Tzield: New weapon in the fight against Type 1 diabetes

Tzield: New weapon in the fight against Type 1 diabetes – the info you want to know

December brought us a gift we have been waiting for longer and harder than my 5-year-old waited for Nintendo switch!

The FDA approval and rollout of Tzield (Teplizumab) for the delay of onset of stage 3 autoimmune diabetes. So let’s unwrap this thing and figure out how all the pieces go together!

What does Tzield do:

Tzield is a monoclonal antibody (Yes, the type of treatment we’re hearing about with Covid treatment)  that alters the Tcell response to specific autoantibodies that cause autoimmune type 1 diabetes. It does not “Suppress” the overall immune system, but basically slows the immune response to specific autoantibodies. This puts a speed bump on the road to beta cell destruction and impairment of insulin production.

Tzield has been shown to delay the onset of hyperglycemia from 2 years to 4 years in a 4-year long study. At the end of the study twice as many of the participants on Tzield had not developed hyperglycemia at all compared to placebo.

Who is Tzield for?

Tzield is approved for children and adults over the age of 8 with stage 2 autoimmune diabetes. This means they have tested positive for antibodies that cause type 1 diabetes but are not yet seeing abnormal elevations in blood sugars and A1C.

How is Tzield administered?

Tzield is administered through IV infusions once per day for 14 days. This can be done in an infusion center, or by a home infusion nurse. The patient’s situation, risk factors and supports would help the doctor determine what parts of the dosing would need to be done in a facility or at home. The infusion itself takes less than an hour.

The patient would also likely get a few rounds of blood work to monitor their response to the infusions. These labs are not required per the package labeling but would be recommended.

What are the side effects of Tzield?

All infusion treatments carry a minimal risk of injury or infection at the infusion site. Tzield had three side effects of note in studies.

• Rash (not severe enough to stop treatment)
• Headache (not severe enough to stop treatment)
• Leukopenia. (Leukopenia is a lowering of white blood cell count and is the only major side effect of Tzield. This is when white blood cell counts can get low enough to increase infection risk). This was rare in studies and transient, which means that when treatment was paused white blood cell numbers returned to normal levels. This is why blood work along the treatment course is recommended.

The person receiving treatment does not need to be isolated since risks of infection were not shown to be higher during or following treatment outside of the participants who did develop leukopenia. So someone could get their infusion while still attending school, work, or other routine activities.  Patients should have all age-appropriate vaccinations before starting Tzield to ensure appropriate immune response. And because they should not have any live attenuated vaccinations during or for several months following Tzield infusion. Because Tzield works on the immune system patients are also recommended to be on fever reducers such as Ibuprofen through the infusion period as well to reduce risks of CRS (Cytokine release Syndrome – an over response of the immune system to infection or immune impacting medications) CRS is temporary, rare and Tzield dosage should be reduced but does not have to be discontinued due to an initial CRS reaction.

How do I know if I, or someone related to me should start Tzield?

We recommend all first-generation relatives (biological siblings, parents, grandparents)  of persons with Type 1 diabetes be screened for autoantibodies. A positive test would indicate that Tzield may be a good fit. For more info on type 1 screening, you can check out: connectedbyt1D.com

How much does Tzield cost?

ProventionBio and Sanofi sources have told us that the anticipated patient cost at rollout is going to be absorbed by the manufacturer. So essentially a zero cost. However, the process is new so it may take a little time to get all the pieces in place and clear up all financial options. So if you initially get a sticker shock price from insurance or infusion resources don’t run scared (The cash price is estimated at around $190k!). Reach out to the Tzield compass coordinator and work with them to coordinate resources. Since this is a brand new medication in a rare disease population coverage and the path to coverage will look quite different for every case. Provention Bio is committed to expanding access to this medication to build those pathways.

Who is not appropriate for Tzield?

At this time there is no indication for people who have already entered stage 3 diabetes. So basically if you’ve started insulin, the FDA does not approve use at this time. HOWEVER, there are studies underway in individuals with recent onset of stage 3 with the hope of prolonging the “honeymoon phase” where insulin need is minimal and management much safer and complication risk is minimized. At this time Tzield is also only indicated for single-time use. There are studies in place to explore the safety and efficacy of “follow-on” dosing. This could theoretically postpone the onset of stage 3 indefinitely.

I want Tzied, how do I start?

First, have a discussion with your doctor about the risks and benefits of Tzield.

Then you’ll want to reach out to the Tzield Compass Patient Support

Fill in the form to get started and you will be contacted by a Provention bio case manager. Their job is to help get all the pieces into place. They will get insurance approval, access resources for infusion as well as payment, they will work with your prescriber to find the right administration method for you as well as follow up lab coordination. They will work with the patient to schedule infusions, labs, and follow up.

I was told I can’t use Tzield, how do I join a study?

Studies for follow on dosing as well as the use of teplizumab in early stage 3 diagnosis are underway.

Keep an eye on clinicaltrials.gov for current and recruiting studies. Here is a link to one such study currently recruiting candidates.

I’m not in the US is Tzield available for me?

Teplizumab has been approved for use to delay onset of stage 3 type 1 diabetes in the US, UK and we are seeing a lot of study data from the EU so we recommend reaching out to prescribers and research oversight bodies for more information.

Much like my son who was losing sleep over the excitement of getting a video game for the holidays, we are excited to see the launch of Tzield. But like my son who received retro Nintendo games, we still have to get this thing set up, figure out how to access and learn the tricks to getting past the bosses before we can really enjoy this new addition to our diabetes world. And yes my son is already telling me that while Mario is cool he still wants the newest system and will continue to hound me. We are excited for a new tool in the fight, but delay is not prevention, and prevention is not cure. We won’t stop asking for more and better treatment options, prevention possibilities and true viable and accessible cures.