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Consistently Good clinical response in patients with early axial spondyloarthritis after 3 years of continuous treatment with etanercept: longterm data of the ESTHER trial.
J Rheumatol. 2014 Oct; 41(10):2034-40.JR

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.

CONCLUSION

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+Show Affiliations

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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.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. Weiβ, German Rheumatism Research Center; B. Buβ, 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.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25028375

Citation

Song, In-Ho, et al. "Consistently Good Clinical Response in Patients With Early Axial Spondyloarthritis After 3 Years of Continuous Treatment With Etanercept: Longterm Data of the ESTHER Trial." The Journal of Rheumatology, vol. 41, no. 10, 2014, pp. 2034-40.
Song IH, Hermann KG, Haibel H, et al. Consistently Good clinical response in patients with early axial spondyloarthritis after 3 years of continuous treatment with etanercept: longterm data of the ESTHER trial. J Rheumatol. 2014;41(10):2034-40.
Song, I. H., Hermann, K. G., Haibel, H., Althoff, C. E., Poddubnyy, D., Listing, J., Weiβ, A., Buβ, B., Freundlich, B., Lange, E., Alten, R., Rudwaleit, M., & Sieper, J. (2014). Consistently Good clinical response in patients with early axial spondyloarthritis after 3 years of continuous treatment with etanercept: longterm data of the ESTHER trial. The Journal of Rheumatology, 41(10), 2034-40. https://doi.org/10.3899/jrheum.140056
Song IH, et al. Consistently Good Clinical Response in Patients With Early Axial Spondyloarthritis After 3 Years of Continuous Treatment With Etanercept: Longterm Data of the ESTHER Trial. J Rheumatol. 2014;41(10):2034-40. PubMed PMID: 25028375.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Consistently Good clinical response in patients with early axial spondyloarthritis after 3 years of continuous treatment with etanercept: longterm data of the ESTHER trial. AU - Song,In-Ho, AU - Hermann,Kay-Geert, AU - Haibel,Hildrun, AU - Althoff,Christian E, AU - Poddubnyy,Denis, AU - Listing,Joachim, AU - Weiβ,Anja, AU - Buβ,Beate, AU - Freundlich,Bruce, AU - Lange,Ekkehard, AU - Alten,Rieke, AU - Rudwaleit,Martin, AU - Sieper,Joachim, Y1 - 2014/07/15/ PY - 2014/7/17/entrez PY - 2014/7/17/pubmed PY - 2016/5/18/medline KW - ANKYLOSING SPONDYLITIS KW - CLINICAL TRIAL KW - ETANERCEPT KW - MAGNETIC RESONANCE IMAGING KW - NONRADIOGRAPHIC AXIAL SPONDYLOARTHRITIS KW - TUMOR NECROSIS FACTOR-α SP - 2034 EP - 40 JF - The Journal of rheumatology JO - J. Rheumatol. VL - 41 IS - 10 N2 - 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. CONCLUSION: There was a consistent and sustained clinical response in patients with early axSpA treated with ETN over 3 years. ClinicalTrials.gov registration number NCT00844142. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/25028375/Consistently_Good_clinical_response_in_patients_with_early_axial_spondyloarthritis_after_3_years_of_continuous_treatment_with_etanercept:_longterm_data_of_the_ESTHER_trial_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&amp;pmid=25028375 DB - PRIME DP - Unbound Medicine ER -