Lopend onderzoek
Background
Graves’ orbitopathy (GO) is an autoimmune inflammatory disorder of the orbital soft tissues, occurring in approximately 25–40% of patients with Graves’ disease (GD). GO typically presents with an initial phase of progressive inflammation (the active phase), during which signs and symptoms develop and gradually worsen. If left untreated, this phase can last for months to years, after which inflammation subsides and the disease transitions into an inactive, fibrotic phase. During the active phase, patients may benefit from immunosuppressive therapy aimed at reducing inflammation, thereby limiting disease severity and long-term complications. However, approximately 40% of patients show an inadequate response to first-line treatment— a 12-week course of high-dose intravenous methylprednisolone (IVMP)—while being exposed to potentially serious side effects. Therefore, there is a strong need for reliable biomarkers that can predict response to IVMP before treatment is initiated.
Objective
In this study, we aim to assess whether IVMP non-responders can be identified prior to treatment using:
- A newly developed in vitro steroid sensitivity assay
- Phenotyping of T-cell and monocyte populations
- Serum proteomics
- Tear film proteomics
Study Design
The indication and dosage of methylprednisolone treatment will not be affected by participation in the study. Mycophenolate mofetil (Cellcept) must not be started alongside methylprednisolone. The frequency of outpatient visits will also remain unchanged, as study timepoints align with standard clinical follow-ups. Blood and tear fluid samples will be collected before starting treatment, after completing the 12-week IVMP course (≈ 3 months), and at 6 months. At these same timepoints, participants will complete a questionnaire.
Inclusion Criteria
- Age ≥ 18 years
- Active, moderate-to-severe Graves’ orbitopathy (clinical activity score of 3 or higher)
Exclusion Criteria- Contraindication to IVMP treatment
- Use of steroids or other immunomodulatory agents within the past 3 months
- Active malignancy within the past 5 years
