32516 Efficacy of intravenous immunoglobulins (IVIG) in improving muscle and skin symptoms in dermatomyositis patients. Results of a large, randomized, placebo-controlled international phase III trial (ProDERM)

Abstract

Dermatomyositis (DM) is a rare chronic systemic autoimmune disease with characteristic skin rashes and progressive proximal muscle weakness. The ProDERM study evaluated the efficacy and safety/tolerability of IVIG (Octapharma) in DM patients in a double-blind, randomized, placebo-controlled, international, phase III clinical trial consisting of a First Period (16 weeks; double-blind, placebo-controlled) and subsequent Extension Period (24 weeks; open label – all IVIG). Patients received a total of 10 infusions (only IVIG or placebo-IVIG).