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Development of Outcome Measures for Large-vessel Vasculitis for Use in Clinical Trials: Opportunities, Challenges, and Research Agenda

Published on Jul 1, 2011in The Journal of Rheumatology3.634
· DOI :10.3899/jrheum.110275
Haner Direskeneli39
Estimated H-index: 39
(Marmara University),
Sibel Zehra Aydin29
Estimated H-index: 29
(Marmara University)
+ 9 AuthorsPeter A. Merkel67
Estimated H-index: 67
(BU: Boston University)
Abstract
Giant cell (GCA) and Takayasu’s arteritis (TAK) are 2 forms of large-vessel vasculitis (LVV) that involve the aorta and its major branches. GCA has a predilection for the cranial branches, while TAK tends to affect the extracranial branches. Both disorders may also cause nonspecific constitutional symptoms. Although some clinical features are more common in one or the other disorder and the ages of initial presentation differ substantially, there is enough clinical and histopathologic overlap between these disorders that some investigators suggest GCA and TAK may be 2 processes within the spectrum of a single disease. There have been few randomized therapeutic trials completed in GCA, and none in TAK. The lack of therapeutic trials in LVV is only partially explained by the rarity of these diseases. It is likely that the lack of well validated outcome measures for LVV and uncertainties regarding trial design contribute to the paucity of trials for these diseases. An initiative to develop a core set of outcome measures for use in clinical trials of LVV was launched by the international OMERACT Vasculitis Working Group in 2009 and subsequently endorsed by the OMERACT community at the OMERACT 10 meeting. Aims of this initiative include: (1) to review the literature and existing data related to outcome assessments in LVV; (2) to obtain the opinion of experts and patients on disease content; and (3) to formulate a research agenda to facilitate a more data-based approach to outcomes development.
  • References (119)
  • Citations (61)
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References119
Newest
#1Peter A. Merkel (BU: Boston University)H-Index: 67
#2Sibel Zehra Aydin (Marmara University)H-Index: 29
Last. Raashid Luqmani (University of Oxford)H-Index: 53
view all 9 authors...
59 CitationsSource
#1Niranjan Khandelwal (PGIMER: Post Graduate Institute of Medical Education and Research)H-Index: 34
#2Naveen Kalra (PGIMER: Post Graduate Institute of Medical Education and Research)H-Index: 31
Last. Sudha Suri (PGIMER: Post Graduate Institute of Medical Education and Research)H-Index: 27
view all 7 authors...
Abstract Objective To analyse the spectrum of Takayasu's arteritis (TA) on multidetector CT angiography (MDCTA). Materials and methods A retrospective analysis of the MDCTA findings was performed on 15 patients clinically diagnosed as Takayasu's arteritis. The spectrum and incidence of imaging findings on CTA were compared to studies in literature on catheter angiography in Takayasu's arteritis. Laboratory parameters were available in nine patients. The disease was considered active if erythrocy...
38 CitationsSource
#1Karen HerlynH-Index: 22
#2Bernhard Hellmich (University of Tübingen)H-Index: 35
Last. Peter A. Merkel (BU: Boston University)H-Index: 67
view all 4 authors...
Objective To assess patients' self-estimates of the burden of disease in vasculitis and to compare data across patient populations from the US, Germany, and the UK. Outcome assessment in vasculitis primarily focuses on physician evaluations of disease activity and damage. Little is known about the patients' perspectives regarding the burden of disease. Methods Patients ranked (scale 0–5) a list of vasculitis-related items to estimate a combination of pain, interference with daily function, disco...
54 CitationsSource
#1Nitin Mahajan (PGIMER: Post Graduate Institute of Medical Education and Research)H-Index: 10
#2Veena Dhawan (PGIMER: Post Graduate Institute of Medical Education and Research)H-Index: 17
Last. Sanjay Jain (PGIMER: Post Graduate Institute of Medical Education and Research)H-Index: 16
view all 4 authors...
Abstract Background Oxidative stress and activation of matrix metalloproteinases (MMPs) together have been widely implicated in various inflammatory vascular disorders. As Takayasu's arteritis (TA) is an inflammatory disorder characterized by destruction of elastic fibers, we hypothesized that oxidative stress and MMPs might play an important role in pathophysiology of the disease. Methods 40 patients with clinically defined TA and equal number of normal, healthy, controls were enrolled in the s...
