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The New England Journal of Medicine Apr 2020
Topics: Adult; Animals; Echinococcosis; Echinococcus granulosus; Exophthalmos; Female; Humans; Orbit; Orbital Diseases
PubMed: 32242360
DOI: 10.1056/NEJMicm1911903 -
International Journal of Clinical... 2023In this study, we conducted a meta-analysis to assess the efficacy and safety of teprotumumab in treating thyroid eye disease. We searched the Cochrane Library, PubMed,... (Meta-Analysis)
Meta-Analysis Review
In this study, we conducted a meta-analysis to assess the efficacy and safety of teprotumumab in treating thyroid eye disease. We searched the Cochrane Library, PubMed, and Embase databases from inception to May 25, 2022, and included all randomized controlled trials. Odds ratios (ORs) were calculated using fixed- or random-effect models. A total of three studies involving 341 patients were identified. Overall, the analysis revealed that teprotumumab demonstrated superior integrated proptosis response compared to placebo in both the intention-to-treat (ITT) population (OR = 17.81, 95% CI = [10.32, 30.76], = 50%) and per-protocol population (OR = 24.53, 95% CI = [12.96, 46.45], = 14%). Furthermore, patients receiving teprotumumab showed significant improvement in overall response (OR = 8.35, 95% CI = [4.74, 14.71], = 79%), diplopia response (OR = 5.53, 95% CI = [3.24, 9.44], = 0%), and achieving a clinical activity score (CAS) of 0 or 1 (OR = 6.26, 95% CI = [3.87, 10.12], = 0%). Moreover, patients treated with teprotumumab experienced greater improvements in proptosis (MD = -2.49, 95% CI = [-2.54, -2.45], = 98%) and Graves' ophthalmopathy-specific quality of life (GO-QOL, MD = 11.48, 95% CI = [11.03, 11.93], = 95%). However, it is important to note that patients receiving teprotumumab had a higher risk of adverse events, including serious adverse events, gastrointestinal adverse reactions, and muscle spasms. In summary, teprotumumab demonstrated greater improvement in proptosis response, proptosis, diplopia response, overall response, GO-QOL, and CAS. Nonetheless, it should be considered that its use is associated with a higher risk of adverse events.
Topics: Humans; Graves Ophthalmopathy; Quality of Life; Diplopia; Randomized Controlled Trials as Topic; Exophthalmos
PubMed: 37588100
DOI: 10.1155/2023/6638089 -
Neuroimaging Clinics of North America Aug 2021Graves disease is an autoimmune disorder caused by the breakdown of immune tolerance to thyroid antigens against the TSH receptor. In approximately 25% of patients, an... (Review)
Review
Graves disease is an autoimmune disorder caused by the breakdown of immune tolerance to thyroid antigens against the TSH receptor. In approximately 25% of patients, an inflammatory condition, Graves eye disease (GED), affects the orbital soft tissues. About 60% of patients develop mild symptoms including fat expansion and inflammation of the levator muscle complex with resultant proptosis, eyelid retraction, and exposure of the globe. The remaining patients experience enlargement of one or more of the extraocular muscles, leading to conjunctival and eyelid edema and congestion, restricted ocular movement with resultant diplopia, and optic nerve compression leading to compressive optic neuropathy.
Topics: Exophthalmos; Graves Ophthalmopathy; Humans; Oculomotor Muscles; Optic Nerve; Optic Nerve Diseases
PubMed: 34243871
DOI: 10.1016/j.nic.2021.04.006 -
Emergency Medicine Journal : EMJ Aug 2014
Topics: Conjunctivitis; Exophthalmos; Eyelid Diseases; Humans; Male; Middle Aged
PubMed: 24136120
DOI: 10.1136/emermed-2013-203249 -
Journal of Neuro-ophthalmology : the... Mar 2022Teprotumumab, a monoclonal antibody that blocks the insulin-like growth factor-1 receptor, has recently been approved by the US Food and Drug Administration (FDA) for... (Review)
Review
BACKGROUND
Teprotumumab, a monoclonal antibody that blocks the insulin-like growth factor-1 receptor, has recently been approved by the US Food and Drug Administration (FDA) for the treatment of thyroid eye disease (TED). Since its approval, aside from data on the safety and clinical efficacy of teprotumumab from Phase-2 and Phase-3 trials, only a handful of reports have been published regarding its use in the wider population. In this review, we briefly describe the mechanism of action of teprotumumab and review the literature to provide an overview of published clinical experience. This information was used to provide recommendations for patient selection, management of patient expectations, infusion details and site options, tips to optimize the authorization process, and how to monitor and mitigate side effects.
