title: Assessment of sensitivity to change of the European Scleroderma Study Group activity index.
abstract: OBJECTIVE
  The European Scleroderma Study Group (EScSG) activity index meets nearly all the OMERACT-standards of truth, discrimination and feasibility. The sensitivity to change remains to be attested. This study assesses sensitivity to change of the EScSG activity index in patients with early and severe diffuse cutaneous Systemic Sclerosis (dcSSc) treated with rituximab.
  
  
  METHODS
  12-month follow-up (open-label study) of 14 consecutive patients with early dcSSc. Patients received an infusion of two times 1000 mg rituximab at month 0 and 6, together with 100 mg methylprednisolone. Clinical read outs (modified Rodnan skin score [mRSS], lung function and echocardiography) and EScSG activity index were performed at month 0, 3, 6 and 12. Mixed models analyses (MMA) were used to evaluate changes in parameters over time.
  
  
  RESULTS
  There was a clinically significant change in skin score with a mean (SD) mRSS of 24.8 (4.44) at baseline and 10.4 (3.12) at month 12 (MMA p<0.001). Also the EScSG activity index decreased significantly, with a mean (SD) of 4.3 (1.79) at baseline and 0.7 (0.83) at month 12 (MMA p<0.001). The estimated mean change of the EScSG activity index was -3.6 (95%CI -4.9; -2.4) over 12 months. Indices of internal organ involvement remained stable throughout the study.
  
  
  CONCLUSIONS
  A significant improvement of the EScSG activity index was observed, in line with the significant improvement of the mRSS and the stabilisation of internal organ involvement. To our knowledge, this is the first study to attest sensitivity to change of the EScSG activity index in the subset of 'early' dcSSc.
  
  
  BACKGROUND
  ClinicalTrials.gov Registration, http://clinicaltrials.gov, number NCT00379431.
authors.affiliation: Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University, Belgium. karin.melsens@ugent.be.
authors.forename: Karin
authors.initials: K
authors.lastname: Melsens
authors.affiliation: Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University; and Department of Rheumatology, Ghent University Hospital, Belgium.
authors.forename: Filip
authors.initials: F
authors.lastname: De Keyser
authors.affiliation: Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University, Belgium.
authors.forename: Saskia
authors.initials: S
authors.lastname: Decuman
authors.affiliation: Department of Respiratory Medicine, Ghent University Hospital, Belgium.
authors.forename: Guy
authors.initials: G
authors.lastname: Brusselle
authors.affiliation: Department of Cardiology, Ghent University Hospital, Belgium.
authors.forename: Michel
authors.initials: M
authors.lastname: De Pauw
authors.affiliation: Department of Public Health, Biostatistics Unit, Ghent University, Belgium.
authors.forename: Ellen
authors.initials: E
authors.lastname: Deschepper
authors.affiliation: Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University, Belgium.
authors.forename: Katelijne
authors.initials: K
authors.lastname: De Wilde
authors.affiliation: Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University; Department of Rheumatology, Ghent University Hospital; and Begium Unit of Molecular Immunology and Inflammation, Inflammation Research Centre-VIB, Ghent, Belgium.
authors.forename: Dirk
authors.initials: D
authors.lastname: Elewaut
authors.affiliation: Department of Rheumatology, Ghent University Hospital, Belgium.
authors.forename: Yves
authors.initials: Y
authors.lastname: Piette
authors.affiliation: Department of Cardiology, Ghent University Hospital, Belgium.
authors.forename: Els
authors.initials: E
authors.lastname: Vandecasteele
authors.affiliation: Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University; and Department of Rheumatology, Ghent University Hospital, Belgium.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Smith
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D001530:Belgium; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004452:Echocardiography; D005260:Female; D006331:Heart Diseases / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008171:Lung Diseases / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage; D008875:Middle Aged; D011237:Predictive Value of Tests; D012074:Remission Induction; D015203:Reproducibility of Results; D012129:Respiratory Function Tests; D012307:Risk Factors; D000069283:Rituximab / Q000008:administration & dosage* / Q000009:adverse effects; D045743:Scleroderma, Diffuse / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000069283:Rituximab; D008775:Methylprednisolone