Predictors of response to intravenous immunoglobulin in patients with dermatomyositis: the ProDERM study
Authors' conclusion
IVIg was effective in treating DM patients regardless of demographic features and autoantibody status (for most autoantibodies). Patients with higher cutaneous disease activity and/or anti-TIF1-γ responded best to IVIg, while pulmonary disease activity predicted a lower, but still effective, IVIg response
Study context
- Population
- Patients with dermatomyositis (DM) in the phase 3 ProDERM study
- Participants
- 95 patients
- Comparison
- Baseline clinical and serological variables as predictors of total improvement score (TIS) response to intravenous immunoglobulin (IVIg)
- Primary endpoint
- Associations between baseline variables (including MDAAT organ involvement and myositis-specific and myositis-associated autoantibodies) and total improvement score (TIS)
- Follow-up
- Week 16 or 40
Methodological detailsprospective, placebo-controlled, open-label extension phase, univariate and multivariate analyses
- Prospective
- Placebo-controlled
- Open-label extension phase
- Univariate and multivariate analyses
Primary result
As reported in the abstract
Predictors of TIS response
- Univariate: no significant association between TIS and age, sex, ethnicity, disease duration/activity, cutaneous, skeletal, gastrointestinal or muscle disease activity, or previous failed or concomitant medications
- Multivariate: higher myositis disease activity assessment tool (MDAAT) cutaneous scores associated with better chance of at least minimal TIS improvement
- Multivariate: higher MDAAT pulmonary scores associated with a lower, but still considerable, chance of improvement
- TIF1-γ antibodies associated with better TIS response; after controlling for cutaneous disease activity, no significant association between antibody classification (including anti-TIF1-γ) and efficacy outcome
Original publication
Predictors of response to intravenous immunoglobulin in patients with dermatomyositis: the ProDERM study. Rheumatology (Oxford). Published 7 February 2025. doi:10.
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