Earlier this month, The Lancet Neurology published results from its PATH study (Polyneuropathy And Treatment with Hizentra), which showed efficacy in treating people with chronic inflammatory demyelinating polyneuropathy (CIDP).
Great news and hope for the CIDP community!
Chronic inflammatory demyelinating polyneuropathy is a rare neurological disorder characterized by inflammation of nerve roots and peripheral nerves and destruction of the myelin sheath. This affects how fast the nerve signals are transmitted and leads to loss of nerve fibers.
The study showed that 81% of patients treated with a high dose of Hizentra and 67% treated with a low dose remained relapse-free for up to 24 weeks!
Furthermore, the study demonstrated that 39% of patients on low-dose and 33% of patients on high-dose Hizentra experienced a CIDP relapse or withdrew from the study over a 24-week treatment period compared with 63% of patients on placebo.
“Subcutaneous administration of immunoglobulin has gained popularity as an alternative route of administration but has never been rigorously examined for the treatment of CIDP until the PATH study,” said Prof. Dr. Ivo N. van Schaik, principal investigator, lead author of The Lancet Neurology publication. “In this groundbreaking study, Hizentra maintained stable disease and prevented relapse, suggesting that subcutaneous immunoglobulin may be used as an alternative maintenance therapy to intravenous immunoglobulin in CIDP patients.”
The drug treatment at the center of the study, Hizentra, is a subcutaneously administered immunoglobulin (SCIG) that is currently approved in 51 countries for the treatment of certain immune deficiencies.
It can be self administered, providing patients an easier and flexible treatment option.
Based on the PATH study data, CSL Behring submitted applications to regulatory authorities in the United States and European Union, among other countries, for a CIDP indication.