Purpose Thyroid eye disease (TED) is a progressive, debilitating and potentially vision-threatening autoimmune disease. Teprotumumab, a novel human monoclonal antibody, has been shown to reverse the clinical manifestations of TED. Patients receiving teprotumumab have been shown in two multicenter, randomized placebo-controlled trials to have decreased proptosis, diplopia and inflammation after 24 weeks of treatment. This study aims to analyse volumetric and inflammatory changes on orbital imaging prior to and after teprotumumab treatment from one of these trials.
Design Retrospective review.
Subjects Six patients enrolled in the phase III teprotumumab clinical trial (OPTIC, NCT03298867) with active TED who received 24 weeks of teprotumumab and had pre- and post-treatment orbital imaging (CT or MRI). Additionally, 12 non-TED patients (24 orbits) were analysed as a comparative control group.
Methods 3D volumetric calculations of the extraocular muscles (EOMs), orbital fat, and bony orbit were measured using previously validated image processing software. 3D volumetric results and changes in EOM inflammation were compared with clinical measurements of TED.
Results Total EOM volume within each orbit was markedly reduced post-teprotumumab in all patients (n=six patients, 12/12 orbits, p<0.02). There was no statistical difference in post-treatment EOM volume when compared to non-TED controls. Total orbital fat volume was also reduced in 11 of 12 studied orbits (n=six patients, p=0.04). Overall EOM inflammation based on MRI signal intensity ratio was reduced in 8/8 orbits (n=four patients, p<0.01).
Conclusion Orbital imaging demonstrated decreased EOM volumes and orbital fat tissue volumes after teprotumumab treatment.
- Treatment Medical
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Contributors The contributors of this research article are the authors. APJ, AK and NG performed the 3D volumetric analysis and SIR calculations. SU performed statistical analysis. RD helped analyse the data. All authors contributed to the writing of the paper.
Funding The JGU Medical Center has received research associated funding from Horizon therapeutics, IL, USA.
Competing interests RD—Consultant Horizon Therapeutics, Consultant Immunovant. AK—Employer, Horizon Therapeutics.
Provenance and peer review Not commissioned; externally peer-reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplemental information.