Inebilizumab for Treatment of IgG4-Related Disease

This phase 3, double blind, randomized trial evaluated the efficacy and safety of inebilizumab, a CD19 targeted Bcell depleting monoclonal antibody, in adults with active IgG4 related disease. Participants (n=135) received inebilizumab (300 mg IV) or placebo on days 1, 15, and week 26, alongside a glucocorticoid taper. The primary endpoint was the first adjudicated disease flare during the 52 week treatment period. Results showed a 87% reduction in flare risk with inebilizumab versus placebo (HR 0.13, 95% CI 0.06–0.28, P<0.001), with 10% of inebilizumab-treated participants experiencing flares compared to 60% in the placebo group. Key secondary endpoints, including annualized flare rate and flare free remission, also favored inebilizumab. Serious adverse events occurred in 18% of inebilizumab recipients versus 9% with placebo, primarily infections and cytopenias. The study concluded that inebilizumab significantly reduces disease flares and supports CD19-targeted therapy for IgG4 related disease.

This phase 3, double blind, randomized trial evaluated the efficacy and safety of inebilizumab, a CD19 targeted Bcell depleting monoclonal antibody, in adults with active IgG4 related disease. Participants (n=135) received inebilizumab (300 mg IV) or placebo on days 1, 15, and week 26, alongside a glucocorticoid taper. The primary endpoint was the first adjudicated disease flare during the 52 week treatment period. Results showed a 87% reduction in flare risk with inebilizumab versus placebo (HR 0.13, 95% CI 0.06–0.28, P<0.001), with 10% of inebilizumab-treated participants experiencing flares compared to 60% in the placebo group. Key secondary endpoints, including annualized flare rate and flare free remission, also favored inebilizumab. Serious adverse events occurred in 18% of inebilizumab recipients versus 9% with placebo, primarily infections and cytopenias. The study concluded that inebilizumab significantly reduces disease flares and supports CD19-targeted therapy for IgG4 related disease.