Obexelimab for the Treatment of IgG4-Related Disease - PubMed
3 hours ago
- #IgG4-related disease
- #clinical trial
- #monoclonal antibody
- Obexelimab is a bifunctional monoclonal antibody that inhibits B-cell activity by coengaging CD19 and FcγRIIb without causing B-cell depletion.
- A phase 3 trial with 194 patients showed obexelimab significantly prolonged time to first disease flare requiring rescue therapy compared to placebo (hazard ratio 0.44).
- 26.8% of patients in the obexelimab group had flares versus 54.6% in the placebo group.
- Obexelimab led to higher complete remission rates (37.1% vs. 19.6%) and lower cumulative glucocorticoid rescue doses (329.5 mg vs. 929.8 mg).
- Common adverse events included arthralgias, hypersensitivity, and diarrhea, with serious adverse events occurring less frequently in the obexelimab group.