ew Analysis Highlights Importance of Adhering to Uninterrupted Full Course of Treatment with TEPEZZA® (teprotumumab-trbw) to Support Thyroid Eye Disease (TED) Patient Outcomes
Horizon Therapeutics plc (Nasdaq: HZNP) today announced new data showing that disrupting the recommended TEPEZZA treatment regimen by lengthening the amount of time between infusions can increase the need for a second course of treatment. These findings, along with new subgroup data from the TEPEZZA Phase 4 clinical trial in patients with long disease duration and low Clinical Activity Score (CAS) and an analysis of the impact of TED on QOL, were shared at the 92nd Annual Meeting of the American Thyroid Association (ATA 2023), Sept. 27-Oct. 1 in Washington, D.C. TEPEZZA is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of TED regardless of disease activity or duration. TED is a serious, progressive, debilitating and potentially vision-threatening rare autoimmune disease.1
The FDA-approved dosing schedule for TEPEZZA is one infusion every three weeks for a total of eight IV infusions. An analysis examined whether patients who experience a treatment disruption, defined as a >60-day gap between consecutive infusions, are more likely to need a second course of treatment. Deidentified data of patients prescribed a second course of TEPEZZA after receiving an initial full course were examined for TED-related claims, enrollment for a second course, number of infusions and time between courses. Undisrupted patients (n=4,230) and disrupted patients (n=1,155) were observed for one year after the initial full course of treatment. The majority of treatment disruptions (96%) were related to the short-term TEPEZZA supply disruption that occurred in late 2020 as a result of government-mandated COVID-19 vaccine production orders. Chi-square tests were performed for significance.
The findings revealed that a higher portion of patients who experienced a disruption in their first course of TEPEZZA were prescribed an additional course of treatment compared with those who completed an undisrupted initial course of TEPEZZA (10.5% vs 6.5%; p<0.0001). There was also a difference in claims of proptosis between the groups, with a 5% increase of proptosis among disrupted patients vs a 19% reduction in the undisrupted group pre- to post- treatment with TEPEZZA.2
“This analysis reinforces the importance of adhering to the FDA-approved dosing schedule for TEPEZZA and not lengthening the time between consecutive infusions unless there is a safety concern,” said Shoaib Ugradar, MD, private practice, Beverly Hills, CA. “Although treatment delays may result from factors that a prescriber may not directly control, such as changes in insurance coverage or scheduling difficulties, and additional research on this is needed, physicians play an important role in making patients aware that delaying infusions could impact results.”
Horizon also announced further results from the TEPEZZA Phase 4 clinical trial in TED patients with long disease duration and low CAS. Findings reinforced a meaningful reduction of proptosis at Week 24 for all subgroups (≥2mm) with comparable improvements regardless of magnitude of baseline proptosis levels (<=25 vs >25mm). Smokers treated with TEPEZZA had a change from baseline (CFB) of -2.83 mm (vs 0.00 CFB for placebo); treated non-smokers had a -2.39 mm CFB (vs -1.00 mm for placebo). Males treated with TEPEZZA (n=10) had a CFB of -2.20 mm (vs -1.00 for placebo, n=2), and in treated females (n=29), CFB was -2.55 mm (vs -0.89 for placebo, n=18).3
Additionally, research on the impact of TED on patients’ QOL was presented at ATA 2023, assessing how characteristics like sex, age and severity of symptoms affect visual functioning and appearance as measured by the Graves’ Ophthalmopathy Quality of Life (GO-QOL) questionnaire. The analysis looked at baseline GO-QOL data for 171 moderate-to-severe TED patients prior to treatment in two clinical trials. Visual functioning results showed that the majority of participants reported limitations in important daily activities like reading (74%) or driving (64%), and nearly all (95%) were affected by the changes in their appearance. Certain sub-populations noted more significant impact on their daily activities, including those with severe diplopia (n=74) and patients with more proptosis (n=104).4
“We are committed to fully understanding the daily challenges that patients with Thyroid Eye Disease experience regardless of their disease activity or duration, including things like symptoms that limit the ability to drive at night, or the mental toll that a lack of independence may bring,” said Beth Scott, OD, MS, vice president, medical affairs, Horizon. “The data presented this weekend help us further our mission of ensuring those in the Thyroid Eye Disease community receive appropriate care.