RESEARCH - Efficacy of MTX treatment in patients with probable RA

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Arthritis & Rheumatism

Volume 56 Issue 5, Pages 1424 - 1432

Published Online: 27 Apr 2007

Research Article

Efficacy of methotrexate treatment in patients with probable

rheumatoid arthritis: A double-blind, randomized, placebo-controlled

trial

Henrike van Dongen 1, Jill van Aken 1, Leroy R. Lard 1, Visser

1, H. Karel Ronday 2, Harry M. J. Hulsmans 2, Irene Speyer 3,

Marie-Louise Westedt 3, André J. Peeters 4, Cornelia F. Allaart 1,

René E. M. Toes 1, Ferdinand C. Breedveld 1, Tom W. J. Huizinga 1 *

1Leiden University Medical Center, Leiden, The Netherlands

2Haga Hospital, The Hague, The Netherlands

3Bronovo Hospital, The Hague, The Netherlands

4Reinier de Graaf Hospital, Delft, The Netherlands

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.

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