Ophthalmology and therapy · 2026
Post Hoc MRI Analysis of Orbital Soft Tissue Volumes Pre- and Post-Teprotumumab in Patients with Chronic, Low-Activity Thyroid Eye Disease.
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Ugradar Shoaib, Kumar Ada, Karon Michael, Wang Zhenxun, Subramanian Prem S, Wester Sara T
Аннотация
INTRODUCTION: A 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).
METHODS: This 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.
RESULTS: Of 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 mm3 (- 25.0%) and - 5017.1 mm3 (- 34.6%), respectively. Mean (%) CFB in full facial fat and study and fellow lacrimal gland volumes were - 12,175.9 mm3 (- 6.6%), - 116.7 mm3 (- 21.9%), and - 150.5 mm3 (- 26.4%), respectively. Proptosis response was observed in 100% (6/6) of study and 66.7% (4/6) of fellow orbits.
CONCLUSION: MRI 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 REGISTRATION: ClinicalTrials.gov identifier NCT04583735.
METHODS: This 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.
RESULTS: Of 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 mm3 (- 25.0%) and - 5017.1 mm3 (- 34.6%), respectively. Mean (%) CFB in full facial fat and study and fellow lacrimal gland volumes were - 12,175.9 mm3 (- 6.6%), - 116.7 mm3 (- 21.9%), and - 150.5 mm3 (- 26.4%), respectively. Proptosis response was observed in 100% (6/6) of study and 66.7% (4/6) of fellow orbits.
CONCLUSION: MRI 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 REGISTRATION: ClinicalTrials.gov identifier NCT04583735.