ArticleOphthalmology and therapy2026
Post Hoc MRI Analysis of Orbital Soft Tissue Volumes Pre- and Post-Teprotumumab in Patients with Chronic, Low-Activity Thyroid Eye Disease.
Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04583735 (A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA® in Treating Patients With Chronic), which is not on this map. Not yet cited in PubMed.
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A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA® in Treating Patients With Chronic (Inactive) Thyroid Eye Disease
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6 authors.
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Abstract
introductionA previous phase 4 trial (Chronic) evaluated teprotumumab treatment in patients with chronic, low-activity thyroid eye disease (TED). In the current study, volumetric changes in the orbital soft tissues, lacrimal glands, and full facial fat were evaluated following teprotumumab in a subset of patients from this chronic TED trial who underwent magnetic resonance imaging (MRI).
methodsThis post hoc exploratory MRI analysis examined volumetric changes of extraocular muscles (EOMs), orbital fat (OF), lacrimal glands, and full facial fat pre- and post-teprotumumab (week 24) in patients from the phase 4 Chronic trial at one preselected trial site. Patients had a TED duration of 2-10 years, diagnosis of chronic, low-activity TED (clinical activity score ≤ 1), and received eight teprotumumab infusions administered once every 3 weeks. The study (more proptotic) and fellow orbit were evaluated separately and together via MRI.
resultsOf the six patients (female n = 5, male n = 1) undergoing MRI at baseline and week 24, the mean age and TED duration was 45.2 and 5.5 years, respectively. At baseline, patients had a mean proptosis of 25.25 mm (study orbits) and 24.00 mm (fellow orbits). Mean (%) changes from baseline (CFB) in total EOM and OF volumes in combined study and fellow orbits after 24 weeks of teprotumumab were - 1107.3 mm
conclusionMRI demonstrated that teprotumumab effectively reduces orbital soft tissue, facial fat, and lacrimal gland volumes in study and fellow orbits of patients with chronic, low-activity TED.
trial registrationClinicalTrials.gov identifier NCT04583735.
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