Objectives To assess the efficacy comparing methotrexate and leflunomide by hand magnetic resonance imaging (h-MRI) in early RA patients.
Methods A prospective cohort of patients with early RA (duration of symptoms <1 year), naïve to DMARD or biologic therapy, were randomly assigned to receive either methotrexate (MTX) and leflunomide (LF) treatment (1:1 ratio). Forty-one patients assigned to the MTX group received an initial dose of 12.5 mg/week that was increased to 20-25 mg if persistent clinical activity and 37 patients were randomized to receive leflunomide 20 mg/day. Low-dose of glucocorticoids and NSAID was allowed and doses were stable during the study period. 1.5T MRI of the dominant hand, clinical assessment, disability (HAQ) and laboratory analyses were obtained before starting treatment and 16 weeks after. MR images were read blind for clinical results and treatment group, without knowing chronological order by 2 experienced readers (MPL, AS) following RAMRIS recommendations. Tenosynovitis was also scored. Data evaluation and statistical analysis were performed using SPSS v.15.
Results A total of 78 RA patients were included, of these 62 pacients had paired h-MRI (33 with MTX and 29 with LF). Sixteen patients withdrew treatment (6 patients moved residence, 6 declined to participate, 3 loss of compliance of treatment and 1 case of pregnancy desire). No patients showed inefficacy or adverse events. Baseline characteristics including MRI parameters were similar (no significantly different) between the 2 treatment groups. Significant improvement in all activity measures, HAQ and RAMRIS synovitis were observed in the LF- and MTX-treated patients after 16 weeks of therapy. MTX group showed significant reduction of tenosynovitis score. No statistically significant differences between 2 treatments were observed, except that the SDAI reduction was greater in the MTX group (table 1).
Conclusions Methotrexate and leflunomide showed comparable clinical efficacy and reduction on MRI synovitis at week 16 without significant differences between the both active treatments.
Disclosure of Interest None Declared
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