N Engl J Med

ACR 2024: NMO drug inebilizumab shows promise in IgG4-related disease trial

November 18, 2024

Inebilizumab significantly reduces the risk of flares in IgG4-related disease and increases the likelihood of achieving flare-free complete remission within one year, according to results slated to be shared at the American College of Rheumatology’s annual meeting.

This phase 3, double-blind, placebo-controlled trial included 135 adults with active IgG4-related disease. Participants were randomized 1:1 to inebilizumab or placebo over a 52-week period, with both groups undergoing identical glucocorticoid tapers.

Only 10% of patients in the inebilizumab group experienced flares compared with 60% in the placebo group (P < 0.001), and the annualized flare rate was significantly lower with inebilizumab than with placebo (rate ratio, 0.14; 95% CI, 0.06 to 0.31; P < 0.001)). Compared with placebo, inebilizumab recipients experienced higher rates of flare-free, treatment-free complete remission (odds ratio [OR], 4.68; 95% CI, 2.21-9.91; P<0.001) and flare-free, glucocorticoid-free complete remission (OR, 4.96; 95% CI, 2.34-10.52; P<0.001). The rate of serious adverse events was 18% in the inebilizumab group vs. 9% in the placebo group.

Source:

Stone JH, et al; MITIGATE Trial Investigators. (2024, November 14). N Engl J Med. Inebilizumab for Treatment of IgG4-Related Disease. https://pubmed.ncbi.nlm.nih.gov/39541094/