Home›Diabetes & Endocrinology› Secukinumab 300 mg subcutaneously failed to demonstrate overall response in adults with active Graves orbitopathy versus placebo
Secukinumab 300 mg subcutaneously failed to demonstrate overall response in adults with active Graves orbitopathy versus placeboSecukinumab showed no benefit for active Graves orbitopathy patients
The Journal of clinical endocrinology and metabolismPublished April 22, 2026Study authors: Wolf Jan, Lorenz Katrin, Othman Ahmed E, Beck Anna, Michel Helena M, Grauhan Lea, Elflein Heike, Luf…PubMed ↗DOI ↗Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease
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Key Takeaway
Note secukinumab 300 mg showed no overall response in adults with active Graves orbitopathy in a randomized trial.
This randomized, double-blind, placebo-controlled, parallel-group, multicenter trial investigated secukinumab in adults with active, moderate-to-severe, non-sight-threatening Graves orbitopathy. The study enrolled 28 participants across a multicenter setting. Participants received either secukinumab 300 mg subcutaneously or placebo subcutaneously. The design included a 16-week double-blind treatment period, followed by an additional 16-week open-label treatment phase.
The primary outcome was defined as an overall response of reduced Clinical Activity Score (CAS) of 2 or more points and a reduction of 2 mm or greater in proptosis from baseline without worsening in the fellow eye at week 16. Secondary outcomes included ophthalmic symptoms and signs, proptosis, lid aperture, eye muscle motility, CAS, health-related quality of life, and serum levels of thyroid-related hormones and antibodies.
Regarding the primary outcome, none in either the secukinumab or placebo group achieved an overall response at week 16. No overall response was achieved at week 32. No clinically meaningful changes were observed for ophthalmic symptoms and signs, proptosis, lid aperture, eye muscle motility, CAS, and health-related quality of life. Furthermore, no meaningful effect was observed regarding serum levels of thyroid-related hormones and antibodies.
Safety data indicated mostly mild adverse events. Neither treatment-induced study discontinuation nor new safety signals were registered. Secukinumab was well tolerated. Serious adverse events were not reported. Limitations include the small sample size of 28.
Secukinumab does not demonstrate efficacy for this indication. Clinicians should consider these negative findings when evaluating treatment options for Graves orbitopathy. The lack of response in both groups warrants further investigation into alternative therapies.
A small study tested a medication called secukinumab for adults with active Graves orbitopathy. This condition affects the eyes and tissues around them, but the trial size was very limited. The study included only twenty-eight adults with moderate to severe symptoms that were not threatening sight. It was a multicenter trial comparing the drug against a placebo injection over a sixteen week period.
Participants received either the medication or a placebo injection twice. After sixteen weeks, none of the patients showed an overall response. There were no meaningful changes in eye symptoms, measurements, or quality of life compared to the placebo group. Results remained the same after thirty-two weeks. Thyroid hormone levels also did not change significantly. Eye muscle movement and lid opening stayed stable without improvement.
The drug was generally well tolerated with mostly mild side effects. Neither treatment caused study discontinuations or new safety signals. However, the small number of participants means these results need more research to be certain. Patients should discuss current treatment options with their doctors rather than expecting this new therapy to work.
What this means for you:
Secukinumab showed no benefit in a small trial for Graves orbitopathy, and more research is needed before considering it.
CONTEXT: Interleukin (IL)-17, a key proinflammatory cytokine, drives inflammation and fibrosis in Graves orbitopathy (GO), and elevated IL-17 and Th17 cells correlate with disease activity and severity.
OBJECTIVE: The ORBIT study aimed to evaluate the efficacy and safety of secukinumab, an IL-17A inhibitor, in individuals with active, moderate-to-severe GO.
METHODS: A randomized, double-blind, placebo-controlled, parallel-group, multicenter trial was conducted. Adults with active, moderate-to-severe, non-sight-threatening GO randomly (1:1) received secukinumab 300 mg or placebo subcutaneously over a 16-week double-blind treatment period, followed by an additional 16-week open-label treatment phase for proptosis nonresponders. Safety parameters, thyroid-related hormones, and autoantibodies were also assessed. The primary end point was overall response of reduced Clinical Activity Score (CAS) of 2 or more points and a reduction of 2 mm or greater in proptosis from baseline without worsening in the fellow eye at week 16.
RESULTS: Twenty-eight adult GO patients with a CAS of 4 or greater were enrolled (secukinumab, n = 14; placebo, n = 14). None in either the secukinumab or placebo group achieved an overall response at weeks 16 and 32, respectively, when all patients received open-label secukinumab. No clinically meaningful changes were observed in ophthalmic symptoms and signs, proptosis, lid aperture, eye muscle motility, CAS, and health-related quality of life either at week 16 or week 32. No meaningful effect on serum levels of thyroid-related hormones and antibodies was observed. Secukinumab was well tolerated, with mostly mild adverse events. Neither treatment-induced study discontinuation nor new safety signals were registered.
CONCLUSION: Secukinumab did not show clinical efficacy vs placebo when treating patients with active, moderate-to-severe GO.
