This article appears in the following Rheumatology issue: Update in systemic sclerosis [View the issue table of contents]
Digital ulcers and outcomes assessment in scleroderma
1Division of Rheumatology, AOUC, Department of Biomedicine, Denothe Center, University of Florence, Florence, Italy and 2University of Michigan Scleroderma Program, Ann Arbor, Michigan, MI, USA.
Correspondence to: J. R. Seibold, University of Michigan Scleroderma Program, 24 Frank Lloyd Wright Drive, PO Box 481, Lobby M, Suite 2500, Ann Arbor, Michigan, MI 48106, USA. E-mail: jseibold{at}umich.edu
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Abstract |
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Ischaemic ulcerations of the fingertips are common in SSc and a source of pain and disability. Healing has been demonstrated with intravenous iloprost and two studies with bosentan have demonstrated reduction in the occurrence of new digital ulcers (DUs) over 4–6 months of treatment. Both bosentan studies showed no benefit in healing DU and because of this, net DU burden is no different between drug and placebo and accordingly secondary measures of outcome including pain and hand functionality are inconsistently affected. While it is likely an artefact, it remains unclear that current outcome measures including the Scleroderma Health Assessment Questionnaire (SHAQ), the UK Functional Score and the Michigan Hand Questionnaire are sensitive to change in the domain of digital ischaemia. Major events including amputation and hospitalization occur too infrequently to serve as practical measures of outcome in trials. Future studies of DU therapies will benefit from development of an ulcer-specific measure of outcome.
KEY WORDS: Digital ulcers, Scleroderma, Systemic sclerosis, Outcome measures
Submitted 1 May 2008; Accepted 3 July 2008