title: Course of dermal ulcers and musculoskeletal involvement in systemic sclerosis patients in the scleroderma lung study.
abstract: OBJECTIVE
  To evaluate changes in vascular and musculoskeletal involvement in subjects in the Scleroderma Lung Study, a multicenter, double-blind, randomized, controlled trial comparing placebo treatment with oral cyclophosphamide (CYC) for 1 year in systemic sclerosis patients with interstitial lung disease. Subjects were then followed off the study agent for an additional 12 months.
  
  
  METHODS
  The following parameters were noted at baseline and every 6 months for each patient: digital tip ulcers, other dermal ulcers, joint swelling, joint tenderness, large joint contractures, muscle tenderness, muscle weakness, oral aperture, hand extension, and fist closure.
  
  
  RESULTS
  A total of 158 patients were enrolled from 13 centers in the US; 79 were randomized to the CYC group and 79 to the placebo group. There were no differences in dermal ulcer and musculoskeletal measures between the CYC and placebo groups at baseline and 12 and 24 months. Improvement in percent predicted forced vital capacity was associated with improvement in the Rodnan skin thickness score (P<0.05) at 12 and 24 months, and with increased mean oral aperture at 24 months (P=0.005).
  
  
  CONCLUSIONS
  These data document the frequency and course of these vascular and musculoskeletal features over time, therefore providing essential information for sample size calculations and magnitude of effect in future clinical trials. There was no treatment effect of CYC on the vascular and musculoskeletal features described.
authors.affiliation: University of California, Los Angeles, Los Angeles, CA 90025, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Au
authors.forename: Maureen D
authors.initials: MD
authors.lastname: Mayes
authors.forename: Paul
authors.initials: P
authors.lastname: Maranian
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Clements
authors.forename: Dinesh
authors.initials: D
authors.lastname: Khanna
authors.forename: Virginia D
authors.initials: VD
authors.lastname: Steen
authors.forename: Donald
authors.initials: D
authors.lastname: Tashkin
authors.forename: Michael D
authors.initials: MD
authors.lastname: Roth
authors.forename: Robert
authors.initials: R
authors.lastname: Elashoff
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Furst
mesh_terms: D000284:Administration, Oral; D003520:Cyclophosphamide / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012594:Scleroderma, Localized / Q000150:complications* / Q000175:diagnosis; D012595:Scleroderma, Systemic / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D012883:Skin Ulcer / Q000175:diagnosis / Q000209:etiology*
chemical_list: D007166:Immunosuppressive Agents; D003520:Cyclophosphamide