RESEARCH - Lack of benefit over two years of low dose prednisolone for RA

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ls of the Rheumatic Diseases 2004;63:797-803

EXTENDED REPORT

Lack of radiological and clinical benefit over two years of low dose

prednisolone for rheumatoid arthritis: results of a randomised

controlled trial

H A Capell1, R Madhok1, J A Hunter3, D Porter3, E on4, J Larkin5,

E A Thomson3, R Hampson1 and F W Poon2 on behalf of the WOSERACT Group*

Background: Evidence for disease modifying activity of low dose

corticosteroid treatment in rheumatoid arthritis is contradictory.

Studies showing radiological benefit suggest that continued treatment is

required to sustain the effect.

Objective: To evaluate the effect of low dose oral prednisolone in early

rheumatoid arthritis on disease activity over two years.

Design: Double blind placebo controlled trial.

Methods: Patients with rheumatoid arthritis, duration <3 years (n =

167), were started on a disease modifying antirheumatic drug (DMARD;

sulphasalazine) and allocated by stratified randomisation to

prednisolone 7 mg/day or placebo. Primary outcome measure was

radiological damage, assessed by the modified Sharp method. Clinical

benefit was a secondary outcome. A proactive approach to identifying and

treating corticosteroid adverse events was adopted. Patients who

discontinued sulphasalazine were offered an alternative DMARD.

Results: 90 of 257 patients eligible for the study refused to

participate (more women than men). Of those enrolled, 84% were

seropositive for rheumatoid factor, median age 56 years, median disease

duration 12 months, female to male ratio 1.8:1. Prednisolone was given

to 84 patients; of these 73% continued prednisolone and 70%

sulphasalazine at 2 years. Of the 83 patients on placebo, 80% continued

placebo and 64% sulphasalazine at 2 years. There were no significant

differences in radiological score or clinical and laboratory measures at

0 and 2 years.

Conclusions: Low dose prednisolone conferred no radiological or clinical

benefit on patients maintained on a DMARD over two years. Low dose

corticosteroids have no role in the routine management of rheumatoid

arthritis treated with conventional disease modifying drugs.

http://ard.bmjjournals.com/cgi/content/abstract/63/7/797

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Mayo Clinic in Rochester

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s Hopkins Medicine

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