NEJM: Intravenous immunoglobulin Octagam for dermatomyositis (ProDEMM study)

In 2021, the US FDA approved the marketing of human intravenous immunoglobulin Octagam 10% for the treatment of adult dermatomyositis

Octagam 10% is an intravenous (human) liquid preparation

This approval is based on the positive results

The trial, which enrolled 95 patients in 36 locations worldwide, was the largest study

During the initial treatment period for the first 16 weeks, patients were randomly assigned to receive high-dose Octagam 10% or placebo therapy, followed by an open-label extended period

The primary endpoint was defined as a total improvement score (TIS) of at least 20 at week 16 (indicating at least minimal improvement) indicating response to treatment and no confirmation of deterioration

The results show:

At week 16, the response rate was 78.

After switching to Octagam 10% during the extended period, the placebo group also achieved a similar response rate to the treatment group at week 40 (a minimum improvement of about 70%).

Figure: TIS improved at 40 weeks after the extended placebo group switched to Octagam

In addition, in terms of secondary endpoints, the treatment group achieved all score improvements except muscle enzymes, including cutaneous dermatomyositis disease area and severity index (CDASI) scores, all of which were statistically significant improvements compared with placebo, and were safe and well

These results suggest that Octagam has a good remission rate of 10% in the treatment of patients with dermatomyositis and is expected to be an important treatment option

Currently, Octagam 10% [Immune Globulin Intravenous (Human)] is developed by Octapharma USA, the first and only intravenous immunoglobulin (IVIg) used to treat dermatomyositis (DM)

Original Source:

Trial of Intravenous Immune Globulin in Dermatomyositis.