β-Cell Function Derived From Routine Clinical Measures Reports and Predicts Treatment Response to Immunotherapy in Recent-Onset Type 1 Diabetes
Authors' conclusion
QRS, fasting C-peptide, and CPest could be used as more efficient, less burdensome primary outcome measures for future immunotherapy trials. The ability of the Beta2 score to predict treatment responses could facilitate adaptive trial designs and help guide treatment decisions in the clinic.
Study context
- Population
- People with recent-onset T1D in the BANDIT trial; validation in trials of rituximab, abatacept and antithymocyte globulin
- Comparison
- Baricitinib vs placebo; routine clinical measures of β-cell function to assess and predict treatment response
Methodological detailsvalidation in rituximab, abatacept and antithymocyte globulin trials
- Validation in rituximab, abatacept and antithymocyte globulin trials
Primary result
As reported in the abstract
AUC of week-12 Beta2 score for predicting quantitative response score (QRS) >0 after 1 year, baricitinib
0.864
AUC of week-12 Beta2 score for predicting QRS >0 after 1 year, other immunotherapies
0.765
Further findings
6.2% decrease in Beta2 score at week 12 as predictor of improvement (combined rituximab, abatacept, antithymocyte globulin data)
- Predicted improvement in HbA1c
- −0.6% or −6 mmol/mol
- Predicted improvement in insulin use
- −0.26 units/kg/day
Original publication
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