Inebilizumab reduces flares and boosts remission in patients with IgG4-related disease
Inebilizumab, a B-cell depleting therapy, significantly reduces the risk of flares and increases the likelihood of sustained remission in patients with IgG4-related disease, according to a study.
The Phase 3, multicenter, randomized, double-blind, placebo-controlled trial, enrolled 135 adult patients with active IgG4-RD, who received either inebilizumab or placebo for 52 weeks. Both groups underwent a standard glucocorticoid taper, but background immunosuppressants were not permitted.
There was a significant reduction in disease flares among patients treated with inebilizumab. Only 10% of participants in the inebilizumab group experienced a flare compared to 60% in the placebo group (hazard ratio 0.13; P < 0.001). The annualized flare rate and odds of achieving treatment-free, flare-free remission were markedly better with inebilizumab. However, serious adverse events were more frequent with inebilizumab versus placebo (18% vs 9%).
Reference
Stone JH, Khosroshahi A, Zhang W, et al; MITIGATE Trial Investigators. Inebilizumab for Treatment of IgG4-Related Disease. N Engl J Med. 2024;doi: 10.1056/NEJMoa2409712. Epub ahead of print. PMID: 39541094.