medwireNews: Treatment with the tumor necrosis factor (TNF) inhibitor etanercept does not reduce pain at 24 weeks, compared with placebo, in patients with erosive hand osteoarthritis (OA), preliminary trial data show.
In spite of this, there was some indication that that the drug was associated with symptomatic relief and structural effects in a proportion of patients, report Margreet Kloppenburg (Leiden University Medical Center, the Netherlands) and co-authors in the Annals of the Rheumatic Diseases.
The proof-of-concept study included 90 patients with symptomatic erosive inflammatory hand OA who were randomly assigned to receive etanercept 50 mg/week for 24 weeks followed by 25 mg/week up to 1 year (n=45), or to receive placebo for the same duration (n=45).
At 24 weeks, there was no significant difference in the mean Visual Analogue Scale (VAS) pain score between the patients who received etanercept and those who received placebo (39.2 vs 46.5). There was also no significant difference between the two groups at the end of the 1-year follow-up (35.7 vs 45.4).
Analysis of radiographs from 54 patients (23 etanercept, 31 placebo) showed significantly more radiographic remodeling in etanercept- compared with placebo-treated joints. Specifically, the change in the Ghent University Scoring System score at 1 year was 2.9 points higher with etanercept than with placebo.
Nonetheless, magnetic resonance imaging (MRI), conducted in 10 patients from each group, showed significantly fewer bone marrow lesions at 1 year with etanercept than with placebo (mean difference=0.22), which the researchers say “was more pronounced in joints with baseline inflammation.”
By contrast, there was no significant between-group difference in synovitis at 1 year, as measured by MRI.
Kloppenburg and team note that 12 patients in the etanercept group and 10 in the placebo group prematurely discontinued treatment. Fewer patients on etanercept than placebo discontinued due to inefficacy (3 vs 6), but more discontinued due to adverse effects (6 vs 1).
Among those who completed treatment and also reported pain and inflammation at baseline (n=61), the mean reduction in VAS pain score at 1 year was significantly lower with etanercept than with placebo (35.1 vs 45.2).
Adverse events occurred in 33% and 27% of patients in the etanercept and placebo groups, respectively, with infection the most commonly reported in each group (24% vs 22%).
Kloppenburg et al conclude that their findings do not “provide evidence for the use of TNF inhibitors in daily treatment of patients with hand osteoarthritis.”
Nonetheless, “[s]tudies investigating treatment strategies specifically targeting inflammation, for example, short-term anti-inflammatory treatment with glucocorticoids or TNF inhibitors during ‘flares’ of the disease, are warranted,” they add.
By Laura Cowen
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