EVIDENCE ACQUISITION
A systemic review of the literature was performed regarding teprotumumab, focusing on its mechanisms of action and published reports on its use on patients with TED. A review of Embase, Medline (PubMed), Web of Science, and Google Scholar was conducted.
RESULTS
Clinical experience following the approval of teprotumumab has confirmed its efficacy in reducing inflammation and proptosis in patients with acute TED (<2 years). The reduction in proptosis occurs due to a reduction in orbital fat and muscle volume. Furthermore, there is evidence for its use in patients with compressive optic neuropathy. There are also reports that show its efficacy in reducing proptosis, inflammation, and diplopia in patients with chronic TED (>2 years). Teprotumumab was associated with side effects, such as muscle spasm, hearing loss, and hyperglycemia. To date, 2 case reports have shown a possible association with flares of inflammatory bowel disease.
CONCLUSIONS
Teprotumumab is a powerful therapeutic option for the treatment of TED. Clinical experience following FDA approval has demonstrated efficacy in treating patients with acute and chronic TED. It is the only therapeutic option that has been shown to reduce orbital soft tissue expansion in TED. However, it is expensive, and sometimes, obtaining insurance authorization can be time consuming and difficult. Further work will reveal its full side effect profile and help to establish its role in the armamentarium used to treat TED.
Topics: Antibodies, Monoclonal, Humanized; Exophthalmos; Graves Ophthalmopathy; Humans; Inflammation; United States
PubMed: 35500236
DOI: 10.1097/WNO.0000000000001515 -
European Journal of Ophthalmology Jul 2023To compare the surgical outcomes of endoscope-navigation (EN)-assisted orbital decompression and non-EN-assisted orbital decompression for Graves' orbitopathy (GO) and...
PURPOSE
To compare the surgical outcomes of endoscope-navigation (EN)-assisted orbital decompression and non-EN-assisted orbital decompression for Graves' orbitopathy (GO) and to assess the potential clinical advantage of EN in orbital decompression surgery.
METHODS
This retrospective cohort study was performed on 227 orbits of 147 GO patients who underwent EN-assisted orbital decompression (185 orbits) or non-EN-assisted orbital decompression (42 orbits). Assessment included proptosis reduction, best-corrected visual acuity (BCVA), diplopia, ocular restriction and surgical complications.
RESULTS
The proptosis reduction in the EN group was 0.9 mm greater than that in the non-EN group in the entire cohort ( = 0.004) and 1.0 mm greater than that in the non-EN group in the propensity score matching cohort ( = 0.025) at 2 years postoperatively. In all, 78.2% of orbits with sight-threatening GO in the EN group and 52.6% of orbits in the non-EN group showed BCVA improvement ( = 0.026). The proportion of patients with improvement in diplopia was significantly greater in the EN group than in the non-EN group ( = 0.026).
CONCLUSIONS
EN offers anatomical localization and deep-seated tissue visualization in orbital decompression and significantly improves the surgical outcomes for GO.
Topics: Humans; Graves Ophthalmopathy; Diplopia; Retrospective Studies; Treatment Outcome; Decompression, Surgical; Orbit; Exophthalmos; Endoscopes
PubMed: 36718496
DOI: 10.1177/11206721231152628 -
Journal of Glaucoma Aug 2019PRéCIS:: Eyes with glaucoma have tauter optic nerves compared with normal eyes, which may exert more force on the optic nerve head tissues during eye movements.
UNLABELLED
PRéCIS:: Eyes with glaucoma have tauter optic nerves compared with normal eyes, which may exert more force on the optic nerve head tissues during eye movements.
PURPOSE
The purpose of this study was to assess the difference in optic nerve tortuosity during eye movements and globe proptosis between primary open angle glaucoma and normal subjects using orbital magnetic resonance imaging (MRI).
METHODS
Ten Chinese subjects matched for ethnicity and refractive errors were recruited, including 5 normal controls and 5 patients with primary open angle glaucoma. All subjects underwent MRI to assess their optic nerves and globes for 3 eye positions: primary gaze, adduction, and abduction. Optic nerve tortuosity (optic nerve length divided by the distance between 2 ends) and globe proptosis (maximum distance between the cornea and interzygomatic line) were measured from MRI images.
