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Etanercept in patients with inflammatory hand osteoarthritis (EHOA): a multicentre, randomised, double-blind, placebo-controlled trial

(2018) ANNALS OF THE RHEUMATIC DISEASES. 77(12). p.1757-1764
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Abstract
Objective Hand osteoarthritis is a prevalent disease with limited treatment options. Since joint inflammation is often present, we investigated tumour necrosis factor (TNF) as treatment target in patients with proven joint inflammation in a proof-of-concept study. Methods T his 1-year, double-blind, randomised, multicentre trial (NTR1192) enrolled patients with symptomatic erosive inflammatory hand osteoarthritis. Patients flaring after non-steroidal anti-inflammatory drug washout were randomised to etanercept (24 weeks 50 mg/week, thereafter 25 mg/week) or placebo. The primary outcome was Visual Analogue Scale (VAS) pain at 24 weeks. Secondary outcomes included clinical and imaging outcomes (radiographs scored using Ghent University Scoring System (GUSS, n=54) and MRIs (n=20)). Results O f 90 patients randomised to etanercept (n=45) or placebo (n=45), respectively, 12 and 10 discontinued prematurely. More patients on placebo discontinued due to inefficacy (6 vs 3), but fewer due to adverse effects (1 vs 6). The mean between-group difference (MD) in VAS pain was not statistically significantly different (-5.7 (95% CI -15.9 to 4.5), p=0.27 at 24 weeks; -8.5 (95% CI -18.6 to 1.6), p=0.10 at 1 year; favouring etanercept). In prespecified per-protocol analyses of completers with pain and inflammation at baseline (n=61), MD was -11.8 (95% CI -23.0 to -0.5) (p=0.04) at 1 year. Etanercept-treated joints showed more radiographic remodelling (delta GUSS: MD 2.9 (95% CI 0.5 to 5.4), p=0.02) and less MRI bone marrow lesions (MD -0.22 (95% CI -0.35 to -0.09), p =0.001); this was more pronounced in joints with baseline inflammation. Conclusion Anti-TNF did not relieve pain effectively after 24 weeks in erosive osteoarthritis. Small subgroup analyses showed a signal for effects on subchondral bone in actively inflamed joints, but future studies to confirm this are warranted.
Keywords
INTERPHALANGEAL FINGER JOINTS, BONE-MARROW LESIONS, KNEE PAIN, EROSIVE, OSTEOARTHRITIS, SCORING SYSTEM, DISEASE, RECOMMENDATIONS, INHIBITION, SYNOVITIS, EFFICACY

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Chicago
Kloppenburg, Margreet, Roberta Ramonda, Klaus Bobacz, Wing-Yee Kwok, Dirk Elewaut, Tom W. J. Huizinga, Feline P. B. Kroon, et al. 2018. “Etanercept in Patients with Inflammatory Hand Osteoarthritis (EHOA): a Multicentre, Randomised, Double-blind, Placebo-controlled Trial.” Annals of the Rheumatic Diseases 77 (12): 1757–1764.
APA
Kloppenburg, M., Ramonda, R., Bobacz, K., Kwok, W.-Y., Elewaut, D., Huizinga, T. W. J., Kroon, F. P. B., et al. (2018). Etanercept in patients with inflammatory hand osteoarthritis (EHOA): a multicentre, randomised, double-blind, placebo-controlled trial. ANNALS OF THE RHEUMATIC DISEASES, 77(12), 1757–1764.
Vancouver
1.
Kloppenburg M, Ramonda R, Bobacz K, Kwok W-Y, Elewaut D, Huizinga TWJ, et al. Etanercept in patients with inflammatory hand osteoarthritis (EHOA): a multicentre, randomised, double-blind, placebo-controlled trial. ANNALS OF THE RHEUMATIC DISEASES. London: Bmj Publishing Group; 2018;77(12):1757–64.
MLA
Kloppenburg, Margreet et al. “Etanercept in Patients with Inflammatory Hand Osteoarthritis (EHOA): a Multicentre, Randomised, Double-blind, Placebo-controlled Trial.” ANNALS OF THE RHEUMATIC DISEASES 77.12 (2018): 1757–1764. Print.
@article{8600952,
  abstract     = {Objective Hand osteoarthritis is a prevalent disease with limited treatment options. Since joint inflammation is often present, we investigated tumour necrosis factor (TNF) as treatment target in patients with proven joint inflammation in a proof-of-concept study. Methods T his 1-year, double-blind, randomised, multicentre trial (NTR1192) enrolled patients with symptomatic erosive inflammatory hand osteoarthritis. Patients flaring after non-steroidal anti-inflammatory drug washout were randomised to etanercept (24 weeks 50 mg/week, thereafter 25 mg/week) or placebo. The primary outcome was Visual Analogue Scale (VAS) pain at 24 weeks. Secondary outcomes included clinical and imaging outcomes (radiographs scored using Ghent University Scoring System (GUSS, n=54) and MRIs (n=20)). Results O f 90 patients randomised to etanercept (n=45) or placebo (n=45), respectively, 12 and 10 discontinued prematurely. More patients on placebo discontinued due to inefficacy (6 vs 3), but fewer due to adverse effects (1 vs 6). The mean between-group difference (MD) in VAS pain was not statistically significantly different (-5.7 (95\% CI -15.9 to 4.5), p=0.27 at 24 weeks; -8.5 (95\% CI -18.6 to 1.6), p=0.10 at 1 year; favouring etanercept). In prespecified per-protocol analyses of completers with pain and inflammation at baseline (n=61), MD was -11.8 (95\% CI -23.0 to -0.5) (p=0.04) at 1 year. Etanercept-treated joints showed more radiographic remodelling (delta GUSS: MD 2.9 (95\% CI 0.5 to 5.4), p=0.02) and less MRI bone marrow lesions (MD -0.22 (95\% CI -0.35 to -0.09), p =0.001); this was more pronounced in joints with baseline inflammation. Conclusion Anti-TNF did not relieve pain effectively after 24 weeks in erosive osteoarthritis. Small subgroup analyses showed a signal for effects on subchondral bone in actively inflamed joints, but future studies to confirm this are warranted.},
  author       = {Kloppenburg, Margreet and Ramonda, Roberta and Bobacz, Klaus and Kwok, Wing-Yee and Elewaut, Dirk and Huizinga, Tom W. J. and Kroon, Feline P. B. and Punzi, Leonardo and Smolen, Josef S. and Vander Cruyssen, Bert and Wolterbeek, Ron and Verbruggen, Gust and Wittoek, Ruth},
  issn         = {0003-4967},
  journal      = {ANNALS OF THE RHEUMATIC DISEASES},
  language     = {eng},
  number       = {12},
  pages        = {1757--1764},
  publisher    = {Bmj Publishing Group},
  title        = {Etanercept in patients with inflammatory hand osteoarthritis (EHOA): a multicentre, randomised, double-blind, placebo-controlled trial},
  url          = {http://dx.doi.org/10.1136/annrheumdis-2018-213202},
  volume       = {77},
  year         = {2018},
}

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