Intravenous Immunoglobulin (Privigen) Effective, Well-Tolerated as Therapy for Chronic Inflammatory Demyelinating Polyneuropathy

In a prospective, multicenter, single-arm, open-label Phase III study, 61 percent of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) responded to induction and maintenance therapy with a 10% liquid human intravenous immunoglobulin (IVIG) (Privigen, CSL Behring), with response defined as improvement of greater than or equal to 1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. Patients received a single induction dose of Privigen (2 g/kg body weight) and up to seven maintenance doses of 1 g/kg each at three-week intervals. Of 31 screened patients, 28 were enrolled, including 13 (46.4 percent) who had previously been treated with IVIG.

At completion of this study, 76.9 percent of IVIG-pretreated patients were responders, in contrast to a response rate of 46.7 percent in IVIG-naïve patients. The median INCAT score improved from 3.5 (95 percent confidence interval, 3.0 to 4.5) points at baseline to 2.5 (1.0 to 3.0) points at completion. Improvements in the mean maximum grip strength (66.7 versus 80.9) and the median Medical Research Council sum score (67.0 versus 75.5) were also observed. Of 108 adverse events, 95 were mild or moderate in intensity and resolved by the end of the study.

The authors concluded that Privigen proved efficacious and well-tolerated as induction and maintenance treatment in patients with CIDP.