Evidence mapPaperPMID 41362233Full record

Trial reportThe Journal of clinical endocrinology and metabolism2026

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

Jan Wolf, Katrin Lorenz, Ahmed E Othman, Anna Beck, Helena M Michel, Lea Grauhan, Heike Elflein, Maximilian Luffy, Anja Eckstein, Harald Lahner and 12 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Jan WolfDepartment of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz 55101, Germany.
Katrin LorenzDepartment of Ophthalmology, JGU Medical Center, Mainz 55101, Germany.
Ahmed E OthmanDepartment of Neuroradiology, JGU Medical Center, Mainz 55101, Germany.
Anna BeckDepartment of Ophthalmology, JGU Medical Center, Mainz 55101, Germany.
Helena M MichelDepartment of Ophthalmology, JGU Medical Center, Mainz 55101, Germany.
Lea GrauhanDepartment of Ophthalmology, JGU Medical Center, Mainz 55101, Germany.
Heike ElfleinDepartment of Ophthalmology, JGU Medical Center, Mainz 55101, Germany.
Maximilian LuffyDepartment of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz 55101, Germany.
Anja EcksteinClinic for Ophthalmology, University Clinic Essen, Essen 45147, Germany.
Harald LahnerClinic for Endocrinology, Diabetology and Metabolism, University Clinic Essen, Essen 45147, Germany.
Michael SchittkowskiDepartment of Ophthalmology, University Medicine Göttingen, Göttingen D 37085, Germany.
Maren HornDepartment of Ophthalmology, University Medicine Göttingen, Göttingen D 37085, Germany.
Wolf A LagrèzeInterdisciplinary Center for Orbital Diseases, Department of Neuroophthalmlogy, Eye Center, Medical Center, Medical Faculty, University Freiburg, Freiburg 79106, Germany.
Tim BleulInterdisciplinary Center for Orbital Diseases, Department of Neuroophthalmlogy, Eye Center, Medical Center, Medical Faculty, University Freiburg, Freiburg 79106, Germany.
Susanne PitzOrbital Center, Department of Ophthalmology, Bürgerhospital, Frankfurt 60318, Germany.
Christian VorländerClinic for Endocrine Surgery, Bürgerhospital, Frankfurt 60318, Germany.
Christelle C PieterseGlobal Medical Affairs, Immunology, Novartis Pharma AG, Basel 4056, Switzerland.
Brian PorterClinical Development, Immunology, Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936-1080, USA.
Andreas ClemensDepartment of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz 55101, Germany.
Steven DraikiwiczClinical Development, Immunology, Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936-1080, USA.
Maximilian ReinhardtGlobal Medical Affairs, Immunology, Novartis Pharma AG, Basel 4056, Switzerland.
George J KahalyDepartment of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz 55101, Germany.ORCID 0000-0003-0441-430X

Funding

Novartis Pharma AG
6 · The paper itself

Abstract

contextInterleukin (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.

objectiveThe ORBIT study aimed to evaluate the efficacy and safety of secukinumab, an IL-17A inhibitor, in individuals with active, moderate-to-severe GO.

methodsA 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.

resultsTwenty-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.

conclusionSecukinumab did not show clinical efficacy vs placebo when treating patients with active, moderate-to-severe GO.

Indexed as

Antibodies, Monoclonal, HumanizedGraves OphthalmopathyAdultAgedDouble-Blind MethodFemaleHumansInterleukin-17MaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedIL17A protein, humanInterleukin-17secukinumabactiveGraves orbitopathyimmunosuppressive treatmentinterleukin-17Amoderate-to-severe GOORBIT trialsecukinumab

Identifiers

PMID41362233
PMCPMC13099189

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.