Efficacy of Intravenous Immunoglobulin for Systemic Manifestations of Dermatomyositis Beyond Muscular and Cutaneous: Sub-analysis of the ProDERM Study
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023728%3A_____%2F25%3AN0000030" target="_blank" >RIV/00023728:_____/25:N0000030 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11110/25:10500081
Result on the web
<a href="https://doi.org/10.1007/s40744-025-00775-5" target="_blank" >https://doi.org/10.1007/s40744-025-00775-5</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1007/s40744-025-00775-5" target="_blank" >10.1007/s40744-025-00775-5</a>
Alternative languages
Result language
angličtina
Original language name
Efficacy of Intravenous Immunoglobulin for Systemic Manifestations of Dermatomyositis Beyond Muscular and Cutaneous: Sub-analysis of the ProDERM Study
Original language description
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. 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. 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 constitutional VAS. With IVIg, the proportions of patients with arthritis (36.2 to 17.8%; P = 0.01), arthralgia (68.1 to 0.0%; P < 0.001), and fatigue (68.1 to 3.3%; P = 0.008) decreased from baseline to week 16. In the combined cohort, the proportions of patients with dysphonia (20.0 to 8.1%; P = 0.04), arthralgia (66.3 to 39.8%; P < 0.001), weight loss (10.5 to 3.4%; P = 0.04), fatigue (75.8 to 50.0%; P < 0.001), and dysphagia (40.0 to 18.4%; P < 0.001) decreased from baseline to week 40. VIg was effective in treating pulmonary, skeletal, constitutional, and gastrointestinal manifestations of dermatomyositis. We advocate exploring IVIg as treatment for dermatomyositis, beyond muscle and skin manifestations.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30226 - Rheumatology
Result continuities
Project
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Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
RHEUMATOLOGY AND THERAPY
ISSN
2198-6576
e-ISSN
2198-6584
Volume of the periodical
12
Issue of the periodical within the volume
5
Country of publishing house
GB - UNITED KINGDOM
Number of pages
7
Pages from-to
855-871
UT code for WoS article
001523352200001
EID of the result in the Scopus database
2-s2.0-105013774424