Postoperative Changes in Strabismus, Ductions, Exophthalmometry, and Eyelid Retraction After Orbital Decompression for Thyroid Orbitopathy

Rootman, Daniel B.; Golan, Shani; Pavlovich, Peter; Rootman, Jack

doi:10.1097/iop.0000000000000758

Cited by 42 publications

(30 citation statements)

References 42 publications

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“…The level of proptosis reduction produced by teprotumumab is comparable with the −3.8 mm reported in a recently published retrospective trial of 169 patients with TED (319 eyes) undergoing orbital decompression [22]. Similarly, in another recently published retrospective study of 263 patients (420 orbits) who had decompression for TED at one institution, the mean reduction in proptosis was also −3.8 mm [23].…”

Section: Discussionsupporting

confidence: 77%

“…The proptosis reduction achieved with teprotumumab (mean −3.14 [range −1.0 to −6.0] mm) at week 24 compares favorably with the proptosis reduction achieved with surgery. If the extent of the proptosis response seen with the phase 2 study is confirmed in the ongoing Phase 3 study, teprotumumab may be an alternative to orbital decompression surgery without its associated complications, such as strabismus, which can occur in up to 33% of patients postoperatively [22].…”

Section: Discussionmentioning

confidence: 99%

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Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active thyroid eye disease: a focus on proptosis

Douglas¹

2018

Eye

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Thyroid eye disease is a disabling autoimmune disease associated with orbital inflammation and tissue remodeling which can result in significant proptosis, leading to visual alterations and is potentially sight threatening. Current evidence indicates that autoantibodies to the insulin-like growth factor 1 receptor (IGF-1R), along with the thyroid-stimulating hormone receptor (TSHR), mediate the pathogenesis in susceptible individuals. Teprotumumab, a monoclonal IGF-1R antagonist, has demonstrated previously in a 24 week, randomized, controlled trial to produce significant changes in composite outcomes of proptosis and clinical activity score as compared with placebo. Further examination of the proptosis results reported here, indicate that the proptosis outcome (≥ 2 mm reduction) was met in 71.4% of the teprotumumab-treated patients as compared with 20% of the placebo-treated patients ( p < 0.001). Additionally, the proptosis benefit was observed early in the trial (study week 6), and all individual patients demonstrated some benefit at week 24. Improvement was noted among smokers, non-smokers, men and women, and particularly those with higher levels of proptosis at baseline. The level of proptosis reduction with teprotumumab reported here is similar to that seen with decompression surgery. If these results are confirmed in the ongoing Phase 3 trial, teprotumumab will offer an alternative to surgery and its associated complications.

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Section: Discussionsupporting

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active thyroid eye disease: a focus on proptosis

Douglas¹

2018

Eye

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“…In a large multicenter, placebocontrolled randomized clinical trial of 87 patients, teprotumumab provided impressive results in terms of overall response (69% in in the teprotumumab group vs 20% in the placebo group), the effect on CAS was rapid, and there was an unexpected and unprecedented (with non-surgical treatments) reduction of exophthalmos, averaging −2.46 mm at 24 weeks, with 40% of patients experiencing a decrease in exophthalmos of ≥4 mm (93). A subsequent post hoc analysis of the proptosis results of this study showed that 55% of teprotumumabtreated patients had a >3 mm decrease in exophthalmos, with a mean decrease of −2.95 mm (94), similar to that obtained after orbital decompression (129). Surprisingly, despite the marked changes in function and appearance, the improvement in the quality of life was not very impressive (93,130).…”

Section: The Road Beyond Initial Investigation Of Biologicals -Restorsupporting

confidence: 67%

Will biological agents supplant systemic glucocorticoids as the first-line treatment for thyroid-associated ophthalmopathy?

