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  3. Secukinumab In Moderate-to-severe Graves Orbitopathy: A Randomized, Double-blind, Placebo-controlled, Multicenter Study.
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  3. Secukinumab In Moderate-to-severe Graves Orbitopathy: A Randomized, Double-blind, Placebo-controlled, Multicenter Study.

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Secukinumab in Moderate-to-Severe Graves Orbitopathy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter

Jan Wolf1, Katrin Lorenz2, Ahmed E Othman3

  • 1Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz 55101, Germany.

The Journal of Clinical Endocrinology and Metabolism
|December 9, 2025

View abstract on PubMed

Summary
This summary is machine-generated.

Secukinumab, an IL-17A inhibitor, did not demonstrate efficacy in treating active Graves' orbitopathy (GO). The study found no significant improvement in clinical activity or proptosis compared to placebo in GO patients.

Keywords:
Graves orbitopathyORBIT trialactiveimmunosuppressive treatmentinterleukin-17Amoderate-to-severe GOsecukinumab

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Area of Science:

  • Ophthalmology
  • Immunology
  • Endocrinology

Background:

  • Interleukin 17 (IL-17) is a pro-inflammatory cytokine implicated in Graves' orbitopathy (GO) pathogenesis.
  • Elevated IL-17 and Th17 cells correlate with GO disease activity and severity.

Purpose of the Study:

  • To evaluate the efficacy and safety of secukinumab, an IL-17A inhibitor, in patients with active, moderate-to-severe GO.
  • The ORBIT study assessed secukinumab's impact on clinical activity and proptosis in GO.

Main Methods:

  • A randomized, double-blind, placebo-controlled, multicenter trial.
  • Adults with active, moderate-to-severe GO received secukinumab 300 mg or placebo subcutaneously for 16 weeks.
  • The primary endpoint was an overall response defined by reduced clinical activity score (CAS) and proptosis.

Main Results:

  • Twenty-eight GO patients were enrolled; none achieved an overall response in either the secukinumab or placebo groups.
  • No clinically meaningful changes were observed in ophthalmic symptoms, proptosis, or quality of life.
  • Secukinumab was well-tolerated with mild adverse events and no new safety signals.

Conclusions:

  • Secukinumab did not demonstrate clinical efficacy compared to placebo in patients with active, moderate-to-severe GO.
  • The study suggests IL-17A inhibition may not be an effective therapeutic strategy for this condition.