RESULTS
In adduction, the tortuosity of normal eyes was significantly larger than that of the glaucomatous eyes. Optic nerve tortuosity in adduction in the control and glaucoma groups were 1.004±0.003 (mean±SD) and 1.001±0.001, respectively (P=0.037). Globe proptosis (primary gaze) in glaucoma subjects (19.14±2.11 mm) was significantly higher than that in control subjects (15.32±2.79 mm; P=0.046).
CONCLUSIONS
In this sample, subjects with glaucoma exhibited tauter optic nerves and more protruding eye globes compared with normal eyes. This may impact optic nerve head deformations in anatomically predisposed patients.
Topics: Aged; Aged, 80 and over; Asian People; Case-Control Studies; Exophthalmos; Eye Movements; Female; Fixation, Ocular; Glaucoma; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Optic Disk; Optic Nerve
PubMed: 31045951
DOI: 10.1097/IJG.0000000000001270 -
JAMA Ophthalmology Feb 2023Thyroid eye disease (TED) results in varying degrees of proptosis and diplopia negatively affecting quality of life (QoL), producing possibly substantial visual changes,...
IMPORTANCE
Thyroid eye disease (TED) results in varying degrees of proptosis and diplopia negatively affecting quality of life (QoL), producing possibly substantial visual changes, disfigurement, and disability.
OBJECTIVE
To determine the association of varying TED severities with QoL in a non-TED population by assessing health state utility scores.
DESIGN, SETTING, AND PARTICIPANTS
This qualitative study, conducted from April 20, 2020, to April 29, 2021, assessed health states for active, moderate-severe TED, and values were elicited using time trade-off methods. Six health states of varying severity were determined from 2 placebo-controlled clinical trials (171 patients with TED and clinical activity score ≥4, ±diplopia/proptosis) and refined using interviews with US patients with TED (n = 6). Each health state description was validated by interviews with additional TED patient advocates (n = 3) and physician experts (n = 3). Health state descriptions and a QOL questionnaire were piloted and administered to a general population. Visual analog scales (VASs) were also administered to detect concurrence of the findings.
MAIN OUTCOMES AND MEASURES
TED health state utility scores and whether they differ from one another were assessed using Shapiro-Wilk, Kruskal-Wallis, pairwise Wilcoxon rank sum, and paired t tests.
RESULTS
A total of 111 participants completed time trade-off interviews. The mean (SD) utility value was 0.44 (0.34). The lowest (worse) mean utility value was observed in the most severe disease state (constant diplopia/large proptosis) with 0.30 (95% CI, 0.24-0.36), followed by constant diplopia/small proptosis (0.34; 95% CI, 0.29-0.40), intermittent or inconstant diplopia/large proptosis (0.43; 95% CI, 0.36-0.49), no diplopia/large proptosis (0.46; 95% CI, 0.40-0.52), and intermittent or inconstant diplopia/small proptosis (0.52; 95% CI, 0.45-0.58). The highest (best) mean value, 0.60 (95% CI, 0.54-0.67), was observed for the least severe disease state (no diplopia/small proptosis).
CONCLUSIONS AND RELEVANCE
These findings suggest that patients with active, moderate-severe TED may have substantial disutility, with increasing severity of proptosis/diplopia more likely to have detrimental associations with QoL. These health state scores may provide a baseline for determining QoL improvement in these TED health states (utility gains) treated with new therapies.
Topics: Humans; Graves Ophthalmopathy; Quality of Life; Exophthalmos; Surveys and Questionnaires; Diplopia
PubMed: 36580313
DOI: 10.1001/jamaophthalmol.2022.3225 -
Acta Radiologica (Stockholm, Sweden :... Sep 2023Computed tomography (CT) can avoid interference factors and has been imported into some software to measure proptosis clinically as the golden standard.
BACKGROUND
Computed tomography (CT) can avoid interference factors and has been imported into some software to measure proptosis clinically as the golden standard.
PURPOSE
To establish a new method for semi-automatically measuring the proptosis on CT and evaluate its accuracy and reproducibility.
