Treatment with intravenous 10% caprylate/chromatography purified human immune globulin (IVIG-C) does not seem to be effective in reducing the dose of daily corticosteroids needed by patients with myasthenia gravis. This is according to a new study published in the journal Neurology

Based on this finding, the authors of the study concluded that the effects of the 2 treatments “are not synergistic and may be mechanistically different.”

To explore whether IVIG-C could facilitate corticosteroid dose reduction in myasthenia gravis patients who are dependent on the drug, a team led by Elsa Mondou, MD, from the Grifols Bioscience Research Group at Research Triangle Park, North Carolina, conducted a multicenter, randomized, double-blind, placebo-controlled clinical trial in 60 corticosteroid-dependent patients with generalized myasthenia gravis. Participants were 18 to 85 years of age.

Read more about the treatment of myasthenia gravis

The participants were given either a loading dose of 2 g/kg of IGIV-C over 2 days or a placebo at the start of the trial. This was followed by maintenance doses of 1 g/kg of IGIV-C or placebo administered every 3 weeks for 36 weeks. Corticosteroid treatment was tapered from week 9 but stopped or increased if the patient’s condition worsened.

The primary outcome measure was the percentage of participants achieving at least a 50% reduction in the dose of corticosteroid they needed from the start of the trial to week 39.

Secondary outcome measures were the mean percent change in the daily dose of corticosteroid from the start of the trial to week 39 and the median time to the first episode of disease worsening from the start of the trial to week 39.

The results showed that IVIG-C was well-tolerated, but there was no significant difference in the corticosteroid dose reduction between patients being treated with IVIG-C and those given placebo. There was also no significant difference between the 2 groups of patients in terms of secondary endpoints.

References

Bril V, Szczudlik A, Vaitkus A, et al. A randomized, double-blind, placebo-controlled trial of the corticosteroid-sparing effects of immunoglobulin in myasthenia gravis. Neurology. Published online October 21, 2022. doi:10.1212/WNL.0000000000201501

Efficacy and safety of IGIV-C in corticosteroid dependent patients with generalized myasthenia gravis. US National Library of Medicine. June 17, 2015. Updated March 30, 2020. Accessed November 1, 2022.