Intravenous Immune Globulin in Dermatomyositis Save

Few drugs have been studied well in the treatment of dermatomyositis (DM) and only recently has intravenous immune globulin (IVIG) been granted FDA approval for the treatment of DM, based on this pivotal trial.

A randomized, placebo-controlled trial of IVIG versus placebo was studied in 95 patients with active dermatomyositis. The IVIG dose was 2.0 g per kilogram of body weight or every 4 weeks for 16 weeks.  Patients in both arms (without confirmed clinical deterioration) were continued in open-label extension phase for another 24 weeks. The primary end point was defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. (TIS scores range from 0 to 100, with higher scores indicating greater improvement).

At 16 weeks, a response was seen in:

• IVIG 79%
• Placebo 44 (P<0.001).

Secondary end points similarly favored IVIG over PBO.

Over 40 weeks, there were numerous adverse events in the IVIG group, including headache (42%), pyrexia (19%), and nausea (16%). there were 9 serious adverse events that included 6 thromboembolic events.

These data document the efficacy and safety concerns for IVIG in patients with active DM.