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Amevive preserves beta-cell function in new-onset type 1 diabetes
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Two 12-week courses of Amevive, approved for the treatment of psoriasis, may help preserve pancreatic beta-cell function in people with newly diagnosed type 1 diabetes, according to recent study findings published in The Journal of Clinical Investigation.
“Achieving long-term benefit following a short course of therapy is a challenging goal,” Gerald Nepom, MD, PhD, director of the Immune Tolerance Network, said in a press release. “Detailed analysis of the T-cell types present in the blood of those who responded to the treatment will help us identify the best way to improve this type of immune therapy for patients with [type 1 diabetes] and potentially other autoimmune diseases.”
Nepom, Mark R. Rigby, MD, PhD, of Indiana University School of Medicine in Indianapolis, and colleagues evaluated 49 patients aged 12 to 35 years with newly diagnosed type 1 diabetes to determine the effect of Amevive (alefacept, Astellas Pharma) on the preservation of beta-cell function. Participants were randomly assigned to alefacept (n = 33) or placebo (n = 16) for two 12-week courses with a 12-week pause in between. Follow-up occurred for 2 years to determine clinical and metabolic effects after the conclusion of treatment.
Primary outcomes included changes in C-peptide response, insulin dose requirements and rates of hypoglycemia.
When using a 4-hour mixed-meal tolerance test, researchers found that the alefacept group had a lower decline in C-peptide production, indicating a greater preservation of beta-cell function, compared with the placebo group (P = .002). Lower mean insulin requirements also were found among the alefacept group compared with placebo (P = .002) as well as lower rates of hypoglycemia (P < .001).
“The 2-year results are remarkable because we observed ongoing preservation of C-peptide secretion 15 months after cessation of treatment,” study researcher Mario Ehlers, MD, PhD, of the Immune Tolerance Network, said in the release. “Moreover, compared to the placebo group, the patients who received alefacept had significantly lower insulin requirements and a significant 50% reduction in major hypoglycemic events (defined as blood glucose level < 55 mg/dL), even at 2 years. This is the first time that documented rates of hypoglycemia — using standardized home glucometers in all patients — have shown a reduction in major hypoglycemic events following an immune intervention in new-onset [type 1 diabetes]. This is important because frequent hypoglycemia is a common and serious complication in this disease.” – by Amber Cox
Disclosure: Nepom reports receiving honoraria from Genentech, GlaxoSmithKline and Pfizer. Rigby and Ehlers report no relevant financial disclosures. Please see the full study for a list of all other authors’ financial disclosures.
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