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Effects of long-term etanercept treatment on clinical outcomes and objective signs of inflammation in early nonradiographic axial spondyloarthritis : 104-week results from a randomized, placebo-controlled study

(2017) ARTHRITIS CARE & RESEARCH. 69(10). p.1590-1598
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Abstract
Objective. To evaluate the long-term clinical and imaging efficacy of etanercept in patients with early, active nonradiographic axial spondyloarthritis (SpA). Methods. Adult patients who satisfied the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA (but not the modified New York radiographic criteria), with symptom duration >3 months to <5 years, and who were unresponsive to >= 2 nonsteroidal antirheumatic drugs (NSAIDs) received double-blind etanercept 50 mg/week or placebo for 12 weeks, followed by open-label etanercept 50 mg/week to week 104. Clinical, magnetic resonance imaging (MRI; Spondyloarthritis Research Consortium of Canada [SPARCC] scores), and safety outcomes at 104 weeks were analyzed. Results. Of 215 randomized patients (etanercept: n=106; placebo: n=109), 205 entered the study (etanercept/etanercept: n=100; placebo/etanercept: n=105) and 169 completed the open-label period (etanercept/etanercept: n=83; placebo/etanercept: n=86). At week 104, 61 of 81 (75%), 49 of 81 (61%), 48 of 80 (60%), and 57 of 81 (70%) patients who received etanercept throughout the trial achieved ASAS20, ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease, and Bath Ankylosing Spondylitis Disease Activity Index criteria for 50% improvement (BASDAI 50) scores, respectively (observed). From baseline to week 104, continued improvements in clinical outcomes (ASDAS-C-reactive protein: -1.5 and -1.7; BASDAI: -3.3 and -3.8 [last observation carried forward]), and SPARCC MRI scores (sacroiliac joint: -6.0 and -3.4; spinal: -2.1 and -0.8 [observed]) were seen in patients receiving etanercept/etanercept and placebo/etanercept. During the study, 8% in the etanercept/etanercept group and 7% in the placebo/etanercept group had serious adverse events; no new safety signals were seen. Conclusion. Patients with early, active nonradiographic axial SpA and an inadequate response to at least 2 NSAIDs demonstrated improvement in clinical and imaging outcomes that were sustained through 104 weeks of etanercept treatment.
Keywords
ANKYLOSING-SPONDYLITIS, 2010 UPDATE, EFFICACY, RECOMMENDATIONS, SAFETY, TRIAL, CRITERIA

