Intravenous Immunoglobulin Demonstrates Efficacy in Treating Cutaneous Symptoms of Dermatomyositis

A recent Phase 3 clinical trial known as ProDERM has provided robust evidence supporting the use of intravenous immunoglobulin (IVIg) in treating the cutaneous symptoms of dermatomyositis (DM). Dermatomyositis is a rare autoimmune disease characterized by skin involvement. This study was published in The Lancet by Victoria P. Werth and colleagues.

In this double-blind, randomized, multicenter trial, adult patients with active DM were administered 2.0 g/kg of IVIg (Octagam 10%; Octapharma AG) or a placebo every 4 weeks during the first period of the study (Weeks 0–16). The subsequent open-label extension period (Weeks 16–40) involved all patients receiving IVIg for an additional 6 cycles. The efficacy of IVIg was assessed using various measures, including the modified cutaneous DM disease area and severity index activity (CDASI-A) and damage (CDASI-D) scores, as well as the myositis disease activity assessment tool (MDAAT), which includes a visual analogue scale (VAS).

• The study, conducted from February 2017 to November 2019, enrolled 95 patients who were randomly assigned to receive either IVIg (47 patients) or a placebo (48 patients) during the initial period.
  
• In total, 664 IVIg infusion cycles were administered, with a median dose of 2.0 g/kg. At Week 16, patients in the IVIg group showed a substantial mean CDASI-A change from baseline of -9.36 (95% CI: -12.52, -6.19), whereas the placebo group demonstrated a change of -1.16 (-3.32, 0.99), resulting in a highly significant difference (p < 0.0001).
• Similar improvements were observed in CDASI-D and the VAS of MDAAT. These positive outcomes were consistent across patients with varying degrees of disease severity at baseline.

ProDERM is the first large, prospective, and randomized trial to provide compelling evidence of IVIg's efficacy in improving the cutaneous manifestations of DM. IVIg treatment led to significant enhancements in dermatological symptoms, irrespective of the severity of the disease before treatment initiation. The study underscores the potential of IVIg as an effective therapeutic option for even the most severe cases of cutaneous DM. These findings represent a critical advancement in the management of DM, particularly its dermatological aspects, and may pave the way for improved treatment strategies for this challenging autoimmune condition.

Reference:

Werth, V. P., Aggarwal, R., Charles-Schoeman, C., Schessl, J., Levine, T., Kopasz, N., Worm, M., & Bata-Csörgő, Z. Efficacy of intravenous immunoglobulins (IVIg) in improving skin symptoms in patients with dermatomyositis: a post-hoc analysis of the ProDERM study. EClinicalMedicine,2023;64(102234):102234. https://doi.org/10.1016/j.eclinm.2023.102234