OBJECTIVES : Thyroid eye disease (TED) also known as Graves’ Orbitopathy or Ophthalmopathy – is an autoimmune condition in which the eye muscles, eyelids, tear glands and fatty tissues behind the eye become inflamed and for which no FDA approved medical therapy was available until last year. The objective of this systematic literature review was to evaluate the efficacy and safety of teprotumumab for the treatment of TED by performing a meta-analysis.

METHODS : MedLine, Embase, Cochrane, clinicaltrials.gov and FDA website were searched on 25^th January, 2020 for relevant placebo-controlled clinical trials with inclusion criterion of patients with TED, teprotumumab treatment, and derivable efficacy and safety outcomes. Study quality of included records was assessed using the Cochrane Risk of Bias instruments. A meta-analysis using fixed effect model was conducted to calculate pooled effect estimates with 95% confidence intervals (CI) for efficacy and safety outcomes.

RESULTS : Two RCTs involving 170 patients were included. Compared to placebo, teprotumumab was significantly associated with mean odds ratio of 0.05 for overall response (95% CI: 0.01, 0.27) and proptosis response (95% CI: 0.01, 0.22); and mean clinical activity score reduction of 1.58 (95% CI: 1.15, 2.01) and proptosis reduction of 2.30mm (95% CI: 1.91, 2.69) from baseline. Furthermore, teprotumumab arm showed no evidence of significant risk of treatment-emergent adverse events (Odds ratio: 0.62; 95% CI: 0.26, 1.45) and overall discontinuations (Odds ratio: 0.97; 95% CI: 0.34, 2.76) compared to placebo.

CONCLUSIONS : Teprotumumab showed significantly better clinical efficacy and safety for the treatment of thyroid eye disorder. Further high-quality RCTs and systematic reviews are required for conclusive determination of its effectiveness and tolerability compared to active comparators.