Katie Tuckwell1, Neil Collinson1, Sophie Dimonaco1, Micki Klearman2, Daniel Blockmans3, Elisabeth Brouwer4, Maria C Cid5, Bhaskar Dasgupta6, Juergen Rech7, Carlo Salvarani8, Sebastian H Unizony9, John H Stone10. 1. Roche Products Ltd., Welwyn Garden City, UK. 2. Genentech, South San Francisco, CA. 3. Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium. 4. Department of Rheumatology and Clinical Immunology, University Medical Center, University of Groningen, Gröningen, The Netherlands. 5. Department of Autoimmune Diseases, Hospital Clínic, Institut d׳Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain. 6. Southend University Hospital, NHS Foundation Trust, Westcliff-on-Sea, UK. 7. Department of Internal Medicine 3-Rheumatology and Immunology, Universitätsklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany. 8. Division of Rheumatology, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy. 9. Rheumatology Unit, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114. 10. Rheumatology Unit, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114. Electronic address: jhstone@mgh.harvard.edu.
Abstract
OBJECTIVE: 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. METHODS: 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. RESULTS: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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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: Susan P Mollan; Jasvir S Virdee; Edward J Bilton; Mark Thaller; Anita Krishan; Alexandra J Sinclair Journal: Eye (Lond) Date: 2021-02-12 Impact factor: 4.456
Authors: John H Stone; Helen Spotswood; Sebastian H Unizony; Martin Aringer; Daniel Blockmans; Elisabeth Brouwer; Maria C Cid; Bhaskar Dasgupta; Juergen Rech; Carlo Salvarani; Robert Spiera; Min Bao Journal: Rheumatology (Oxford) Date: 2022-07-06 Impact factor: 7.046
Authors: Vibeke Strand; Sophie Dimonaco; Katie Tuckwell; Micki Klearman; Neil Collinson; John H Stone Journal: Arthritis Res Ther Date: 2019-02-20 Impact factor: 5.156
Authors: Sara Gale; Jessica C Wilson; Jenny Chia; Huong Trinh; Katie Tuckwell; Neil Collinson; Sophie Dimonaco; Susan Jick; Christoph Meier; Shalini V Mohan; Khaled Sarsour Journal: Rheumatol Ther Date: 2018-05-11