The Predict Study: low risk for digital ulcer development in patients with systemic sclerosis with increasing disease duration and lack of topoisomerase 1 antibodies
DEAR EDITOR, Digital ulcers (DUs) pose a significant clinical problem in systemic sclerosis (SSc) having a major impact on patients' quality of life and ability to work. DUs are extremely painful, slow to heal and difficult to treat. The conditions for the development of DUs, including both risk factors and protective factors, are only partially understood. It is known that among patients with SSc, 15 25% have active DUs. The percentage of patients with SSc who have or have had DUs in the past varies considerably, from 35% to 65% Most of the clinical studies that have investigated clinical risk factors for DU development have used a cross sectional design, in which a considerable number of patients (25 35% did not have current DUs or a history of prior DUs. Of interest, in the cohort of the German registry the prevalence of DUs during follow up did not change, whereas the prevalence of other organ involvement increased substantially over time (Moinzadeh et al. and unpublished observation) To date it is not known what percentage of patients with SSc will develop DUs during further disease evolution. The current study had a multicentre, observational design. All of the patients met the classification criteria as having limited cutaneous SSc or diffuse cutaneous SSc (dcSSc) according to the American College of Rheumatology (ACR) criteria of SSc and the LeRoy criteria. A small number of patients had symptoms compatible with overlap SSc. Patients had either current active DU (cohort 1) reliably documented SSc related DU in the past (cohort 2) or no current active DU and no prior history of DU (cohort 3) Patients in cohort 3 were followed up at months 6, 12, 18 and 24 for the development of DU. Active DUs were defined as a loss of both epidermis and dermis in an area of at least 2 mm diameter at the distal phalanx of the fingers but not over bony prominences, encompassing the palmar (volar) area. The study was planned to be concluded
The British journal of dermatology