BETA-2 score is an early predictor of graft decline and loss of insulin independence after pancreatic islet allotransplantation

Abstract

This study aimed to evaluate whether the BETA‐2 score is a reliable early predictor of graft decline and loss of insulin independence after islet allotransplantation. Islet transplant procedures were stratified into 3 groups according to clinical outcome: long‐term insulin independence without islet graft decline (group 1, N = 9), initial insulin independence with subsequent islet graft decline and loss of insulin independence (group 2, N = 13), and no insulin independence (group 3, N = 13). BETA‐2 was calculated on day 75 and multiple times afterwards for up to 145 months posttransplantation. A BETA‐2 score cut‐off of 17.4 on day 75 posttransplantation was discerned between group 1 and groups 2 and 3 (area under the receiver operating characteristic 0.769, P = .005) with a sensitivity and negative predictive value of 100%. Additionally, BETA‐2 ≥ 17.4 at any timepoint during follow‐up reflected islet function required for long‐term insulin independence. While BETA‐2 did not decline below 17.4 for each of the 9 cases from group 1, the score decreased below 17.4 for all transplants from group 2 with subsequent loss of insulin independence. The reduction of BETA‐2 below 17.4 predicted 9 (1.5‐21) months in advance subsequent islet graft decline and loss of insulin independence (P = .03). This finding has important implications for posttransplant monitoring and patient care.

Metabolic measures before surgery and long-term diabetes outcomes in recipients of total pancreatectomy and islet autotransplantation

“…17 Several surrogate indices using these markers in combination have been developed and used to monitor posttransplant β-cell function and glycemic control in patients with allogeneic islet transplantation (Table 1). [18][19][20][21][22][23][24] However, the clinical utility of these surrogate indices in preoperative assessment of TP-IAT has not been established.…”

Post-Hoc Analysis of a Randomized, Double Blind, Prospective Study at the University of Chicago: Additional Standardizations of Trial Protocol are Needed to Evaluate the Effect of a CXCR1/2 Inhibitor in Islet Allotransplantation

“…Each of the patients in our cohort received over 5,000 IEQ/kg of islet mass during each transplant whereas 49% of the remaining transplants in the multicenter trial contained a lower islet mass 5 . A higher islet mass enhanced islet engraftment and graft function in our cohort 12 . Additionally, previous reports corroborate our observation that ATG in combination with anti-inflammatory (anti-TNF) therapy during initial ITx optimized conditions for islet engraftment and led to superior outcomes as compared to basiliximab 19 .…”

“…Optimal islet engraftment is critical in order to achieve long-term insulin independence after islet transplantation 12 . Sufficient quantity and quality of islet mass must be transplanted in the setting of favorable local conditions at the engraftment site for optimal islet mass engraftment.…”

Effects of islet transplantation on microvascular and macrovascular complications in type 1 diabetes

“…A BETA-2 score ≥17 at Day 75 post-first transplant discriminates people that will not require exogenous insulin in the longer term. 40 A 2018 joint consensus report from the International and European Pancreas and Islet Transplantation Associations (IPITA/EPITA) recommends the use of clinical and metabolic factors to define islet transplant success, and the current British Transplant Society specifically highlights the use of the beta and BETA-2 scores. 41 IPITA/EPITA also highlights the utility of an HbA1c < 53 mmol/mol (<7%) without SH, with >50% reduction in insulin requirement and restoration of clinically significant C-peptide secretion.…”