OP0175 METHOTREXATE IN PATIENTS WITH HAND OSTEOARTHRITIS REFRACTORY TO ANALGESICS: A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL

Abstract

Background To date, no studies have been published on the effect of Methotrexate (MTX) in hand osteoarthritis (HOA). Objectives The aim of our study is to examine the effect of methotrexate on pain in symptomatic erosive HOA, as well as its functional and structural effect using MRI and radiography. Methods This prospective, single-center, randomized, double-blind, placebo-controlled study followed patients with HOA over 12 months. Patients were randomized to Methotrexate 10 mg per week or placebo. The primary endpoint was pain assessment at 3 months, and secondary endpoints were clinical (Visual Analogue Scale “VAS” pain at 12 months), and radiographic (radiographic anatomical score, then the Ghent University Score System “GUSS” and MRI). All subjects aged between 45 and 85 years, who had apparent NSAIDs and pain traitement failure with an VAS greater than 4/10, and at least one erosive joint were included. Results Out of 71 evalued patients with symptomatic erosive HOA, and 64 matched the inclusion criteria and were randomized. Among them, 32 patients were randomized in the placebo group and 32 in the Methotrexate group. There was no significant difference between the two groups on the primary endpoint at 3 months, with an average decrease in VAS in the placebo group of 8.36 mm (+/- 25.15), and 17.47 mm (+/- 28.37) in the treatment group (p = 0.1797). At 12 months, no difference was found in the evolution of pain between the two groups (p = 0.6045) as well as in the functional evolution. In subjects taking Methotrexate, erosive joints move more to a remodeling phase undergoing treatment (27%) than placebo subjects (15%) (p = 0.0278). They also seem to evolve less towards erosion when their joints present a space loss (29% become erosive under placebo, against 8% in the Methotrexate group) (p = 0.0879). No predictor of erosive outcome was found in patients with non-erosive hand osteoarthritis. Conclusion Our study does not show superior efficacy of MTX over placebo over pain and function in subjects with erosive HOA. Our results suggest a possible structural effect on the radiological evolution of HOA under Methotrexate. Disclosure of Interests None declared