Inebilizumab for Treatment of IgG4-Related Disease Save

Inebilizumab is an monoclonal antibody that targets and depletes CD19+ B cells and has been studied in adults with IgG4-related disease. A phase 3, double-blind, randomized, placebo-controlled trial, and was shown to reduce IgG4-related disease Flares and increased the odds of complete remission at 1 year.

 

A total of 135 IgG4-related disease patients were randomized (1:1) to receive inebilizumab (300-mg intravenous infusions on days 1 and 15 and week 26) or placebo for a 52-weeks. Both groups received identical glucocorticoid tapers. The primary end point was flare rates, followed by treatment-free and glucocorticoid-free complete remission.

 

Inebilizumab had significantly fewer flares (10% vs 60%) compared to placebo.  group (hazard ratio, 0.13; 95% confidence interval [CI], 0.06 to 0.28; P<0.001).  

 

Flare-free, treatment-free complete remission was more frequently achieved with inebilizumab than placebo group (odds ratio, 4.68; 95% CI, 2.21 to 9.91; P<0.001).   However, there were more serious adverse events (SAE) inebilizumab (18% vs 9%) compared to placebo.

 

Targeting CD19-B-cell for depletion iss a potent treatment option for patients iwth IgG4-related disease.