Secukinumab in Moderate-to-Severe Graves Orbitopathy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
Authors' conclusion
Secukinumab did not show clinical efficacy vs placebo when treating patients with active, moderate-to-severe GO.
Study context
- Population
- Adults with active (Clinical Activity Score (CAS) ≥4), moderate-to-severe, non-sight-threatening Graves orbitopathyrandomized 1:1
- Participants
- 28 adults
- Comparison
- Secukinumab 300 mg SC vs placebo
- Secukinumabn = 14
- Placebon = 14reference
- Primary endpoint
- Overall response: CAS reduced by ≥2 points and proptosis reduced by ≥2 mm from baseline without worsening in the fellow eye
- Follow-up
- Week 16
Methodological detailsdouble-blind, placebo-controlled, parallel-group, multicenter, 16-week open-label phase for proptosis nonresponders
- Double-blind
- Placebo-controlled
- Parallel-group
- Multicenter
- 16-week open-label phase for proptosis nonresponders
Primary result
As reported in the abstract
Overall response
Secukinumab
0
events
Placebo
0
events
Further findings
Ophthalmic symptoms and signs, proptosis, lid aperture, eye muscle motility, CAS, health-related QoL · week 16 or week 32
- No clinically meaningful changes
Serum thyroid-related hormones and antibodies
- No meaningful effect
Safety
- Secukinumab well tolerated, mostly mild adverse events; no treatment-induced discontinuation or new safety signals
Original publication
Secukinumab in Moderate-to-Severe Graves Orbitopathy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study. J Clin Endocrinol Metab. Published 9 December 2025. doi:10.
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