title: Controlling the digital ulcerative disease in systemic sclerosis is associated with improved hand function.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  In patients with SSc, control of the ulcerative disease for 1 year was associated with significant attenuation of hand disability.
authors.affiliation: Department of Internal Medicine, Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Paris Descartes University, 27, Rue du Faubourg Saint-Jacques, 75679 Paris, France. Electronic address: luc.mouthon@cch.aphp.fr.
authors.forename: Luc
authors.initials: L
authors.lastname: Mouthon
authors.affiliation: Department of Vascular Medicine, University Hospital Grenoble, Grenoble, France.
authors.forename: Patrick H
authors.initials: PH
authors.lastname: Carpentier
authors.affiliation: Department of Dermatology, University Hospital Amiens, Amiens, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Lok
authors.affiliation: Department of Orgamétrie Biostatistics, Roubaix, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Clerson
authors.affiliation: Actelion Pharmaceuticals France, Paris, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Gressin
authors.affiliation: Department of Internal Medicine, Claude Huriez Hospital, Lille 2 University, Lille, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Hachulla
authors.affiliation: Department of Internal Medicine, Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Paris Descartes University, 27, Rue du Faubourg Saint-Jacques, 75679 Paris, France.
authors.forename: Alice
authors.initials: A
authors.lastname: Bérezné
authors.affiliation: Department of Internal Medicine, Bretonneau Hospital, Tours, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Diot
authors.affiliation: Department of Internal Medicine, Saint Eloi Hospital, Montpellier, France.
authors.forename: Aurélie Khau
authors.initials: AK
authors.lastname: Van Kien
authors.affiliation: Department of Internal Medicine, University Hospital Rennes, Rennes, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Jego
authors.affiliation: Department of Internal Medicine, University Hospital Nantes, Nantes, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Agard
authors.affiliation: Department of Dermatology, University Hospital Rouen, Rouen, France.
authors.forename: Anne-Bénédicte
authors.initials: AB
authors.lastname: Duval-Modeste
authors.affiliation: Department of Dermatology, University Hospital Limoges, Limoges, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Sparsa
authors.affiliation: Department of Dermatology, Saint Jacques Hospital, Besançon, France.
authors.forename: Eve
authors.initials: E
authors.lastname: Puzenat
authors.affiliation: Department of Dermatology, Assistance Publique-Hôpitaux de Marseille, Timone Hospital, Aix-Marseille University, Marseille, France.
authors.forename: Marie-Aleth
authors.initials: MA
authors.lastname: Richard
mesh_terms: D000328:Adult; D000368:Aged; D000077300:Bosentan; D004185:Disability Evaluation; D065128:Endothelin Receptor Antagonists / Q000627:therapeutic use*; D005260:Female; D006225:Hand / Q000503:physiopathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012595:Scleroderma, Systemic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D012883:Skin Ulcer / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D065128:Endothelin Receptor Antagonists; D013449:Sulfonamides; D000077300:Bosentan
keywords: Bosentan; Digital ulcers; Disability; Hand; Systemic sclerosis