, biopharmaceutical company Zai Lab Ltd. and global immunology company argenx SE recently shared that positive topline data was available from the Phase 2 ADHERE study of VYVGART Hytrulo as a potential therapeutic option for chronic inflammatory demyelinating polyneuropathy (CIDP).

322 adults enrolled in the ADHERE study. To enroll, participants must have not been treated over the prior six months OR were currently using corticosteroids and immunoglobulin therapy. “Stage A,” which enrolled the full set of participants, was open label. The treatment was found to be safe and well-tolerated. While some side effects did occur, these were typically mild-to-moderate injection site reactions. VYVGART Hytrulo contributed to improvements in grip strength and inflammation.

Next, in the placebo-controlled “Stage B,” 221 people who had responded to treatment continued on. At week 24, 54% of people taking the placebo experienced a relapse compared to just 26% of those on VYVGART Hytrulo. By week 48, the rates rose to 60% and 34% respectively. People using VYVGART Hytrulo also had more time between relapse, more disease stabilization, and clinically meaningful functional improvement. Altogether, the research team suggests that the treatment reduces the risk of relapse by 61%.

About VYVGART Hytrulo

VYVGART Hytrulo is a subcutaneously administered infusion that contains a combination of efgartigimod alfa and hyaluronidase. The treatment works by binding to and blocking the neonatal Fc receptor (FcRn). FcRn is known to play a role in the development of autoantibodies. Since CIDP is believed to be an autoimmune disorder, autoantibodies can drive disease progression. Thus, binding to FcRn could reduce inflammation and other immune-related damage to the body. Learn more about VYVGART Hytrulo here.

About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Chronic inflammatory demyelinating polyneuropathy is a rare neurological disorder in which nerve roots and peripheral nerves become inflamed. At the same time, the protective covering of nerve fibers (called the myelin sheath) becomes damaged and destroyed. Nerve fibers are then unable to transmit signals, causing a number of physical, motor, and sensory symptoms. CIDP affects males 2x more than females and also typically manifests around age 50. However, this is a variable disease and can affect all age groups.

To diagnose CIDP, people must show symptoms for at least 8 weeks or more. Some individuals may experience constant symptoms, while others may experience periods of stability and relapse. Potential symptoms of CIDP may include:

  • Fatigue and general weakness
  • Voice changes such as slurred speech or hoarseness
  • Symmetrical muscle weakness in the hips, shoulders, hands, and feet
  • Loss of deep tendon reflexes
  • Dysphagia (difficulty swallowing)
  • Numbness or decreased sensation, burning, pain, or tingling
  • Incoordination
  • Difficulty walking or breathing
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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