In-Ho Song1, Kay-Geert Hermann1, Hildrun Haibel1, Christian E Althoff1, Denis Poddubnyy1, Joachim Listing1, Anja Weiß1, Beate Buß1, Bruce Freundlich1, Ekkehard Lange1, Rieke Alten1, Martin Rudwaleit1, Joachim Sieper2. 1. 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. 2. 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.
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 BathAnkylosing 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 andsacroiliac 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.
RCT Entities:
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: Jürgen Braun; Xenofon Baraliakos; Kay-Geert Hermann; Robert Landewé; Pedro M Machado; Walter P Maksymowych; Owen Davies; Bengt Hoepken; Tommi Nurminen; Christian Stach; Désirée van der Heijde Journal: RMD Open Date: 2017-04-24
Authors: Johan K Wallman; Meliha C Kapetanovic; Ingemar F Petersson; Pierre Geborek; Lars Erik Kristensen Journal: Arthritis Res Ther Date: 2015-12-24 Impact factor: 5.156
Authors: Désirée van der Heijde; Xenofon Baraliakos; Kay-Geert A Hermann; Robert B M Landewé; Pedro M Machado; Walter P Maksymowych; Owen R Davies; Natasha de Peyrecave; Bengt Hoepken; Lars Bauer; Tommi Nurminen; Juergen Braun Journal: Ann Rheum Dis Date: 2018-01-17 Impact factor: 19.103