June 27, 2012
/PRNewswire/ -- Data presented today from the Privigen Impact on Mobility and Autonomy (PRIMA) trial at the Peripheral Nerve Society Inflammatory Neuropathy Consortium Meeting in
, suggests that treatment with Privigen® [Immune Globulin Intravenous (Human), 10% Liquid], an intravenous immunoglobulin (IVIg), may lead to improvement in function in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
PRIMA, a prospective, multicenter, open-label, single-arm study investigating the efficacy and safety of Privigen in previously IVIG-treated and untreated patients with CIDP achieved its primary efficacy endpoint, which was the percentage of patients responding—as measured by the Inflammatory Neuropathy Cause and Treatment (INCAT) scale—at study completion compared to baseline. The overall response rate was 60.7 percent. The 25-week treatment period permitted the observation that a response to IVIG can occur late (i.e., after more than 6 weeks of therapy). This finding may encourage some treating physicians to continue IVIG therapy longer in their CIDP patients before assessing whether or not the therapy is working.
"CIDP is a rare, progressive disease that may cause permanent nerve damage and studies show that current treatment options may not work for all patients," said
, M.D., Hospital de la Salpetriere. "Finding new treatment options to slow the advancement of the disease is extremely important. The results from this study are promising as they suggest that Privigen may help decrease weakness and loss of motor function in people with CIDP."
Functional improvement was evaluated by the INCAT scale, which is used to measure a patients' ability to perform tasks (i.e., walking, motor hand tasks, etc.). On this scale, patient scores rise with increasing weakness and disability, whereas improvement in basic motor functions is indicated by a reduction in the score. Results presented today showed that mean overall INCAT score significantly improved from 3.7 at baseline to 2.3 at completion of treatment. Half of the responders achieved the clinically meaningful threshold by Week 4.