Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study
Jazyk angličtina Země Anglie, Velká Británie Médium electronic
Typ dokumentu randomizované kontrolované studie, multicentrická studie, klinické zkoušky, fáze III, časopisecké články, práce podpořená grantem
PubMed
38233885
PubMed Central
PMC10792872
DOI
10.1186/s13075-023-03232-2
PII: 10.1186/s13075-023-03232-2
Knihovny.cz E-zdroje
- Klíčová slova
- Dermatomyositis, Intravenous immunoglobulin, Myositis, Safety, Tolerability,
- MeSH
- dermatomyozitida * farmakoterapie MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- intravenózní imunoglobuliny škodlivé účinky MeSH
- intravenózní infuze MeSH
- lidé MeSH
- myozitida * chemicky indukované MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- intravenózní imunoglobuliny MeSH
BACKGROUND: Dermatomyositis 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. METHODS: ProDERM 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. RESULTS: The 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. CONCLUSIONS: Results 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 REGISTRATION: ProDERM study (NCT02728752).
Department of Dermatology and Allergology University of Szeged Szeged Hungary
Department of Neurology University of Kansas Medical Center Kansas City KS USA
Division of Clinical Immunology Faculty of Medicine University of Debrecen Debrecen Hungary
Division of Rheumatology Medical College of Georgia at Augusta University Augusta GA USA
Octapharma Pharmazeutika Produktionsges m b H Vienna Austria
Phoenix Neurological Associates Ltd Phoenix AZ USA
Tareev Clinic of Internal Diseases Sechenov 1st Moscow State Medical University Moscow Russia
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ClinicalTrials.gov
NCT02728752