Smith

Bartalena

2019

European Journal of Endocrinology

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In this article, the two authors present their opposing points of view concerning the likelihood that glucocorticoids will be replaced by newly developed biological agents in the treatment of active, moderate-to-severe thyroid-associated ophthalmopathy (TAO). TAO is a vexing, disfiguring and potentially blinding autoimmune manifestation of thyroid autoimmunity. One author expresses the opinion that steroids are nonspecific, frequently fail to improve the disease and can cause sometimes serious side effects. He suggests that glucocorticoids should be replaced as soon as possible by more specific and safer drugs, once they become available. The most promising of these are biological agents. The other author argues that glucocorticoids are proven effective and are unlikely to be replaced by biologicals. He reasons that while they may not uniformly result in optimal benefit, they have been proven effective in many reports. He remains open minded about alternative therapies such as biologicals but remains skeptical that they will replace steroids as the first-line therapy for active, moderate-to-severe TAO without head-to-head comparative clinical trials demonstrating superiority. Despite these very different points of view, both authors are optimistic about the availability of improved medical therapies for TAO, either as single agents or in combination. Further, both agree that better treatment options are needed to improve the care of our patients with active moderate-to-severe TAO.

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“…25 The reductions observed across all components of the Clinical Activity Score suggest a therapeutic mechanism upstream from the inflammation in orbital tissues. The marked reduction in proptosis is similar to that reported after decompression surgery.…”

Section: Discussionmentioning

confidence: 99%

Teprotumumab for Thyroid-Associated Ophthalmopathy

et al. 2017

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BACKGROUND Thyroid-associated ophthalmopathy, a condition commonly associated with Graves’ disease, remains inadequately treated. Current medical therapies, which primarily consist of glucocorticoids, have limited efficacy and present safety concerns. Inhibition of the insulin-like growth factor I receptor (IGF-IR) is a new therapeutic strategy to attenuate the underlying autoimmune pathogenesis of ophthalmopathy. METHODS We conducted a multicenter, double-masked, randomized, placebo-controlled trial to determine the efficacy and safety of teprotumumab, a human monoclonal antibody inhibitor of IGF-IR, in patients with active, moderate-to-severe ophthalmopathy. A total of 88 patients were randomly assigned to receive placebo or active drug administered intravenously once every 3 weeks for a total of eight infusions. The primary end point was the response in the study eye. This response was defined as a reduction of 2 points or more in the Clinical Activity Score (scores range from 0 to 7, with a score of ≥3 indicating active thyroid-associated ophthalmopathy) and a reduction of 2 mm or more in proptosis at week 24. Secondary end points, measured as continuous variables, included proptosis, the Clinical Activity Score, and results on the Graves’ ophthalmopathy–specific quality-of-life questionnaire. Adverse events were assessed. RESULTS In the intention-to-treat population, 29 of 42 patients who received teprotumumab (69%), as compared with 9 of 45 patients who received placebo (20%), had a response at week 24 (P<0.001). Therapeutic effects were rapid; at week 6, a total of 18 of 42 patients in the teprotumumab group (43%) and 2 of 45 patients in the placebo group (4%) had a response (P<0.001). Differences between the groups increased at subsequent time points. The only drug-related adverse event was hyperglycemia in patients with diabetes; this event was controlled by adjusting medication for diabetes. CONCLUSIONS In patients with active ophthalmopathy, teprotumumab was more effective than placebo in reducing proptosis and the Clinical Activity Score. (Funded by River Vision Development and others; ClinicalTrials.gov number, NCT01868997.)

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Postoperative Changes in Strabismus, Ductions, Exophthalmometry, and Eyelid Retraction After Orbital Decompression for Thyroid Orbitopathy

Cited by 42 publications

References 42 publications

Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active thyroid eye disease: a focus on proptosis

Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active thyroid eye disease: a focus on proptosis

Will biological agents supplant systemic glucocorticoids as the first-line treatment for thyroid-associated ophthalmopathy?

Teprotumumab for Thyroid-Associated Ophthalmopathy

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