Golimumab could improve type 1 diabetes outcomes

Golimumab, a human monoclonal antibody, has been approved to treat a number of autoimmune conditions in both the adult and pediatric populations. This success has led to curiosity over whether the drug could help patients with type 1 diabetes. A new investigation in the New England Journal of Medicine looked into the efficacy of golimumab in preserving beta-cell function in pediatric patients who had a new diagnosis of overt (stage 3) type 1 diabetes.¹

The investigators ran a phase 2, multicenter, placebo-controlled, double-blind, parallel-group trial. They randomly assigned children and young adults who were aged 6 to 21 years and had a new diagnosis of stage 3 type 1 diabetes in a 2:1 ratio to be given either subcutaneous golimumab or placebo for a period of 52 weeks. The researcher’s primary end point at week 52 was endogenous insulin production, which was assessed as the area under the concentration–time curve for C-peptide level following a 4-hour mixed-meal tolerance test. Other end points for the researchers included the glycated hemoglobin level, the number of hypoglycemic events, the ratio of fasting proinsulin to C-peptide over time, response profile, and insulin use.

There were a total of 84 children and young adults who went through randomization, with 56 being put into the golimumab treatment group and 28 being put into the placebo group. Investigators found that the average area under the concentration–time curve for C-peptide level following a 4-hour mixed-meal tolerance test at week 52 was significantly different between the golimumab group and the placebo group group (0.64±0.42 pmol per milliliter vs. 0.43±0.39 pmol per milliliter, P<0.001). Using a treat-to-target approach resulted in good glycemic control in both of the group and no significant difference was seen in the glycated hemoglobin level in both arms. The use of insulin was lower in the golimumab treatment group than in the placebo group. Additionally, a partial remission response, which was defined as an insulin dose–adjusted glycated hemoglobin level score (calculated as the glycated hemoglobin level plus 4 times the insulin dose) of ≤9, occurred in 43% of the participants in the treatment group and 7% in the placebo group (difference, 36 percentage points; 95% CI, 22 to 55). The average number of hypoglycemic events showed no difference between the groups. Hypoglycemic events that were severe enough to be recorded as adverse events at the discretion of the researchers occurred in 13 participants in the golimumab group and 2 in the placebo group.

The researchers concluded that in pediatric patients who had a new diagnosis of type 1 diabetes, golimumab led to better endogenous insulin production as well as less insulin use than those who were given a placebo.

Reference

1. Quattrin T, Haller M, Steck A, et al. Golimumab and beta-cell function in youth with new-onset type 1 diabetes. New England Journal of Medicine. 2020;383(21):2007-2017. doi:10.1056/NEJMoa2006136