Co-Stimulation Modulation with Abatacept in Patients with Recent-Onset Type 1 Diabetes: Follow-Up One Year After Cessation of Treatment

  1. The Type 1 Diabetes TrialNet Abatacept Study Group
  1. Joslin Diabetes Center, Boston, Massachusetts (TO); University of South Florida, Tampa, Florida (BB, JPK); University of Pittsburgh, Pittsburgh, Pennsylvania (DJB); Indiana University School of Medicine, Indianapolis, Indiana (LD); University of California San Francisco, San Francisco, California (SEG); Columbia University, New York, New York (RG); University of Colorado Barbara Davis Center for Childhood Diabetes, Aurora Colorado (PAG); Benaroya Research Institute, Seattle, Washington (CJG); University of Miami Diabetes Research Institute, Miami, Florida (JBM, JSS); Childrens Hospital Los Angeles (RM); University of Minnesota, Minneapolis, Minnesota (AM); King’s College London, UK (MP); University of Texas Southwestern Medical School, Dallas, Texas (PR); Vanderbilt University (WER); University of Florida, Gainesville, Florida (DAS); Hospital for Sick Children, University of Toronto, Toronto, Ontario (DW); and Stanford University, Stanford, California (DMW).
  1. Corresponding Author: Jay S. Skyler, E-mail: jskyler{at}


Objective We previously reported that two years of co-stimulation modulation with abatacept slowed decline of beta-cell function in recent-onset type 1 diabetes mellitus (T1DM). Subsequently, abatacept was discontinued, and subjects followed to determine whether there was persistence of effect.

Research Design and Methods In 112 subjects (ages 6-36) with T1DM, 77 received abatacept and 35 received placebo infusions intravenously for 27 infusions over two years. The primary outcome – baseline-adjusted geometric mean 2-hour area under the curve (AUC) serum C-peptide during a mixed meal tolerance test (MMTT) at two years – showed higher C-peptide with abatacept versus placebo. Subjects were followed an additional year, off treatment, with MMTTs performed at 30 and 36 months.

Results C-peptide AUC means, adjusted for age and baseline C-peptide, at 36 months were 0.217 (95% CI: 0.168, 0.268) and 0.141 (95% CI: 0.071, 0.215) nmol/L for abatacept and placebo groups, respectively (p=0.046). The C-peptide decline from baseline remained parallel with an estimated 9.5 months’ delay with abatacept. Moreover, HbA1c levels remainded lower in the abatacept group than in the placebo group. The slightly lower (non-significant) mean total insulin dose among the abatacept group reported at 2 years was the same as the placebo group by 3 years.

Conclusions Co-stimulation modulation with abatacept slowed decline of beta-cell function and improved HbA1c in recent-onset T1DM. The beneficial effect was sustained for at least one year after cessation of abatacept infusions, or three years from T1DM diagnosis.

  • Received March 11, 2013.
  • Accepted November 22, 2013.

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  1. Diabetes Care
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