In the past, Hyqvia [immune globulin infusion 10% [human] with recombinant human hyaluronidase] was approved to treat people with primary immunodeficiencies (PIs) ages two and older. Now, following data from the Phase 3 ADVANCE-CIDP 1 and ADVANCE-CIDP 3 trials, the U.S. Food and Drug Administration (FDA) approved Hyqvia as a maintenance therapy for adults living with chronic inflammatory demyelinating polyneuropathy (CIDP).
Isabelle Ciconne, MPH, shared in Neurology Live that the trials explored how safe and effective the subcutaneous treatment is in treating CIDP. Findings from the study show that:
- Hyqvia showed significant benefits in preventing CIDP relapses, characterized by neuromuscular impairment.
- While intravenous immunoglobulin (IVIG) treatment has been used to prevent CIDP relapses, the research team found Hyqvia to be more easily accessible for patients. Infusions are long-lasting and prompt durable responses. Hyqvia can be dosed monthly and given in a variety of settings, promoting more easy infusions for patients and reducing the barriers to treatment that some people face.
- This treatment was safe, effective, and well-tolerated. However, some individuals experienced adverse reactions. These reactions included fevers, fatigue, nausea, itchiness, abdominal and back pain, and skin redness.
Understanding Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic inflammatory demyelinating polyneuropathy is a rare neurological disorder which causes:
- Nerve root and peripheral nerve inflammation
- Myelin sheath (the protective covering of nerve cells) destruction
As the nerves become inflamed, and the myelin sheath destroyed, nerve signals become slowed or blocked. Nerve fibers are lost and destroyed. Doctors don’t know exactly what causes CIDP, but the current hypothesis is that this is an autoimmune condition. Autoimmune disorders mean that the body’s immune system mistakenly attacks healthy body tissue. While CIDP can happen in people of all ages and genders, it affects males 2x more than females.
Symptoms of CIDP may, but do not always, include:
- Symmetric weakness of muscles around the hips, shoulders, hands, and feet
- Difficulty walking due to weakness or lack of feeling
- Fatigue
- Difficulty swallowing
- Reduced or absent deep tendon reflexes
- Abnormal or uncoordinated movement
- Double vision
- Sensation changes such as burning, tingling, pain, numbness, or decreased sensation
- Hoarseness or slurred speech
Additional treatments that might be leveraged for chronic inflammatory demyelinating polyneuropathy include corticosteroids or plasmapheresis.
