Subcutaneous Immune Globulin Effective as Maintenance Treatment in Chronic Inflammatory Demyelinating Polyneuropathy

A pivotal multinational, Phase III, placebo-controlled study demonstrated both low-dose and high-dose therapy with a licensed, self-administered subcutaneous immune globulin (SCIG) product was efficacious and well-tolerated as maintenance treatment for patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Approximately two-thirds of patients with CIDP currently need long-term intravenous IG (IVIG) therapy.

One hundred and seventy two adults with definite or probable CIDP who responded to IVIG treatment were randomly allocated in a 1:1:1 ratio to weekly maintenance treatment with 0.2 g/kg or 0.4 g/kg of CSL Behring’s Hizentra 20% SCIG product or placebo (2% human albumin solution). The Polyneuropathy And Treatment with Hizentra (PATH) study met its primary endpoint, with 39 percent and 33 percent of patients on low- and high-dose Hizentra regimens experiencing a CIDP relapse or withdrawing from the study over a 24-week treatment period, compared with 63 percent of patients on placebo (p = 0.007 and 0.001, respectively). Additionally, the study found that 81 percent and 67 percent of high- and low-dose patients, respectively, remained relapse-free for up to 24 weeks.

Both SCIG dose regimens were well-tolerated. Local reactions accounted for most adverse events, and all were either mild (95 percent) or moderate (5 percent). “Hizentra maintained stable disease and prevented relapse, suggesting that subcutaneous immunoglobulin may be used as an alternative maintenance therapy to intravenous immunoglobulin

Editor’s note: In March, CSL Behring’s Hizentra was approved by the U.S. Food and Drug Administration for the treatment of CIDP as maintenance therapy to prevent relapse of neuromuscular disability and impairment.