Efficacy of Intravenous Immunoglobulin for Systemic Manifestations of Dermatomyositis Beyond Muscular and Cutaneous: Sub-analysis of the ProDERM Study

作者：Rohit Aggarwal, Joachim Schessl, Zsuzsanna Bata‐Csörgõ, Mazen M. Dimachkie, Zoltán Griger, Sergey Moiseev, Chester V. Oddis, Elena Schiopu, Jiří Vencovský, Elisabeth Clodi, Todd Levine, Christina Charles‐Schoeman, the ProDERM investigators · 发表于：Rheumatology and Therapy · 年份：2025 · DOI：10.1007/s40744-025-00775-5 · 被引用次数：3 · 研究领域：Inflammatory Myopathies and Dermatomyositis、Musculoskeletal Disorders and Rehabilitation、Muscle and Compartmental Disorders

INTRODUCTION: Muscle and skin involvement are well defined in dermatomyositis but other symptoms contribute significantly to the disease burden and their treatment is not well characterized. This post hoc analysis of ProDERM assessed the effect of intravenous immunoglobulin (IVIg) treatment on other manifestations of dermatomyositis beyond muscular and cutaneous involvement. METHODS: ProDERM was a randomized, placebo-controlled study. For weeks 0-16, patients with dermatomyositis received 2.0 g/kg IVIg (Octagam, 10%) or placebo every 4 weeks. Eligible patients entered the open-label extension, where all received IVIg to week 40. Pulmonary, skeletal, constitutional, gastrointestinal, and cardiovascular disease activity was assessed using the myositis disease activity assessment tool, comprising a visual analog scale (VAS; 0-10 cm) and myositis intention-to-treat activity index. RESULTS: Of 95 patients enrolled, 47 received IVIg and 48 received placebo to week 16. At baseline, 37.9% of patients experienced pulmonary, 64.2% experienced skeletal, 76.8% experienced constitutional, 33.7% experienced gastrointestinal, and 15.8% experienced cardiovascular involvement (VAS > 0.5). Among these patients, for those on IVIg, the following mean VAS scores decreased from baseline to week 16: pulmonary (37.7%; P = 0.001), skeletal (52.6%; P < 0.001), constitutional (44.4%; P < 0.001), and gastrointestinal (49.2%; P = 0.005). No corresponding improvement was seen with placebo except for const...