Rituximab May Slow Beta-Cell Destruction in Patients With Type 1 Diabetes
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Rituximab May Slow Beta-Cell Destruction in Patients With Type 1 Diabetes

DALLAS -- December 4, 2009 -- New findings suggest that the monoclonal antibody rituximab, which is already approved by the US Food and Drug Administration for the treatment of autoimmune disorders, might also help slow the destruction of beta cells in patients recently diagnosed with insulin-dependent (type 1) diabetes. These are the conclusions of an article published online in the most recent issue of the New England Journal of Medicine.

Researchers at University of Texas (UT) Southwestern and 14 other centres worldwide found that rituximab slowed beta-cell destruction in the pancreas of those newly diagnosed with type 1 diabetes for at least 1 year, suggesting a potential treatment option that might improve management and reduce long-term complications of the disease.

Philip Raskin, MD, UT Southwestern, Dallas, Texas, principal investigator of the trial’s local effort and one of the study authors called the findings “extremely exciting.”

“Our findings in no way suggest that rituximab should be used as a treatment or that it will eliminate the need for daily insulin injections,” said Dr. Raskin. “This is not a cure for type 1 diabetes.

“The results do, however, provide evidence that beta cells play a significant role in type 1 diabetes and that selective suppression of these beta cells may deter the destruction of the body’s beta cells.”

Researchers conducted a randomised, double-blind study in which 81 participants received infusions of either rituximab or a placebo once a week for 4 weeks. The participants, who ranged in age from 8 to 40 years and had been diagnosed with type 1 diabetes within 100 days of enrolment in the study, returned approximately every 3 months for 2 years to undergo blood tests and meet with a physician. Two-thirds of the 81 participants received the drug.

The 1-year results show that participants who received rituximab required lower doses of insulin and were able to produce more of their own insulin than those who received the placebo. They also had better control of their blood sugar.

Dr. Raskin said researchers do not think rituximab could ever be used to completely reverse type 1 diabetes because the pancreas typically is too damaged by the time diabetes is diagnosed.

He also said that while the exact mechanism of how rituximab affects type 1 diabetes remains unclear, the study clearly shows that a therapy that targets beta cells may improve beta-cell function in early type 1 diabetes.

The next step is to evaluate the potential effects of rituximab in diabetes, Dr. Raskin said.

SOURCE: New England Journal of Medicine.

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