medwireNews: The tumor necrosis factor (TNF) inhibitor adalimumab does not improve pain or function in people with knee osteoarthritis (OA), indicate phase 2 trial results.
Speaking at the EULAR 2022 Congress in Copenhagen, Denmark, Walter Maksymowych (University of Alberta, Edmonton, Canada) explained that TNF is a potential “target cytokine” in OA given its role in enhancing tissue remodeling and expression of proinflammatory mediators. He also noted that the cytokine increases synovial inflammation, which is “strongly associated” with knee pain and damage progression in people with knee OA.
For the OKINADA trial, 59 patients from Canada with radiographic evidence of knee OA at Kellgren–Lawrence grade 2–3, clinical signs of knee effusion, and persistent knee pain for at least 1 month were randomly assigned to receive 16 weeks of treatment with adalimumab 40 mg every 2 weeks or placebo, after which time all participants were given adalimumab.
Maksymowych reported that the proportion of patients achieving an OMERACT–OARSI response at week 16 – the study’s primary endpoint – was not significantly different in the adalimumab and placebo groups, at 30.0% and 24.1%, respectively. Similarly, the TNF inhibitor had no significant impact on pain outcomes, with a comparable proportion of patients in the adalimumab and placebo groups achieving a KOOS improvement of at least 20% (36.7 vs 24.1%) or 50% (16.7 vs 20.7%) from baseline to week 16.
These findings suggest that “TNF inhibition is not effective in ameliorating symptoms of OA of the knee in patients with clinical features of inflammation in a timeframe of 16 weeks,” said the presenter.
He reported that adalimumab had a favorable safety profile in the OKINADA study, with no serious adverse events and no new safety signals. A total of three participants withdrew from the trial due to adverse events, including two in the adalimumab group (one due to chest tightening and hot flushes; one due to pain in the knees and back) and one in the placebo arm (due to hives post-injection).
Maksymowych cautioned that the study was limited by the short-term design of the placebo-controlled period, which “does not permit an assessment of the structure-modifying effect” of adalimumab, and noted that magnetic resonance imaging findings will be analyzed separately.
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