Patients with hand osteoarthritis with an inflammatory phenotype may benefit from methotrexate treatment, a study shows. During 6 months of therapy with methotrexate 20 mg, clinically meaningful reductions in pain provided evidence of efficacy.
Community-dwelling participants aged 40 to 75 years in Australia had hand osteoarthritis (Kellgren and Lawrence grade ≥2 in at least 1 joint) and MRI-detected synovitis of grade 1 or more. During the multisite, parallel-group, double-blind trial, patients were block randomized to methotrexate 20 mg or identical placebo orally once weekly for 6 months.
The primary outcome of pain reduction (measured with a 100-mm visual analog scale, VAS) in the study hand at 6 months showed these results: “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.”