title: Newly diagnosed vs. relapsing giant cell arteritis: Baseline data from the GiACTA trial.
abstract: To report entry criteria and clinical features of patients with newly diagnosed and relapsing giant cell arteritis (GCA) enrolled in a randomized trial of tocilizumab, an interleukin-6 receptor-alpha inhibitor.
  
  
  
  Newly diagnosed GCA was defined as diagnosis ≤6 weeks before baseline. Relapsing GCA was defined as diagnosis >6 weeks before baseline with ≥2 consecutive weeks of prednisone ≥40mg/day. All patients had active GCA within 6 weeks of baseline. All statistical results are exploratory.
  
  
  
  Of 251 patients, 119 (47%) had newly diagnosed and 132 (53%) had relapsing GCA. Mean age was 69 years in both subsets; 75% were women. Relapsing patients were heavier [difference in means (95% CI): women, 4.18kg (0.49-7.87, P = 0.027); men, 8.25kg (1.42-15.09, P = 0.019)] and had higher mean body mass index [difference in means (95% CI): women, 1.72kg/m2(0.44-2.99, P = 0.009); men, 2.85kg/m2(0.32-5.37, P = 0.028)]. Relapsers had higher baseline prevalence of depression (16% vs. 4%) and osteopenia/osteoporosis (33% vs. 23%, P = 0.002 and P = 0.062, respectively). At diagnosis, 67% had new-onset headaches; 34% had mouth pain/jaw claudication. One-fifth had polymyalgia rheumatica symptoms but no cranial manifestations; 62% had positive temporal artery biopsy findings; 37% were enrolled on the basis of cross-sectional imaging study findings.
  
  
  
  Demographics of the GiACTA population reflect the epidemiologic profile of GCA. Baseline comorbidities associated with glucocorticoids were more prevalent among relapsing patients than among those with newly diagnosed disease, highlighting the need for new GCA treatment options. More than one-third of patients were enrolled based on large-vessel imaging.
authors.affiliation: Roche Products Ltd., Welwyn Garden City, UK.
authors.forename: Katie
authors.initials: K
authors.lastname: Tuckwell
authors.affiliation: Roche Products Ltd., Welwyn Garden City, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Collinson
authors.affiliation: Roche Products Ltd., Welwyn Garden City, UK.
authors.forename: Sophie
authors.initials: S
authors.lastname: Dimonaco
authors.affiliation: Genentech, South San Francisco, CA.
authors.forename: Micki
authors.initials: M
authors.lastname: Klearman
authors.affiliation: Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium.
authors.forename: Daniel
authors.initials: D
authors.lastname: Blockmans
authors.affiliation: Department of Rheumatology and Clinical Immunology, University Medical Center, University of Groningen, Gröningen, The Netherlands.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Brouwer
authors.affiliation: Department of Autoimmune Diseases, Hospital Clínic, Institut d׳Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Cid
authors.affiliation: Southend University Hospital, NHS Foundation Trust, Westcliff-on-Sea, UK.
authors.forename: Bhaskar
authors.initials: B
authors.lastname: Dasgupta
authors.affiliation: Department of Internal Medicine 3-Rheumatology and Immunology, Universitätsklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.
authors.forename: Juergen
authors.initials: J
authors.lastname: Rech
authors.affiliation: Division of Rheumatology, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Salvarani
authors.affiliation: Rheumatology Unit, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114.
authors.forename: Sebastian H
authors.initials: SH
authors.lastname: Unizony
authors.affiliation: Rheumatology Unit, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114. Electronic address: jhstone@mgh.harvard.edu.
authors.forename: John H
authors.initials: JH
authors.lastname: Stone
mesh_terms: D000368:Aged; D015992:Body Mass Index; D015897:Comorbidity; D004305:Dose-Response Relationship, Drug; D005260:Female; D013700:Giant Cell Arteritis / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects*; D012008:Recurrence
chemical_list: D005938:Glucocorticoids; D011241:Prednisone
keywords: Biologicals; Clinical trial; Giant cell arteritis; Glucocorticoids; Positron emission tomography (PET)