title: Effects of treatment with etanercept versus methotrexate on sleep quality, fatigue and selected immune parameters in patients with active rheumatoid arthritis.
abstract: OBJECTIVE
  To compare sleep quality, disease activity and patient-reported outcomes such as fatigue and immune parameters in patients with rheumatoid arthritis treated with etanercept (ETA) or methotrexate (MTX).
  
  
  METHODS
  Of 36 patients (28-joint Disease Activity Score, DAS28CRP≥3.2) in this 16-week (w), open, prospective study, 19 (11 women) received MTX 12.5-17 mg/w, and 17 (14 women) received ETA 25 mg x 2/w, alone or in combination with MTX. Clinical (DAS28CRP, visual analogue scale), laboratory (C-reactive protein [CRP]), sleep (polysomnography), functional (Multidimensional Fatigue Inventory; Health Assessment Questionnaire-Disability Index (HAQ-DI); 36-item Short-Form Health Survey (SF-36), immunological (humoral/cellular) and neuroendocrine (hormonal) parameters were recorded at baseline (BL), w8 and w16.
  
  
  RESULTS
  BL characteristics did not differ significantly between the ETA and MTX groups except disease duration: mean age (years): 48.6±8.8 vs. 49.4±16.6; mean disease duration (months): 19.6±46.3 vs. 81.2±79.2; and DAS28CRP: 4.4±0.9 vs. 4.4±1.7, respectively. DAS28CRP, SF-36, and HAQ-DI improved significantly in both groups from BL to w16 (p≤0.05). The DAS28CRP improvements at w16 (mean changes -1.8 in the ETA group, and -1.4 in MTX group), were not statistically significant from each other. The absolute values of sleep efficiency, total sleep time, and stage 2 sleep duration increased significantly in the ETA group, but no significant changes were reported in the MTX group.
  
  
  CONCLUSIONS
  Both therapies improved disease activity, CRP, SF-36 and HAQ-DI, with faster, more pronounced changes in DAS28CRP in the ETA group, which alone had significantly improved sleep parameters.
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Germany.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Detert
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin; and German Rheumatism Research Center (Deutsches Rheumaforschungszentrum, DRFZ), Berlin, Germany.
authors.forename: René
authors.initials: R
authors.lastname: Dziurla
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin; and German Rheumatism Research Center (Deutsches Rheumaforschungszentrum, DRFZ), Berlin, Germany.
authors.forename: Paula
authors.initials: P
authors.lastname: Hoff
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin; German Rheumatism Research Center (Deutsches Rheumaforschungszentrum, DRFZ); and Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Berlin, Germany.
authors.forename: Timo
authors.initials: T
authors.lastname: Gaber
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Germany.
authors.forename: Pascal
authors.initials: P
authors.lastname: Klaus
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Germany.
authors.forename: Hans
authors.initials: H
authors.lastname: Bastian
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Germany.
authors.forename: Tanja
authors.initials: T
authors.lastname: Braun
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin; and German Rheumatism Research Center (Deutsches Rheumaforschungszentrum, DRFZ), Berlin, Germany.
authors.forename: Saskia
authors.initials: S
authors.lastname: Schellmann
authors.affiliation: Sleep Medicine Center, Charité-Universitätsmedizin Berlin, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Penzel
authors.affiliation: Sleep Medicine Center, Charité-Universitätsmedizin Berlin, Germany.
authors.forename: Ingo
authors.initials: I
authors.lastname: Fietze
authors.affiliation: Medical Director Global Innovative Pharma, Pfizer Pharma GmbH, Berlin, Germany.
authors.forename: Peter-Andreas
authors.initials: PA
authors.lastname: Loeschmann
authors.affiliation: pj statistics, Berlin, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Jaehnig
authors.affiliation: Laboratory of Experimental Rheumatology and Neuroendocrino-Immunology, Department of Internal Medicine I, University Hospital Regensburg, Regensburg, Germany.
authors.forename: Rainer H
authors.initials: RH
authors.lastname: Straub
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Germany.
authors.forename: Gerd R
authors.initials: GR
authors.lastname: Burmester
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Buttgereit
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D004185:Disability Evaluation; D004359:Drug Therapy, Combination; D000068800:Etanercept / Q000009:adverse effects / Q000627:therapeutic use*; D005221:Fatigue / Q000276:immunology / Q000503:physiopathology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D010865:Pilot Projects; D017286:Polysomnography; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012074:Remission Induction; D012890:Sleep / Q000187:drug effects*; D012893:Sleep Wake Disorders / Q000276:immunology / Q000503:physiopathology / Q000517:prevention & control*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018501:Antirheumatic Agents; D000068800:Etanercept; D008727:Methotrexate