Efficacy of methotrexate treatment in patients with probable rheumatoid arthritis: A double‐blind, randomized, placebo‐controlled trial

Abstract

Objective. To determine whether patients with undifferentiated arthritis (UA; inflammatory, nontraumatic arthritis that cannot be diagnosed using current classification criteria) benefit from treatment with methotrexate (MTX).Methods. The PRObable rheumatoid arthritis: Methotrexate versus Placebo Treatment (PROMPT) study was a double-blind, placebo-controlled, randomized, multicenter trial involving 110 patients with UA who fulfilled the American College of Rheumatology (ACR) 1958 criteria for probable RA. Treatment started with MTX (15 mg/week) or placebo tablets, and every 3 months the dosage was increased if the Disease Activity Score was >2.4. After 12 months, the study medication was tapered and discontinued. Patients were followed up for 30 months. When a patient fulfilled the ACR criteria for RA (primary end point), the study medication was changed to MTX. Joint damage was scored on radiographs of the hands and feet.Results. In 22 of the 55 patients (40%) in the MTX group, UA progressed to RA compared with 29 of 55 patients (53%) in the placebo group. However, in the MTX group, patients fulfilled the ACR criteria for RA at a later time point than in the placebo group (P ‫؍‬ 0.04), and fewer patients showed radiographic progression over 18 months (P ‫؍‬ 0.046).Conclusion. This study provides evidence for the efficacy of MTX treatment in postponing the diagnosis of RA, as defined by the ACR 1987 criteria, and retarding radiographic joint damage in UA patients.

2010 Rheumatoid arthritis classification criteria: An American College of Rheumatology/European League Against Rheumatism collaborative initiative

“…Moreover, it has been recognized that early therapeutic intervention improves clinical outcomes and reduces the accrual of joint damage and disability (21)(22)(23). Undoubtedly, treating patients at a stage at which evolution of joint destruction can still be prevented would be ideal.…”

Evidence for interaction between 5-hydroxytryptamine (serotonin) receptor 2A and MHC type II molecules in the development of rheumatoid arthritis

“…Several facts show that both genetic and environmental risk factors for ACPA-positive and ACPA-negative RA are different, 17,19 as well as the clinical course, histology and response to therapy. 20,21 The aim of this study was to use three different relatively large case-control studies to investigate the potential interactions between HTR2A and HLA-DRB1 SE alleles in proving risk for RA, and to estimate where biological interaction may take place.…”

Condicionantes demográficos y clínicos para la elección inicial de la vía de administración de metotrexato y motivos para un posterior cambio de vía (Estudio MOTICAR)

“…Otros estudios recientes también indican que el cambio de metotrexato oral a subcutáneo comporta beneficios farmacoeconómicos de coste-efectividad, ya que la administración de metotrexato subcutáneo se asocia a un retraso en la instauración de tratamiento con agentes biológicos [27,[29][30][31]. En nuestro país, un estudio farmacoeconómico comparativo entre metotrexato subcutáneo (Metoject®) y metotrexato oral, ha mostrado que los costes adicionales de Metoject® respecto a los del metotrexato oral se ven compensados por su mejora en la efectividad, expresada en términos de años de vida Tabla 5.…”