PNS Congress 2023
Peripheral Nerve Society 2023 Annual Meeting
Octapharma is proud to support the Peripheral Nerve Society (PNS) 2023 Annual Meeting!
Through this page, you will access detailed information about Octapharma's most recent Phase III clinical studies with IVIG in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Dermatomyositis (DM), as well as some additional insights on Dermatomyositis and our IVIG products, panzyga® and octagam®, now approved for the treatment of CIDP and DM respectively.
Efficacy and Safety of IVIG in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic inflammatory demyelinating polyneuropathy (CIDP) is an immune mediated neuropathy characterised by progressive weakness and impaired sensory function in the limbs.
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 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®.
Efficacy, Tolerability and Safety of IVIg (octagam® 10%) in Adult Patients with Active Dermatomyositis
Dermatomyositis is a rare, idiopathic autoimmune disorder, with patients commonly suffering from skin rashes, chronic muscle inflammation and progressive muscle weakness.
The ProDERM study was a double-blind, placebo-controlled randomised trial that investigated the efficacy and safety of octagam® 10% in adults with dermatomyositis. A significantly higher proportion of the patients randomised to octagam® 10% showed a response to treatment compared with the placebo group in the initial 16-week period (79% vs 44%, p=0.0008).
Based on the results from the phase ProDERM study, the U.S. Food and Drug Administration (FDA) has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis.
Octagam® 10% has also been approved for the treatment of dermatomyositis in the EU and is indicated for use in adults with active dermatomyositis treated with immunosuppressive drugs, including corticosteroids, or with intolerance or contraindications to those drugs.