Monitoring Disease Activity in Patients With Takayasu Arteritis With the OMERACT Takayasu Ultrasound Score (OTUS)

This is an observational study. The study concerns a diagnostic procedure (vascular US) that is part of normal clinical practice for patients with large-vessel vasculitis (LVV). The decision to perform vascular US in patients with TAK will remain independent from the decision to enroll the patient in the study. No investigational medicinal product or experimental device is involved. The procedure under study is an ultrasonographic scoring system derived from vascular US examinations of selected arterial segments in patients with TAK. Examinations will be performed according to standardized OMERACT protocols, including assessment of the common carotid, subclavian and axillary arteries, and the abdominal aorta. For each patient, an OMERACT-derived OTUS score will be calculated at each assessment. No comparator is mandated; however, clinical disease activity state and results from other imaging modalities (FDG-PET, MRA, CTA), when available as part of routine clinical care, will be collected for exploratory analyses. Study participation will last 24 months, during which patients will undergo serial US examinations at predefined follow-up visits as part of routine clinical monitoring. Vascular US is a non-invasive, radiation-free and contrast-free technique, already employed in standard clinical care and used here exclusively for observational purposes.

• Correlation between OTUS changes and clinical/laboratory markers of disease activity in Takayasu arteritis [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]
• Agreement between OTUS-based disease activity classification and Physician Global Assessment (PGA) in Takayasu arteritis [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]
• To evaluate the agreement between OTUS-based activity assessment and NIH disease activity score [Срок оценки: Baseline, month 1, month 3, month 6, month 12, month 18, month 24]
• Hazard ratio for time to relapse per unit increase in baseline OTUS score [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]
• Hazard ratio for time to vascular damage progression per unit increase in baseline OTUS score [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]
• Odds ratio for successful glucocorticoid discontinuation per unit increase in baseline OTUS score [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]
• Hazard ratio for time to relapse per unit increase in OTUS change from baseline to month 3 [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]
• Hazard ratio for time to vascular damage progression per unit increase in OTUS change from baseline to month 3 [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]
• Odds ratio for successful glucocorticoid discontinuation per unit increase in OTUS change from baseline to month 3 [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]
• To assess the diagnostic ability of OTUS to detect clinical relapse during follow-up. [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]
• Absolute OTUS score in treatment responders vs non-responders [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]
• OTUS change from baseline (ΔOTUS) in treatment responders vs non-responders [Срок оценки: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.]