Methotrexate disappoints in hand osteoarthritis trial
medwireNews: Methotrexate does not improve pain or physical function among people with symptomatic erosive hand osteoarthritis (OA), indicate results from the placebo-controlled ADEM trial.
Presenting the findings at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, Christian Roux (Université Cote d’Azur, Nice, France) said that there was no significant difference in pain reduction over 3 months among the 32 hand OA patients with an inadequate response to prior treatment who were randomly assigned to receive methotrexate 10 mg/week compared with the 32 given placebo.
Specifically, average VAS pain score decreased from 65.7 mm at baseline to 48.2 mm at month 3 for patients given methotrexate, and from 63.9 to 55.5 mm for those treated with placebo.
These findings were consistent at the 12-month follow up, with comparable mean VAS pain scores of 47.5 and 48.2 mm in the methotrexate and placebo groups, respectively.
Moreover, there was no significant difference between the two groups in a number of secondary outcomes, including physical function as measured by the Dreiser score, and ability to perform daily activities as measured by the Cochin scale.
Discussing the possible reasons why methotrexate did not impact pain or physical function in the ADEM trial, Roux speculated that the chosen dose may have been too low, and he said in a press release that “[i]t is possible that we have to treat earlier if we want to have an effect on pain.”
Nonetheless, he reported that methotrexate reduced joint damage progression relative to placebo. For example, a significantly higher proportion of erosive joints progressed to a remodeling phase among patients treated with methotrexate versus placebo (27.2 vs 15.2%). The researchers also demonstrated that interleukin-6 levels and the presence of synovitis and at study baseline were significant predictors of erosive disease.
Roux said that methotrexate had a favorable safety profile in the ADEM trial, with similar rates of adverse events in the two groups.
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