Lack of radiological and clinical benefit over two years of low dose prednisolone for RA

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Ann Rheum Dis. 2004 Jul;63(7):797-803.Lack of radiological and clinical benefit over two years of low doseprednisolone for rheumatoid arthritis: results of a randomised controlledtrial.Capell HA, Madhok R, Hunter JA, Porter D, on E, Larkin J, Thomson EA,Hampson R, Poon FW.Centre for Rheumatic Diseases, Glasgow Royal Infirmary, North GlasgowUniversity NHS Trust, Castle St, Glasgow G40SF, UK..Capell@...BACKGROUND: Evidence for disease modifying activity of low dosecorticosteroid treatment in rheumatoid arthritis is contradictory. Studiesshowing radiological benefit suggest that continued treatment is required tosustain the effect. OBJECTIVE: To evaluate the effect of low dose oralprednisolone in early rheumatoid arthritis on disease activity over twoyears. DESIGN: Double blind placebo controlled trial. METHODS: Patients withrheumatoid arthritis, duration <3 years (n = 167), were started on a diseasemodifying antirheumatic drug (DMARD; sulphasalazine) and allocated bystratified randomisation to prednisolone 7 mg/day or placebo. Primaryoutcome measure was radiological damage, assessed by the modified Sharpmethod. Clinical benefit was a secondary outcome. A proactive approach toidentifying and treating corticosteroid adverse events was adopted. Patientswho discontinued sulphasalazine were offered an alternative DMARD. RESULTS:90 of 257 patients eligible for the study refused to participate (more womenthan men). Of those enrolled, 84% were seropositive for rheumatoid factor,median age 56 years, median disease duration 12 months, female to male ratio1.8:1. Prednisolone was given to 84 patients; of these 73% continuedprednisolone and 70% sulphasalazine at 2 years. Of the 83 patients onplacebo, 80% continued placebo and 64% sulphasalazine at 2 years. There wereno significant differences in radiological score or clinical and laboratorymeasures at 0 and 2 years.CONCLUSIONS: Low dose prednisolone conferred no radiological or clinicalbenefit on patients maintained on a DMARD over two years. Low dosecorticosteroids have no role in the routine management of rheumatoidarthritis treated with conventional disease modifying drugs.PMID: 15194574http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstract & list_uids=15194574 & itool=iconabstr