Type 1 diabetes is an autoimmune disease in which the body's own immune system destroys the critical insulin-producing beta cells of the pancreas.
"People have been trying to change the immune system to treat type 1 diabetes, the rationale being that it's an autoimmune disease where you get antibodies that destroy the cells in the pancreas that produce insulin," Fonseca explained.
Up to now, much research has focused on the immune cells known as T-lymphocytes, the immune cells that attack the pancreas, but there has been increasing speculation that another type of cell, called B-lymphocytes, may also play a role. B cells work a step back in the process, stimulating the T cells to do their damage, Pescovitz explained. Rituximab targets B-lymphocytes.
"This deals with a whole new clinical pathway to try to deal with type 1 diabetes," he said.
In this phase 2 trial, 87 patients with newly diagnosed type 1 diabetes were randomly assigned to receive rituximab infusions or a placebo at one-week intervals for four weeks.
After one year, C-peptide levels -- an indicator of how much insulin is being produced by the body -- were higher in people taking rituximab versus those in the placebo group.
Those in the rituximab group also needed less external insulin and had fewer B cells.
Side effects faded with time, although Pescovitz pointed out that long-term adverse effects from rituximab are not yet known.
It's also not clear if this treatment would be superior to other immunosuppressive strategies, but it is certainly easier to deliver, he said.
"This [B cell] approach is all done as an outpatient basis whereas the [other agents] are done as inpatients," said Pescovitz.
And treatment over only three weeks gave a response that lasted a year, Fonseca noted.
Next, researchers need to determine if additional infusions over time will
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