PHILADELPHIA – Administering abatacept to patients with newly diagnosed type 1 diabetes resulted in immune modulation of the autoimmune process for a duration of 36 months, according to data from a late-breaking abstract presented here at the American Diabetes Association’s 72nd Scientific Sessions.
Tihamer Orban, MD, and the Type 1 Diabetes Trialnet Abatacept Study Group, conducted a phase 2, randomized, double-masked trial to determine the effect of abatacept (Orencia, Bristol-Myers Squibb) — a co-stimulation modulator that blocks T-lymphocyte activation — in patients with type 1 diabetes. Data were reported in 2011. Today, Orban presented results on the effect of abatacept 1 year after the drug’s discontinuation.
“We reported earlier that co-stimulation modulation with abatacept slowed the decline of beta cell function over 2 years. Data from this follow-up study indicate that the beneficial effects of abatacept persist beyond the drug administration,” Orban and colleagues wrote in their abstract.
The study included 112 patients aged 6 to 36 years with recently diagnosed type 1 diabetes who were randomly assigned to abatacept (27 IV infusions during 2 years; n=77) or placebo (n=35). The primary endpoint was adjusted C-peptide AUC.
At 2 years, adjusted C-peptide AUC was 59% higher in the abatacept group vs. placebo (P=.0014), a difference that was apparent throughout the trial. Orban also reported that patients in the abatacept arm had lower HbA1c with no difference in insulin use (P<.001).
Patients were followed for 1 year after discontinuing infusions. At 36 months, C-peptide AUC information was available for 64 patients in the treatment group and 29 in placebo. The AUC was 0.215 pmol/mL (95% CI, 0.168-0.265) in the treatment group vs. 0.135 pmol/mL (95% CI, 0.0692-0.205) in the placebo group (P=.033).
According to Orban, these rates were similar to those observed during treatment. Additionally, the decline in C-peptide from baseline remained parallel with an estimated 9.5 months’ delay with abatacept.
One year after treatment discontinuation, abatacept was associated with lower HbA1c, with no difference in insulin use (P<.001). According to Orban, this was the most significant finding, as the difference in HbA1c at 3 years was practically more than 1%. In addition, 85% of patients were aged 18 years or younger; previous studies demonstrate that achieving HbA1c as low as 7.5% over a long period is critically important to avoid complications among these patients, he said.
“It seems you may not need 2 years of treatment to achieve this effect, which is wonderful. First, the good news is you don’t need to continue treatment forever to maintain these results. We don’t know how long beyond 3 years [the effects will last], but at least [they last] for 1 year. It’s very logical to start a shorter course of the drug and see if a similar effect can be achieved.”
Additionally, Orban said abatacept might be useful in prevention studies in people at high risk for type 1 diabetes, or as a component in studies using a combination of different treatment strategies for type 1 diabetes. – by Stacey L. Fisher
For more information:
Orban T. Abstract #150-LB. Presented at: the American Diabetes Association’s 72nd Scientific Sessions; June 8-12, 2012; Philadelphia.
Disclosure: Dr. Orban is founder and CEO of Orban Biotech.