START – Molecular stratification of patients with giant cell arteritis to tailor glucocorticoid and tocilizumab therapy


The present research aims to develop and validate biomarkers whose quantification in temporal artery biopsies (TABs) might predict response to glucocorticoids and tocilizumab in patients with giant cell arteritis (GCA) and to stratify patients according to molecular signatures in TABs. Glucocorticoids are the standard of care in GCA but about 40% of patients relapse when glucocorticoids are tapered. Tocilizumab plus glucocorticoids has recently been proven effective at increasing the percentage of GCA patients in remission and sparing glucocorticoids.

Facts and figures

Project lead
N Pipitone
Azienda Unità Sanitaria Locale
FOREUM research grant: € 600.000

Meet the team

N Pipitone
Azienda Unità Sanitaria Locale
S Croci
Azienda Unità Sanitaria Locale
F Ciccia
Università della Campania Vanvitelli
R Alessandro
University of Palermo
S Fontana
University of Palermo
M Gonzalez-Gay
Hospital Universitario Marqués de Valdecilla
S Castaneda
Hospital La Princesa
J Martin
Institute of Parasitology and Biomedicine López-Neyra
P Liò
University of Cambridge
D Saadoun
Pitie-Salpetriere Hospital
P Villiger
University Hospital Bern
D Conti
Associazione Malati Reumatici Emilia Romagna
J Baquero
Foro Español de Pacientes
Dr V Romero
Liga Reumatologica Española
Dr L Carmona
Liga Reumatologica Española


  • Identification of biomarkers in TABs whose quantification may allow to predict at diagnosis patients’ response to glucocorticoids and tocilizumab.
  • Stratification of GCA patients according to molecular signatures in TABs and correlation of such signatures to the clinical characteristics of patients.    
  • Validation of the potential predictors and signatures.

The long-term objective is to create the basis for a therapeutic approach in patients with GCA, tailored to molecular characteristics in TABs at diagnosis, aiding physicians to achieve the best outcome in each patients (maximum efficacy with minimal adverse effects) in the shortest time.

Patient voice

One Italian (AMRER) and two Spanish (FEP and LIRE) associations of patients are involved as patient research partners (PRPs). EULAR guidelines for Patient Research Partners (PRP) inclusion have been followed. We have discussed the design of the project and the burden for patients with the PRPs integrating their feedback. PRPs are involved in all phases of the project.

Patients with GCA subjected to a biopsy of temporal artery for diagnosis, performing different kinds of molecular analyses on the inflamed tissue biopsies (RN sequencing, DNA methylation and proteomics) were recruited. Patients receive a therapy with glucocorticoids or glucocorticoids plus tocilizumab according to the physicians' evaluation and clinical practice and are followed up to 78 weeks. Molecular profile is compared between patients who experience relapses and patients who effectively respond to therapy and between patients with different clinical manifestations.
It's expected to provide tools to select the likely most effective therapy for each patient right from the time of diagnosis, with a positive impact on patients' quality of life: lower recurrences of symptoms, less adverse effects from therapy and higher likelihood to achieve remission.


EULAR Abstracts


  • SAT0338: Contrast-enhanced ultrasonography in the evaluation of myositis

Go to EULAR Abstract Archive


Month 12: Completion of patient recruitment for the glucocorticoid study
Month 18: Completion of patient recruitment for the tocilizumab study
Month 21: Completion of RNA, protein and DNA methylation analyses in TABs
Month 24: Completion of patients follow up for the glucocorticoid study & Definition of molecular signatures associated to clinical characteristics
Month 30: Completion of patients follow up for the tocilizumab study
Month 33: Definition of predictors of response to therapy
Month 36: Validation of the candidate biomarkers and signatures