WEDNESDAY, Nov. 25 (HealthDay News) -- In patients newly diagnosed with type 1 diabetes, a four-dose course of rituximab helps preserve some beta-cell function after a year, according to a study in the Nov. 26 issue of the New England Journal of Medicine.
Mark D. Pescovitz, M.D., of the Indiana University School of Medicine in Indianapolis, and colleagues randomly assigned 87 patients aged 8 to 40 years to receive either infusions of rituximab or placebo on days one, eight, 15 and 22 of the study.
After one year, the researchers found that the rituximab group had a significantly higher geometric mean area under the curve (AUC) for the level of C peptide, lower levels of glycated hemoglobin, and a lower insulin requirement than the placebo group. They also found that rituximab was associated with an initial depletion of CD19+ B lymphocytes which increased to 69 percent of baseline values.
"It is unlikely that treatment with rituximab as administered in this study would be optimal," the authors conclude. "We observed an initial improvement shortly after the administration of rituximab but with a subsequent resumption in the decline of the AUC for C peptide. Neither repeat nor long-term administration of rituximab was attempted, since information concerning the relative efficacy or safety of such an approach was lacking. Given our results, we believe that other anti-B-lymphocyte agents should be tested -- for example, humanized anti-CD20 antibodies. Whether anti-B-lymphocyte therapy would prevent or delay diabetes in patients with autoantibodies, dysglycemia, or both is currently unknown."
Authors of the study reported financial relationships with the pharmaceutical industry.
Abstract
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