Trial reportRheumatology (Oxford, England)2021
Intravenous immunoglobulins as first-line treatment in idiopathic inflammatory myopathies: a pilot study.
Trial report in Rheumatology (Oxford, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05832034 (Treatment With add-on IVIg in Myositis Early In the diSease Course May be sUperior to Steroids Alone for Reaching CLinical improvemEnt), which is not on this map. Cited by 25 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Treatment With add-on IVIg in Myositis Early In the diSease Course May be sUperior to Steroids Alone for Reaching CLinical improvemEnt
Who cites it
25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- Non-targeted immunosuppressive and immunomodulatory therapies for idiopathic inflammatory myopathies.The Cochrane database of systematic reviews · 2025Pooled it
- Direct and indirect costs of idiopathic inflammatory myopathies in adults: A systematic review.PloS one · 2024Pooled it
- Efficacy and safety of rituximab treatment in patients with idiopathic inflammatory myopathies: A systematic review and meta-analysis.Frontiers in immunology · 2022Pooled it
- Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study.Arthritis research & therapy · 2024Trial
- Emerging therapies in idiopathic inflammatory myopathies.Journal of neuromuscular diseases · 2026Review
- International IVIg prescription patterns in idiopathic inflammatory myopathies: real-world insights from the MyoNet survey.EULAR rheumatology open · 2026Article
- FcRn Inhibitor Therapies in Neurologic Diseases.CNS drugs · 2024Review
- Pathogenic role and clinical significance of neutrophils and neutrophil extracellular traps in idiopathic inflammatory myopathies.Clinical and experimental medicine · 2024Review
- Immune-Mediated Necrotizing Myopathies: Current Landscape.Current neurology and neuroscience reports · 2024Review
- Non-viral delivery of nucleic acid for treatment of rare diseases of the muscle.Journal of biosciences · 2024Review
- Intravenous Immunoglobulin in Idiopathic Inflammatory Myopathies: a Practical Guide for Clinical Use.Current rheumatology reports · 2023Review
- Article
- B-cell receptor profiling before and after IVIG monotherapy in newly diagnosed idiopathic inflammatory myopathies.Rheumatology (Oxford, England) · 2023Article
- A Narrative Review of Acthar Gel for the Treatment of Myositis.Rheumatology and therapy · 2023Review
- TCRβ clones in muscle tissue share structural features in patients with idiopathic inflammatory myopathy and are associated with disease activity.Frontiers in immunology · 2023Article
- Ultrasound and MR muscle imaging in new onset idiopathic inflammatory myopathies at diagnosis and after treatment: a comparative pilot study.Rheumatology (Oxford, England) · 2022Article
- Assessment of disability in idiopathic inflammatory myopathy: a call for linearity.Rheumatology (Oxford, England) · 2022Article
- Pathophysiological Mechanisms and Treatment of Dermatomyositis and Immune Mediated Necrotizing Myopathies: A Focused Review.International journal of molecular sciences · 2022Review
- Antibody Therapies in Autoimmune Inflammatory Myopathies: Promising Treatment Options.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesWe explored efficacy and safety of IVIg as first-line treatment in patients with an idiopathic inflammatory myopathy.
methodsIn this investigator-initiated phase 2 open-label study, we included 20 adults with a newly diagnosed, biopsy-proven idiopathic inflammatory myopathy, and a disease duration of less than 9 months. Patients with IBM and prior use of immunosuppressants were excluded. The standard treatment regimen consisted of IVIg (Privigen) monotherapy for 9 weeks: a loading dose (2 g/kg body weight) and two subsequent maintenance doses (1 g/kg body weight) with a 3-week interval. The primary outcome was the number of patients with at least moderate improvement on the 2016 ACR/EULAR Total Improvement Score. Secondary outcomes included time to improvement, the number of patients requiring rescue medication and serious adverse events.
resultsWe included patients with DM (n = 9), immune-mediated necrotizing myopathy (n = 6), non-specific myositis/overlap myositis (n = 4) and anti-synthetase syndrome (n = 1). One patient was excluded from analyses because of minimal weakness resulting in a ceiling effect. Eight patients (8/19 = 42.0%; Clopper-Pearson 95% CI: 19.6, 64.6) had at least moderate improvement by 9 weeks. Of these, six reached improvement by 3 weeks. Seven patients required rescue medication due to insufficient efficacy and prematurely ended the study. Three serious adverse events occurred, of which one was pulmonary embolism.
conclusionFirst-line IVIg monotherapy led to at least moderate improvement in nearly half of patients with a fast clinical response in the majority of responders.
trial registrationNetherlands Trial Register identifier, NTR6160.
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Registered trials
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.