MATERIAL AND METHODS
A total of 50 orbital CT images were collected of healthy individuals, 25 patients with Graves ophthalmopathy (GO), and 25 patients with orbital fracture (OF). A new image processing software, MedrawHDC, was developed to semi-automatically measure the proptosis (MedrawHDC method). The classic radiological (CR) method (measuring proptosis with the software called Mimics) and MedrawHDC method were applied in all three groups (measured by observer S). Hertel's exophthalmometer (HE) method was also applied in the GO group. Moreover, two other observers were asked to measure the proptosis using MedrawHDC, to evaluate its reproducibility.
RESULTS
The MedrawHDC method was highly consistent with the CR method in measuring proptosis (normal group: intraclass correlation coefficient [ICC] = 0.989; GO group: ICC = 0.979; OF group: ICC = 0.979). In the GO group, the value of proptosis measured by two radiological methods were consistent with that measured by the HE method (CR method: ICC = 0.703; MedrawHDC method: ICC = 0.697). Bland-Altman plots showed similar results. The measurements obtained by three observers were highly reproducible (ICC = 0.995).
CONCLUSION
The newly established MedrawHDC method, with high accessibility, convenience, and repeatability, is reliable in assessing proptosis. It shows high potential for wide application, having clinical value for scientific evaluation of proptosis.
Topics: Humans; Reproducibility of Results; Exophthalmos; Graves Ophthalmopathy; Orbital Fractures; Tomography, X-Ray Computed; Observer Variation
PubMed: 37501503
DOI: 10.1177/02841851231187859 -
Ophthalmic Plastic and Reconstructive...To evaluate periorbital volume changes, using quantitative photogrammetric stereoimaging, after bony orbital decompression for thyroid eye disease (TED) and compare this...
PURPOSE
To evaluate periorbital volume changes, using quantitative photogrammetric stereoimaging, after bony orbital decompression for thyroid eye disease (TED) and compare this to changes in Hertel exophthalmometry. Tissue volumes of the upper and lower eyelids were also assessed independently.
DESIGN
Prospective, nonrandomized, nonconsecutive series of patients.
SUBJECTS
Adults with inactive TED who had elected to undergo bony orbital decompression at Moorfields Eye Hospital between 2015 and 2017.
METHODS
With their eyes gently closed, patients with inactive TED underwent imaging using the VECTRA M3 system (Canfields Imaging, Fairfield, NJ), both before and at least 3 months after orbital decompression. Proptosis was assessed by Hertel exophthalmometry. Using the manufacturer's software, changes in periorbital volumes between the preoperative and postoperative images were calculated for the upper and lower eyelids. The Pearson product-moment correlation coefficient was used to assess the linear relationship between changes in periorbital volume and exophthalmometry.
MAIN OUTCOME MEASURES
Change in stereoimaging volumes of the upper and lower eyelids, and clinical proptosis as measured with Hertel exophthalmometry.
RESULTS
Thirty-three patients (11 males; 33%) underwent lateral decompression (39 orbits in 26 patients), lateral decompression with complete ethmoidectomy (3 orbits in 3 patients), combined decompression of lateral wall, medial wall, and medial half of floor (10 orbits in 6 patients), or bilateral lateral, medial, and complete floor decompression (1 patient). The corresponding average volumetric changes were 1.74 ml (median 1.64; range 0.39-3.73 ml), 3.38 ml (median 3.38, range 1.89-4.88 ml), 4.05 ml (median 3.53, range 1.72-6.43 ml), and 4.52 ml (range 4.36-4.68 ml), respectively. Similarly, the average reduction in proptosis was 3.6 mm (median 3; range 1.5-7 mm), 5.3 mm (median 5; range 5-6 mm), 7.4 mm (7.5; range 6-9 mm), and 9 mm (range 8-10 mm). Periorbital volume changes were related to the reduction in exophthalmometry (r = 0.713, p < 0.0001), and reduction of lower eyelid volume did not increase further with more than two-wall decompression.
CONCLUSION
Graded orbital decompression reduces both proptosis and the upper and lower eyelid tissue volumes, the eyelid changes being likely to influence decisions about future restorative eyelid surgery. The significant changes in eyelid profiles underlines the established principle of thyroid periocular rehabilitation, namely decompression, then strabismus surgery, and finally eyelid surgery.
Topics: Adult; Decompression, Surgical; Exophthalmos; Graves Ophthalmopathy; Humans; Male; Orbit; Photogrammetry; Prospective Studies; Retrospective Studies; Treatment Outcome
PubMed: 33237668
DOI: 10.1097/IOP.0000000000001885