Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study
Authors' conclusion
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.
Study context
- Population
- Adults with active DM5 switched placebo to intravenous immunoglobulin (IVIg)
- Participants
- 95 adults
- Comparison
- IVIg 2.0 g/kg every 4 weeks vs placebo (weeks 0-16), then IVIg for all in open-label extension
- IVIgn = 47
- Placebon = 48reference
- Primary endpoint
- Safety and tolerability: TEAEs
Methodological detailsdouble-blind, placebo-controlled, multicentre, phase 3, open-label extension (weeks 16-40), 664 IVIg infusion cycles administered
- Double-blind
- Placebo-controlled
- Multicentre
- Phase 3
- Open-label extension (weeks 16-40)
- 664 IVIg infusion cycles administered
Primary result
As reported in the abstract
TEAEs possibly/probably related to treatment · first period (weeks 0-16)
| Group | Value | Related treatment-emergent adverse events (TEAEs) | Patients receiving IVIg |
|---|---|---|---|
| IVIg | 57.7% | 113 | 52 |
| Placebo | 22.9% | 38 |
Value
IVIg57.7%
Placebo22.9%
Related treatment-emergent adverse events (TEAEs)
IVIg113
Placebo38
Patients receiving IVIg
IVIg52
Placebo— not stated in the abstract
Safety
| Outcome | IVIg |
|---|---|
| Thromboembolic events (TEEs) | |
| TEEs | 8 |
| Possibly/probably related TEEs | 6 |
| Patients with related TEEs | 5 |
- Discontinuation due to IVIg-related TEAEs
- 8 · events
Thromboembolic events (TEEs)
- Patients with TEEs had more baseline TEE risk factors than those without (2.4-15.2-fold higher)
- Lowering infusion rate reduced TEE rate; none at the lower IVIg dose
Haemolytic transfusion reactions or deaths
- None occurred
- 0
Original publication
Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study. Arthritis Res Ther. Published 17 January 2024. doi:10.
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