Objectives To develop an Outcome Measures in Rheumatology (OMERACT) ultrasonography score for monitoring disease activity in giant cell arteritis (GCA) and evaluate its metric properties.
Methods The OMERACT Instrument Selection Algorithm was followed. Forty-nine members of the OMERACT ultrasonography large vessel vasculitis working group were invited to seven Delphi rounds. An online reliability exercise was conducted using images of bilateral common temporal arteries, parietal and frontal branches as well as axillary arteries from 16 patients with GCA and 7 controls. Sensitivity to change and convergent construct validity were tested using data from a prospective cohort of patients with new GCA in which ultrasound-based intima–media thickness (IMT) measurements were conducted at weeks 1, 3, 6, 12 and 24.
Results Agreement was obtained (92.7%) for the OMERACT GCA Ultrasonography Score (OGUS), calculated as follows: sum of IMT measured in every segment divided by the rounded cut-off values of IMTs in each segment. The resulting value is then divided by the number of segments available. Thirty-five members conducted the reliability exercise, the interrater intraclass correlation coefficient (ICC) for the OGUS was 0.72–0.84 and the median intrareader ICC was 0.91. The prospective cohort consisted of 52 patients. Sensitivity to change between baseline and each follow-up visit up to week 24 yielded standardised mean differences from −1.19 to −2.16, corresponding to large and very large magnitudes of change, respectively. OGUS correlated moderately with erythrocyte sedimentation rate, C reactive protein and Birmingham Vasculitis Activity Score (corrcoeff 0.37–0.48).
Conclusion We developed a provisional OGUS for potential use in clinical trials.
- giant cell arteritis
- outcome assessment, health care
- systemic vasculitis
Data availability statement
Data are available upon reasonable request.
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CD and CP contributed equally.
Contributors All authors were involved in data acquisition. CDe wrote the first version of the manuscript. All authors reviewed it and made extensive comments and appropriate changes to it. All authors approved the final version of the manuscript. CDe accepts full responsibility for the work, had access to the data, and controlled the decision to publish.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests CDe has received grant support from AbbVie and consulting/speaker’s fees from Abbvie, Eli Lilly, Janssen, Galapagos, Novartis, Pfizer, Sparrow, Roche and Sanofi, all unrelated to this manuscript. CPo is or has been the principal investigator of studies by AbbVie, Sanofi and Novartis and has received consulting/speaker’s fees from Vifor, AstraZeneca, GlaxoSmithKline and Roche, all unrelated to this manuscript. LT received speakers fee from Roche, Novartis, Janssen, Pfizer, UCB and GE. PB received grant support from Pfizer and speaker’s fees from Janssen. CDu has received consultancy or speaker fees and travel expenses from Abbvie, AOP Orphan, Astra-Zeneca, Bristol-Myers-Squibb, Eli-Lilly, Janssen, Galapagos, Merck-Sharp-Dohme, Novartis, Pfizer, Roche, Sandoz, UCB, Vifor and research support from Eli-Lilly, Pfizer, UCB, all unrelated to this manuscript. E-MH has received fees for speaking and/or consulting from Novartis, AbbVie, Sanofi, Sobi; research funding to Aarhus University Hospital from Novo Nordic Foundation, Danish Rheumatism Association, Danish Regions Medicine Grants, Roche, Novartis, AbbVie; travel expenses from Pfizer, Sobi, AbbVie. E-MH has been the principal investigator of studies by SynACT Pharma and involved as site principal investigator in trials by AbbVie, Novartis, Novo and Sanofi, all unrelated to this manuscript. AI received honoraria, advisory boards, speakers’ bureau, educational grants and research support from AbbVie, Alfasigma, Amgen, Biogen, BMS, Celgene, Celltrion, Eli-Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, Sanofi Genzyme, SOBI and UCB. KDT is or was a research investigator of studies for Novartis, Astra Zeneca, Glaxo SmithKline, Amgen; has received consulting fees from Aurinia, Novartis and Astra Zeneca; and is a contracted researcher of Bioclinica. KSMvdG received a speaker fee from Roche. WAS is or has been the principal investigator of studies by Abbvie, Amgen, GlaxoSmithKline, Novartis, Roche, Sanofi and has received consulting/speaker’s fees from Abbvie, Amgen, Bristol-Myers Squibb, Chugai, GlaxoSmithKline, Johnson & Johnson, Medac, Novartis, Roche and Sanofi, all unrelated to this manuscript. The other authors declare no conflicts of interest.
Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
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