A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III TRIAL OF IVIG 10% IN PATIENTS WITH DERMATOMYOSITIS. THE PRODERM STUDY: RESULTS ON EFFICACY AND SAFETY
Authors: R. Aggarwal et al.
Current therapies of adult dermatomyositis (DM) encompass corticosteroids, other immunosuppressants and intravenous immunoglobulins (IVIg). None of these therapies is however are proven by randomized controlled phase 3 studies.
In an international multi-center, phase III clinical trial, DM patients were randomized 1:1 to either high dose IVIg (2g/kg every 4 weeks) or placebo. To be included, subjects must have active DM with a manual muscle testing score < 142/150. The primary endpoint was the proportion of responders in the IVIg vs. placebo arm at week 16. Response was defined per 2016 ACR/EULAR Myositis response criteria of at least minimal improvement and without clinical worsening at 2 consecutive visits up to week 16.
The study met the primary endpoint at week 16, with the proportion of responders being significantly higher in the IVIg group (78.7%) as compared to the placebo group (43.8%; p-value 0.0008).
A 45.2% higher response rate for at least moderate improvement, and a 23.6% higher response rate for at least major improvement was also observed in the IVIG group as compared to placebo.
This is the first large international phase III randomized, placebo-controlled trial demonstrating the efficacy and safety of IVIg as a treatment for patients with DM.