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MLA
Dougados, Maxime et al. “Effects of Long-term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis : 104-week Results from a Randomized, Placebo-controlled Study.” ARTHRITIS CARE & RESEARCH 69.10 (2017): 1590–1598. Print.
APA
Dougados, M., van der Heijde, D., Sieper, J., Braun, J., Citera, G., Lenaerts, J., Van den Bosch, F., et al. (2017). Effects of long-term etanercept treatment on clinical outcomes and objective signs of inflammation in early nonradiographic axial spondyloarthritis : 104-week results from a randomized, placebo-controlled study. ARTHRITIS CARE & RESEARCH, 69(10), 1590–1598.
Chicago author-date
Dougados, Maxime, Désirée van der Heijde, Joachim Sieper, Jürgen Braun, Gustavo Citera, Jan Lenaerts, Filip Van den Bosch, et al. 2017. “Effects of Long-term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis : 104-week Results from a Randomized, Placebo-controlled Study.” Arthritis Care & Research 69 (10): 1590–1598.
Chicago author-date (all authors)
Dougados, Maxime, Désirée van der Heijde, Joachim Sieper, Jürgen Braun, Gustavo Citera, Jan Lenaerts, Filip Van den Bosch, James Cheng-Chung Wei, Ron Pedersen, Randi Bonin, Heather Jones, Lisa Marshall, Isabelle Logeart, Bonnie Vlahos, Jack F Bukowski, and Walter P Maksymowych. 2017. “Effects of Long-term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis : 104-week Results from a Randomized, Placebo-controlled Study.” Arthritis Care & Research 69 (10): 1590–1598.
Vancouver
1.
Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Lenaerts J, et al. Effects of long-term etanercept treatment on clinical outcomes and objective signs of inflammation in early nonradiographic axial spondyloarthritis : 104-week results from a randomized, placebo-controlled study. ARTHRITIS CARE & RESEARCH. 2017;69(10):1590–8.
IEEE
[1]
M. Dougados et al., “Effects of long-term etanercept treatment on clinical outcomes and objective signs of inflammation in early nonradiographic axial spondyloarthritis : 104-week results from a randomized, placebo-controlled study,” ARTHRITIS CARE & RESEARCH, vol. 69, no. 10, pp. 1590–1598, 2017.
@article{8538355,
  abstract     = {Objective. To evaluate the long-term clinical and imaging efficacy of etanercept in patients with early, active nonradiographic axial spondyloarthritis (SpA). 
Methods. Adult patients who satisfied the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA (but not the modified New York radiographic criteria), with symptom duration >3 months to <5 years, and who were unresponsive to >= 2 nonsteroidal antirheumatic drugs (NSAIDs) received double-blind etanercept 50 mg/week or placebo for 12 weeks, followed by open-label etanercept 50 mg/week to week 104. Clinical, magnetic resonance imaging (MRI; Spondyloarthritis Research Consortium of Canada [SPARCC] scores), and safety outcomes at 104 weeks were analyzed. 
Results. Of 215 randomized patients (etanercept: n=106; placebo: n=109), 205 entered the study (etanercept/etanercept: n=100; placebo/etanercept: n=105) and 169 completed the open-label period (etanercept/etanercept: n=83; placebo/etanercept: n=86). At week 104, 61 of 81 (75%), 49 of 81 (61%), 48 of 80 (60%), and 57 of 81 (70%) patients who received etanercept throughout the trial achieved ASAS20, ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease, and Bath Ankylosing Spondylitis Disease Activity Index criteria for 50% improvement (BASDAI 50) scores, respectively (observed). From baseline to week 104, continued improvements in clinical outcomes (ASDAS-C-reactive protein: -1.5 and -1.7; BASDAI: -3.3 and -3.8 [last observation carried forward]), and SPARCC MRI scores (sacroiliac joint: -6.0 and -3.4; spinal: -2.1 and -0.8 [observed]) were seen in patients receiving etanercept/etanercept and placebo/etanercept. During the study, 8% in the etanercept/etanercept group and 7% in the placebo/etanercept group had serious adverse events; no new safety signals were seen. 
Conclusion. Patients with early, active nonradiographic axial SpA and an inadequate response to at least 2 NSAIDs demonstrated improvement in clinical and imaging outcomes that were sustained through 104 weeks of etanercept treatment.},
  author       = {Dougados, Maxime and van der Heijde, Désirée and Sieper, Joachim and Braun, Jürgen and Citera, Gustavo and Lenaerts, Jan and Van den Bosch, Filip and Wei, James Cheng-Chung and Pedersen, Ron and Bonin, Randi and Jones, Heather and Marshall, Lisa and Logeart, Isabelle and Vlahos, Bonnie and Bukowski, Jack F and Maksymowych, Walter P},
  issn         = {2151-464X},
  journal      = {ARTHRITIS CARE & RESEARCH},
  keywords     = {ANKYLOSING-SPONDYLITIS,2010 UPDATE,EFFICACY,RECOMMENDATIONS,SAFETY,TRIAL,CRITERIA},
  language     = {eng},
  number       = {10},
  pages        = {1590--1598},
  title        = {Effects of long-term etanercept treatment on clinical outcomes and objective signs of inflammation in early nonradiographic axial spondyloarthritis : 104-week results from a randomized, placebo-controlled study},
  url          = {http://dx.doi.org/10.1002/acr.23276},
  volume       = {69},
  year         = {2017},
}

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