Thyroid disease

A Novel Monoclonal Antibody Degrades the Thyrotropin Receptor Autoantibodies in Graves' Disease

Endocr PractPublished Exploratory controlled trial

Authors' conclusion

Targeting the FcRn markedly reduces the disease-specific TSH-R-Ab in patients with GD. The novel and rapid TSH-R-Ab bioassay improves diagnosis and management of patients with GD.

Study context

Population
Patients with thyroidal and extrathyroidal Graves' disease (GD)
Comparison
Anti-FcRn monoclonal antibody (mAb) vs placebo
Primary endpoint
TSH-R-Ab degradation (serial serum TSH-R-Ab levels by 3 binding and cell-based assays)
Methodological detailsplacebo-controlled
  • Placebo-controlled

Primary result

As reported in the abstract

Serum TSH-R-Ab levels · 12-week therapy; changes already at week 7

Early and significant decrease in serum TSH-R-Ab with mAb, in all 3 assays

>60%

Further findings

Correlation between TSH-R-Ab assays

Binding immunoassay vs luciferase bioassay, r (P <.001)
.91
Binding vs cyclic adenosine monophosphate (cAMP) bioassay, r (P <.001)
0.86
Luciferase vs cAMP bioassay, r (P =.006)
0.71
  • Samples of both study groups

Correlation with extrathyroidal clinical parameters

Serological results correlated with the course of clinical activity score and proptosis

Original publication

A Novel Monoclonal Antibody Degrades the Thyrotropin Receptor Autoantibodies in Graves' Disease. Endocr Pract. Published 18 April 2023. doi:10.1016/j.eprac.2023.04.002

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