Teprotumumab meets endpoints for proptosis reduction in long-duration thyroid eye disease
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Key takeaways:
- Teprotumumab was associated with a 2.41 mm mean proptosis reduction in adults with chronic thyroid eye disease and low disease activity.
- Of the teprotumumab group, 62% had a proptosis reduction of at least 2 mm.
Teprotumumab is associated with a greater reduction in proptosis than placebo at 24 weeks among adults with chronic thyroid eye disease and a low clinical activity score, according to topline results.
As Healio previously reported, data from phase 2 and phase 3 trials revealed teprotumumab (Tepezza, Horizon Therapeutics) met its primary endpoint of reducing proptosis among adults recently diagnosed with thyroid eye disease and those with higher clinical activity scores. The data led to teprotumumab becoming the first FDA-approved drug for the treatment of thyroid eye disease in January 2020. New data from a phase 4 trial showed teprotumumab also reduced proptosis among adults with thyroid eye disease for at least 2 years and lower clinic activity scores.
“Given this new and positive clinical evidence in patients with long-duration thyroid eye disease and low clinical activity score, it is important for physicians to thoroughly assess all of their thyroid eye disease patients to determine whether Tepezza might be an option,” Raymond Douglas, MD, PhD, trial principal investigator and director of the orbital and thyroid eye disease program at Cedars-Sinai in Los Angeles, said in a press release. “It is important to specifically ask patients if their symptoms are interfering with their ability to work, socialize and go about daily activities. These conversations can help physicians uncover the true burden of the disease and need for treatment, regardless of how much inflammation they have behind the eye or how long they have been living with the disease.”
In a randomized, double-masked, phase 4 trial, researchers enrolled adults with a diagnosis of thyroid eye disease 2 to 10 years prior to enrollment and a low clinical activity score. Participants were randomly assigned to receive either teprotumumab or placebo. In intent-to-treat analysis, adults in the teprotumumab group had a greater mean reduction in proptosis compared with placebo (mean reduction, 2.41 mm vs. 0.92 mm; P = .0004). The percentage of participants who had a proptosis reduction of at least 2 mm was also greater in the teprotumumab group than with placebo (62% vs. 25%; P = .0134).
“We are thrilled with the topline results, which reinforce that Tepezza significantly reduces proptosis in people living with thyroid eye disease, regardless of their disease activity or duration, and underscores what we learned from our initial trials and what we have seen through more than 3 years of real-world use of Tepezza,” Elizabeth H.Z. Thompson, PhD, executive vice president of research and development for Horizon, said in a press release. “With Tepezza, physicians have a medicine that can be used in a broad range of thyroid eye disease patients, including those with long-duration disease of more than 5 years on average in this trial, which is important because we know the negative impact of the disease can be significant across all types of thyroid eye disease patients. We look forward to discussing these data with the FDA to determine our next steps.”
There were no new safety signals observed in the phase 4 trial. According to the press release, Horizon Therapeutics plans to present the data at a future medical congress and publish them in a peer-reviewed medical journal in the future.
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