The following article is part of coverage from the American Diabetes Association’s 80th Scientific Sessions (ADA 2020). Because of concerns regarding the coronavirus disease 2019 (COVID-19) pandemic, all ADA 2020 sessions and presentations were transitioned to a virtual format. While live events will not proceed as planned, readers can click here to view more news related to research presented during the ADA 2020 virtual experience.
Golimumab, a human monoclonal antibody currently approved for the treatment of several rheumatic conditions and ulcerative colitis,1 may preserve β-cell function and reduce the need for exogenous insulin in children and young patients with type 1 diabetes (T1D), according to study results presented during the American Diabetes Association’s 80th Scientific Sessions, held online from June 12 to 16, 2020.2
Patients aged 6 to 21 years with newly diagnosed stage 3 T1D were enrolled in a phase 2a double-blind trial that compared the effects of treatment with golimumab vs placebo over 52 weeks. Subcutaneous doses of golimumab were based on body surface area for patients with a body weight of <45 kg. For patients who had a body weight of ≥45 kg, the researchers used fixed doses of the study drug.
A total of 56 patients were randomly assigned to receive golimumab treatment and 28 patients received placebo. The investigators assessed C-peptide area under the curve after a 4-hour mixed-meal tolerance test as the primary outcome and followed up on changes in insulin use, hemoglobin A1c, occurrence of hypoglycemia, and proinsulin to C-peptide ratios over the 52-week study period.
Both groups maintained good glycemic control and golimumab was generally well tolerated, with no new safety signals reported. At week 52, mean 4-hour area under the curve for C-peptide level was significantly greater in the golimumab-treated group (0.64±0.423 pmol/mL) than in the placebo group (0.43±0.388 pmol/mL; P <.001). In addition, patients who received golimumab had reduced insulin use, lower rates of hypoglycemia, and lower proinsulin to C-peptide ratios compared with patients who received placebo.
The study authors concluded that “golimumab demonstrated the ability to preserve endogenous insulin production and improve clinical and metabolic parameters in children and young adults with newly diagnosed stage 3 T1D.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry, including Janssen Pharmaceuticals, the manufacturer of golimumab. Please see the original reference for a full list of authors’ disclosures.
1. Simponi® (golimumab) official website. Janssen Pharmaceuticals. Updated September 2018. Accessed June 10, 2020. https://www.simponihcp.com/
2. Quattrin T, Haller MJ, Steck A, et al. Golimumab (GLM) preserved β-cell function and reduces insulin use and hypoglycemia in children and young adults with recently diagnosed type 1 diabetes (T1D): the phase 2 T1GER study. Presented at: American Diabetes Association 80th Scientific Sessions; June 12-16, 2020. Abstract 3-LB.
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