Teprotumumab Benefits Patients With Mild Inflammation and Real-world Adherence Remains High

Posters presented at the American Academy of Ophthalmology 2021 annual meeting showed that even patients with mild inflammation with their thyroid eye disease benefitted from teprotumumab and that real-world adherence was consistent with the pivotal clinical trials.

As the first and only approved therapy for thyroid eye disease (TED), teprotumumab (Tepezza) can spare patients from undergoing surgery to treat their condition. TED is an inflammatory condition that causes the eyes to be pushed forward and bulge outwards.

In the 2 pivotal trials that FDA reviewed for teprotumumab’s approval, the patients evaluated had more severe inflammation and eye bulging, known as proptosis. New research presented at the American Academy of Ophthalmology (AAO) 2021 annual meeting showed that even patients with mild inflammation can benefit from teprotumumab and experience a reduction in proptosis.1

Patients in the 2 pivotal trials had clinical activity scores (CAS) of at least 4, but the patients being studied in the new poster presented at AAO had CAS less than 4. They analyzed the response in 15 patients, who had a TED duration of a mean of 11.7 months. The mean baseline proptosis was 22.3 mm. After 8 infusions of teprotumumab over the course of 24 weeks, 13 (86.7%) of the patients were responders with a mean proptosis reduction of 2.9 mm.

Among the 12 patients who had CAS less than 3, 83.3% were responders with a mean proptosis reduction of 2.6 mm.

“We know from the Phase 2 and 3 clinical trials that Tepezza is effective in reducing proptosis in thyroid eye disease patients with high inflammatory activity and are pleased to see comparable efficacy in those with low-level inflammation,” Raymond Douglas, MD, PhD, study investigator and director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center, said in a statement. Douglas presented the results of the poster at AAO. “This analysis is encouraging for physicians looking to prescribe Tepezza for patients who have little to no inflammatory activity but are still living with other devastating symptoms that affect their everyday lives.”

Another study presented at AAO 2021 evaluated the real-world adherence to teprotumumab in patients with TED.2 In the 2 pivotal trials, 91% of patients completed their full course of treatment.

The researchers evaluated 1101 patients who began their treatment with teprotumumab prior to July 2020. They allowed patients at least 8 months to complete the full course of 8 doses and collected data through AllCare, a subsidiary vendor of IQVIA, in March 2021.

The majority of patients (71%) were female, and the mean age was 58 years. Overall, 90.37% of patients finished the full course of therapy. The mean number of infusions received was 7.68 (median, 8).

The primary reason for discontinuing the prescribed treatment was adverse events (AEs) (8%), followed by noncompliance (1%), site of care challenges or payer restrictions (< 1%), and patient or physician concern (< 1%).

Among the patients who discontinued due to AEs, the most common AEs were muscle spasms, fatigue, nausea, diarrhea, hearing loss, blood glucose increase, and headache. Generally, these AEs were consistent with those observed in the clinical trials, according to the researchers.

They noted that a single AE was not identified as the cause of discontinuation and some patients had multiple AEs.

“Data from this analysis of the real-world use with teprotumumab suggest that adherence (90%) to teprotumumab treatment is high in clinical practice, consistent with the controlled trial findings,” according to the researchers.

References

1. Douglas RS, Francis-Sedlak M. Teprotumumab efficacy in TED patients with low inflammation as measured by clinical activity score. Presented at: AAO 2021; November 12-15, 2021; New Orleans, LA. Poster PA059.

2. Douglas RS, Francis-Sedlak M, Holt RJ, Daily RA. Real-world adherence with teprotumumab in TED. Presented at: AAO 2021; November 12-15, 2021; New Orleans, LA. Poster PO026.