The introduction of any new treatment regimen requires a period of adjustment for the clinicians charged with using it. Teprotumumab was approved by the FDA in January for the treatment of thyroid eye disease (TED). Three experts recently discussed use of the drug in TED during an Ask the Experts session at the American Academy of Ophthalmology 2020 Virtual meeting.
“There has been a paradigm shift in TED, and clinicians are now able to offer patients new options,” said Sara T. Wester, MD, FACS, of University of Miami Health System.
During the session, Dr. Wester, together with Andrea N. Kossler, MD, of Stanford University School of Medicine, and Andrea A. Tooley, MD, of Mayo Clinic, answered questions from the virtual audience about updates in TED.
The first question they discussed was, “Tell us more about how to use teprotumumab?”
“Teprotumumab has totally changed my practice,” said Dr. Kossler, adding that she now uses the drug as her first-line treatment for patients with active moderate to severe TED. “Clinical trials tell us that this drug leads to significant improvement in proptosis, double vision, Clinical Activity Scores (CAS), and quality of life,” she said.
There are also some patients who would previously be considered as having stable disease that she has seen improvement in with teprotumumab. Dr. Wester agreed, adding that she has also used the drug in patients with smoldering or more chronic disease and had great results. “I’m definitely looking forward to ongoing studies in chronic patients,” Dr. Wester said. “We have a lot to learn about who might benefit the most from this drug.”
The second question discussed was about what side effects occur with teprotumumab and how best to handle them. “There is a paper coming out soon in the Journal of Neuro-Ophthalmology that is an attempt at a guideline on this from some investigators involved in the phase III OPTIC study,” Dr. Wester said.
In her own practice, she said that if a patient has an underlying issue with true diabetes or impaired glucose tolerance, she will follow the patient more closely. For patients with normal HbA1c and glucose, she checks glucose at baseline, week 12, and week 24. She also gets a complete blood count and CHEM-7 panel. In addition, she also gets a urine analysis for women of child-bearing age. Finally, she always asks patients if they have a history of inflammatory bowel disease.
In clinical trials, muscle cramps were the most common side effect. Thinning of the hair may also occur. “I find though that I have to really have to ask about these specific things,” Dr. Kossler said.
In fact, both she and Dr. Wester said that they have experienced patients not wanting to admit experiencing side effects because they are so satisfied with the drug and do not want to have to stop taking it.
The final question from the audience was about the cost of teprotumumab and how best to get insurance approval for its use.
Teprotumumab is an expensive treatment, and clinicians may run into some issues getting insurance to cover treatment, Dr. Westner said. However, both Drs. Westner and Kossler said they have protocols in place on what information must be included in the chart to gain approval.
“We include the CAS, amount of proptosis, other treatments that we have done or failed, why a patient can’t have steroids or why steroids are not a good idea, why the patient is not a good candidate for radiation, and a complete examination,” Dr. Kossler said. “I think if you send a complete note with justification, you have a better chance of getting approved.”