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Abatacept led to short-term improvement in beta cell function
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ADA 71st Scientific Sessions
SAN DIEGO — Abatacept, a co-stimulation modulator and preventer of T-cell activation, reduced the rate of beta cell function decline in patients with newly diagnosed type 1 diabetes. The beneficial effects were most notable during the first 6 months of treatment, according to data from a multicenter, randomized, double blind trial.
Patients aged 6 to 45 years with newly diagnosed diabetes (n=112) were randomly assigned to one of two IV infusions: 10 mg/kg abatacept (Orencia, Bristol-Myers Squibb) or placebo. The drug and placebo were administered during a 2-year period on days 1, 14, 28 and every month thereafter for a total of 27 infusions. Serum C-peptide levels after a mixed-meal tolerance test at the 2-year follow-up was the primary outcome.
At the study end, adjusted C-peptide AUC was 59% higher (95% CI, 6.1-112) with abatacept compared with placebo (0.378 nmol/L vs. 0.238 nmol/L). Treatment was associated with a delay in C-peptide reduction for an estimated 9.6 months (95% CI, 3.47-15.6).
“This indicates that [abatacept] may be a potential component in a combination therapy approach,” Jay Skyler, MD, chairman of the NIH-funded Type 1 Diabetes TrialNet study group, said during a press conference on new therapies for type 1 diabetes.
Infusion-related adverse events were reported in 22% of patients in the abatacept group and 17% in the placebo group. Rates of infection and neutropenia were also similar between the two groups.
“Abatacept has characteristics that support it as a potential candidate to be tested in a prevention trial, or to be a candidate as a useful component of a combination therapy protocol in recent-onset type 1 diabetes,” Skyler and colleagues wrote in their study, which was published online first in The Lancet. “Until further studies are done, use of abatacept in type 1 diabetes in clinical practice is not appropriate.” – by Stacey L. Fisher
For more information:
- Orban T. Lancet. 2011;doi:10.1016/S0140-6736(11)60886-6.
- Ludvigsson J. Treatment of type 1 diabetes – Update on clinical trials. Presented at: American Diabetes Association’s 71st Scientific Sessions; June 24-28, 2011; San Diego, Calif.
Disclosures: Dr. Skyler reports no relevant financial disclosures.
We are actually quite encouraged by the positive responses seen with immunomodulatory responses at 1 year and in some cases 2 years post diagnosis. From a practical perspective, we need to understand what improvements in C-peptide in the short term mean in the long term. Does sustainability of C-peptide lead to metabolic memory and delayed complications and/or easier disease management with less acute complications such as hypoglycemia and ketoacidosis? The benefit and risk of each of the immunomodulatory therapies needs to be closely examined by TrialNet and the scientific community on an ongoing basis. Insulin is not a cure, and therapies aimed at cure and prevention need to be actively pursued.
– Desmond Schatz, MD
Professor and Associate Chairman of Pediatrics
Medical Director of the Diabetes Center
Director of the GCRC at the University of Florida, Gainesville
Disclosure: Dr. Schatz has no relevant financial disclosures.
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