Teprotumumab for the treatment of chronic thyroid eye disease

Ugradar, Shoaib; Kang, Julia; Kossler, Andrea L; Zimmerman, Erin; Braun, Jenna; Harrison, Andrew R.; Bose, Swaraj; Cockerham, Kimberly P.; Douglas, Raymond S.

doi:10.1038/s41433-021-01593-z

Cited by 53 publications

(68 citation statements)

References 28 publications

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“…This prospective interventional case series showed that MMF plus low-dose oral prednisolone as a new treatment regimen was significantly effective in 94.2% of patients, consistent with data previously reported on the effect of MMF on moderate to severe GO (16,(18)(19)(20)(21). Similar to the results of teprotumumab (novel insulin-like growth factor I receptor antibody) in active TED (22,23), as expected, MMF plus low-dose oral prednisolone showed the greatest effectiveness on CAS, proptosis and diplopia, and this factor significantly decreased during the study, and this decrease occurred earlier in CAS than proptosis and diplopia, suggesting that; MMF like teprotumumab was more efficient than corticosteroids in controlling local inflammation. The overall clinical response rate of the patients who received MMF + oral low-dose prednisolone significantly increased with increasing time, confirming that a fixed dosage in a longer duration of oral MMF + oral-low dosage prednisolone might lead to a better response.…”

Section: Discussionsupporting

confidence: 88%

“…Therefore, it seems that the EOM enlargement is one of the reasons for the late response to the treatment regimen. In this regard, Wang et al showed that patient with fibrotic changes, which cause chronic complications, are difficult to respond to treatment; therefore, early intervention with a proper regimen, especially immune system modulators (primary pathophysiology), can provide a better and faster response (22).…”

Section: Discussionmentioning

confidence: 99%

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Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy

et al. 2022

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Although corticosteroids are currently the first-choice drug for thyroid eye disease (TED), in 20–30% of cases, patients show poor or non-existent responses, and when the drug is withdrawn, 10–20% of patients relapse. Thus, in this study, we aimed to investigate the efficacy of the combined use of mycophenolate mofetil (CellCept®) and low dose oral prednisolone in patients with moderate to severe Graves' orbitopathy (GO). For the first time, we investigated the relationship between TED-related parameters and proptosis reduction. In a prospective, non-randomized, interventional case series, 242 patients with moderate-to-severe GO were, assigned to receive oral prednisolone (5 mg/ d) and mycophenolate mofetil (CellCept®) (one 500 mg tablet twice per day according to the therapeutic response). The patients were monitored regularly during the 3rd, 6th, 12th, and 18th month of treatment. The main outcome measures were the clinical activity score (CAS), intraocular pressure (IOP), diplopia, proptosis and visual acuity. We also assessed the relationship between the main outcomes with proptosis changes and time to improvement (months). Adverse effects were recorded during each visit. The clinical response rate increased from 67.7% on the third month to 89.2% on the sixth month, and 94.2% on the 12th month. This therapeutic response continued until the 18th month of follow-up. The CAS responses [disease inactivation (CAS <3)] improved during our study: 70.6% on the third month, 90.0% on the sixth month, and 92.5% at 12th month. These conditions continued until the 18th month of follow-up. Proptosis improvement was 52% on the third month, 71% on the sixth month, 83% on the 12th month, and 87.1% on the 18th month. Changes in IOP and visual acuity were not significant (P = 0.568 and 0.668, respectively). The patient showed significant improvement in the Gorman score. A Shorter duration of treatment was seen in patients with earlier onset of intervention, younger age, and lack of all extraocular muscle (EOM) enlargement on computed tomography (CT) scan (p < 0.05). In addition, a better response (more reduction) in proptosis was related to: younger age at disease, earlier treatment intervention (less interval from the time the diagnosis of moderate-to-severe GO was made until medication initiation), shorter treatment time (less time to improvement), less IOP, lack of EOM enlargement on CT scan, and lack of diplopia (P < 0.05). Adverse events occurred in six patients. Findings show that mycophenolate mofetil (CellCept®) plus low-dose prednisolone can be introduced as a new optimal dosing regimen in GO due to its better effect on chronic complications such as proptosis and diplopia.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy

et al. 2022

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“…Although further studies are needed to determine whether teprotumumab will be helpful in chronic disease, studies showing notable improvement in proptosis and reduction in extraocular muscle volume have recently been reported in patients with chronic TED and low CAS, suggesting that teprotumumab may alter disease course even in patients with inactive or quiescent TED. [ 111 113 114 ] In a prospective study involving 23 consecutive patients treated with teprotumumab, all euthyroid at the time of treatment and with a mean CAS of 3.4, a significant reduction in upper and lower lid retraction was observed after teprotumumab therapy: Mean MRD1 was 5 mm before treatment and 4.3 mm following therapy ( P < 0.01), whereas mean MRD2 was 6.3 mm before therapy and 5.9 mm posttherapy ( P < 0.05). [ 115 ]…”

Section: Biologic Agentsmentioning

confidence: 99%

Management of eyelid retraction related to thyroid eye disease

Osaki¹,

Osaki²,

Monteiro³

2022

Taiwan J Ophthalmol

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Eyelid retraction related to thyroid eye disease (TED) is a challenging condition. It is one of the main clinical signs and a major diagnostic criterion in TED. This condition may threaten vision due to exposure keratopathy, in addition to its esthetic alterations, which may lead to psychosocial implications and affect the patient's quality of life. Although it is more commonly observed in the upper eyelid, it may be present on both the upper and lower lids. Numerous surgical and nonsurgical treatment modalities have been described and will be reviewed in this article. Management should be based on an individual patient assessment, taking into consideration the disease stage, severity, and clinician experience.

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“…Segmentation and measurements were performed independently by 2 graders to review repeatability (Fig. 2) (9,12,14).…”

Section: Understanding the Food And Drug Administration Scope Of Appr...mentioning

confidence: 99%

“…

T eprotumumab is the first and only Food and Drug Administration (FDA)-approved medication for the treatment of thyroid eye disease (TED). At the time of writing, aside from the clinical information from the original trials on the safety and efficacy of teprotumumab (1-4), only a handful of clinical reports have been published (5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17). This review discusses the mechanism of action of teprotumumab and provides an overview of real-world experience with teprotumumab 21 months after the approval.

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mentioning

confidence: 99%