About the ProDERM study
The ProDERM study (NCT02728752) was an international, multicenter, double-blind, randomized, placebo-controlled phase III clinical trial that investigated the efficacy, safety and tolerability of octagam® 10% in adults with dermatomyositis. In the initial 16-week placebo-controlled period, 95 patients from 36 sites in 10 countries were randomized to receive either octagam® 10% (2.0 g/kg) or placebo every four weeks. This was followed by an open-label extension period during which all patients received octagam® 10% for a further 24 weeks (excluding patients who had shown clinical worsening while receiving octagam® 10% in the first period). The primary endpoint was the proportion of patients who responded to treatment at Week 16.
About Octagam® 10%
Octagam® 10% [Immune Globulin Intravenous (Human)] is an immune globulin intravenous (human) liquid preparation indicated for the treatment of:
Chronic immune thrombocytopenic purpura (ITP) in adults
Dermatomyositis (DM) in adults
WARNINGS
THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam® 10%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of immune globulin intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam® 10% does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or renal failure, administer Octagam® 10% at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
About CIDP
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.
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®.
About Panzyga®
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 Octapharma
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 nearly 12,000 employees worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Hematology and Critical Care.
Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. Octapharma has 40 years of experience in patient care.