Background/Purpose: No studies have assessed the effect of methotrexate (MTX) in osteoarthritis of the hand (HOA). The purpose of our study was to examine the effect of MTX on pain and structural progression in symptomatic erosive HOA (EHOA).

Methods: This 1-year prospective, monocentric, randomized, double-blind, placebo-controlled study (NCT1968405) followed patients with symptomatic EHOA. Patients were randomized into two groups: 10 mg MTX per week or placebo. The primary endpoint was pain assessment at 3 months, and secondary endpoints were clinical features (pain on visual analog scale (VAS)), radiographic features (Verbruggen anatomical radiographic score and Gent University Score System), and magnetic resonance imaging (MRI) at 12 months.

Results: Sixty-four EHOA patients were randomized to either the placebo or MTX group. At 3 months, there was no significant difference in the mean decrease in VAS pain score (mm) (MTX: 17.5 (28.4) vs placebo: 8.4 (25.2); p=0.2). Erosive joints progressed significantly more to a remodeling phase in the MTX group than in the placebo group (27% vs 15%) (p=0.03). Joints with joint space loss appeared to be less eroding in the MTX group than in the placebo group (8% vs 29%; p=0.2). Interleukin-6 level (p< 0.0001) and synovitis findings on MRI (p=0.02) at baseline were found to be predictive factors for erosive structural evolution of non-erosive joints. Conclusion: Our study shows that MTX did not demonstrate superior efficacy over placebo on pain and function evolution at 3 and 12 months in subjects with EHOA.. However, MTX significantly reduced the progression of joint damage compared to placebo and seems to facilitate bone remodeling. The presence of systemic and local inflammations at baseline were predictors of erosive progression.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/methotrexate-in-patients-with-hand-erosive-osteoarthritis-refractory-to-usual-treatments-a-randomized-double-blind-placebo-controlled-trial/