20 CitationsSource
#1Sibel Zehra Aydin (Dokuz Eylül University)H-Index: 29
#2Neslihan Yilmaz (Dokuz Eylül University)H-Index: 11
Last. Haner Direskeneli (Dokuz Eylül University)H-Index: 19
view all 15 authors...
61 CitationsSource
#1Khader N. Mustafa (UJ: University of Jordan)H-Index: 8
#2Azmy M. Hadidy (UJ: University of Jordan)H-Index: 7
Last. Nadera J. Sweiss (U of C: University of Chicago)H-Index: 27
view all 3 authors...
The prevalence of Takayasu’s arteritis (TA) varies greatly among world populations, and little is known about this disease in Eastern Mediterranean Arab populations. We conducted a retrospective chart review of patients diagnosed with TA from 1996 to 2008 at a single large referral center in Jordan. Eight patients (seven females, one male) with angiographically diagnosed TA were seen at the Jordan University Hospital between 1996 and 2008. All patients were of Arabic ethnicity. The age at presen...
8 CitationsSource
#1Francesca Pugliese (NIH: National Institutes of Health)H-Index: 37
#2Oliver Gaemperli (NIH: National Institutes of Health)H-Index: 7
Last. Paolo G. Camici (UniSR: Vita-Salute San Raffaele University)H-Index: 14
view all 9 authors...
Objectives We sought to investigate whether positron emission tomography/computed tomography (CT) angiography using [ 11 C]-PK11195, a selective ligand for peripheral benzodiazepine receptors expressed in activated macrophages, can be used to image vascular inflammation. Background Activated macrophages and T lymphocytes are fundamental elements in the pathogenesis of large-vessel vasculitides. Methods Fifteen patients (age 52 ± 16 years) with systemic inflammatory disorders (6 consecutive sympt...
94 CitationsSource
#1Alexandre Wagner Silva de Souza (UNIFESP: Federal University of São Paulo)H-Index: 13
#2Natália Pereira Machado (UNIFESP: Federal University of São Paulo)H-Index: 4
Last. Emília Inoue Sato (UNIFESP: Federal University of São Paulo)H-Index: 19
view all 7 authors...
Background: Vessel wall inflammation, atherosclerosis and hypercoagulability may be responsible for ischemic events in Takayasu arteritis (TA). No study has evaluated the effect of antiplatelet therapy for the prevention of ischemic events in TA. Methods and Results: Forty-eight patients who met the ACR Classification Criteria for TA under follow-up at the Vasculitis Unit of Universidade Federal de Sao Paulo were evaluated retrospectively for clinical manifestations, therapy and arterial ischemi...
56 CitationsSource
#1John T. SharpH-Index: 40
#2Wayne Tsuji (Amgen)H-Index: 20
Last. Richard Newmark (Amgen)H-Index: 14
view all 6 authors...
Objective Osteoclast-mediated bone loss in the hand predicts future bone erosions in patients with rheumatoid arthritis (RA). Osteoclast activity depends on RANKL, which is inhibited by denosumab, an investigational fully human monoclonal antibody against RANKL. We measured metacarpal shaft cortical bone thickness using a novel computer-based technique, digital x-ray radiogrammetry (DXR), to evaluate the effects of denosumab on cortical bone in RA. Methods Patients (n = 227) with active, erosive...
50 CitationsSource
#1Omer Karadag (Hacettepe University)H-Index: 23
#2Kenan Aksu (Ege University)H-Index: 26
Last. Sedat Kiraz (Hacettepe University)H-Index: 32
view all 17 authors...
A possible relationship between Takayasu arteritis (TA) and tuberculosis (TB) has been suggested. An increased frequency of tuberculin skin test (TST) was observed in TA patients. Quantiferon-TB Gold test (QFT) is a new in vitro assay measuring interferon-gamma response to M. tuberculosis antigens and helpful in diagnosing latent TB infection. The aim of this study was to investigate latent TB infection among TA patients by the use of both TST and QFT Gold test. Ninety-four (male/female: 7/87) T...
