In patients aged 49 to 75 years with hand osteoarthritis and synovitis, methotrexate 20 mg once weekly for 6 months had a moderate but potentially clinically meaningful effect on reducing pain, researchers report. The study provides “proof of concept that methotrexate might have a role in the management of hand osteoarthritis with an inflammatory phenotype,” the authors conclude.
At multiple sites in Australia, participants were block-randomized to methotrexate 20 mg or identical placebo orally once weekly for 6 months. Based on a primary outcome of pain reduction as measured on a 100-mm visual analogue scale (VAS), the investigators found: “Between Nov 22, 2017, and Nov 8, 2021, of 202 participants who were assessed for eligibility, 97 (48%) were randomly assigned to receive methotrexate (n = 50) or placebo (n = 47). 68 (70%) of 97 participants were female and 29 (30%) were male. 42 (84%) of 50 participants in the methotrexate group and 40 (85%) of 47 in the placebo group provided primary outcome data. The mean change in VAS pain at 6 months was –15.2 mm (SD 24.0) in the methotrexate group and –7.7 mm (25.3) in the placebo group, with a mean between-group difference of –9.9 (95% CI –19.3 to –0.6; P = 0.037) and an effect size (standardised mean difference) of 0.45 (0.03 to 0.87). Adverse events occurred in 31 (62%) of 50 participants in the methotrexate group and 28 (60%) of 47 participants in the placebo group.”