Dataset Information

Teprotumumab: a disease modifying treatment for graves' orbitopathy.

ABSTRACT: Background:On 21st January 2020, the FDA approved Tepezza (teprotumumab-trbw) for the treatment of active Graves' orbitopathy (GO) in adults. This approval was based on positive results from two multinational randomised double-blind placebo-controlled clinical trials. Discussion:This article discusses the outcomes of those trials and the potential role of teprotumumab in altering current treatment paradigms in Graves' orbitopathy. Future challenges are explored, including the need to confirm its disease-modifying effect, to establish its optimal position in the treatment pathway, and to define the appropriate subset of patients who would benefit from its use. Conclusions:The results from these two large clinical trials have shown teprotumumab to have remarkable effects on multiple clinical outcomes in GO, particularly in its ability to reverse proptosis. It may herald a new era in the treatment of thyroid eye disease and could offer an alternative to surgery and its associated complications. Additional studies will continue to shape the treatment of GO and define the role of teprotumumab within the treatment paradigm.

SUBMITTER: Ting M

PROVIDER: S-EPMC7334856 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Teprotumumab: a disease modifying treatment for graves' orbitopathy.

Ting Michelle M Ezra Daniel G DG

Thyroid research 20200704

<h4>Background</h4>On 21st January 2020, the FDA approved Tepezza (teprotumumab-trbw) for the treatment of active Graves' orbitopathy (GO) in adults. This approval was based on positive results from two multinational randomised double-blind placebo-controlled clinical trials.<h4>Discussion</h4>This article discusses the outcomes of those trials and the potential role of teprotumumab in altering current treatment paradigms in Graves' orbitopathy. Future challenges are explored, including the need ...[more]

PMID: 32636936

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Project description:Background: Intravenous glucocorticoid (GC) has been proposed to treat moderately severe Graves' orbitopathy (GO); however, the optimal regime remains debatable. We therefore performed this network meta-analysis to objectively determine the comparative efficacy and safety of different intravenous GC regimes, including daily, weekly, or monthly intravenous regimes, for the treatment of GO. Methods: We electronically searched Medline (via PubMed), EMBASE (via OVID), and the Cochrane Central Register of Controlled Trials (CENTRAL) (via OVID) to retrieve randomized controlled trials (RCTs) investigating the comparative efficacy and safety of different intravenous GC regimes in GO patients from the inception of each database to March 2021. The latest search was updated in June 2021. The risk of bias of original studies was assessed using the Cochrane risk bias assessment tool. A random-effects Bayesian network meta-analysis was conducted using the Markov chain Monte Carlo (MCMC) simulation. Ranking probabilities of all regimes were calculated to rank all regimes. Statistical analysis was conducted using the ADDIS software. Results: A total of 10 studies involving 593 patients met the selection criteria. Network meta-analysis suggested that the weekly intravenous GC regime (WR) [response: odds ratio (OR), 4.27; 95% creditable interval (CrI); 1.82 to 11.02; clinical activity score change (CASC): standard mean difference (SMD), -0.59; 95% CrI; -1.19 to -0.03) and monthly intravenous regime (MR) (response: OR, 6.32; 95% CrI; 1.25 to 34.96; CASC: SMD, -1.17; 95% CrI; -2.32 to -0.01) were superior to the oral GC (OGC) regime in response and CASC. Meanwhile, pooled results also indicated that the WR was related to the decreased risk of AEs compared with the OGC regime (OR, 0.22; 95% CrI; 0.08-0.62) and daily intravenous GC regime (DR) (OR, 0.19; 95% CrI; 0.03-0.97). Ranking probabilities indicated that the MR and WR have a relatively higher probability of becoming the best option for response, proptosis, and AEs. Conclusion: Based on limited evidence, the WR or MR should be preferentially prescribed to treat patients with moderately severe GO. However, more studies with a large sample size should be conducted to further confirm our findings and compare the WR with the MR.

Dataset Information

Teprotumumab: a disease modifying treatment for graves' orbitopathy.

Publications

Teprotumumab: a disease modifying treatment for graves' orbitopathy.

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