24 CitationsSource
Cited By61
Newest
#2Kaitlin QuinnH-Index: 2
Last. Peter C. GraysonH-Index: 16
view all 9 authors...
Objective Disease activity in large-vessel vasculitis (LVV) is traditionally assessed by clinical and serological parameters rather than vascular imaging. This study determined the effect of treatment on 18F-fluorodeoxyglose positron emission tomography (FDG-PET) vascular activity in relationship to clinical and serologic-based assessments. Methods Patients with giant cell arteritis (GCA) or Takayasu’s arteritis (TAK) were prospectively evaluated at 6-month intervals in an observational cohort. ...
3 CitationsSource
#1Benjamin Benhuri (UT: University of Toledo)
#2Ammar ELJack (UT: University of Toledo)
Last. Ritu Chakravarti (UT: University of Toledo)H-Index: 13
view all 4 authors...
Aortitis can be the manifestation of an underlying infectious or noninfectious disease process. An autoimmune cause is suggested in a large proportion of noninfectious causes. Similar to other autoimmune diseases, the pathophysiology of aortitis has been investigated in detail, but the etiology remains unknown. Most cases of aortitis often go undetected for a long time and are often identified at late stages of the disease. Recent advances in imaging techniques have significantly improved the di...
Source
Source
#1Zhiqin Li (Fourth Military Medical University)H-Index: 1
#2Zhaohui ZhengH-Index: 8
Last. Ping ZhuH-Index: 20
view all 11 authors...
Objective. To evaluate the utility of contrast-enhanced ultrasound (CEUS) compared with 18F-fluorodeoxyglucose–positron emission tomography (FDG-PET) in assessing vessel inflammation of Takayasu arteritis (TA). Methods. This is a retrospective analysis of 71 patients with TA who had undergone carotid CEUS. Twenty-two of 71 patients underwent FDG-PET after CEUS. Clinical disease activity was assessed by Kerr criteria and the Indian Takayasu Clinical Activity Score 2010 (ITAS2010). We investigated...
2 CitationsSource
#1David S. Younger (NYU: New York University)H-Index: 21
Source
AbstractTakayasu arteritis (TAK) and giant cell arteritis (GCA) affect mainly large- and medium-sized arteries. In refractory cases, vascular remodeling progresses and leads to serious outcomes. St...
2 CitationsSource
#1Gunnar Tomasson (University of Iceland)H-Index: 14
#2John T. FarrarH-Index: 61
Last. Peter A. MerkelH-Index: 67
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OBJECTIVE: The Patient Reported Outcome Measurement Information System (PROMIS) is a collection of item banks of self-reported health. This study assessed the feasibility and construct validity of using PROMIS instruments in vasculitis. METHODS: Data from a multicenter longitudinal cohort of subjects with systemic vasculitis were used. Instruments from 10 PROMIS item banks were selected with direct involvement of patients. Subjects completed PROMIS instruments using computer adaptive testing (CA...
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#1Tanaz A. Kermani (UCLA: University of California, Los Angeles)H-Index: 18
#2Sehriban Diab (McMaster University)H-Index: 2
Last. Nader Khalidi (McMaster University)H-Index: 23
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Abstract Objectives To evaluate large-vessel (LV) abnormalities on serial imaging in patients with giant cell arteritis (GCA) and discern predictors of new lesions. Methods Clinical and imaging data from patients with GCA (including subjects diagnosed by LV imaging) enrolled in a prospective, multicenter, longitudinal study and/or a randomized clinical trial were included. New arterial lesions were defined as a lesion in a previously unaffected artery. Results The study included 187 patients wit...
3 CitationsSource
#1Tanaz A. Kermani (UCLA: University of California, Los Angeles)H-Index: 18
4 CitationsSource
Abstract Objectives Giant cell arteritis (GCA) is the most common form of systemic vasculitis. Glucocorticoids are an effective treatment but have significant adverse events and relapses are common. Interleukins 12 (IL-12) and 23 (IL-23) stimulate TH1 and TH17 responses and are implicated in the pathogenesis of GCA. The aim of this study was to evaluate the efficacy and safety of IL-12/23 blockade with ustekinumab in GCA. Methods We performed a prospective open label study of ustekinumab in pati...
6 CitationsSource