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Mouthon, Luc, MD, PhD; Carpentier, Patrick H., MD; Lok, Catherine, MD; Clerson, Pierre, MD; Gressin, Virginie, MD; Hachulla, Eric, MD, PhD; Bérezné, Alice, MD; Diot, Elisabeth, MD, PhD; Van Kien, Aurélie Khau, MD; Jego, Patrick, MD, PhD; Agard, Christian, MD, PhD; Duval-Modeste, Anne-Bénédicte, MD; Sparsa, Agnès, MD, PhD; Puzenat, Eve, MD; Richard, Marie-Aleth, MD, PhD
Seminars in arthritis and rheumatism, 06/2017, Volume: 46, Issue: 6Journal Article
Abstract Objectives Ischemic digital ulcers (DU) represent a major complication of systemic sclerosis (SSc). We investigated the impact of controlling the ulcerative disease on disability, pain, and quality of life in SSc patients receiving bosentan. Methods ECLIPSE (Study AC-052-517) is a 2-year prospective, multicenter, and observational study. Patients with SSc who experienced at least 1 DU in the previous year and received bosentan were included between October 2009 and March 2011. Disability scores Cochin Hand Function Scale (CHFS) and Health Assessment Questionnaire Disability Index (HAQ-DI), pain scores (visual analog scale), and quality-of-life scores (SF-36) were collected at inclusion and 1 year later (primary endpoint). A controlled ulcerative disease was defined by the absence of ongoing/new DU episode between inclusion and 1-year follow-up. Results Data were available at 1 year for 120 patients out of 190 included. During follow-up, 46 (38.3%) patients experienced a new DU episode. The number of DU per patient decreased from 1.4 ± 1.8 at inclusion to 0.6 ± 1.6 ( p < 0.0001) at 1 year. Disability scores decreased from 1.0 ± 0.7 to 0.9 ± 0.7 ( p = 0.04) for the HAQ-DI and from 29 ± 20 to 25 ± 20 ( p = 0.005) for the CHFS; the pain score decreased from 4.3 ± 3.1 to 2.9 ± 2.8 ( p < 0.0001). This improvement was attributed to patients with a controlled ulcerative disease (48.3%), who significantly improved HAQ-DI ( p = 0.04), CHFS ( p = 0.04), and pain score ( p = 0.046). Conclusions In patients with SSc, control of the ulcerative disease for 1 year was associated with significant attenuation of hand disability.
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