Teplizumab-mzwv injection approved to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.
A monoclonal antibody targeting the CD3 T cells surface marker.
Tradename Tzeild.
The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.
Teplizumab-mzwv injectionbinds to certain immune system cells and delays progression to stage 3 type 1 diabetes.
It may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.
It is administered by intravenous infusion once daily for 14 consecutive days.
In a randomized, double-blind, event-driven, placebo-controlled trial with 76 patients with stage 2 type 1 diabetes, patients randomly received Teplizumab or a placebo once daily via intravenous infusion for 14 days.
The primary measure of efficacy was the time from randomization to development of stage 3 type 1 diabetes diagnosis.
The trial results showed that over a median follow-up of 51 months, 45% of the 44 patients who received Teplizumab were later diagnosed with stage 3 type 1 diabetes, compared to 72% of the 32 patients who received a placebo.
The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Teplizumab and 25 months for those who received a placebo.
This represents a statistically significant delay in the development of stage 3 type 1 diabetes.
The most common side effects of teplizumab include:
decreased levels of lymphocytes, rash and headache.
Warnings and precautions include:
premedicating and monitoring for symptoms of Cytokine Release Syndrome; risk of serious infections; decreased levels of lymphocytes; risk of hypersensitivity reactions.
There is a need to administer all age-appropriate vaccinations prior to treatment, avoiding concurrent use of live, inactivated and mRNA vaccines.
Two 12 day courses of teplizumab in children in adolescents, with newly diagnosed type one diabetes showed benefit with respect to the primary endpoint of preservation of beta cell function, but not but did not show significant differences with respect to secondary endpoints.