Golimumab (brand name Simponi) was originally approved by the U.S. Food and Drug administration (FDA) in 2009 for the purpose of treating adults who have rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis. It’s what’s known as a human monoclonal antibody. It blocks the action of a protein called tumor necrosis factor (TNF), which is implicated in abnormal inflammatory and immune responses. As sometimes happens with new medications, what was designed for one disease was found to be of value in treating another, and in 2013 the FDA approved golimumab for treating of ulcerative colitis. Now this new study suggests that it can be of considerable use in type 1 diabetes.
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The researchers pointed out that golimumab “has already been approved for the treatment of several autoimmune conditions in adults and children.” And they reasoned that because type 1 diabetes is “an autoimmune disease characterized by progressive loss of pancreatic beta cells,” golimumab might be able to preserve or enhance beta cell function in young people newly diagnosed with type 1 diabetes (the beta cells in the pancreas produce and secrete insulin).
The researchers screened 108 children and young adults (ages 6 to 21) with newly diagnosed type 1 diabetes. They excluded potential subjects who had additional significant conditions, including other autoimmune diseases, and recruited 82 participants. They randomly assigned them into one of two groups — 56 were given golimumab injections every two weeks and 28 were given a placebo (an inactive substance). The trial was done at 27 sites throughout the United States and lasted 52 weeks, during which the participants kept electronic records of daily insulin use, blood glucose levels and episodes of low blood sugar (hypoglycemic events). The amount of golimumab the subjects received by injection depended upon body weight.
The goal of the trial was to assess, after one year, the amount of insulin that the subjects’ bodies were producing (known as endogenous insulin) as opposed to the insulin in the blood that came from an external source (known as exogenous insulin). The researchers measured the endogenous insulin production by means of a test called the 4-hour C-peptide AUC, which is commonly used in clinical trials to evaluate beta cell function in patients with new-onset type 1 diabetes.
After the trial was concluded, the researchers reported that the 4-hour C-peptide AUC was significantly higher in the golimumab group than in the placebo group (0.64 versus 0.43). Their reports went on to say, “In this phase 2 trial involving children and young adults with newly diagnosed overt type 1 diabetes, golimumab resulted in better endogenous insulin production than placebo…. Although glycemic control in children and young adults with type 1 diabetes can be very challenging, both groups in our trial had better glycemic control than that reported in patients with type 1 diabetes in the general population. The participants in the golimumab group generally attained this level of glycemic control with significantly less insulin therapy than those in the placebo group.”
The researchers pointed out that their study had some limitations. The number of participants was small and few had coexisting conditions. However, lead author Teresa Quattrin, MD, of the Jacobs School of Medicine and Biomedical Sciences, Buffalo, said, “People want a cure, but the fact is, a cure is not available yet. So, this is an intermediate step towards a cure…. There are advantages to being on a small insulin dose…. The most important finding of our work is that this drug, golimumab, is a potential disease-modifying agent for newly diagnosed type 1 diabetes.” The article was accompanied by an editorial by Domenico Accili, MD, of the Columbia University Diabetes and Endocrinology Research Center. He wrote, “the effect is actually very small…. There’s nothing wrong in and of itself with improving those outcomes. I just wouldn’t assign them as game-changers.” But if golimumab is approved as a treatment for type 1 diabetes, he added, “I would tell patients it exists and let them make the decision whether they want to try it. I wouldn’t say you must try it.”
Want to learn more about type 1 diabetes? Read “Type 1 Diabetes Questions and Answers,” “Six Type 1 Diabetes Symptoms You Need to Know” and “Living With Type 1 Diabetes: Four Tips to Get You Started.”