LACHEN, Zwitserland – (BUSINESS WIRE) – Octapharma heeft aangekondigd dat de resultaten van de ProCID-studie voor het eerst werden gedeeld als posterpresentatie tijdens de virtuele American Academy of Neurology (AAN) 2020 jaarlijkse bijeenkomst. ProCID was de eerste prospectieve studie waarin verschillende onderhoudsdoses van Panzyga® (NewGam), een intraveneus immunoglobuline (IVIg), werden vergeleken bij patiënten met chronische inflammatoire demyeliniserende polyneuropathie (CIDP).
IVIg is de meest voorkomende eerstelijnsbehandeling voor patiënten met CIDP, een zeldzame auto-immuungemedieerde polyneuropathie. Het standaardbehandelingsregime is een oplaaddosis van 2,0 g / kg, gevolgd door een onderhoudsdosis van 1,0 g / kg om de drie weken. Richtlijnen bevelen aan de IVIg-onderhoudsdosis en -frequentie te titreren om aan de individuele behoeften van de patiënt te voldoen1. In de meeste klinische onderzoeken is echter slechts één enkele onderhoudsdosis IVIg beoordeeld en tot dusver is in slechts één klein prospectief, gerandomiseerd onderzoek verschillende doses vergeleken2. Onderzoek naar IVIg-onderhoudsdoses boven de standaard 1,0 g / kg is daarom van groot klinisch belang. De ProCID-studie beoordeelde de werkzaamheid van Panzyga® in deze grote studie van IVIg bij CIPD-patiënten: het is de grootste klinische studie waarbij een lagere en een hogere onderhoudsdosis IVIG is geanalyseerd in vergelijking met de standaarddosis van 1 g / kg.
Final results from the ProCID study of efficacy and safety of 3 different dosages of Panzyga® (NewGam) in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) presented at AAN 2020
LACHEN, Switzerland–(BUSINESS WIRE)– 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’ needs1. However, most clinical studies have assessed only a single maintenance dose of IVIg and only one small prospective, randomised study to date has compared different doses2. 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.
CIDP is an immune mediated neuropathy characterised by progressive weakness and impaired sensory function in the limbs. In patients with CIDP, only 20-30% are cured while the rest require long term treatment3. Many suffer permanent disability. In addition to IVIg, other front-line therapy options include corticosteroids and plasma exchange.
Panzyga® is a 10% human normal immunoglobulin solution ready for intravenous administration. The manufacturing process achieves a significant viral reduction through a combination of three dedicated manufacturing process steps: solvent/detergent treatment, ion-exchange chromatography and nanofiltration (20 nm) and thus complies with the latest international consensus on best practices for viral safety. Panzyga® is approved for use in treatment of primary immunodeficiency and idiopathic thrombocytopenic purpura in several countries.
About the ProCID study
The ProCID study (NCT02638207) was a prospective, double-blind, randomized, parallel group, multi-center phase III study which investigated the efficacy and safety of Panzyga® in patients with CIDP at the standard maintenance dose (1.0 g/kg) and at a lower (0.5 g/kg) and a higher (2.0 g/kg) maintenance dose every 3 weeks for up to 24 weeks. The study was conducted across 25 sites and a total of 142 patients were enrolled and treated with Panzyga®.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy, and Critical Care.
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of approximately 8 million litres of plasma per annum.
In addition, Octapharma operates more than 140 plasma donation centres across Europe and the US.
1 van den Bergh PYK, Hadden RDM, Bouche P, et al. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society – first revision. Eur J Neurol 2010; 17: 356–63. https://doi.org/10.1111/j.1468-1331.2009.02930.x.
2 Kubori T, Mezaki T, Kaji R, et al. The clinical usefulness of high-dose intravenous immunoglobulin therapy for chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy. No To Shinkei 1999; 51: 127–35.
3 Gorson KC, van Schaik IN, Merkies ISJ, et al. Chronic inflammatory demyelinating polyneuropathy disease activity status, Recommendations for clinical research standards and use in clinical practice. J Peripher Nerv Syst 2010;15:326–33.