medwireNews: Phase 3 trial results suggest that intravenous immunoglobulin (IVIG) may be a promising treatment option for patients with dermatomyositis (DM).
As reported at the EULAR 2021 Virtual Congress, the study involved 95 participants (median age 53 years, 75% women) with definite or probable DM and active disease who were randomly assigned to receive 16 weeks of double-blind treatment with high-dose IVIG 10% (2 g/kg once every 4 weeks) or placebo.
Rohit Aggarwal (University of Pittsburgh, Pennsylvania, USA) and ProDERM co-investigators found that the proportion of patients with a treatment response at week 16 was significantly higher in the IVIG group compared with the placebo group, at 78.72% versus 43.75%. Responders were defined as patients with a Total Improvement Score (TIS) of at least 20 points according to the 2016 ACR/EULAR myositis response criteria.
The average TIS at week 16 was also significantly higher among patients treated with IVIG versus placebo (48.4 vs 21.6 points), as was the proportion of patients with at least a moderate (68.1 vs 22.9%) or major (31.9 vs 8.3%) response according to the ACR/EULAR criteria.
Aggarwal explained that following the double-blind treatment period, placebo-treated patients switched to open-label IVIG for a 24-week open-label extension period, while IVIG-treated patients without confirmed deterioration continued to receive the same treatment.
At the end of the extension period (study week 40), the proportion of patients with a TIS response was maintained in the IVIG group, at 71.1%, and rose to 69.6% in those who switched from placebo to IVIG.
In all, 65.3% of participants experienced treatment-emergent adverse events (TEAEs), most commonly headache, pyrexia, and nausea. The presenter said that the proportion of participants with serious TEAEs during the double-blind period was similar in the IVIG and placebo arms, at 5.8% and 4.2%, respectively.
Taken together, the ProDERM results “clearly confirmed the efficacy, safety, and tolerability of IVIG in patients with dermatomyositis,” concluded Aggarwal.
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