Data show longer-term efficacy of teprotumumab in severe, less severe thyroid eye disease
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Additional data from the OPTIC-X extension trial and pooled analysis of phase 2 and 3 trial data confirm the efficacy of teprotumumab for the treatment of thyroid eye disease in the longer term and at different degrees of disease severity.
Tepezza (teprotumumab, Horizon Therapeutics) is a human monoclonal antibody inhibitor of insulin-like growth factor-1 receptor (IGF-1R) that halts the IGF-1R/thyroid-stimulating hormone receptor signaling at the source of the thyroid eye disease, reducing inflammation and reversing retro-orbital tissue expansion and hyaluronan production. The phase 3 OPTIC trial demonstrated efficacy in 82% of cases, with significant reduction of proptosis, inflammation and diplopia and no severe adverse events at 24 weeks.
“The OPTIC-X extension study evaluated patients during the following treatment-off period and showed that the majority of patients (56%) who were 24-week responders maintained the response at week 72,” Raymond S. Douglas, MD, PhD, said at the virtual American Academy of Ophthalmology annual meeting. “Patients in which flare occurred over the treatment-off time received a second course of the treatment, and 63% responded well.”
Delayed treatment was not less effective, Douglas said. Response was almost identical, with 89% of responders among patients who were previously on placebo and were switched to teprotumumab after 1 year on average of disease activity.
In the teprotumumab trials, the worse affected eye of each patient was designated as the study eye. In order to evaluate treatment response in eyes with less severe thyroid eye disease, a pooled analysis of the phase 2 and 3 trials was performed on the less affected fellow eyes. In a poster, Douglas and co-authors reported that at week 24, 63% of the patients in the treated group had a proptosis reduction of more than 2 mm as compared with 8% in the placebo group. Worsening of proptosis occurred in 30 patients in the placebo group vs. none in the teprotumumab group.
The clinical activity score (CAS), evaluating inflammation, decreased by a mean of –3.42 with the treatment vs. –2.00 in the placebo group, and more patients had 0 or 1 CAS, indicating disease inactivation. The poster showed the case of one patient who had visible, complete resolution of diplopia in both eyes at week 24.
According to the authors, these findings indicate that teprotumumab halts disease progression in both severe and less severe disease.
“This study adds to the growing body of evidence that teprotumumab targets the molecular pathways underlying [thyroid eye disease] pathogenesis and that inhibition of the IGF-1R restores orbital homeostasis,” they said.
Reference:
Douglas RS, et al. Long-term assessment of proptosis and diplopia from the optic trial of teprotumumab in thyroid eye disease. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).
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Douglas RS, et al. Improvement in the fellow eye of patients with TED: Pooled analyses from the teprotumumab studies. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).
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