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Background: Thyroid eye disease (TED) is a visionthreatening and debilitating condition that until very recently had no Food and Drug Administration (FDA)approved medical therapies. Teprotumumab has recently been approved to treat TED. We aim to provide guidance for its use, based on the input of the US investigators who participated in Phase 2 and Phase 3 clinical trials. Methods: An expert panel was convened on October 11th and November 16th of 2019. All panel members had extensive experience as investigators in the Phase 2 and/ or Phase 3 clinical trials of teprotumumab. Consensus among those investigators was reached to determine patient characteristics most appropriate for teprotumumab treatment. Safety guidelines were also reviewed and agreed on. Results: The authors recommend that teprotumumab be considered first-line therapy for patients with clinically significant ophthalmopathy, including those with disease duration exceeding 9 months. The clinical activity score (CAS) may be useful for longitudinal monitoring but should not be used to determine treatment eligibility. Criteria will likely be expanded after more experience with the drug. Using teprotumumab for patients with TED with substantial signs, symptoms, or morbidity without a CAS score of .4 (e.g., progressive proptosis, diplopia, and early compressive optic neuropathy) or more, could be considered. Diabetes mellitus and inflammatory bowel disease comorbidities should not be exclusionary, but stringent monitoring in these patients is recommended. Drug dosing, administration interval, and duration should adhere to the study protocol: 8 infusions, separated by 3 weeks. Patients with more severe disease may benefit from additional doses. Corticosteroids can be used before or during teprotumumab therapy. Clinical and laboratory monitoring should be consistent with good clinical practice for patients receiving teprotumumab. Conclusions: Confirming the efficacy of teprotumumab usage outside the narrow parameters of the completed clinical trials will require rigorous scientific validation. As a step in that direction, we believe its on-label usage is appropriately applied to all patients with TED with substantial symptoms or morbidity, as judged by their physician.
Purpose The goal of this study is to evaluate parameters on orbital computed tomographyas predictors of visual outcome in orbital compartment syndrome from retrobulbar hematoma or orbital cellulitis. The study will assess the assertion that certain patients are anatomically predisposed to vision loss in these conditions. Methods A retrospective chart review of consecutive patients with the diagnosis of either orbital cellulitis or orbital hematoma from the clinic of a single provider in an academic practice from 2006 to 2009was performed. Exclusion criteria included pre-existing vision loss, lack of CT scan for analysis, or lack of one month follow-up for final visual acuity. Measurements of final visual acuity, medial wall length, lateral wall length, distance from globe to apex, and a novel measurement of posterior globe tenting (stretch angle) were obtained. Patients were divided into two groups: normal visual acuity and vision loss. Statistical analysis was performed to identify significant differences between the two groups. Results The normal vision group consisted of 11 patients all with vision of 20/30 or better. The average length of the medial and lateral wall was 43.9mm and 41.6mm respectively. The average distance from the globe to the apex was 26.3mm in the uninvolved eye and 30.3mm in the involved eye resulting in an average difference of 4.18mm. The average stretch angle measurement was 28.9º in the uninvolved eye and 28.5º in the involved eye resulting in an average difference of 0.41º. The vision loss group consisted of four patients all with vision of count fingers or worse. The average length of the medial and lateral wall was 46.9mm and 45.7mm respectively. The average distance from the globe to the apex was 32.2mm in the uninvolved eye and 36.7mm in the involved eye resulting in an average difference of 4.50mm. The average stretch angle measurement was 32.3º in the uninvolved eye and 21.1º in the involved eye resulting in an average difference of 11.2º. The difference in stretch angle between eyes in the vision loss and normal vision groups were found to be highly significant with a p-value of less than 0.001. The difference between the two orbits for globe to apex is a rough measurement of proptosis and was not statistically different in the two groups (p = .71). Whereas, the length from the globe to apex in the uninvolved eye was statistically different between the vision loss group and normal vision group (p = <0.001). Conclusions Orbital compartment syndrome is a potentially vision threatening condition. Minimal objective data is currently available in the literature to guide physicians in clinical judgment making regarding these patients. The results of this study indicate that comparing the novel stretch angle between the patient’s two eyes as well as measuring the length from the globe to orbital apex can help identify patients at risk for poor visual outcome. This study provides objective measurements that can aid ophthalmologist and radiologist in determining the relative thr...
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