Etanercept linked with pain relief in prespecified per-protocol analysis of symptomatic hand OA
LAS VEGAS — Although investigators found non-superiority of etanercept compared with placebo overall in their study, they noted an analysis of patients with symptomatic and inflammatory hand osteoarthritis treated with etanercept had superior pain scores.
“In the total study population, etanercept was not superior over placebo on VAS pain at 24 weeks. That was our primary outcome. However, in our prespecified per-protocol analysis where we looked into those patients who had really symptomatic and inflammatory disease and completed the study, etanercept was superior over placebo both for pain and for erosive [evolution],” Margreet Kloppenburg, PhD, said during her presented at the Osteoarthritis Research Society International World Congress. She added, “It turns out that etanercept especially had an effect in those joints that had inflammation at baseline.”
Kloppenburg and colleagues randomly assigned 91 patients with primary hand osteoarthritis to receive either 50 mg of etanercept per week for 24 weeks and then 25 mg per week or to a placebo group. Primary outcome measure was VAS pain after 24 weeks. Researchers also evaluated erosive evolution with the Ghent University Scoring System.
Results showed improvement after 24 weeks in both the etanercept and placebo groups, with patients in the etanercept group experiencing slightly better improvement. However, according to Kloppenburg, this was not statistically significant.
“After 1 year, you see the same effect, although the mean difference between the etanercept and the placebo group was a little larger, 8.5 mm, which was still not statistically significant,” she said.
Kloppenburg noted 61 patients were included in a per-protocol analysis, which showed a mean difference in pain in favor of the etanercept group. Of the 54 radiographs available, results showed a patients in the etanercept group had statistically significant more remodeling.
“We did some additional analysis and we saw that there was a statistical interaction between treatment and baseline state of inflammation in the joint,” Kloppenburg said. – by Casey Tingle
Kloppenburg M, et al. Paper #1. Presented at: Osteoarthritis Research Society International World Congress; April 27-30, 2017; Las Vegas.
Disclosure: This study was supported by Pfizer.