Giant cell arteritis (GCA) is the most common vasculitis in the elderly and is usually treated with long-term corticosteroid therapy. Many patients experience relapses and treatment-related side effects. Current diagnostic and monitoring methods provide limited prognostic information and cannot reliably distinguish active from inactive disease during relapse. This project addresses the clinical need for improved tools to identify patients at high risk of relapse and to develop more effective methods for disease monitoring.
The aim is to develop new tools that enable more personalized treatment of GCA. By combining vascular ultrasound with novel blood biomarkers, we seek to predict disease course and relapse risk. The specific objectives are:
* To identify ultrasound and blood biomarkers that can predict long-term disease control. * To determine which ultrasound parameters and blood biomarkers can distinguish active from inactive disease during treatment. * To evaluate whether extended vascular ultrasound protocols can improve diagnostic accuracy.
The ultimate goal is to establish safe, practical tools for improved diagnosis and follow-up in patients with GCA.
Individuals referred for evaluation due to suspected giant cell arteritis (GCA).
Ability to provide written informed consent.
Previous diagnosis of GCA.
Previous temporal artery biopsy performed as part of prior GCA evaluation.
Treatment with high-dose corticosteroids (>7.5 mg/day) for more than two weeks before initiation of the diagnostic work-up.
Inability to provide informed consent.
A new cohort will be recruited. Individuals presenting with suspected GCA at Sahlgrenska University Hospital in Gothenburg, Sweden, or at Skaraborg Hospital Skövde, Sweden, will be invited to participate in the study. Diagnostic ultrasound examinations and follow-up assessments will be conducted at Sahlgrenska University Hospital in Gothenburg. After study enrollment, participants diagnosed with GCA will be followed for 12 months, with scheduled visits at 1, 6, and 12 months after initiation of treatment. If clinical relapse of GCA is suspected outside of the scheduled visits, an additional examination will be performed. Participants who are not diagnosed with GCA will be followed up by telephone after 6 months to confirm diagnostic status.
Cohort
Prospective
Not listed
Sustained remission
Defined as achievement of a daily glucocorticoid dose of ≤5 mg after 12 months of standardized treatment according to the treatment protocol recommended by the Swedish Society for Rheumatology. Primary Objective: To determine which ultrasound parameters and novel biomarkers, individually and as a composite measure (intima-media thickness \[IMT\] + morphological neovascularization), have prognostic value for remission and relapse in patients with giant cell arteritis (GCA). Primary Hypotheses: 1a. The composite measure (IMT + morphological neovascularization) predicts remission at 12 months more accurately than each individual parameter or previously established ultrasound metrics. 1b. Clinically applicable threshold values exist for the composite measure and for selected biomarkers that distinguish patients achieving remission from those who do not.
Relapse
Defined as recurrence of symptoms attributable to GCA (after exclusion of alternative causes) and/or erythrocyte sedimentation rate (ESR) ≥30 mm/h and C-reactive protein (CRP) ≥10 mg/L, with improvement of symptoms and/or ESR or CRP following escalation of anti-inflammatory therapy. Secondary Objectives (1): To identify ultrasound parameters and biomarkers that best differentiate active from inactive vascular inflammation during ongoing GCA treatment in patients with suspected relapse. Secondary Hypotheses (1): 1a. Changes in neovascularization, alone or combined with IMT, correlate more strongly with clinically defined relapse than changes in IMT alone. 1b. The combination of ultrasound parameters and biomarkers provides higher diagnostic accuracy (AUC) for distinguishing active from inactive disease during treatment follow-up than current standard measures.
Final Diagnosis of GCA
Final diagnosis is based on clinical and imaging criteria in accordance with the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for GCA. Diagnosis will be re-evaluated after 6 months. Secondary Objectives (2): To evaluate whether an extended vascular ultrasound protocol (beyond temporal and axillary arteries) improves diagnostic accuracy compared to current EULAR recommendations, and whether ultrasound-detected neovascularization corresponds to histological neovascularization in temporal artery biopsy specimens. Secondary Hypotheses (2): 2a. The extended ultrasound protocol increases sensitivity for GCA diagnosis without reducing specificity compared with the standard protocol. 2b. Ultrasound-detected neovascularization corresponds with histological findings of angiogenesis in temporal artery biopsy samples (reference test).
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