OCTAPHARMA has announced that results from the ProCID study were shared for the first time as a poster presentation during the virtual American Academy of Neurology (AAN) 2020 annual meeting.
ProCID was the first prospective study to compare different maintenance doses of Panzyga (NewGam), an intravenous immunoglobulin (IVIg) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
IVIg is the most common first-line therapy for patients with CIDP, a rare autoimmune-mediated polyneuropathy. The standard treatment regimen is a 2.0 g/kg loading dose followed by a 1.0 g/kg maintenance dose every three weeks. Guidelines recommend titrating IVIg maintenance dose and frequency to suit the individual patients’ needs 1.
However, most clinical studies have assessed only a single maintenance dose of IVIg and only one small prospective, randomized study to date has compared different doses 2 . Studies of IVIg maintenance doses beyond the standard 1.0 g/kg are therefore of great clinical interest.
The ProCID study assessed the efficacy of Panzyga ® in this large study of IVIg in CIPD patients: It is the largest clinical trial to have analysed a lower and a higher maintenance dose of IVIG compared to the 1 g/kg standard dose.
The ProCID study was a prospective, double-blind, randomised, multi-centre phase III study that assessed the efficacy and safety of Panzyga ® in patients with CIDP and compared two different maintenance dosages of Panzyga ® (a higher one of 2.0 g/kg and a lower one of 0.5 g/kg) with the standard dosing scheme of 1.0 g/kg every 3 weeks. The study enrolled 142 patients from 25 sites in 9 countries. The results of the study confirmed the efficacy of Panzyga in adults with CIDP at the standard dose of 1.0 g/kg every 3 weeks. Almost 80% (55/69) of patients responded to treatment with a decrease of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (INCAT) disability score by the end of the 24-week treatment period. Results also suggested a dose response with a greater proportion of patients responding with increasing doses of Panzyga: 64.7%, 79.7% and 91.7% of patients were considered responders on the adjusted INCAT score in the 0.5, 1.0 and 2.0 g/kg treatment groups, respectively. Panzyga was generally well tolerated.
Professor David Cornblath of John Hopkins University School of Medicine, presenting author of the poster and Chair of the ProCID Study Steering Committee, commented “In this large study comparing 3 different IVIg maintenance doses in CIDP, the results suggest a dose-dependent response to Panzyga.
This dose response is observed in the primary as well as the secondary efficacy endpoints. The results are important to clinicians as they consider the best dose of IVIg to maximize patient benefit. I am certain this study will be widely discussed.”
Olaf Walter, Board Member at Octapharma, added “the new insights that ProCID provided on different dosing regimens will help doctors to tailor better the CIDP therapies to the patients’ individual needs. We are proud to contribute to expanding treatment options for this patient group as part of our mission to improve the lives of patients.”
The results of the ProCID study confirm the efficacy and safety of Panzyga ® in patients with CIDP and suggest that the standard dosing regimen may not be optimal in some patients. The important results from this study will help doctors determine the right dose for their patients.
– May 20, 2020 @ 13:09 GMT /