Discontinued Rx Could Return as T1DM Therapy

Discontinued Rx Could Return as T1DM Therapy
Discontinued Rx Could Return as T1DM Therapy

Patients with new-onset type 1 diabetes showed preserved beta cell function after receiving two courses of alefacept shortly after diagnosis, according to a study in the Journal of Clinical Investigation.

The Immune Tolerance Network's (ITN) T1DAL study was a Phase 2, randomized, placebo-controlled, double-blind, multicenter clinical trial testing alefacept, in new-onset type 1 diabetes patients aged 12–35. Forty-nine participants were randomized to receive either two 12-week courses of alefacept or  placebo, with a 12-week gap between treatments, and were followed for two years to monitor clinical and metabolic effects after stopping treatment. Endpoints for both groups included changes in C-peptide response, insulin dose requirements, and rates of hypoglycemia.

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The alefacept arm had a significantly lower decline in C-peptide production, indicating greater preservation of beta cell function, from baseline to two years vs. the placebo group as measured by a four-hour mixed meal tolerance test. Rates of C-peptide decline varied among participants in the alefacept group, but 30% showed no decline whatsoever and were considered “complete responders”; only one of 12 participants in the placebo group met this criteria. Patients receiving alefacept also had overall better metabolic function with lower insulin requirements and fewer major hypoglycemic events than the placebo group, with no drug-associated serious adverse events.

Alefacept was indicated for the treatment of moderate to severe chronic plaque psoriasis but was voluntarily discontinued in November 2011. The discontinuation was not based on any specific safety concern nor was it the result of a Food and Drug Administration (FDA)-mandated or voluntary product recall. Alefacept interferes with T cell activation by specifically targeting the CD2 surface marker found on T cells. Future studies will attempt to create even longer lasting responses by combining alefacept with other therapeutic agents.

For more information visit ImmuneTolerance.org.