Trial reportArthritis research & therapy2024
Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study.
Trial report in Arthritis research & therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02728752 (Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis), which is not on this map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM Study")
Who cites it
15 citing papers in PubMed, 18 citations in OpenAlex.
- Pharmacokinetics, Safety, and Tolerability of Single-Dose Dazukibart in Healthy Adults in China and Japan: Results From 2 Randomized, Double-Blind, Phase 1 Studies.Clinical pharmacology in drug development · 2025Trial
- Predictors of response to intravenous immunoglobulin in patients with dermatomyositis: the ProDERM study.Rheumatology (Oxford, England) · 2025Trial
- Early detection and intervention in dermatomyositis: current evidence and clinical implications.Clinical rheumatology · 2026Review
- Myopathies in clinical care: a focus on treatable causes.Journal of neural transmission (Vienna, Austria : 1996) · 2026Review
- Increased severity and relapse rate in adult anti-nuclear matrix protein 2 antibody positive myositis patients with distal limb weakness: a retrospective study in China.Frontiers in medicine · 2026Article
- Dermatomyositis: Prevalence, Clinical Spectrum, Diagnostic Approach, and Management Strategies.Archives of internal medicine research · 2026Article
- A retrospective natural history study in adult and juvenile patients with incident dermatomyositis and polymyositis using real world data.Clinical rheumatology · 2025Observational
- Efficacy of Intravenous Immunoglobulin for Systemic Manifestations of Dermatomyositis Beyond Muscular and Cutaneous: Sub-analysis of the ProDERM Study.Rheumatology and therapy · 2025Article
- Integrative Approaches to Myopathies and Muscular Dystrophies: Molecular Mechanisms, Diagnostics, and Future Therapies.International journal of molecular sciences · 2025Review
- Progressive Muscle Weakness and Dysphagia in Late-Onset Systemic Lupus Erythematosus: A Case Report.Cureus · 2025Article
- Characteristics of adverse events and clinical risks of intravenous immunoglobulin: a pharmacovigilance study based on FDA Adverse Event Reporting System (FAERS).Frontiers in medicine · 2025Article
- Systemic capillary leak syndrome.Nature reviews. Disease primers · 2024Review
- Pharmacological Strategies in Dermatomyositis: Current Treatments and Future Directions.Medical science monitor : international medical journal of experimental and clinical research · 2024Review
- Anti-TIF1-γ Antibody-Positive Dermatomyositis Leading to Identification of Diffuse Large B-Cell Lymphoma.Journal of general internal medicine · 2024Article
- Prevalence and Risk Factors of Thromboembolic Events in Dermatomyositis in China: A 10-Year Retrospective Analysis.Journal of inflammation research · 2024Article
Corrections and comments
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Authors and funding
14 authors at 11 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDermatomyositis is an idiopathic inflammatory myopathy characterised by rashes and progressive muscle weakness. The recent ProDERM (Progress in DERMatomyositis) study is the first large randomised, placebo-controlled trial to establish the efficacy and safety of intravenous immunoglobulin (IVIg) in adult patients with dermatomyositis. Objectives of this analysis were to closely examine the safety and tolerability of IVIg in patients from the ProDERM study.
methodsProDERM was a double-blind, randomised, placebo-controlled, multicentre, phase 3 study. In the first period (weeks 0-16), adults with active dermatomyositis received 2.0 g/kg IVIg (Octagam 10%; Octapharma AG) or placebo every 4 weeks. In the open-label extension period (weeks 16-40), all patients received IVIg for 6 additional cycles; dose reduction (1.0 g/kg) was permitted if patients were stable. Treatment-emergent adverse events (TEAEs) were documented.
resultsThe 95 patients enrolled were randomised to receive IVIg (N = 47) or placebo (N = 48) in the first period, with 5 switching from placebo to IVIg. Overall, 664 IVIg infusion cycles were administered. During the first period, 113 TEAEs were possibly/probably related to treatment in 30/52 patients (57.7%) receiving IVIg and 38 in 11 patients (22.9%) on placebo. Eight patients discontinued therapy due to IVIg-related TEAEs. Eight thromboembolic events (TEEs) occurred in six patients on IVIg; six in five patients were deemed possibly/probably related to IVIg. Patients with TEEs exhibited more baseline TEE risk factors than those without TEEs (2.4-15.2-fold higher). Lowering infusion rate reduced the rate of TEEs, and none occurred at the lower IVIg dose. No haemolytic transfusion reactions or deaths occurred.
conclusionsResults from this study demonstrate that IVIg has a favourable safety profile for treatment of adult dermatomyositis patients and provides evidence that will help to inform treatment choice for these patients. Dermatomyositis patients receiving high-dose IVIg should be monitored for TEEs, and a low rate of infusion should be used to minimise TEE risk, particularly in those with pre-existing risk factors.
trial registrationProDERM study (NCT02728752).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.