This is a multicenter prospective observational study aimed at evaluating the role of an ultrasonographic score in monitoring disease activity in patients with Takayasu arteritis (TAK). Patients with active disease, either at new diagnosis or during relapse, will undergo serial vascular US assessments during follow-up according to routine clinical practice at each participating centers. For each patient, an OMERACT-derived US score (OTUS) will be calculated. This score was developed and preliminarily validated in previous phases of a multistep project endorsed by OMERACT (Outcome Measures in Rheumatology), an international initiative focused on the development and validation of outcome measures in rheumatology. The study hypothesis is that this score is sensitive to change over time and can be used to monitor disease activity and predict outcome in patients with TAK.
Age ≥18 years
Male and female
Diagnosis of TAK according to the 1990 ACR and/or 2022 ACR/EULAR classification criteria
Clinical domain: new onset or worsening of clinical signs and/or symptoms attributable to TAK;
Inability or contraindication to undergo vascular US
Severe comorbidities limiting participation or follow-up
Concomitant conditions that may confound ultrasound findings (e.g., significant atherosclerosis requiring intervention, complete occlusion of one of the arterial segments under investigation)
Diagnosis of another rheumatologic disease
The study population will consist of patients with TAK and active disease, either newly diagnosed or experiencing a relapse. Active disease is defined as the presence of clinical signs and/or symptoms attributable to TAK, with or without elevation of inflammatory markers (ESR, CRP), and/or imaging evidence of active vasculitis (excluding US findings used in OTUS scoring). Patients of any gender, aged ≥18 years, will be eligible.
Cohort
Prospective
Not listed
Change in OTUS between active disease and remission in patients with Takayasu arteritis
Change in OTUS from baseline (active disease) to the first visit at which clinical remission is achieved, as determined by the treating physician (blinded to ultrasound results).
Correlation between OTUS changes and clinical/laboratory markers of disease activity in Takayasu arteritis
Correlation between OTUS variation and: (i) ESR/CRP; (ii) clinical disease activity, as assessed by the Physician Global Assessment (PGA) of disease activity (0-10 visual analogue scale) and the National Institutes of Health (NIH) disease activity score for Takayasu arteritis.
Agreement between OTUS-based disease activity classification and Physician Global Assessment (PGA) in Takayasu arteritis
Cohen's kappa coefficient measuring agreement between OTUS-based disease activity classification and Physician Global Assessment (PGA) of disease activity, assessed on a 0-10 visual analogue scale.
To evaluate the agreement between OTUS-based activity assessment and NIH disease activity score
Cohen's kappa coefficient measuring agreement between OTUS-based disease activity classification and the National Institutes of Health (NIH) disease activity score for Takayasu arteritis (range 0-4, with higher scores indicating more active disease).
Hazard ratio for time to relapse per unit increase in baseline OTUS score
Time to disease relapse (months), defined as recurrence of clinical signs and/or symptoms attributable to TAK with or without elevation of inflammatory markers, as judged by the treating physician. The hazard ratio per unit increase in baseline OTUS score will be estimated using Cox proportional-hazards regression.
Reference values for arterial wall thickness measured by vascular ultrasound in assessed arterial segments
Arterial wall thickness (mm) measured by standardized vascular ultrasound in the bilateral common carotid, subclavian and axillary arteries, and abdominal aorta. Descriptive statistics will be used to define reference values and proposed normality cut-offs.
Change in OTUS score over time stratified by treatment class
Change in OTUS score (continuous, expressed as ΔOTUS from baseline) over 24 months, compared across therapeutic classes (e.g., glucocorticoids alone, conventional immunosuppressants, biologics). Differences between treatment groups will be analyzed using linear mixed-effects models.
Proportion of patients with changes in ultrasound lesion characteristics over time stratified by treatment class
Proportion of patients (%) showing new, resolved, or persistent elementary ultrasound lesions (macaroni sign, stenosis, occlusion) as defined by OMERACT criteria, compared across therapeutic classes. Differences between treatment groups will be described using proportions and compared using chi-square or Fisher's exact test as appropriate.
To compare OTUS findings with FDG-PET, MRA and/or CTA obtained as part of routine clinical practice.
Concordance between OTUS and PET/MRA/CTA findings, both qualitative and quantitative (when available).
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IRCCS San Raffaele
Lead sponsor
Azienda USL Reggio Emilia - IRCCS
Collaborator
University Hospital Padova
Collaborator
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