New Study Shows Possible Improvement for CIDP Patients
- By BSTQ Staff
New study results suggest 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).
The Privigen Impact on Mobility and Autonomy (PRIMA) trial at the Peripheral Nerve Society Inflammatory Neuropathy Consortium Meeting in Rotterdam, Netherlands, a prospective, multicenter, open-label, single-arm study, investigated the efficacy and safety of Privigen in previously IVIG-treated and untreated patients with CIDP. The study 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 with 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 six weeks of therapy).
The INCAT scale is used to measure a patient’s 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 from this study showed that the 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 four. 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 Jean-Marc Leger, MD, 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.”
