Phase 3 Trial Shows Intravenous Immunoglobulin Therapy Safe and Effective for Adult Patients With Dermatomyositis

Intravenous immunoglobulins (IVIG) treatment was found to be safe and effective for patients with dermatomyositis, according to study results presented at the European Alliance of Associations for Rheumatology (EULAR) 2021 Virtual Congress, held between June 2 and 5, 2021.

In the double-blind placebo-controlled study, patients with definite or probably dermatomyositis were randomly assigned to receive 2 g/kg of IVIG every 4 weeks or placebo. Patients receiving placebo and those without clinical worsening after administration of IVIG were enrolled into the open-label extension period of the study at 24 weeks.

A total of 95 adult patients with dermatomyositis (47 receiving IVIG and 48 receiving placebo) were included in the analysis. Mean age of study participants was 53 years; 75% were women; 92% were White. At week 16, the primary endpoint was achieved, with the percentage of responders being significantly higher in the treatment vs placebo group (78.7% vs 43.8%, respectively; P =.008).

At week 16, the researchers observed a 45.2% higher response rate for at least moderate improvement (P <.0001) and a 23.6% higher response rate for at least major improvement (P <.0062) in the treatment vs placebo group. The overall mean Total Improvement Score was also significantly higher in the IVIG (48.4±24.2) vs placebo (21.6±20.2) group at week 16.

At 24 weeks, patients in the placebo group who entered the extension period of the study and received 2 g/kg of IVIG every 4 weeks had similar responses at week 40 as that of the initial treatment group at week 16 (ie, 70% for minimal improvement).

Secondary endpoints, which included all the sub-components of Total Improvement Score, except muscle enzyme and Cutaneous Dermatomyositis Disease Area and Severity Index, also showed statistically significant improvements in the treatment vs placebo group. The safety and tolerability profiles were consistent with previous reported safety outcomes for IVIG.

According to the researchers, “This is the first large international phase [3] randomized, placebo-controlled trial demonstrating the efficacy and safety of [IVIG] as a treatment for patients with [dermatomyositis].”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Aggarwal R, Charles-Schoeman C, Schessl J, et al. A randomized, double-blind, placebo-controlled phase III trial of IVIg 10% in patients with dermatomyositis the ProDERM study: results on efficacy and safety. Presented at: EULAR 2021 Virtual Congress; June 2-5, 2021. Abstract #OP0008.