The prospective, multicenter, single-arm, open-label phase III PRIMA trial has evaluated the efficacy and safety of Privigen ( 10% liquid human intravenous immunoglobulin [ IVIG ], stabilized with L-proline ) in patients with chronic inflammatory demyelinating polyneuropathy ( CIDP ).
Patients received one induction dose of Privigen ( 2 g/kg body weight ) and up to seven maintenance doses ( 1 g/kg body weight ) at 3-week intervals.
The primary efficacy endpoint was the responder rate at completion, defined as improvement of greater than or equal to 1 point on the adjusted Inflammatory Neuropathy Cause and Treatment ( INCAT ) disability scale.
The preset success criterion was the responder rate being greater than or equal to 35%.
Of the 31 screened patients, 28 patients were enrolled including 13 ( 46.4% ) IVIG-pretreated patients.
The overall responder rate at completion was 60.7%. IVIG-pretreated patients have demonstrated a higher responder rate than IVIG-naïve patients ( 76.9% vs 46.7% ).
The median INCAT score improved from 3.5 points at baseline to 2.5 points at completion, as did the mean and the median Medical Research Council sum score ( 67.0 vs 75.5 points ).
Of 108 adverse events ( 0.417 adverse reactions per infusion ), 95 adverse events ( 88.0% ) were mild or moderate in intensity and resolved by the end of study.
Two serious adverse reactions of hemolysis were reported that resolved after discontinuation of treatment. Thus, Privigen provided efficacious and well-tolerated induction and maintenance treatment in patients with chronic inflammatory demyelinating polyneuropathy. ( Xagena )
Léger JM et al, J Peripher Nerv Syst 2013; 18:130-140