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Teplizumab Shows Potential to Extend Honeymoon Phase in Newly Diagnosed Type 1 Diabetes

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Teplizumab, also known as Tzield, is a medication used to slow down the progression through the stages of type 1 diabetes (T1D) by modifying the body’s T cells, preventing them from attacking pancreatic ?-cells.

Stage 1: In stage 1 of T1D, blood glucose levels may be normal, but autoantibodies to ?-cells start to appear in the bloodstream.

Stage 2: Stage 2, or the preclinical stage, is characterized by the beginning of ?-cell destruction, but normal blood glucose levels may still remain.

Stage 3: By stage 3, the final and clinical stage of T1D, the disease’s most recognizable symptoms, such as frequent urination, and persistent thirst, appear with the near complete loss of ?-cell function.

In 2022, the FDA approved the use of Teplizumab to slow the onset of stage 3 type 1 diabetes in people 8 years and older with stage 2 of the disease.

Since the effect of Tzield may differ depending on the stage of the individual, investigators of a recent study published in The New England Journal of Medicine in October 2023 aimed to examine whether two courses of teplizumab would conserve ?-cell function and improve other clinical indicators among children and adolescents newly diagnosed with stage 3 T1D.

teplizumabOver 300 participants aged 8 to 17 years were enrolled in a phase 3 randomized control trial, with 217 participants receiving teplizumab and 111 receiving a placebo. All participants had been diagnosed with stage 3 T1D within 6 weeks of study enrollment. The teplizumab treatment group received the drug intravenously in two 12-day courses, with 26 days separating each course.

The control group was administered the placebo on the same schedule. The primary outcome was to determine if there was a change in ?-cell function, measured via C-peptide levels, after a 78-week follow-up period. Secondary outcomes of interest to the researchers included participant HbA1c levels, time-in-range, insulin doses required to meet glycemic goals, and the number of hypoglycemic events reported.

Findings from the study indicate that participants who were treated with teplizumab had significant improvement of stimulated C-peptide levels when compared to the participants in the placebo group after 78 weeks.

Though, there were no significant differences between groups for the secondary endpoints evaluated. Nevertheless, study results show that the drug may prolong the honeymoon phase for those treated with Tzield. Additionally, findings support that treatment with teplizumab in the method administered allows for faster restoration of circulating immune cells, and may not cause chronic immunosuppression as compared to other, similar treatments tested in individuals with T1D.

The public health impact of teplizumab used for this purpose is immense.

An extended honeymoon period not only means more time where one’s own pancreas secretes insulin, but it also means youth may be able to better maintain glycemic control during a time when doing so can be challenging.  However, it is important to keep in mind that, although the FDA has approved Tzield to delay the onset of clinical type 1 diabetes, the medication has not yet been approved to prolong the honeymoon stage in those recently diagnosed with type 1 diabetes. Despite this, there are several, currently available ways to improve or prolong insulin production in this population. Please reach out to the IDS office and schedule with one of our clinicians to learn more.

Article by IDS intern, Krystal Bosenbark, MPH, MS

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