title: Consistently Good clinical response in patients with early axial spondyloarthritis after 3 years of continuous treatment with etanercept: longterm data of the ESTHER trial.
abstract: OBJECTIVE
  In patients with early active axial spondyloarthritis (axSpA) with a disease duration of < 5 years, the longterm efficacy of 3 years of continuous etanercept (ETN) treatment was assessed.
  
  
  METHODS
  In a previously reported ESTHER trial, patients with axSpA were randomized to treatment with ETN (n = 40) versus sulfasalazine (SSZ; n = 36) in the first year. We analyzed the clinical, laboratory, and magnetic resonance imaging (MRI) response in the pooled dataset of patients (study population; n = 61), including patients with ankylosing spondylitis (AS, n = 31) and nonradiographic axSpA (nr-axSpA, n = 30) who were continuously treated with ETN for 3 consecutive years. Data were analyzed using the last observation carried forward and completer analysis.
  
  
  RESULTS
  In the entire group of patients in the study population (n = 61), the mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) decreased from 5.7 (± 1.3) at baseline to 2.6 (± 2.4) at Year 3. The Ankylosing Spondylitis Disease Activity Score (ASDAS) decreased from 3.4 (± 0.8) to 1.5 (± 1.0). Also, mean values for MRI spine and sacroiliac joint scores showed a significant decrease. Response rates in the nr-axSpA group were similar and at least as good compared to the AS group for all outcome measures. When comparing remission stages, we found that ASDAS inactive disease correlated better with C-reactive protein and MRI remission than with Assessment of SpondyloArthritis international Society partial remission.
  
  
  CONCLUSIONS
  There was a consistent and sustained clinical response in patients with early axSpA treated with ETN over 3 years. ClinicalTrials.gov registration number NCT00844142.
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: In-Ho
authors.initials: IH
authors.lastname: Song
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Kay-Geert
authors.initials: KG
authors.lastname: Hermann
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Hildrun
authors.initials: H
authors.lastname: Haibel
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Christian E
authors.initials: CE
authors.lastname: Althoff
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Denis
authors.initials: D
authors.lastname: Poddubnyy
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Joachim
authors.initials: J
authors.lastname: Listing
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Anja
authors.initials: A
authors.lastname: Weiß
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Beate
authors.initials: B
authors.lastname: Buß
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Bruce
authors.initials: B
authors.lastname: Freundlich
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Ekkehard
authors.initials: E
authors.lastname: Lange
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Rieke
authors.initials: R
authors.lastname: Alten
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University.
authors.forename: Martin
authors.initials: M
authors.lastname: Rudwaleit
authors.affiliation: From the Department of Rheumatology and the Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin; German Rheumatism Research Center, Berlin, Germany; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Pfizer; Schlosspark-Klinik; Endokrinologikum, Berlin, Germany.I-H. Song, Rheumatology, Charité Medical University; K-G. Hermann, Department of Radiology, Charité Medical University; H. Haibel, Rheumatology, Charité Medical University; C.E. Althoff, Department of Radiology, Charité Medical University; D. Poddubnyy, Rheumatology, Charité Medical University; J. Listing; A. Weiß, German Rheumatism Research Center; B. Buß, Rheumatology, Charité Medical University; B. Freundlich, Division of Rheumatology, University of Pennsylvania; E. Lange, Pfizer; R. Alten, Schlosspark-Klinik; M. Rudwaleit, Rheumatology, Charité Medical University, and Endokrinologikum; J. Sieper, Rheumatology, Charité Medical University. joachim.sieper@charite.de.
authors.forename: Joachim
authors.initials: J
authors.lastname: Sieper
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D000068800:Etanercept / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D012446:Sacroiliac Joint / Q000473:pathology; D025241:Spondylarthritis / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000068800:Etanercept
keywords: ANKYLOSING SPONDYLITIS; CLINICAL TRIAL; ETANERCEPT; MAGNETIC RESONANCE IMAGING; NONRADIOGRAPHIC AXIAL SPONDYLOARTHRITIS; TUMOR NECROSIS FACTOR-α