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The diagnostic evaluation and management of hyperthyroidism due to Graves’ disease, toxic nodules, and toxic multinodular goiter
Published in David S. Cooper, Jennifer A. Sipos, Medical Management of Thyroid Disease, 2018
More specific pharmacologic therapies for Graves’ ophthalmopathy have been studied. There has been great interest in selenium supplementation since the publication of a report from Italy of a masked randomized controlled trial of selenium 100 mcg twice a day versus placebo for 6 months in mild thyroid eye disease (185). In this study, selenium therapy significantly improved ophthalmopathy scores and quality of life compared to placebo. The proposed underlying rationale is selenium’s role as an antioxidant and free radical scavenger, decreasing oxidative stress to orbital fibroblasts (186). However, it is unclear whether selenium supplementation will benefit persons who do not live in relative selenium-deficient geographical areas, such as the United States (187). Rituximab, a mouse-human monoclonal antibody directed against the CD 20 antigen on B lymphocytes, has been shown to be effective versus glucocorticoids in one randomized trial (188) but not effective versus a placebo in another similarly designed trial (189). It has been hypothesized by Salvi et al. (190) that the difference in outcomes between the two trials might be explained by the younger age, lower levels of TRAb, and shorter duration of disease in the trial. Recently, favorable results were reported from a randomized placebo-controlled trial of the IGF-1 receptor blocking drug teprotumumab (191). Other potential targets in the treatment of thyroid eye disease include anti-interleukin-6 antibodies and somatostatin analogs (192).
Neuro-Ophthalmic Literature Review
Published in Neuro-Ophthalmology, 2022
David A. Bellows, John J. Chen, Hui-Chen Cheng, Panitha Jindahra, Peter W. MacIntosh, Collin McClelland, Michael S. Vaphiades, Xiaojun Zhang
Teprotumumab is the first treatment for thyroid eye disease (TED). A 3-round modified-Delphi panel was conducted between October 2020 and February 2021 with experts in the management of patients with TED. Key areas regarding the use of teprotumumab were investigated, including eligible patient populations, concomitant treatments, and assessment of response and adverse events. This used two survey rounds via an online questionnaire, where statements were scored using 9-point Likert scales. Statements with conflict were included in the third round, involving a consensus meeting via videoconference. Consensus was obtained for all statements (n = 75); of which, 56% were revised to enable agreement of the group. The consensus meeting provided agreement regarding which populations should receive teprotumumab therapy, including all adult patients with TED with a clinical activity score of ≥4. Treatment with teprotumumab can also be considered for TED patients displaying the following characteristics: a clinical activity score (CAS) of <3, lid retraction of ≥2, and mild or early optic neuropathy with close clinical observation. Further recommendations included suitability of treatment for those beyond 16 months following the initial diagnosis of TED, low CAS, concomitant treatment with steroids in some cases, retreatment for those who have relapses, and finally a recommendation to continue therapy for all eight infusions despite the lack of response by the fourth infusion.
Drug safety in thyroid eye disease – a systematic review
Published in Expert Opinion on Drug Safety, 2022
Jan Wolf, Kamila I. Mitka, Alicja Hubalewska-Dydejczyk, Irene Krämer, George J Kahaly
Fortunately, these tables tell us that we are facing a highly acceptable efficacy:risk ratio of the current medications considered for the management of patients with clinically active and moderate-to-severe TED. Additionally, an overview of the AE/SAE rates encountered with the various drugs is offered in Figure 3. In this figure, it is apparent that for example mycophenolate has a low rate of AE/SAE (≈20%), while oral GC (50% AE) and Teprotumumab (82% AE) rather show frequent adverse reactions. The higher morbidity of oral GC, which have been administered since decades, explains why EUGOGO and the ETA recommend IVGC with a better efficacy:morbidity ratio. Furthermore, since the strict recommendations of EUGOGO pertaining to a maximal cumulative dose of 8 g of methylprednisolone per cycle and 0.75 g per single dose, no SSE or fatal causalities have been reported. With respect to Teprotumumab, the still low number of patients included in the various trials limits the objective and definitive evaluation of its safety profile.
Advances in steroid sparing medical management of active thyroid eye disease
Published in Seminars in Ophthalmology, 2020
Victor D. Liou, Michael K. Yoon
Study TED01 RV compared the outcomes in patients with active TED receiving either teprotumumab or placebo in a prospective, double-blind clinical trial.14 The medication or placebo was given via intravenous infusion every 3 weeks for eight doses. The dose of teprotumumab was 10 mg/kg of body weight for the first infusion followed by 20 mg/kg for the next seven infusions. Inclusion criteria were adults with TED no more than 9 months after symptom onset and a clinical activity score (CAS) of ≥4. Subjects were excluded if they had received prior surgery or intravenous steroids. Oral steroid use was permitted if the cumulative dose was less than 1 g methylprednisolone or equivalent with last administration over 6 weeks before randomization. This study assessed overall responder rate based on the percentage of patients with ≥2 mm reduction in proptosis and a ≥2 point reduction in CAS from baseline. Quality of life improvement was measured with the standard Graves ophthalmopathy-specific quality-of-life questionnaire (GO-QoL).16