TUESDAY, Nov. 19, 2024 (HealthDay News) -- For patients with immunoglobulin G (IgG)4-related disease, inebilizumab reduces the risk for flares and increases the likelihood of flare-free complete remission, according to a study published online Nov. 14 in the New England Journal of Medicine to coincide with the annual meeting of the American College of Rheumatology, held from Nov. 14 to 19 in Washington, D.C.
John H. Stone, M.D., M.P.H., from Massachusetts General Hospital in Boston, and colleagues conducted a phase 3, multicenter, double-blind, randomized trial involving adults with active IgG4-related disease. A total of 135 participants were randomly assigned to receive inebilizumab (300-mg infusions on days 1 and 15 and week 26) or placebo (68 and 67 participants, respectively). In both groups, participants received identical glucocorticoid tapers.
The researchers found that flare risk was reduced with inebilizumab treatment: 10 and 60 percent of participants in the inebilizumab and placebo groups had at least one flare, respectively (hazard ratio, 0.13). A lower annualized flare rate was seen with inebilizumab than placebo (rate ratio, 0.14). Flare-free, treatment-free complete remission and flare-free, glucocorticoid-free complete remission occurred in more participants in the inebilizumab group than the placebo group (odds ratios, 4.68 and 4.96, respectively). During the treatment period, serious adverse events occurred in 18 and 9 percent of participants receiving inebilizumab and placebo, respectively.
"The magnitude and consistency of the efficacy results suggest inebilizumab as a treatment option for patients with IgG4-related disease," the authors write.
The study was funded by Amgen, the manufacturer of inebilizumab.
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