Etanercept in patients with inflammatory hand osteoarthritis (EHOA): a multicentre, randomised, double-blind, placebo-controlled trial. Issue 12 (3rd October 2018)

• Record Type: Journal Article
• Authors: Kloppenburg, Margreet; Ramonda, Roberta; Bobacz, Klaus; Kwok, Wing-Yee; Elewaut, Dirk; Huizinga, Tom W J; Kroon, Féline P B; Punzi, Leonardo; Smolen, Josef S; Vander Cruyssen, Bert; Wolterbeek, Ron; Verbruggen, Gust; Wittoek, Ruth
• Is Part Of: Annals of the rheumatic diseases. Volume 77:Issue 12(2018)
• Page Start: 1757
• Page End: 1764
• Publication Date: 2018-10-03
• Subjects: hand osteoarthritis -- TNF-alpha -- treatment -- inflammation; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2018-213202
• Languages: English
• ISSNs: 0003-4967

Abstract

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: This 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: Of 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.